1



### BID II: Response to Comments

Risk and Technology Review for Wood Furniture Manufacturing and Shipbuilding and Ship Repair (Surface Coating) Operations

Comment No. Commenter Affiliation

37 J. Frye

38 John Gahm Kitchen Kompact

39 Bob Terhune Masco Cabi netry

40 Sheila Holman North Carolina Department of Environment and Natural Resources (NC DENR)

41 Melvin Keener Coalition for Responsible Waste Incineration

42 Vinson Hellwig and Robert Colby National Association of Clean Air Agencies (NACAA)

43 Bill Perdue American Home Furnishings Association

44 Traylor Champion Georgia

- Pacific

45 Emma Cheuse and Jim Pew Earthjustice

46 Shannon Broome Air Permitting Forum

48 Anthony Wagner American Chemical Council

– Glycol Ethers Panel

49 David Darling American Coatings Association (ACA)

50 Dick Titus Kitchen Cabinets Manufacturers Association

51 Laura Brust American Chemical Council

– Formaldehyde Panel

52 Mathew Todd The Residual Risk Coalition

53 Thomas Hoerman AkzoNobel Coatings

54 Wayne S. Holt Environ mental Technologies Panel

- National Shipbuilding Research Program

55 Harvey Clewell and

Mel Andersen The Hamner Institutes for Health Sciences on behalf of American Chemistry Council2

I. GENER

AL COMMENTS PERTAINI NG TO BOTH WOOD FURN ITURE
COATINGS AND SHIP BU ILDING AND REPAIR CO ATINGS

................................ ......... 3

A. RISK ASSESSMENT

................................ ................................ ................................ .. 3

B. SSM PROVI SIONS

................................ ................................ ................................ ... 31

C. ENVIRONMENTAL JUSTIC E

................................ ................................ ............... 50

II. WOOD FURNITURE

................................ ................................ ................................ .. 52

A. RI SK ASSESSMENT

................................ ................................ ................................ 52

B. FORMALDEHYDE LIMIT

................................ ................................ ..................... 66

C. GLYCOL ETHERS

................................ ................................ ................................ .. 71

D. SPRAY GUNS

................................ ................................ ................................ ............ 73

E. SSM PROVISIONS

................................ ................................ ................................ ... 78

F. RULE TEXT CORRECTION S

................................ ................................ ................ 79

III. SHIPBUILDING

................................ ................................ ................................ ............ 81

A. RISK ASSESSMENT

................................ ................................ ................................ . 81

B. WELDING AND ABRASIVE BLASTING

................................ ............................. 84

C. ENVIRONMENTAL JUSTIC E

................................ ................................ ............... 953

I. GENERAL COMMENTS PER TAINING TO BOTH WOOD FURNITURE
COATINGS AND SHIP BU ILDING AND REPAIR CO ATINGS
A. RISK ASSESSMENT

1. Comment : A few commenters (40, 42, and 45) agreed with EPA's use of California Reference Exposure Levels (RELs) and conducting refined analyses for acute exposures regarding risk results above threshold levels.

However, the three commenters disagreed with the use of emergency exposure limits like Acute Exposure Guideli ne Levels (AEGLs) or Emergency Response Planning Guidelines (ERPGs).
The commenter asserted that the use of AEGLs and ERPGs are not appropriate because the target population is not the general public, but emergency response personnel.

Commenter 42 noted a December 2002 EPA document, A Review of the Reference Dose and Reference Concentration Processes : EPA stated that the primary purpose of the AEGL program is to develop guidelines
for once

- in

- a

- lifetime short

- term exposures to airborne concentrations of acu tely toxic chemicals. They are not meant to evaluate the acute impacts from routine emissions that occur over the life of a facility. Unlike the reference concentrations (RfCs) for chronic exposures, the AEGLs and ERPGs do not include adequate safety and

u ncertainty factors and cannot be relied upon to protect the public from the adverse effects of exposure to toxic air pollutants.

Commenter 45 cited a review by the Science Advisory Board (SAB):
SAB review of EPA‘s draft entitled, ―Risk and Technology Revie w (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,‖ EPASAB

- 10

- 007 at 6 (May 07, 2010)) (―SAB May 2010‖) The
AEGL and ERPG numbers wo uld be expected to underestimate risk over a longer time period. This is because exposure levels that may not cause acute effects after a short exposure can cause effects over longer time periods. Using values derived for use for acute exposures to represe nt chronic exposures is scientifically incorrect. Doing so is likely to discount or cloak the level of risk to the maximum exposed individual. These values are therefore not appropriate for use in the section 112(f)(2) residual risk analysis. They simply d o not provide sufficient protection for health.

Several commenters stated that AEGL, ERPG, and Immediately Dangerous to Life and Health ( IDLH ) values should not be used in assessing the risk from acute exposures to ethylene oxide because these values were developed for accidental release planning and are not appropriate for assessing daily human exposure scenarios. One commenter stated that EPA‘s acute assessment discounted the use of the National Institute of Occupational Safety and Health (NIOSH) 10

- minut e ceiling value of 5 parts per million (ppm) (9 mg/m 3 ), and noted that EPA‘s maximum acute exposure estimate for this source category (23 mg/m 3 ) exceeds the NIOSH value. Two of the commenters stated that EPA‘s new acute reference
concentration value for et hylene oxide should be used when it becomes available.4

Response : EPA uses AEGL and ERPG values (when available) in conjunction with REL values (again, when available) to fully characterize potential acute risks.
W e also examine a wider range of available acute health metrics which may include IDLH
values to reduce data gaps and inconsistencies in acute reference values. Then, when interpreting the results, we are careful to note the definition of the benchmark being used and the health implications assoc iated with any specific benchmark being exceeded. Historically, comparisons of the estimated maximum off

- site one

- hour exposure levels have not been typically made to OSHA occupational levels for the purpose of characterizing public health risks
in RTR as sessments. This is because occupational ceiling values are not generally considered protective for the general public because they are designed to protect the worker population (presumed healthy, working age adults) for short duration (<15 minute) increas es in exposure. As a result, for most chemicals, the 15

- minute occupational ceiling values are set at levels higher
than a one

- hour AEGL

- 1, making comparisons to them irrelevant unless the AEGL

- 1 or ERPG

- 1
levels are exceeded. Such is not the case when c omparing the available inhalation NIOSH acute occupational guideline ceiling value for formaldehyde. The worst

- case maximum estimated 1

- hour exposure to formaldehyde exceeds the 15

- minute (NIOSH REL

- ceiling value of 0.12 mg/m 3 ;) by a factor of 3. In any event, we have concluded that th ese source categor ies do

not present acute health risks that warrant further regulation based upon the worst

case nature of the screening approach used.

2. Comment: Two commenters (42 and 45) were concerned that EPA used lon g

- term concentrations affecting the most highly

- exposed census block for each facility. According to commenter 42, this analysis ―dilutes the effect of sources‘ emissions by estimating the impact at
the centroid of the census block instead of at the facili ty fence or the property line.‖

According to commenter 45, the center of a census block is almost always further away from the facility than the fenceline. The commenter noted that census blocks vary greatly in size but EPA provided no evidence of reviewi ng census block sizes or configurations to consider how pollutant concentrations might vary within these blocks. The commenter was concerned that the

area

- weighted centers of census blocks may be significantly underestimating exposure in some
cases. The co mmenter recommended moving receptor points closer to the facility to assess chronic exposure in those instances where local residents live nearer to a facility than the geographic centroid of the census block.

Commenter 42 continued by stating that over ti me homes and businesses could locate closer to any facility. The commenter doubted that population distribution is homogenous over a census block resulting in inaccuracy in the predicted impacts.

Response : As we have noted in the development of previous R TRs, such as the SOCMI
HON RTR (71 FR 76603, December 21, 2006) , EPA contends that, in a national

- scale assessment of lifetime inhalation exposures and health risks from facilities in a source category, it is appropriate to identify exposure locations wher e it may be reasonably expected that an individual will spend a majority of his or her lifetime. Further, EPA asserts that it is appropriate to use census block information on where people actually reside, rather than points on a fence

line, to locate the estimation of exposures and risks to individuals living near such facilities.5

Census blocks are the finest resolution available as part of the nationwide population data (as developed by the US Census Bureau); each is typically comprised of approximately 4 0 people or about 10 households. In EPA risk assessments, the geographic centroid of each census block containing at least one person is used to represent the location where all the people in that census block live. The census block centroid with the highe st estimated exposure then becomes the location of maximum exposure, and the entire population of that census block experiences the maximum individual risk. In some cases, because actual residence locations may be closer to or farther from facility emissio n points, this may result in an overestimate or underestimate of the actual annual concentrations (although there is no systematic bias for average levels). Given the relatively small dimensions of census blocks in densely

- populated areas, there is little uncertainty introduced by using the census block centroids in lieu of actual residence locations

. There is the potential for more uncertainty when census blocks are larger, although there is still no bias on average. EPA concludes that the most appropriate locations at which to estimate chronic exposures and risks are the census block centroids because: 1) census blocks are the finest resolution available in the national census data, 2) facility fencelines do not typically represent locations where chronic exposures are likely, and 3) there is no bias introduced in to the estimate of the MIR by using census block centroid locations

.

3. Comment: Commenters 42 and 45 agreed with EPA's approach in considering the acute risks for HAPs at the ―point of highest off

- si te exposure for each facility (i.e., not just the census block centroids)‖ for the non

- cancer health effects.

Response : In contrast to the development of ambient concentrations for evaluating long

term exposures, which was performed only for occupied censu s blocks, worst

- case acute (one

hour) concentrations were estimated both at the census block centroids and at points nearer the facility that represent locations where people may be present for short periods, but generally no
nearer than 100 meters from th e center of the facility (note that for large facilities, this 100

- meter ring could still contain locations inside the facility property). For facilities with HQ values exceeding 1, a refined evaluation of GIS maps was conducted to verify that the locati on associated with the exceedance was actually off

- site.

4. Comment : Commenters 42 and 45 urged EPA to respond to the SAB‘s recommendation to present the risk assessment results ―in the broader context of aggregate and cumulative risks, including background c oncentrations and contributions from other sources in the area.‖

On the other hand, commenter 46 stated that even if legally permissible, consideration of background risks would result in a program that sets caps on total exposures for HAPs in geographic a reas. The commenter stated:

Consideration of background exposures to HAPs could result in policies that effectively prevent any HAP emissions from a source regulated under section 112 in a given area if EPA determines that the emissions, when coupled with background exposure levels, could result in a Hazard Quotient or total cancer risk level that exceeds an acceptable risk. Implementation of this policy would incorrectly and unfairly place a disproportionate burden on individual sources up for review. If ambient concentrations from EPA‘s NATA program are used in determining acceptability or ample margin of safety for individual source categories (as suggested by EPA as one possibility), these sources would not only have to compensate for6

other high emittin g stationary sources of HAPs, they may also have to compensate for mobile source emissions that may be unacceptably high due to traffic congestion. Moreover, the Clean Air Act expressly excludes mobile source emissions from the
definition of ―stationary so urce.‖ 42 U.S.C. §§7411(a)(3). The inequities would be further compounded by the fact that EPA bases decisions for source categories on the individual source posing the highest potential risks. Other sources in the source category may not be located in are as of high background concentrations, but would likely be forced to install the same control technologies. EPA‘s decision to consider background concentrations would recast the program from a source

- category driven program to a program that focuses on tota l loadings and total exposures. The Clean Air Act, however, clearly distinguishes between source category programs and programs that focus on total loadings or exposures, such as the National Ambient Air Quality Standards (―NAAQS‖) under section 108 or the Prevention of Significant Deterioration (―PSD‖) program under Part C of Title I of the Clean Air Act.

Response : An assessment of the cumulative cancer risks from emitted carcinogens and the
cumulative noncancer hazard indices from all emitted non

- carcino gens affecting the same target organ system for both the source category emissions and the facility

- wide emissions was conducted by EPA . This is excluding background contributions. While the incorporation of additional background concentrations from the e nvironment in our risk assessments (including those from mobile sources and other industrial and area sources) could be technically challenging, they are neither mandated nor barred from our analysis. In developing the decision
framework in the Benzene NE SHAP 1 currently used for making residual risk decisions, EPA rejected approaches that would have mandated consideration of background levels of pollution in assessing the acceptability of risk, concluding that  ̳ ̳comparison of acceptable risk should not be associated with levels in polluted urban air‘‘ (54 FR 38044, 38061

, September 14, 1989). Background levels of certain HAPs can be relatively high, perhaps even above a level that might be considered  ̳ ̳safe.‘‘ B ackground levels (including natural background ) are not barred from EPA‘s ample margin of safety (AMOS) analysis, but EPA may consider them, as appropriate and as available, along with other factors, such as cost and technical feasibility, in the second step of its 112(f) analysis. In this analysis ba ckground levels were not considered because it is technically infeasible. This is because for these source categories technical limitations in the data set would be insufficient to create a reliable analysis.

5. Comment : Commenter 42 urged EPA to reach the lo west, most health

- protective level of risk by assessing the population at risk for cancer by measuring the number of people at greater
than one

- in

- one million risk, greater than ten

- in

- one

- million risk, and greater than 100

- in

- one

million risk. The comment er supported that approach for decisions concerning acceptability and ample margin of safety determinations under Section 112(f) of the Clean Air Act.

Commenter 45 asked that EPA, before finalizing, strengthen the residual risk standard for formaldehyde e missions from wood furniture manufacturing to decrease the cancer risk to be no greater than 1

- in

- 1 million. The commenter asked that EPA address what standard is needed ―to

1 National 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 Recover y Plants (54 FR 38044, September 14, 1989) (Benzene NESHAP).7

provide maximum feasible protection against risks to health‖ by ―protecting the gr eatest number of persons possible‖ to a lifetime risk level no greater than 1

- in

- 1 million, 75 Fed. Reg. at 80,223 (quoting Benzene NESHAP).

Response : As stated in the Benzene NESHAP, in determining the need for residual risk
standards in the risk acceptab ility determination , we strive to limit to no higher than approximately 1

- in

- 10 thousand (100

- in

- 1 million) the estimated risk that a person living near a plant would have if he or she were exposed to the maximum pollutant concentrations for 70 years and, in the ample margin of safety determination, to protect the greatest number of persons possible to an individual lifetime risk level of no higher than approximately 1

- in

- 1 million. However, in determining whether to require additional standards, these lev els are not considered rigid lines, and we weigh the cancer risk values with a series of other health measures and factors, including estimates of uncertainty, in both the risk acceptability and the ample margin of safety determinations. If we determine th at the risk is unacceptable, we must impose additional requirements to reduce emissions without consideration of cost. However, as part of our determination of whether standards protect public health with an ample margin of safety, we do not look solely at whether technology is ―feasible,‖ (as urged by the commenter) but also
consider cost , as statutorily required . We are also required to consider cost as part of technology review under section 112(d)(6), which we are required to perform periodically.

6. Com ment : Commenters 42 and 45 urged EPA to take additional steps to address facility

wide risks.

Alternatively, commenter 46 noted that consideration of facility

- wide or background risks is contrary to the express language of the statute, is bad policy, and s hould not apply to EPA‘s residual risk review under Section 112(f).

EPA‘s proposal to conduct facility

- wide residual risk determinations and to consider potential background exposures is contrary to the express language of section 112. The plain meaning o f the statute in section 112(f) requires that each source category be evaluated and regulated separately. Reviewing the emissions on a facility basis,
rather than a source

- by

- source basis, may over estimate the risks associated with the sources covered by the applicable MACT standard being reviewed and, on the other hand, may not properly account for the emissions from the other source categories to present an appropriate residual risk review under section 112(f). EPA cannot exceed its authority by imposing a more stringent requirement to address potential (and uncertain) risks not caused by the sources and not contemplated by Congress.

Commenter 52 further stated that the ―total facility‖ approach to conducting risk assessment exceeds EPA‘s authority under § 112(f).

EPA explains in the Proposal that, ―To put the source category risks in context, we also examined the risks from the entire ―facility,‖ where the facility includes all
HAP

- emitting operations within a contiguous area and under common control.
Be cause the CAA requires residual risk determinations to be conducted on a category by category basis, EPA does not have authority to consider the combined8

emissions from entire facilities when making a § 112(f) risk assessment for a given source category.

Commenter 46 noted that consideration of facility

- wide risks would have adverse policy

consequences: The practical effect could be to constrain the ample margin of safety level for individual source categories well beyond the level provided for in the 1989 Benzene Rule decision framework for individual MACT source categories. For facilities that may have multiple MACTs, the consequences of allowing the facility

- wide ample margin of safety determinations could significantly reduce the allowable emission
leve ls, with unacceptable and unpredictable implications for the operation of the facility. Second, implementation of facility

- wide ample margin of safety, even at the stage of addressing the last relevant MACT source category, is likely to be infeasible
for m any facilities. Trying to reconcile aggregated risk from different HAPs from disparate sources which may be geographically far apart ( e.g. , process unit fugitives vs. a distant tank or stack) would be difficult to accomplish and is unlikely to
illuminate b etter emission reduction opportunities than residual risk analyses for individual MACT source categories.

Commenter 46 stated the 1989 Benzene Rule itself, codified in the CAA, does not call for facility

- wide risk determinations or regulation. Instead, the rule focuses on emission sources included in the benzene NESHAP categories.

Even where the 1989 Benzene Rule considers more than a single emission source, it only aggregates emissions from sources within the same category or subcategory

, describing these emissions as emissions from two or more sources in the same source category that are located so closely together that they may result in greater risks to individuals because they are potentially exposed to both sources at the same time. 54 Fed. Reg. at 38 ,045. This very limited concept of co

- located sources in the same category is wholly different from what EPA appears to describe as a ―facility

- wide‖ residual risk determination in the Proposed Rule.

According to commenter 52, Section 112(f)(2)(A) unambigu ously requires EPA, within 8 years after adopting a MACT standard for a given source category or subcategory to promulgate standards for such category or subcategory if promulgation of such standards is required in order to provide an ample margin of safet y to protect public health.

It is not reasonable to construe these provisions as authorizing EPA to consider emissions from entire facilities in conducting risk assessments and potentially revising the underlying rule for the simple reason that the Congre ss clearly envisioned that full implementation of the MACT program would take longer than 8 years. Consequently, it would be impossible for EPA to fulfill its unambiguous obligation for § 112(f) standards to protect public health with an ample margin of sa fety in cases where facilities contain sources in a category where the 8 year deadline for conducting the § 112(f) risk review precedes the adoption of MACT standards for other sources at the facilities. One example is the boiler source category. The provi sions at §112(f)(2)(A) unambiguously requires the risk assessment to be focused exclusively on ―emissions from a source in the category or subcategory.‖ For this9

reason alone, EPA does not have authority to consider emissions from any sources
other than th ose in the source category or subcategory under review at that time.

Commenter 46 responded to EPA‘s request for comments concerning whether NATA might be used to measure background exposures for purposes of decision making under section 112(f). 75
Fed. Re g. at 80,225.

Given the plain meaning of the statute and the text of the 1989 Benzene Rule, section 112 does not allow the consideration of background concentrations in determining acceptable risk or ample margin of safety. However, even if it were legall y permissible to consider background HAP concentrations, NATA remains a too blunt and inexact instrument to be used for this regulatory purpose. As EPA states on its NATA website, NATA should only be used for determining regulatory priorities, not
for maki ng individual regulatory decisions: ―These [NATA] assessments are based on assumptions and methods that limit the range of questions that can be answered reliably. The results cannot be used to identify exposures and risks for specific individuals, or even to identify exposures and risks in small geographic regions such as a specific census block, i.e., hotspots.‖ ( http://www.epa.gov/ttn/atw/natamain/ )

Commenter 46 endorsed EPA‘s decision to adhere to the 1987 Vinyl Chloride decision ( NRDC,
Inc. v. EPA , 824 F.2d 1146 (D.C. Cir. 1987)), and the decision framework established in the 1989 Benzene Rule (54 Fed. Reg. 38,044 (Sept. 14, 1989)), codified by statute under section 112(f)(2)(B).

The 1989 Benzene Rule states that maximum individual risks as high as one

- in

- ten thousand can be presumptively considered ―safe‖ or ―acceptable.‖ Maximum individual
risks greater than one

- in

- ten thousand may also be considered safe based on a careful review of the specific hea lth factors and uncertainties involved.

EPA appears to have followed an acceptable approach in the Proposed Rule. For Shipbuilding and Ship Repair, EPA found an acceptable risk. EPA then ―weighed all health
risk measures and information considered in the risk acceptability determination, along with the costs an economic impacts of emissions controls, technological feasibility, uncertainties, and other relevant factors.‖ As an example, EPA looked at requiring enclosure of some or all coating operations and requiring emissions to be routed to a control device, but found this proposal ―is not practicable or technically feasible in many cases, would not be cost

- effective, and we are not aware of any facility using an enclosure of this size [(i.e., entire ship o r large portion of a ship)].‖ Id. EPA followed a similar approach for Wood Furniture Manufacturing, finding the risks from the source category were acceptable. Id. at 80,245. EPA then appropriately considered costs and feasibility to
determine whether addi tional controls are warranted for an ample margin of safety. Id. at 80,245

- 80,246. Thus, EPA appropriately considered whether technical or economic feasibility would exclude this technology option from being required as part of the ample margin of safety de cision under section 112(f).

EPA again confirmed that bright

- line, inflexible decision points for acceptable risks or an ample margin of safety for future residual risk standards should be avoided: ―As explained more fully in our Residual Risk Report to Co ngress, EPA does not define  ̳rigid line[s] of10

acceptability,‘ but considers rather broad objectives to be weighed with a series of other health measures and factors (EPA

– 453/R

– 99

– 001, p. ES

– 11).‖ The Forum continues to support this approach to allow for fl exibility. Nonetheless, while EPA may consider other health measures and factors in applying the benzene decision framework, these factors were intended primarily to address uncertainties in the risk estimates, and do not serve as an open ended invitation for the Agency to include factors that would dramatically alter the fundamental elements of the program and the decision framework in the 1989 Benzene Rule. The 1989 Benzene Rule and Congress‘s codification of it (and therefore the statutory terms) should not be rendered meaningless. Thus, so long as EPA finds the risks acceptable and protective with an ample margin of safety under the 1989 Benzene Rule framework, EPA can properly determine that no further regulation is necessary under section 112(f).

Comm enter 52 suggested that EPA provide justification or a rational basis for considering demographics in deciding whether an ample margin of safety has been achieved. The commenter noted that this is a departure from the risk assessment methods established in prior § 112(f)
residual risk determinations.

Section 112(f)(2)(A) expr essly instructs EPA to impose additional emissions controls if needed to provide an ample margin of safety ―to protect public health. The term ―public health‖ is not defined in § 112 or in EPA‘s Part 63 regulations. The term ―public health‖ cannot reasonab ly be interpreted to include consideration of environmental justice in the § 112(f) context. Therefore, EPA‘s proposal to consider demographic analyses in conducting risk reviews under § 112(f) is not a proper exercise of Agency authority. In the context o f EPA‘s national ambient air quality program, the Supreme Court has observed that public health means ―the health of the public.‖ The word ―public‖ should be construed expansively as describing the people as a whole, and not particular demographic segments

. EPA‘s established approach to assessing potential impacts on public health under the NAAQS program is consistent with this meaning. EPA reasonably interprets the term ―public health‖ to include consideration not only of potential impacts to the populati on as a whole, but also to sensitive subpopulations

– recognizing that the objective is to protect the group rather than any particular individual in the group.

Commenter 46 agreed with commenter 52 that sensitive subpopulations should be identified
accord ing to their particular health

- based sensitivities ( e.g. , asthmatics) rather than demographic classifications unrelated to particular health

- based sensitivities ( e.g. , population without a high school diploma):

EPA cannot presume that sensitive subpopulati ons exist without supporting health evidence linking the pollutant being emitted to greater health effects in the subpopulation. Nor can EPA presume that race, income, age or education is a surrogate for a sensitive subpopulation. Because EPA has failed to provide this evidence in this rulemaking, EPA cannot consider race, education or income in decisions regarding acceptable risk or ample margin of safety for the source categories addressed in this proposal. In any event, EPA found ―no demographic group is exposed to an unacceptable level of risk.‖ 75 Fed. Reg. at 80,252.11

In analyzing potential demographic risks, EPA focused on populations within 50 km of any facility estimated to have exposures to HAP which result in cancer risks greater than one

- in

- a

- mill ion or non

- cancer HI of 1 or greater. 75 Fed. Reg. at 80,231. Commenter 46 agrees, to the extent EPA conducts an EJ analysis, that EPA should focus on risks of potential concern, EPA has recognized that a 5 km radius generally encompasses more than 90 perc ent of the population that are estimated, using conservative assumptions, to have risks greater than one in a million. 75 Fed. Reg. at 65,080. The expansion from 5km to 50km may reduce the accuracy of the resulting information, including the potential link between source category emissions and the population at risk. This is especially true given the conservative assumptions EPA uses in developing individual and population risk estimates, and the need to provide health evidence showing that the population c ategory in question is more sensitive than the population at large to health effects that could be caused by emissions from the source category.

Response : We examined facility

- wide risk to provide additional context to the source category risks. In May 201 0, the SAB advised us ―* * * RTR assessments will be most useful to decision makers and communities if results are presented in the broader context of aggregate and cumulative risks, including background concentrations and contributions from other sources in the area.‖ The development of facility

- wide risk estimates provides additional information about the potential cumulative risks in the vicinity of the RTR sources, as one means of informing potential risk

- based decisions about the RTR source category or categories in question. While we recognize that, because these risk estimates were derived from facility

- wide emissions estimates which have not generally been subjected to the same level of engineering review as the source category emission estimates, th ey may be less certain than our risk estimates for the source categories in question, they remain important for providing context, as long as their uncertainty is taken into consideration in the process.

Further, for the two RTRs we are finalizing, our ev aluation of facility

- wide risk did not change our decisions about acceptability and ample margin of safety for these two source categories. Therefore, comments on how this factor was used by EPA in determining acceptable risks are not germane to these fina l rules. We note, however, that section 112(f)(2) of the CAA expressly preserves our use of the two

- step process for developing standards to address residual risk and interpret ―ample margin of safety‖ as developed in the Benzene NESHAP. In both the Benzen e NESHAP and our Residual Risk Report 2 to Congress, we explain that we do not define ―rigid line(s) of acceptability‖ and that we will consider a series of other health measures and factors in determining if risk is acceptable.

As stated in the Benzene NE SHAP, in determining the need for residual risk standards, in the risk acceptability determination , we strive to limit to no higher than approximately 1

- in

- 10 thousand (100 in a million) the estimated cancer risk that a person living near a plant would ha ve if he or she were exposed to the maximum pollutant concentrations for 70 years and, in the ample margin of safety determination, to protect the greatest number of persons possible to an individual lifetime risk level of no higher than approximately 1

- in

- 1 million. These considerations are made for all people regardless of racial or socioeconomic status. In

2 See Residual Risk Report to Congress , EPA

– 453/R

– 99

– 001 (March 1999).12

determining whether to require additional standards, these levels are not considered rigid lines, and we weigh the cancer risk values with a series of other health measures and factors in both the decision regarding risk acceptability and in the ample margin of safety determination. We also consider cost of controls in the ample margin of safety determination. While we provided a demographic analysi s of populations surrounding the facilities in the source categories addressed by these RTRs and found some demographic differences in exposed populations compared to nationwide estimates, the results of our demographic analysis only serve to provide infor mation about the demographic make

- up of the populations exposed to each of these source categories which might benefit from the proposed rules

. Our authority to use the two

- step process laid out in the Benzene NESHAP, and to consider a variety of measures of risk to public health is discussed more thoroughly in the preamble to the proposal. See 75 FR 80222

– 80225.

7. Comment : Commenter 45 agreed with EPA in the removal of the unlawful malfunction exemption under the existing rules but noted that EPA failed to consider increased acute health risks and possibly chronic risk from malfunction or other violations of the MACT standard.

EPA must consider data regarding the use of the SSM exemption and enforcement actions in the past, at minimum, and other informati on it has regarding the history or likelihood of malfunctions or other violations of the standard, as part of its analysis. EPA must recognize that a certain level of malfunctions and other violations of the MACT is likely, and factor this into its analysi s of the risk to public health and the
environment.

Failing to look at the true potential for spikes will significantly underestimate the amount of emissions considered for this analysis. The Act specifically requires EPA to base its risk analysis on the h ighest possible level of risk

– i.e. , the risk ―to the individual most exposed to emissions from a source in the category or subcategory.‖ 42 U.S.C. § 7412(f)(2)(A). To do this, it is necessary for EPA to determine the highest level of potential emissions from the worst

- performing source, and then use that information to establish the maximum individual risk. That requires
consideration of malfunction

- and other violation

- based emissions.
Research by the Environmental Integrity Project (―EIP‖) from 2004 fou nd that significant emission exceedances occur routinely, across a range of different industries. Moreover, EIP found that ―releases from upsets actually dwarf a facility‘s routine emissions. EPA must look at data, like the EIP report, and ensure that its risk analysis and resulting standard prepare for the likelihood that malfunctions will occur and that the public will need protection from the high emissions they cause.

Response : We believe SSM events do not contribute significantly to chronic cancer or noncancer risks for the source categories. SSM events for these source categories are inherently
short

- term and infrequent relative to continuous annual operations and emissions. The commenter did not supply any data to the contrary that would change the acute multipliers calculated for these source categories that would lead us to believe that peak modeled hour
events are under

- estimated. See response to comments in Section I.B. (SSM provisions) for additional information on expected infrequency of SSM e vents.13

8. Comment : Commenter 45 pointed out that EPA may not set any HAP risk level at zero. The commenter noted that Section 112(f)(2) of the CAA creates a critical duty and opportunity for EPA to conduct a comprehensive and protective analysis of residual r isk to public health and the environment. It is a serious problem for EPA‘s analysis that ―some HAP continue to have no reference values.‖ 75 Fed. Reg. at 80,234.

Even over twenty years after the Clean Air Act was amended, sufficient studies for
some HAPs have not been conducted to allow calculation of reference doses or reference concentrations or potency values. Moreover, the IRIS process has bogged down. As the Center for Progressive Reform has recognized, EPA should prevent the delay in this process fr om undermining its residual risk analysis. It should prioritize those HAPs for which it needs data in this rulemaking and the next upcoming rulemakings and ensure that the development of this process and IRIS review have sufficient funding and resources to get the job done.

Even if no reference values are available, this does not justify EPA setting the risk at zero for any HAP. EPA must address this uncertainty by selecting a health

- protective value based on what is known so that it may consider the potent ial risk and find an appropriate way to address that risk in this rulemaking.

EPA should make this issue a priority for the National Toxicology Program or ensure that the data are generated by another means. If data are available to support the
derivation of a reference concentration and potency estimate, or the IRIS process is in progress but not yet complete, EPA should put these compounds on a priority to complete the IRIS process. EPA must also set a regulatory deadline, such as four or eight years fro m the finalization of these rules, when it shall commit again to review the current residual risk analysis and again perform a residual risk rulemaking once additional data become available. It is not enough for EPA to say that it will potentially revisit this issue. It must set a regulatory deadline for this action that citizens can help enforce.

Two commenters contended that EPA considered factors that might lessen the concern for risks, but did not give equal weight to factors that increase concern. For example, the EPA‘s analysis ignored HAP for which the Agency lacks cancer potency values.

Response : This issue was addressed by the EPA‘s Science Advisory Board (SAB) in their May 10, 2010, (EPA

- SAB

- 10

- 007) response to the EPA Administrator; http://yosemi te.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File /EPA

- SAB

- 10

- 007

- unsigned.pdf. In that response, the SAB Panel recommended that, for HAPs that
do not have dose

- response values from EPA‘s hierarchy list, EPA should consider and utilize, as appropriate, additional sources for such values that have undergone adequate and rigorous scientific peer review. They further recommended that the inclusion of additional sources of
dose

- response values into the EPA‘s hierarchy should be adequately doc umented in a transparent manner in any residual risk assessment case study. We agree with this approach and have
considered other sources of dose

- response data when conducting our risk determinations under
RTR.14

The SAB Panel and EPA also agree that the E PA should ultimately develop toxicity values for all Hazardous Air Pollutants (HAPs) utilizing all credible and relevant toxicity information. The need to update assessments with newly available data as well as the need to complete toxicological assessment s for all HAPs lacking dose

- response assessments further increases the importance of Agency activities to streamline and fully utilize the EPA‘s already overloaded IRIS program. To that end, EPA has always prioritized for future IRIS assessments those HAP
without dose

- response values but with the greatest potential for public exposure. As a result of this prioritization, while not all HAPs may have scientifically accepted dose

- response values that can be used in residual risk assessments, it is clear that the vast majority of HAPs which might carry the potential to significantly impact the results of residual risk assessments do, in fact, have
credible dose

- response values. Thus, while we are not yet at the point where all HAPs have
dose

- response values, we are generally capable of deriving reasonable risk estimates for those HAP which dominate the risks from any one source category. In the course of each residual risk assessment, should we encounter HAP without dose

- response values which carry the potent ial to create significant risks, we shall clearly point those out as uncertainties and target them for future
IRIS assessments.

9. Comment : Commenter 45 noted that EPA understated risk by not addressing the health risks posed by clusters of facilities within each of the source categories. The commenter referenced EPA‘s residual risk assessment for the synthetic organic chemical manufacturing industry (SOCMI). The assessment noted that while ―HEM

- 3 models one facility at a time . . . another facility nearby ma y impact the same people, resulting in higher risk to those people (i.e., the cluster effect).‖ See EPA, SOCMI

- Residual Risk Assessment (EPA

- HQ

- OAR

- 2005

- 0475

- 0108), at 4

- 9 (Sept. 2005).

The commenter opined that EPA could easily replicate its SOCMI clus ter analysis for both of the source categories evaluated in the agency‘s current proposal. The SOCMI cluster analysis was developed using the outputs from HEM

- 3. EPA‘s proposal for shipbuilding and ship repair and for wood furniture manufacturing relies on the same model and outputs. EPA should utilize ―allowable‖ emissions in calculating the cluster risks. Such clusters of facilities likely impact the MIR; if not, they almost certainly increase other health risks faced by individuals living within
50 km of more than one facility.

Response : In our current risk modeling methodology, which has been updated since we performed the analyses for the SOCMI HON RTR , overlapping risks for the same source category are automatically included in determining the MIR, inc idence, etc. Any risks from clusters of facilities in the source categories investigated were included in the reported results of the analysis for the source category.

10. Comment : Commenter 45 stated that EPA failed to consider or account for cumulative
risk. According to the commenter, there is no rational or scientific basis to dismiss consideration of the cumulative risk of exposures to HAPs due to uncertainties. The commenter urged that these uncertainties require protective action rather than inaction. Th e commenter continued:

As EPA recognizes, the SAB in May 2010 urged it to use the RTR rulemaking process to do this as well as perform a sensitivity analysis to identify the major uncertainties in both the human health and ecological risk assessments. The SAB and numerous other scientific experts have15

developed, and are in the process of developing, cutting edge methods to perform these assessments. EPA, as the lead environmental agency of the United States, has a responsibility to show leadership in this process. It should rely on the significant information already available, and also use the current and future RTR rulemakings to further advance this process.

The commenter stated that it could be done on a site

- specific basis or it could be done for the
i ndustry as a whole. Uncertainty in estimates of HAPs in ambient air has been characterized, so the data available from the NATA would allow a defensible estimate of what might be expected
from other sources.

Response We disagree with the comment that we f ailed to consider or account for cumulative
risk. EPA modeled whole

- facility risks for both chronic cancer and non

- cancer impacts to understand the risk contribution of the sources within this MACT category and those attributed
to other emission sources. The individual cancer risks for each source category were aggregated for all carcinogens. In assessing noncancer hazard from chronic exposures for pollutants that have similar modes of action or (where this information is absent) that affect the same targ et organ, we aggregated the HQs. This process creates, for each target organ, a target

- organ

- specific hazard index (TOSHI), defined as the sum of hazard quotients for individual HAPs that affect the same organ or organ system. All TOSHI calculations pres ented here were based exclusively on effects occurring at the ―critical dose‖ (i.e., the lowest dose that produces adverse health effects). Whole facility risks were estimated utilizing the 2005 NEI, with updated facility

- wide and source category data fil es developed by EPA thru emission data updates from industry, 2005 NATA updates, and refined EPA profiles for this source category.

We further disagree with the commenter‘s assertion that a dditional quantitative assessment of
risks from sources outside the source category is required under the statute. Instead, to provide the quantitative risk information necessary to inform RTR regulatory decisions, EPA conducts a comprehensive assessment of the risks associated with exposure to the HAPs emitted by the source category and supplements that with additional information that is available about other possible concurrent and relevant risks. In some cases, we have additional information about
HAP emissions from outside the source category but within the boun daries of the subject facilities. In other cases, we may have ambient HAP monitoring data. In still other cases, we may have very little additional risk information. In all cases, however, when we consider additional information about risks, we also con sider its attendant uncertainties, and information which carries significant uncertainties generally carries less weight in the regulatory decision.

11. Comment: Commenter 45 stated that EPA must consider and account for the higher risk
created for vulnerabl e individuals.

There is a particular need for EPA to address and incorporate the new science on vulnerable individuals, including youth, into its risk analysis. For example, as the Science Advisory Board has pointed out to EPA: ―California‘s Office of En vironmental Health Hazard Assessment (OEHHA) has recently updated its methodology in ways that could affect the development of RfC and URE values. EPA should examine these developments to make sure that the RTR process adequately covers children‘s risks.‖ SAB May 2010 at 6, 34. EPA‘s inhalation analysis16

should also address the higher chronic risk that children face from inhalation. EPA should address and incorporate this higher level of risk into its residual risk analysis.

Where EPA has information that th ere is a greater risk when exposure occurs at a young age or during the prenatal period, it must analyze that risk for the source category and create a lifetime exposure analysis that recognizes that risk susceptibility is greater due to the earlier exposu re.

Commenter 45 recommended that EPA reassess environmental impacts using current scientific research. The commenter cited the following references (and included them as appendices to the comments):

[1] Risk Assessment Guidance for Superfund: Volume I. Human Health Evaluation Manual (Part A). Interim Final. Washington DC. Office of Solid Waste and Emergency Response, US Environmental Protection Agency; October 1989. http://www.epa.gov/oswer/riskassessment/ragsa/index.htm.

[2] Linda K. Teuschler and Richard C. Her tzberg. 1995. Chemical mixtures and quantitative risk assessment: Current and future risk assessment guidelines, policy, and methods development for chemical mixtures. Toxicology Volume 105, Issues 2

- 3, 28 December 1995, Pages 137

- 144. doi:10.1016/0300

- 483 X(95)03207

- V.

[3] Framework for Cumulative Risk Assessment 1

- 3, EPA/630/P

- 02/001F (May 2003)

[4] National Research Council. 2008. Phthalates and Cumulative Risk Assessment: The Tasks Ahead. Executive Summary.

The commenter also recommended EPA focus on population s that may be more susceptible to
environmental factors:

The issue of more susceptible populations has been another target of investigative and policy developments over recent decades. Efforts developed in response to the Food Quality Protection Act of 199 6 led to the agency taking actions to cancel uses of pesticides in case when the aggregate risk from different sources of pesticides were too great. This reflects the scientific consensus that people are not exposed to only one thing at a time and that ass essments must reflect the biological reality in which people live. It also reflects the new scientific understanding, as stated by the National Academy of Sciences, that ―children are not little adults‖ (National Research Council.
1993. Pesticides in the D iets of Infants and Children. Committee on Pesticides in the Diets of Infants and Children. Board on Agriculture and Board on Environmental Studies and Toxicology. Commission on Life Sciences. National Academy Press. Washington, D.C (attached in Appendix)) . Prior to this time, methods for assessing chemicals hazards and risks had largely ignored children and considered them to simply be smaller adults. This report pointed out that the developmental process, which begins in the womb, before birth, is exquisi tely sensitive to chemicals because it is directed by chemical signals in the body. Myriad organs, systems, and processes have to develop, grow, and connect correctly during the development process, which17

extends into early adulthood. These processes can b e easily disrupted by chemical exposures. The idea of a ―lifetime dose‖ of a chemical that would correspond to a
1

- in

- 1 million cancer risk is largely irrelevant for children. They can be affected by doses over much shorter periods of time and that are muc h lower than what would affect adults. This has implications, obviously, for the residual risk program, none of which EPA seems to recognize.

EPA and the public now have significant information on the greater vulnerability to pollution faced by children an d the elderly. California has developed child

- specific reference doses to address the greater risks affecting children . Science shows that ―[e]nvironmental contaminants can affect children quite differently than adults, both because children may be more h ighly exposed to contaminants and because they may be more vulnerable to the toxic effects of contaminants.‖ Recently, EPA‘s Children‘s Health Protection Advisory Committee has recommended addressing the developmental origins of adult disease that come fro m childhood exposure to air pollution and other environmental contaminants. Similarly, the Committee has recommended that EPA incorporate a more robust analysis of childhood and prenatal exposure to environmental contaminants into its risk assessment metho d. The greater understanding today of the higher risk to children and other vulnerable groups, like the elderly, which environmental pollution creates is likely to affect the public‘s view of what level of environmental risk is acceptable today. These new studies speak to numerous EPA acceptability factors. For example, for factors one to three, these studies give EPA significant knowledge (factor 3) that there is both greater ―certainty and severity of the risk‖ for children (factor 1) and that the effects are particularly likely to be harmful (and not reversible) when there is early exposure (factor 2).
In addition to new data on children‘s particular vulnerability to environmental hazards (and the long

- term effects of early exposure), EPA now has greater knowledge of the toxic body burden of healthy adults. This is also relevant to the consideration of EPA‘s acceptability factors one through three. For example, in the most recent 2010 national biomonitoring report, the Center for Disease Control stated
tha t it had found 212 chemicals present in people‘s bodies, including 75 chemicals never before found in human beings. This new information has led to changes in behavior and calls for reform ranging from demands for greater protection from
toxics in kitchen products and water and baby bottles, to changes in eating habits that aim to avoid contaminants like mercury in fish and drinking water through filters, to a greater consumption and market for pesticide

- free food. These examples show how
new science has af

fected the public‘s growing concern about environmental health risks, of which EPA is well aware. These changes represent a further shift downward in the level of risk that the public deems acceptable from the unnecessary intake of toxic chemicals, whether through the air, water, or food.

Response : We acknowledge that population subgroups, including children, may have the potential for risk greater than the general population due to greater relative exposure and/or greater susceptibility to the toxicant. As explained in previous actions, including the final
SOCMI HON RTR , the assessments we undertake to estimate risk account for this potential vulnerability. With respect to exposure, the risk assessments we perform implicitly account for this greater potenti al for exposure by assuming lifetime exposure, in which populations are18

conservatively presumed to be exposed to airborne concentrations at their residence continuously, 24 hours per day for a full lifetime, including childhood. With regard to children‘s

p otentially greater susceptibility to non

- cancer toxicants, the assessments rely on Agency (or comparable) hazard identification and dose

- response values which have been developed to be protective for all subgroups of the general population, including child ren. For example, a review 3 of the chronic reference value process concluded that the Agency‘s reference concentration (RfC) derivation processes adequately considered potential susceptibility of different subgroups with specific consideration of children, such that the resultant RfC values pertain to the full human population  ̳ ̳including sensitive subgroups,‘‘ a phrase which is inclusive of childhood.

On the issue of cancer dose

- response values, EPA‘s revised cancer guidelines and supplemental guidance rec ommend applying default adjustment factors to account for exposures occurring during early

- life exposure to those chemicals thought to cause cancer via a mutagenic mode of
action. 4 For these chemicals, the supplemental guidance indicates that, in lieu of c hemical

specific data on which age or life

- stage specific risk estimates or potencies can be determined, default  ̳ ̳age dependent adjustment factors‘‘ can be applied when assessing cancer risk for early

life exposures to chemicals which cause cancer through a mutagenic mode. At the present time, there have been no peer

- reviewed assessments that explicitly make a determination that any of the chemicals emitted by the source categories considered in this action cause cancer via a mutagenic mode of action. Howe ver, the estimated risks must also be considered in the context of the full set of assumptions used for this risk assessment. For example, we used a health

protective assumption of a 70

- year exposure duration in our risk estimates; however, using the
natio nal average residency time of 12 years would reduce the estimate of risk by roughly a factor of 6. Our unit risk estimates for HAP are considered a plausible upper

- bound estimate; actual potency is likely to be lower and some of which could be as low as ze ro. After considering these and other factors, we continue to consider the risks from emissions after application of the MACT standards for these source categories to provide an ample margin of safety (within the meaning of the Benzene NESHAP decision fram ework).

12. Comment : Commenter 45 disagreed with EPA‘s reliance on the Benzene Rule‘s presumption that a 100

- in

- 1 million lifetime cancer risk is acceptable today, as this fails to account for evolving science and societal standards. EPA can no longer presume that the level of risk that is acceptable has remained the same since 1988, when it promulgated the Benzene Rule.

To address the court‘s direction to consider context and what is ―acceptable in the world in which we live,‖ at the time of the Benzene rule, EPA performed a Survey of
Societal Risk (July 1988) to consider various types of health risks at that time. Id. at 28,513. [EPA] relied on this study to set a presumptive limit on maximum individual lifetime risk (MIR) of approximately 1

- in

- 10 thousand, o r 100

- in

- 1 million people, as a benchmark (but not a ―rigid line‖). 54 Fed. Reg. at 38,045. In establishing this presumptive benchmark, EPA assumed that the maximum exposed individual was a person out of context. It did not consider the potential that diff erent persons, at the same exposure level, might face different levels of risk. To choose this number, EPA

3 A Review of the Reference Dose and Reference Concentration Process. U.S. Environmental Protection Agency.
Risk Assessment F orum. EPA/630/P

– 02/002F. December 2002.

4 ―Guidelines for Carcinogen Risk Assessment ,‖ (EPA/630/P

- 03/001F), March 2005; and ― Supplemental Guidance for Assessing Susceptibi lity from Early

- Life Exposure to Carcinogens,‖ (EPA/630/R

- 03/003f), March 2005.19

considered a broad range of risks, such as driving a car and breathing air, and found that ―the presumptive level established for MIR [maximum indivi dual 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 risks common ‘in the world in which we live. ‘‖ Id. at 38,046 (emphasis added). Eve n so, EPA recognized that it could not easily compare the presumption it chose and many of the risk levels studied because of numerous differences. Specifically, EPA stated that the consideration of the acceptability of a specific level of risk depends on factors including: [1] [t]he certainty and severity of the risk; [2] the reversibility of the health effect; [3] the knowledge or familiarity of the risk; [4] whether the risk is voluntarily accepted or involuntarily imposed; [5] whether individuals are co mpensated for their exposure to the risk; [6] the advantages of the activity; and [7] the risks and advantages for any alternatives. 53 Fed. Reg. at 28,513. Although this is not a comprehensive list of factors that EPA must consider, the fact that so much has changed to affect these factors demonstrates that, even within EPA‘s original analysis, the presumptive level of what risk is acceptable requires a reduction.]

EPA still applied the acceptability presumption developed from that 1988 survey in this prop osal to determine that the level of risk for both shipbuilding and ship repair and wood furniture is ―acceptable.‖ 75 Fed. Reg. at 80,238, 80,245. The ongoing use of the 1988 presumption, that risk below 100

- in

- 1 million is acceptable, today, in 2011, is a rbitrary and capricious for numerous reasons.

Commenter 45 further noted that EPA does not justify its conclusion that this level of risk is acceptable. EPA recognizes that disparities in risk exist, with certain demographic groups, including Hispanics, pe ople living below the poverty line, and people over age 25 without a high school diploma, more likely to experience a higher level of risk. The commenter urged EPA not to rely on the old Benzene presumption that any level of risk under 100

- in

- 1 million is acceptable. Section 112(f)(2) requires EPA to set standards for the maximum exposed individual and it has not adequately supported its analysis that the level of residual risk for this source category is acceptable. Commenter 45 states the document "Surve y of Societal Risks" was not
obtainable from the EPA Air docket.

Relying on this type of out

- dated presumption contravenes the purpose of section 112(f)(2) which is to make regulatory changes based on what EPA, and the public, have learned from the impleme ntation of the MACT standard. Section 112(f)(2) explicitly requires EPA to assess residual risk within 8 years after promulgation of the MACT standard. 42 U.S.C. § 7412(f)(2)(A), (C). This allows time for the MACT
standard to take effect and ensures that E PA must assess that impact, including the acceptability factors, to see what pollution and environmental health impacts remain after implementation of the MACT, and to consider whether or not the residual risk is acceptable in the contemporary view.

The re view for residual risk is a key moment within the statutory framework for HAPs when public health must be considered. It provides an overarching review of whether public health is protected through application of the technologies specified through the MACT process. Technological development may or may not be sufficient to protect public health. The advantage of technology

- based standards is that they are20

relatively easier to implement because they require only assessment of whether technologies exist. But a t some point the question of whether they protect public health must also be asked, and that is the express purpose of the residual risk review.

The residual risk analysis requires a fresh look at whether there is a need for more stringent pollution contro ls to protect public health and the environment. That includes a current look at what the contemporary view of ―acceptable‖ risk is, in relation to environmental pollution. By requiring the 8

- year review, Congress inherently directed EPA to act based on an d to take account of new, future circumstances that EPA had not considered in promulgating the initial standard. If EPA were allowed to go back in time to a single snapshot view of what was ―acceptable‖ from 1988, forever, this would undermine the Act‘s go al of ensuring an evolving, improved approach to pollution control through the review and revision

process. As pollution

- control technology and industrial practices have evolved to be able to better protect human health, their evolution has also changed th e ―world in which we live‖ and with it, the public‘s views on what level of risk may be acceptable (or not).
The fact that other lower emission or lower

- risk coatings or technologies are now available must be considered, regardless of cost, as a factor in determining whether the old presumption about risk acceptability ( i.e. , that a cancer risk below 100

- in

- 1 million could be acceptable) still applies. Where cancer risks from a specific polluting source can be further reduced using available technologies, a nd indeed, where another jurisdiction has already required this to happen, EPA cannot justify continuing to expose a child today to a level of risk simply because it was considered to be acceptable decades ago.

In sum, for all of these reasons, even lookin g only at EPA‘s own list of acceptability factors, EPA cannot assume that Americans today would consider a lifetime cancer
risk below 100

- in

- 1 million to be acceptable (even assuming it once was). This is an especially poor assumption for environmental exp osure that is completely out of a person‘s control and is most likely to affect people who have the least ability to escape this type of pollution due to socioeconomic factors. If EPA wishes to use some presumptive level of risk in its residual risk review , EPA must assess risk ―in the world in which we live,‖ both by addressing evolving science and performing an updated assessment of contemporary values. The world has changed so dramatically since 1988 that EPA can have no rational justification for contin uing to apply the Benzene rule‘s 100

- in

- 1 million presumption, automatically, based on the 1988 Survey , to the source categories under review.
Although in the HON case the D.C. Circuit affirmed EPA‘s use of certain elements of the Benzene rule, it did not rubber stamp the Benzene Rule‘s approach in full. The court‘s interpretation of CAA § 112, stating that Congress incorporated the Benzene approach in the 1990 CAA Amendments, is limited to the issue raised in that case by petitioners: specifically, whether subsection 112(f)(2)(A) required EPA to revise
standards to reduce lifetime excess cancer risk to 1

- in

- 1 million. NRDC v. EPA , 529 F.3d 1077, 1081 (D.C. Cir. 2008). The court held that this was not required under the statute, finding that ―the Benzene sta ndard established a maximum excess risk of 100

- in

- one million, while adopting the one

- in

- one million standard as an aspirational21

goal .‖ Id. at 1082 (emphasis added). The HON court did not address the questions raised in this rulemaking. It also did not bro adly hold that EPA can do in every future residual risk rulemaking precisely what it did at each step of the Benzene NESHAP. By urging EPA to continue to ―aspire‖ to reach the 1

- in

- 1 million level, it implicitly recognized that 100

- in

- 1 million was a maxim um, such that EPA should continue striving to reduce risk over time and in context.

A lifetime cancer risk below the level of 100

- in

- 1 million can no longer be considered ―safe‖ or ―acceptable‖ in ―the world in which we live‖ ( i.e ., the contemporary
standa rd required by the D.C. Circuit that the HON court left undisturbed). Specifically, EPA must reassess whether a level below 100

- in

- 1 million and closer to the ―aspirational goal‖ of 1

- in

- 1 million should be adopted as a more stringent, presumptive outward limit for what is considered ―acceptable.‖ This is a question that EPA cannot evade by attempting to rely on the different issue addressed in the HON case, or on the overbroad theory that everything it did in the Benzene Rule is per se lawful

– for all tim e and all source categories

– even when, as here, circumstances have changed so dramatically.

Each of the significant findings of the above

- described new research greatly
undermines the idea that an MIR below 100

- in

- 1 million could still be considered an

a cceptable level for environmental health risks, in every context.
The commitment to environmental justice must inform EPA‘s evaluation of ―acceptable‖ risk. During the last two decades, American values have evolved to consider the issue of environmental j ustice and to acknowledge and address disproportionate environmental health impacts. It is a shameful, longstanding reality that much more toxic pollution in this country has been sited[sic] in or near particular communities and urban neighborhoods that ha ve higher minority and lower

- income populations.

These important concerns all affect EPA‘s consideration of the acceptability factors, including the greater knowledge of the certainty and severity of the risk for certain communities, especially where canc er is the potential health effect ( i.e. , often irreversible). Environmental justice should also inform the question of how acceptable it is today for disproportionate risks to be ―involuntarily imposed,‖ without compensation, where there are alternatives.

Response : As an initial matter, we note that in 1990 Congress codified in section 112(f) of the CAA the approach we use for our residual risk analyses. Under that approach, the 100 in a million cancer risk is not a bright line indicating that risk is ―acce ptable,‖ but rather we consider this health metric in conjunction with a variety of health factors to determine whether the risk is acceptable. Where we conclude that the risk is not acceptable, we cannot consider costs in requiring controls to bring risks down to an acceptable level. However, the analysis of whether risk is acceptable is not the endpoint. Once we determine that controls are sufficient to ensure risk is acceptable, we again review the health metrics in conjunction with considering the costs of controls to determine whether additional controls should be required to provide an ample margin of safety.22

Moreover, the commenter does not support its contention that people are now unwilling to accept a level of risk that was acceptable at the tim e the CAA was amended in 1990. Nor does the commenter support how science has evolved in a way that would undermine the codified framework for determining acceptability. EPA notes that Commenter 45 obtained a copy of "Survey of Societal Risks" from the Air Docket subsequent to filing comments in this rulemaking. EPA has added the document, from OAQPS Docket 79

- 3, Docket Item X

- B

- 1, to the docket for this rulemaking. We note that for purposes of the proposed rule, we performed demographic (environmental jus tice) analysis for the purpose of informing the public, and that analysis is in the docket.
13. Comment : Commenter 45 suggested that EPA include a plain

- language statement of the health risks and benefits from EPA‘s proposed action.

As part of determining whet her these risks are ―acceptable,‖ EPA should include a plain statement of the risks at issue. Although it provides the MIR and chronic and risk numbers, these are not easily understandable by the general public. EPA does not state in the rule proposal the types of cancer or the nature of the health disorders or other adverse effects that these risks represent to the public. For example, although it states that the reproductive system and nervous system are at particular risk for these source categories, it does not describe, analyze, or explain what types of effects these would be, or put this in terms that the public can understand. If particular people are more likely to be susceptible to such risks, such as children, elderly, women of childbearing age, in dividuals with preexisting diseases, EPA should also discuss this, as the SAB has urged it to do. SAB May 2010 at 50.
This type of ―[e]xpanded discussion is important to understanding the  ̳real

- world‘ risk, including dealing with health disparities. For ex ample, it would be important to recognize if a risk driver for a particular facility exacerbated asthma and the community surrounding the facility was a low

- income population with an elevated incidence of asthma.‖ Id. If a small number of people are expose d at a high risk to an extremely debilitating disease, this may make a level of risk unacceptable, or require a larger ―margin of safety‖ than might be true in a different circumstance. Yet, EPA does not even list the health problems at issue with the emis sions from these source categories, including xylenes, ethyl benzene, toluene, formaldehyde or glycol ether emissions. Doing so is necessary to fully evaluate the risks (and to demonstrate the value of the new residual risk standard that EPA is proposing). Without this, it is difficult for the public to provide meaningful comment, such as on EPA‘s proposal not to set a standard for shipbuilding and ship repair and not to set a standard for glycol ether emissions from wood furniture manufacturing operations. EPA should provide a statement and analysis in this residual risk rulemaking and all others on the ―real world‖ health effects at issue in the rulemaking, so that the public has a clear understanding of what the risk is, and precisely what types of harm t o public health EPA is determining are either ―acceptable‖ or ―unacceptable.‖

Response : It is EPA‘s goal to make all rule preambles and risk assessments in plain language. The document s ha ve been made to be in plain language as much as possible.23

14. Comment : C ommenter 46 suggested that EPA delist all source categories that EPA believes meet Section 112(c)(9) criteria and use Title V to enforce emission lim i ts and standards as part of Section 112(c)(9) delisting:

Section 112(c) requires EPA to list and regulate , on a prioritized schedule, ―all categories and subcategories of major sources and areas sources‖ that emit one or more hazardous air pollutants. 42 U.S.C. §7412(c)(1). EPA may delete any source category from the list under this subsection, on petition of any person or on its own motion, whenever it determines the source category meets certain criteria. Id. §7412(c)(9). To the extent EPA‘s risk assessment finds the source ca tegory (or subcategory) has low risk, EPA should delist th e so urce category (or sub category). If not delisted and EPA finds that it may continue to revise the standard based on new technologies (which we dispute), sources will be subject to an endless technology ratchet, uncertainty and costs as new technologies are developed. All despit e the fact that the sources within the category pose little risk, if any, to the public. EPA has recognized the availability of section 112(c)(9) ―to remove the burden of the repetitive review of Section 112 standards for low risk source categories.‖ 71 Fe d. Reg. 17,729, 17,735 (Apr. 7, 2006). We support EPA‘s determination to investigate approaches for removing low

- risk source categories from the section 112 universe. Id.

Delisting is appropriate even after MACT standards have been in place. Section 112(c )(9) expressly states EPA has the author ity to delist categories ―whenever.‖ Moreover, the residual risk review comes after EPA issues a MACT standard, and EPA should be allowed to use the residual risk review under section 112(f) to
determine if the sourc e should now be delisted. EPA has previously delisted sources based on a finding that emissions were significantly lower than previously estimated, posing reduced risks. 60 Fed. Reg. 61,550 (Nov. 30, 1995) (delisting asbestos processing area source categor y). This decision was based, in part, on findings that U.S. processors currently employ very effective baghouse collection methods and these ―control methods will continue to be employed even after the area source category is delisted.‖ Id. at 61,551; see also 61 Fed. Reg. 30,816, 30,821 (June 18, 1996) (delisting pollutant where facility agreed to limit emissions below certain risk level). Those elements of the MACT standard that might be needed to sustain the low
risk determination and could be establishe d as part of the source category delisting decision. These requirements could be enforceable and maintained in existing Title V permits to ensure the public health protection contemplated by section 112(c)(9).

Response : Based on our risk assessment of the Wood Furniture Manufacturing and the Shipbuilding and Ship Repair (surface coating) source categories, we did not find that these source categories have low risk with cancer risks below 1 in a million. The cancer risks from
these sources are considered ac ceptable with MIRs of 10 in a million , and the existing MACT
standards provid e an ample margin of safety to protect public health. In addition , for wood furniture manufacturing, we are adopting additional standards under 112(d)(6) , as explained
elsewhere in this document and the preamble to the final rule . Therefore, delisting these source categories would not be appropriate based on the risk estimates. We note that we have previously discussed our position on delisting low

- risk source categories in the final residual risk action for the Magnetic Tape Manufacturing Operations source category (71 FR 17724).24

15. Comment : Commenter 45 stated EPA has provided no rational explanation for refusing to update the technology standards for both categories to meet the CAA § 112(d)(6) requirement, at minimum, by matching the limits of what sources have achieved and what other jurisdictions have required.

We urge EPA to do so in the final rule. Where, as here, there are ―significant developments‖ in technology, and where , as here, sources have achieved lower levels of emissions ―in practice‖ than are ―MACT

- allowable,‖ it is abundantly clear that § 112(d)(6) requires EPA to revise its standards in accordance with CAA § 112(d)(2)

- (3), (6), 42 U.S.C. § 7412(d)(2)

- (3), (6).

R esponse : The EPA has concluded the technology review for the wood furniture manufacturing operations NESHAP by setting a formaldehyde limit based on formulation (1 percent by weight) of finish coatings and contact adhesives with a compliance alternative of using no more than 400 pounds of formaldehyde per 12 months. Also under the technology review we are adopting a restriction of conventional spray guns limiting use to when emissions
from finishin g applications are routed to a control device. The commenter refers to volatile organic compounds (VOC) standards of the Bay Area and South Coast Air Quality Management Districts (BAAQMD and SCAQMD). These two standards are nearly identical in VOC formulation limits. Through the RTR process, the EPA evaluates risk and technology developments associated with HAP for the source categories under consideration. HAP and VOC describe different sets of compounds, although a large subset of VOC are considered HAP. As discussed in the preamble of the proposed rule, we estima te that of all VOC in wood furniture coatings, 50 percent on average are HAP. This is an average value that in fact varies from facility to facility and coating to coating, depending on the facility‘s use of coatings specific to their operation. This is es pecially true for many niche companies. The EPA acknowledges BAAQMD and SCAQMD implementation of VOC limits, but these limits are not justified as nation

- wide standards to reduce HAP from Wood Furniture Manufacturing. They are not technically feasible
to b e implemented nationally based on different operating and environmental conditions as well

as based on the cost effectiveness. By the commenter‘s own admission, there are facilities that are having a difficult time complying with the BAAQMD standard within its region. Moreover, based on available information, the EPA maintains that both area regulations are not cost effective as national standards to reduce HAP. As discussed in the preamble to the proposed rule, adoption of the BAAQMD VOC limits would resul t in 56 tpy of HAP reduction at a cost of $30,000 per ton. Although the commenter asserts based on a conversation with BAAQMD staff that companies in the area are generally complying with BAAQMD limits, EPA already assumed compliance when we estimated HAP reductions and cost effectiveness of the BAAQMD limits. We have not changed our conclusion that the BAAQMD and SCAQMD regulation s are not cost effective as a national standard.

16. Comment : Commenter 45 stated that it is not rational or lawful for EPA to as sume there is no potential for multi

- pathway or environmental risks from HAP emissions.

EPA recognizes that there is a human inhalation risk posed by the hazardous air pollutants emitted from both source categories. Yet ―multi

- pathway exposures and enviro nmental risks were deemed negligible‖ for both source categories. The minimal analysis EPA performed on25

this issue does not satisfy the statutory requirement ―to prevent . . . an adverse environmental effect.‖ 42 U.S.C. § 7412(f)(2)(A).

EPA‘s approach is illogical and unlawful. Chemicals that are persistent in the environment and bioaccumulative in living tissue should not be evaluated on the basis of acute toxicity. The persistence of such chemicals means that their levels will increase over time, particu larly in areas of high use. Accordingly, any additional exposure from current activities would thus be added to a background that is likely unsafe already.

Where there are human health risks from inhalation, it is unclear how, without analysis, EPA can

con clude that there would be no effects either to wildlife or to natural resources in the environment either from inhalation or air deposition of HAP emissions, exacerbated by persistence and bioaccumulation. As the SAB has stated: ―The assumption that ecolog ical receptors will be protected if human health is protected is incorrect.‖ SAB May 2010 at 48.

EPA must perform an appropriate ecological assessment. Its failure to do so here is especially problematic for shipbuilding and ship repair because these opera tions are likely to be located at or near a port, and very close to water.

Further, polycyclic organic matter (―POM‖), a carcinogenic HAP with a mutagenic mode of action that is emitted by facilities in both source categories, is a Great Waters pollutant o f concern and EPA has previously noted that the section 112(f)(2) residual risk rulemaking is an important time to address this type of environmental risk.

EPA has recognized that the coatings at issue for these sources ―evaporate and can contribute to

gro und

- level ozone and air pollution.‖ Doc. No. EPA

- HQ

- OAR

- 2010

- 0786

- 0023 at § 1.2 (Memo re: Developments in Practices, Processes, and Control Technologies for Wood Furniture Manufacturing Operations). Not only does ground level ozone result in harm to human health, it is also known to cause adverse environmental effects. In view of this, EPA must analyze the residual environmental effects, after the CAA § 112(d) standards are in place, and determine whether to set a standard to prevent this.

Finally, as the S AB recommended, EPA should include an analysis of both background and incremental risk. As the SAB has explained: ―[a] residual risk analysis that does not add exposures to baseline contamination to the estimates of on

- going contamination may vastly
undere stimate the hazard quotient at the site and incorrectly conclude that the on

- going releases pose risks at less than threshold levels.‖ SAB May 2010 at 41.

Response : Contrary to the commenter‘s assertions, we addressed the commenter‘s concerns as part of o ur multi

- pathway exposure and environmental risk analyses. The potential for significant human health risks due to exposures via routes other than inhalation (i.e., multipathway chronic exposures) was screened by first determining whether any sources emit ted any hazardous air pollutants known to be persistent and bioaccumulative in the environment (PB

- HAP). Emissions of 3 different PB HAP were identified in the emissions inventory for the Wood Furniture Manufacturing source category; they are POM, lead, an d cadmium. These emissions were evaluated for potential non

- inhalation risks and adverse environmental impacts26

using the screening scenario which was developed for use with the TRIM.FaTE model. This screening scenario uses environmental media outputs from the peer

- reviewed TRIM.FaTE model to estimate the maximum potential ingestion risks for any specified emission scenario by using a generic farming/fishing exposure scenario that simulates a subsistence environment. In the scenario, the farmer/recreational fisher was located at the point of the maximum impact to agricultural land near the hypothetical facility, and our assessment included the consumption of all types of home produced fruit, vegetables, beef, pork, and dairy products, as well as locally caugh t fish. The pathways included in this assessment were inhalation, soil ingestion, produce ingestion, fish ingestion, drinking water ingestion, and breast milk ingestion for infants. The farmer was assumed to consume locally caught fish at the rate of a rec reational fisher, with high

end consumption rates based on EPA values from the  ̳ ̳Exposure Factors Handbook‘‘ were included in the analysis to increase confidence that individuals that may have higher consumption would be protected. 5 Risks were estimated us ing the health protective assumption of lifetime continuous exposures. The screening scenario retains many of the ingestion and scenario inputs developed for EPA‘s Human Health Risk Assessment Protocols (HHRAP) for
hazardous waste combustion facilities. 6 I n the development of the screening scenario a sensitivity analysis was conducted to ensure that its key design parameters were established such that environmental media concentrations were not underestimated, and to also minimize the occurrence of false po sitives for human health endpoints. For the purpose of developing emission
rates for our multi

- pathway screening, we derived emission levels for each PB HAP at which the
maximum human health risk would be 1 in a million for lifetime cancer risk or a hazard quotient of 1.0 for noncancer impacts. The POM and cadmium emissions from the wood furniture manufacturing source category were at least 3 orders of magnitude below the emission rates for these two pollutants.

In evaluating the potential multi

- pathway ri sks from emissions of lead compounds, rather than developing a screening emission rate, we compared maximum estimated chronic (3

- month average) atmospheric concentrations with the current National Ambient Air Quality Standard (NAAQS) for lead. The maximum annual average off

- site concentration of lead for this source category was 2 orders of magnitude below the NAAQS and was considered to have a low potential for multi

- pathway risks.

We evaluated the potential for significant ecological exposures to non PB

- HAP from
exceedances of chronic human health inhalation thresholds in the ambient air near these
facilities. Human health dose

- response threshold values are generally derived from studies conducted on laboratory animals (such as rodents) and developed with the inclusions of uncertainty factors that could be as high as 3000. As a result, these human threshold values are often significantly lower than the level expected to cause an adverse effect in an exposed rodent.
It should be noted that there is a scarci ty of data on the direct atmospheric impact of these HAPs on other receptors, such as plants, birds, and wildlife and that the EPA will continue to monitor the scientific literature for new data in this area. Thus, if the maximum inhalation hazard in an

ec osystem is below the level of concern for humans, we have generally concluded that mammalian receptors should be at no risk of adverse effects due to inhalation exposures from

5 EPA‘s Exposure Factors Handbook (Final); http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=12464

6 EPA‘s HHRAP for Hazardous Waste Combustion Facilities (Final);
htt p://www.epa.gov/osw/hazard/tsd/td/combust/risk.htm27

non PB

- HAP, and have assurance that other ecological receptors are also not at a ny significant risk from direct atmospheric impact. In some isolated cases where we have data indicating potential adverse impacts on plants, birds, or other wildlife due to the direct atmospheric impacts of specific HAPs, we note that as an uncertainty an d, where possible, refine our analysis by comparing our modeled impacts to available threshold values from the scientific literature. The approach described here for evaluating human multipathway exposures and risks consists of an initial, screening

- level tier that can be conducted quickly and efficiently to determine those facilities for which multipathway chronic risks are expected to be below levels of concern. Regarding ground

- level ozone, the language cited by the commenter was brief descriptive
inform ation in a memo on developments in technology in wood furniture manufacturing. As described in the preamble to the final rule, EPA conducted a risk assessment for HAP from the source category, including an analysis of multipathway and environmental effect s, which is precisely what is required by section 112(f). EPA properly evaluated the risks from the HAP at issue from this source category.

17. Comment : Commenter 52 stated that EPA fails to provide a rational basis for using
allowable emissions in conductin g risk assessments under § 112(f). EPA uses the term ―MACT allowable‖ emissions in the preamble to mean ―the highest emission level that could be emitted by the facility without violating the MACT standards.‖ The Agency asserts that considering
MACT allowa ble emissions in determining residual risk under § 112(f) ―is inherently reasonable since these risks reflect the maximum level sources could emit and still comply with national emission standards.‖ Without further explanation as to why it might be appropr iate to determine and apply MACT allowable emissions in § 112(f) risk assessments, the Agency goes on to explain that it developed a ratio method of estimating MACT allowable emissions and ―applied these ratios on a facility

- by

- facility basis to the maximu m chronic risk values from the inhalation risk assessment to obtain facility

- specific maximum risk values based on MACT

- allowable emissions.‖ The Agency considered risks based on MACT allowable emissions in its proposed risk assessments for the two subject source categories.

EPA cannot lawfully use MACT allowable emissions in the proposed risk assessments and residual risk determinations because the Agency has failed to provide any reasoned explanation for why risk assessments based on actual emissions esti mates are inadequate. The Agency‘s risk assessment methodology already is rife with conservative assumptions. For example, health benchmarks, such as acute reference doses, typically incorporate two to three orders of magnitude of conservatism to account f or uncertainties, such as the extrapolation of animal toxicity testing data to humans. Similarly, the dispersion models used to predict off

- site ambient HAP concentrations attributable to emissions from affected sources incorporate numerous
conservative as sumptions to simplify the analysis of highly complex factors, such as meteorology and atmospheric chemistry. In addition, risk assessments assume exposure to the most exposed individual on a continuous basis for an entire lifetime.

In light of the conserv atism that already is inherent to EPA‘s risk assessment methodology, it makes no sense to apply yet another layer of conservatism

– this time based on the hypothetical assumption that affected sources should be expected to emit more than the actual data in dicate

– to § 112(f) risk assessments. EPA has provided no data or analyses indicating that its current methodology results in negative bias. EPA has provided no data demonstrating that affected sources actually do emit at levels significantly higher than the actual data show for any28

significant period of time. In short, EPA‘s proposal to use hypothetical emissions levels in § 112(f) risk assessments is justified on nothing more than the bald assertion that sources might emit at these higher levels. The fai lure to provide a reasoned explanation as to why this approach is justified and the failure to provide any record evidence supporting the use of MACT allowable emissions render this proposal insupportable under the law.

Response : We have explained our use of both allowable and actual emissions in previous actions, including the final Coke Oven Batteries residual risk rule (70 FR 19998

- 19999, April 15, 2005) and in the proposed and final SOCMI HON residual risk rules (71 FR 34428, June 14, 2006, and 71 FR 76 603, December 21, 2006, respectively). In those actions, we noted that modeling the allowable levels of emissions (i.e., the highest emission levels that could be emitted while still complying with the NESHAP requirements) is inherently reasonable since t hey reflect the maximum level sources could emit and still comply with national emission standards. But we also explained that it is reasonable to consider actual emissions, where such data are available, in both steps of the risk analysis, in accordance with the Benzene NESHAP. We also note that our use of allowable emissions levels in the risk assessments in this rulemaking did not result in revising the previously established standards based on risk concerns.

18. Comment : Commenter 45 pointed out that EPA‘s own data show greater reductions are being achieved and able to be achieved. EPA recognizes that certain sources have ―achieved‖ a level of ―actual‖ emissions that is below the level allowed under the existing MACT standards. EPA explains that ―the  ̳actua l‘ emission levels are often lower than the emission levels that a facility might be allowed to emit and still comply with the MACT standards.‖ EPA‘s expectation that sources in these two categories are generally operating at half the level of emissions al lowed under the existing MACT standard is at the core of its emission data analysis. Once EPA has this information, it must factor this into the technology review under section 112(d)(6). Doing so should lead EPA to revise the existing MACT for both source categories to require additional
emission reductions.

As part of the required section 112(d)(6) rulemaking, EPA can have no possible justification for failing to recalculate the MACT floors based on new technology or emission reductions now achieved by th ese source categories.

The court in the HON decision stated that it did ―not think the words  ̳review, and revise as necessary‘‖ required EPA to recalculate the floors ―from scratch‖ in that case. NRDC , 529
F.3d at 1084

. In short, the NRDC Court expressly declined to decide whether EPA was required to recalculate floors where, as here, there have been developments in practices, processes, and control technologies.

As already noted above, for these source categories, there are such ―developments.‖ Therefore, EPA cannot rely on the HON case to evade its duty to satisfy section 112(d)(6). The HON case did not authorize EPA to ignore data showing that significant emission reductions below the ―MACT

- allowable‖ emissions level have been ―achieved‖ in practice. Eve n under
NRDC

– assuming arguendo that its section 112(d)(6) holding is in any way relevant here

– section 112(d)(6) requires EPA to recalculate the MACT floor when there have been advances in technology (after taking account of the factors listed in sectio n 112(d)(6)), and when there is29

information showing that greater emission reductions are ―achieved in practice.‖ Commenters contend that, based on the information EPA has, it is therefore ―necessary‖ for EPA to strengthen the existing MACT floor to ensure it now complies with section 112(d)(2)

- (3).

EPA must consider and address whether the existing MACT, including the floor, remains lawful in view of the greater levels of emission reductions that have been achieved.

Response : The commenter is mistaken on se veral grounds. First, the commenter asserts that ―the EPA recognizes that certain sources have  ̳achieved‘ a level of  ̳actual‘ emissions that is below the level allowed under the existing MACT standards‖ and cites the NPRM preamble at
75 FR at 80227. This w as a qualitative, introductory statement about how National Emissions Inventory (NEI) and other sources of data typically contain estimates of actual emissions that are ―often‖ lower than allowable emissions. The statement was not specific to Wood Furnitur e or Shipbuilding facilities or data and in any event did not contain any quantitative determination
about actual emissions levels.

Second, the commenter asserts that the EPA has an ―expectation‖ that wood furniture and shipbuilding sources are ―generally operating‖ at half of allowable emissions and once the EPA has this information, it must use it under CAA section 112(d)(6) to revise MACT standards, including recalculating MACT floors under section 112(d)(2)

- (3). The comment apparently
refers to the MACT allowable to actual emissions ratio developed for the source categories in this rulemaking. The commenter is incorrect in characterizing this ratio as a determination of the level of actual emissions achieved in practice in either source category. The act ual to allowable ratio represents the lowest concentration of HAP in a coating available to the industry compared to the maximum allowed under the MACT. The allowable ratio is used for providing a worst

case scenario for estimating allowable emissions from the source. As clarification, for these coating rules, the concentrations of HAP in the coatings are considered the emissions from the

source.

Third, the commenter is incorrect in asserting that the EPA must recalculate MACT floors under CAA section 112( d)(2)

- (3). As explained in prior RTR rulemakings, the EPA does not read 112(d)(6) as requiring a reanalysis or recalculation of MACT floors. See proposed National Emission Standards for Coke Oven Batteries (69 FR 48388, 48351 (August 9, 2004)). Instead, we interpret section 112(d)(6) as essentially requiring us to consider developments in pollution control in the industry (―taking into account developments in practices, processes, and control technologies‖), and assessing the costs of potentially stricter s tandards reflecting those developments. We read this provision as providing the EPA with substantial latitude in weighing these factors and arriving at an appropriate balance in considering revisions to our standards. This discretion also provides us with substantial flexibility in choosing how to apply modified standards, if necessary, to the affected industry.

The EPA reviewed other potential developments in practices, processes, and control technologies for the Wood Furniture Manufacturing Operations and Shipbuilding and Ship Repair (Surface Coating) source categories and evaluated costs of potentially more stringent30

standards reflecting any such developments. 7 EPA believes this review and the revisions finalized in this rulemaking satisfy the EPA‘s oblig ations under CAA 112(d)(6) for the Wood Furniture and Shipbuilding source categories.

19. Comment : For the residual risk review, commenter 45 stated that EPA should not rely on industry

- reported, unverified emissions. EPA‘s Office of the Inspector General (OIG ) has reviewed the NEI data and found problems with accuracy and significant data gaps, e.g. , 57 percent of the data points were blank, and unpopulated records represented about 39 percent of total point source emissions. The OIG further concluded that ―EP A‘s reliance on voluntary efforts to provide air toxics NEI data has not provided assurance that the data are accurate and reliable,‖ and recommended that EPA require reporting of data in order to gain the data needed
to do an accurate residual risk assess ment.

Commenter 45 also noted that the use of voluntarily reported emission data results in an underestimation of risk. EPA‘s proposal relies on the NEI, Toxics Release Inventory searches, and EPA‘s own estimate or modeling of missing data, based on defaul t assumptions. The commenter encouraged EPA to make every effort in this and future rulemakings to use the section 114 information collection process and develop the best, most accurate dataset possible. Whenever voluntary reporting, estimates, emission fa ctors, or assumptions are used to develop data, this creates room for serious underestimates of risk, whether due to human error or other problems.

According to the commenter these and other elements of uncertainty present in EPA‘s emissions dataset weigh in favor of taking a conservative, health

- protective approach in the residual risk rulemaking process for each of these source categories.

Response: The emissions data for the two risk assessments in the proposed rules were
derived from the National Emissi on Inventory (NEI) and directly from industry and states. The sources of the data are documented in the docket. More generally, we note that we have greatly improved the NEI for HAPs since the 1996 NEI, which was the basis for the IG Report referred to by the commenter. We have worked diligently with state and local agencies and tribes to improve emission inventories over the years and we have instituted a number of QA measures to improve data received from state and local agencies since 1996. The 2005 NEI underwent a number of QA steps that were not used in the 1996 NEI. Documentation for the 2005 NEI point source emissions inventory is available on EPA's CHIEF website, http://www.epa.gov/ttn/ chief/net/2005inventory.html . Quality assurance and augmentation procedures used for the 2005 NEI point sources are contained in the report, EI Quality Assurance and Data Augmentation for Point Sources, posted at:

7 The EPA‘s review and analysis for the shipbuilding source category can be found in Affordability of Add

- on Controls for Surface Coating Operations at Shipbuilding and Ship Repair Facilities , dated 10/28 /2010, and for the wood furniture surface category in Affordability of Lower VHAP Coating and Add

- on Controls for Wood Furniture Manufacturing Operations, dated October 28, 2010. Other significant memos describing the EPAs technology
review are: Develop ments in Practices, Processes, and Control Technologies for Wood Furniture Manufacturing Operations

, dated August 24, 2010; Impacts of Prohibiting the Use of Conventional Spray Guns in the Wood Furniture Manufacturing Operations Source Category , dated Oct ober 19, 2010; Cost Analyses for Control Options , dated September 27, 2010; Cost Analyses for Add

- on Controls for Surface Coating Operations at Shipbuilding and Ship Repair Facilities , dated September 9, 2010

.31

http://www.epa.gov/ttn/chief/net/2002inventory.html . The 2005 NEI data have been reviewed extensively internally and externally during a 9 month effort as part of the development of the 2005 National Air Toxics Assessment (NATA). A s part of the 2005 NATA review, more than one million records for HAPs were revised. Updated test data and emission point information were received during the public comment period that addressed inaccuracies in the data.

For these source categories, EPA‘s review included an evaluation of facilities contained in the source category, the emissions units expected to be included for the processes in the source categories, coordinates and stack parameters and the HAP compounds and emissions levels typically see n. The EPA often had additional information on the source category, and where better data were available, this information was included in the proposal datasets. Sections V.A.1and V.B.1 of the December 21, 2010 proposal preamble (75FR80220) set forth a det ailed explanation of the review that EPA performed on the emissions data for the source categories subject to this final rule.

In addition, as part of the December 21, 2010 proposal, we made the data sets available for review using a RTR data review tool i n the docket and solicited comments on the data sets The RTR review of the proposal data sets act as another external third party review mechanism in addition to the external 2005 NATA review of the RTR data sets. Several opportunities have been provided t o review the data used in the current proposal during the last 3 years. Through enhanced NEI QA procedures, 2005 NATA review, public comment on proposal files, source category

- specific engineering reviews, and modeling, improvements to the data files have been made. We believe the data sets used in this rulemaking are sufficiently accurate and complete and constitute the best information EPA has concerning the emissions and risk from these source categories for conducting RTRs.

B. S SM PROVISIONS

20. Comment: Comm enter 52 disagreed with EPA‘s proposal to eliminate the SSM exemptions, arguing that EPA lacks authority, did not analyze why sources can be expected to meet the standards during SSM periods, and could have set separate standards for these periods.

The pr oposal to eliminate the SSM provisions in the proposed rule is not based on an accurate reading of Sierra Club , is not supported by any rational explanation as to why the elimination of the SSM provisions is justified, and is arbitrary and capricious given that EPA fails to provide any analysis of why affected sources reasonably can be expected to meet the emissions limitations and standards that the Agency proposes to apply during periods of SSM.
To begin, EPA‘s proposal ―that the standards in these rules apply at all times is not, as EPA claims, ―[c]onsistent with Sierra Club v. EPA .‖ The decision in that case was grounded in the court‘s assertion that § 112 requires emissions standards to apply a t all times. Based on this, the court held the SSM General Provisions do not comport with § 112 because, in the eyes of the court, the SSM provisions are not ―section 112

- compliant‖ emissions standards. Notably, the court did not hold that EPA is prohibite d from setting separate standards for periods of SSM. It simply held that standards for such periods must be developed according to the § 112(d) MACT

process.32

EPA‘s flawed legal analysis provides no support for the proposal to eliminate the SSM provisions in the two subject rules. This fundamental legal flaw is magnified by the Agency‘s failure to provide any explanation whatsoever as to why it is appropriate to now apply the existing emissions standards to periods of SSM. For example, EPA made no effort t o obtain emissions information from the two source categories for periods of SSM and provides no other evidence or analysis supporting its assertion that it is appropriate to apply the existing standards to periods of SSM. Moreover, EPA fails to investigat e the record data developed during the promulgation of the existing standards to assess whether those data are characteristic and representative of emissions during periods of SSM. In short, the Agency simply asserts with no record basis that, ―because ope rations and emissions do not differ from normal operations during these periods, [the Agency] has not proposed different standards for these periods. This unsupported assertion provides no basis for extending the existing standards to periods of SSM. The f ailure to seek relevant data, assess existing data, and investigate whether the existing standards should appropriately apply to periods of SSM is facially arbitrary and capricious and provides no support for the Agency‘s proposal.

Commenter 41 stated tha t sources most likely cannot meet the MACT floor standards during
SSM events:

EPA‘s statement that sources can meet the standards during SSM events is not based on any data. In fact it is most likely wrong. The current standards were developed during stead y

- state operations. It cannot reflect the variations that will be experienced during SSM events because no data was taken during these events. If EPA decides to require facilities to meet the same emission standards under both normal operations and during SSM events, they must use data gathered during both normal operations and SSM events in developing those standards.

Typically, regulations require that a facility perform an initial test to show that they are in compliance with their current emission stan dards. EPA requires these tests to be run under steady

- state conditions. In addition, this test is used to set operating parameters that the facility will show that it remains in compliance with the emission standards. EPA requires these tests to be run un der steady

- state conditions. In addition, this test is used to set operating parameters that the facility will show that it remains in compliance with the emission standards on a day

- to

- day basis. It is reasonable to use these operating parameters to show continued compliance during normal operations. However, conditions are constantly changing during SSM. The relationships developed during the initial test (and subsequent tests) between emissions and operating parameters are no longer valid under these con ditions and cannot and should not be used to show compliance. To expect a facility to comply with the same operating limits during transient events would require extrapolation outside the range of the data used to develop the relationship. If a facility we re to ask the Agency to be allowed to extrapolate an operating limit outside what was demonstrated during the test, it is likely that this request would be refused because there is no data to show that the relationship is still valid. The Agency could be

c orrect in rejecting this request, depending upon the request. Yet, EPA is telling33

facilities to do just that during transient events

- extrapolate beyond the range of the data used to develop the relationship. This is not scientifically correct nor is it

app ropriate.

Commenter 46 asserted that although the D.C. Circuit vacated the application of a ―general duty‖ to minimize emissions during SSM periods for standards promulgated under section 112 in the SSM Decision, it did so because it found that the genera l duty standard was not a ―Section 112

- compliant‖ standard. 551 F.3d at 1027

- 28

. The D.C. Circuit found that EPA need not apply the
same standard for normal operations during SSM periods and that EPA may justify the general duty standard for SSM periods u nder the alternative provisions of section 112(h). Id. EPA has not established that the standards that are now applicable to SSM periods are ―Section 112

- Compliant.‖ Section 112(d) requires a determination by EPA that the maximum degree of reduction requir ed is ―achievable.‖42 U.S.C. §7412(d)(2). In setting the floors, the D.C. Circuit has affirmed EPA must look to what the best controlled unit ―achieved under the worst
foreseeable circumstances.‖ Sierra Club v. EPA , 167 F.3d 658, 665 (D.C. Cir. 1999); see also Nat’l Lime Ass’n v. EPA , 233 F.3d 625, 631 (D.C. Cir. 2000). Thus, the Sierra Club decision does not require wholesale removal of the SSM exemptions.

The SSM Decision, however, does require EPA to ensure that the SSM standards are
section 112

- complia nt. While EPA purports to carefully consider the provisions related to the SSM requirements, 75 Fed. Reg. at 80,226, 80,240, EPA wholly fails to carefully examine its new policy regarding SSM, which it does not support, with respect to the specific standar ds at issue here. In fact, EPA asserts that this rule ―raises novel legal and policy issues,‖ 75 Fed. Reg. at 80,250, yet EPA does not address whether work practice standards are available in this case, or how its proposed revisions render the new SSM stan dards 112

- compliant for these specific sources. Indeed, the discussion on EPA‘s rationale for its actions related to the SSM provisions mirrors that in an earlier proposed rule, wholly failing to recognize the distinctions between the analysis, content and form of the standards at issue here. Compare 75 Fed. Reg. at 65,074, with 75 Fed. Reg. at 80,225

- 80,226. The public cannot meaningfully comment without fully understanding the rationale behind EPA‘s actions or their impacts.

Moreover, EPA‘s actions are ar bitrary and capricious because EPA failed to provide adequate support for its actions here and thus has not provided a ―reasonable‖ interpretation of section 112(d). It continues to fail to support its claims that ―[p]eriods of startup, normal operations, and shutdown are all predictable and routine aspects of a source‘s operations,‖ and wholly fails to do so with respect to these source categories specifically. 75 Fed. Reg. at 80,225. It is likely that startup and shutdown operations differ among source ca tegories, and there is no basis for such a generalized statement. For malfunctions, EPA simply asserts that it ―determined that malfunctions should not be viewed as a distinct operating mode, and, therefore, any emissions that occur during malfunctions do not need to be factored into development of CAA section 112(d) standards, which, once promulgated, apply at all times.‖ Id

. Nowhere in the Clean Air Act is the term ―distinct operating mode‖ used. Rather, the D.C. Circuit has, as noted above, expressly fou nd that EPA must consider emissions under the ―worst foreseeable conditions‖ and under ―recognized variations in34

operations.‖ Malfunctions fall under both these categories. Contrary to EPA‘s assertion, this does not require it to ―anticipate and account fo r the innumerable types of potential malfunction events in setting emission standards.‖ Id. at 80,224

- 80,225. EPA need only provide a rationale basis for its determination. EPA cannot, however, simply ignore malfunctions in setting emissions standards.

Res ponse : EPA notes as a preliminary matter that the comments concerning requirements applicable during startup and shutdown periods appear to be limited to facilities using a control device as a means of compliance to meet a numerical emission limit in the r elevant NESHAP.
As discussed in the Residual Risk Assessment for the Wood Furniture Manufacturing Source Category, 8 EPA believes that no more than 12 of 406 facilities subject to the Wood Furniture
MACT use control systems for compliance with these standa rds. For Shipbuilding and Ship Repair facilities, we are only aware of the standard being met by the use of compliant coating. The overwhelming majority of facilities use compliant coatings, without a control device, to
meet the standards. None of the co mments raised startup, shutdown, or malfunction issues arising from use of compliant coatings without a control device or from complying with work practice requirements.

In Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), the United States Court of App eals
for the District of Columbia Circuit vacated the startup, shutdown, and malfunction (SSM) exemption contained in section 63.6(f)(1) and (h)(1) of the part 63 General Provisions. The decision did not, as one commenter suggests, vacate the ―general dut y‖ provision or determine that the general duty ―may‖ be justified as a 112(h) standard during SSM events. The court did note that EPA had not purported to act under section 112(h). The EPA agrees that we are not prohibited from setting separate standards for periods of startup and shutdown (see discussion below and response to comments section of the final rule for EPA‘s response on issues related to malfunctions). EPA is finalizing the removal of the startup and shutdown exemptions and is not promulgati ng separate emission standards for these source categories that apply during periods of startup and shutdown because EPA has no reason or data to support setting such separate standards. EPA did not propose separate emission standards for periods of start up and shutdown, because EPA had no data or other basis to set different standards for these periods. As discussed in the preamble to the proposed rule, EPA made available the facility

- specific data used in the analyses for this rule and requested comment s on the data, such as improvements and corrections to the datasets. The data elements for each facility specifically included fields for ―Startup Emissions,‖ ―Startup Emissions Max Hourly,‖ ―Shutdown Emissions,‖ and ―Shutdown Emissions Max Hourly.‖ EPA did not receive any such data from any commenter for periods of startup or shutdown at any facility in the database. Although certain commenters disagreed with EPA‘s proposed actions and criticized EPA‘s lack of data regarding startup and shutdown
emissio ns, they did not submit any emissions or operational data regarding sources in either source category to support a different standard for periods of startup and shutdown.

EPA solicited comments from regulated sources and the public to inform our decision to remove the exemptions for periods of startup and shutdown. If EPA had received data in support of commenters‘ claims that compliance during startup and shutdown is impracticable, we could
have assessed whether the data would cause us to reconsider our position and take steps to set

8 Memorandum can be found in the docket for this rulemaking, EPA

- HQ

- OAR

- 2010

- 0786

- 0017.35

different standards for periods of startup and shutdown. No such data was received for the source categories under consideration.

Commenters‘ allegations that sources may not be able to meet the MACT standards during

sta rtup and shutdown are conclusory and lack supporting information or data. Based on information available to EPA, there are relatively few wood furniture facilities that use a control device to comply with the Wood Furniture NESHAP, and there is no reason to believe that processes at such facilities produce HAP emissions higher during startup or shutdown than during normal operations. To address the commenter‘s example, a wood furniture facility using a regenerative thermal oxidizer (RTO) as a control devi ce to comply with the NESHAP can use solely natural gas as a fuel during startup and shutdown of the control device and send overspray stream to the control device only when the control unit is ready, e.g., performing at combustion temperatures. Under the se conditions, facilities in the source categories in this rule should have no difficulty complying with applicable emission limits in the relevant NESHAP. EPA received no data or other information in public comments that contradicted these conclusions.

The commenter is correct that testing for emissions from a control device used as a means of compliance such as a regenerative thermal oxidizer (RTO) should be done during steady

- state conditions, and periods of startup and shutdown generally do not q ualify. In the case of spray lines controlled by an RTO, the spray is either on or off; so long as the spray is turned on only when the RTO is operating properly at combustion temperatures, EPA expects emissions will be much lower, not higher, during start up and shutdown than during steady

- state conditions. Extrapolation is not necessary to show compliance during startup and shutdown because there is no transient period of emissions for these source categories. Provided that the control device is
functioni ng properly prior to starting (and until completing) coating operations, and provided the control device has the necessary control efficiency, there is no reason to believe excess emissions will occur. For facilities that use RTOs as a means of compliance, the start

- up and shutdown periods can be performed while running solely on an independent fuel source such as natural gas. Once the RTO reaches the proper operating temperature and is functioning properly, coating application may commence and over

- spray c an be routed to the RTO for destruction of HAP in compliance with the NESHAP.

Thus, commenters have not identified any technical limitations or any other reason that startup or shutdown of the process or of a control device from a facility in the two source categories in this rule would cause a source to exceed an applicable emission limit.. In sum, while some commenters state that EPA lacks data to justify elimination of the exemption in the MACT standards for periods of startup and shutdown, as to so urces relying on control devices for compliance, EPA believes there is a reasonable basis to eliminate the exemption and expect sources will not have difficulty complying with applicable MACT standards during startup and shutdown. Further, commenters have not identified any factual or legal basis to justify different standards during such periods.

Periods of startup, normal operations, and shutdown are all predictable and routine aspects of a source‘s operations. However, by contrast, malfunction is de fined as a ―sudden, infrequent, and not reasonably preventable failure of air pollution control and monitoring equipment, process equipment or a process to operate in a normal or usual manner * * * ‘‘(40 CFR 63.2). One36

commenter criticizes EPA for using t he phrase ―distinct operating mode‖ in explaining its approach to malfunctions. EPA‘s choice of that phrase is not significant to its analysis. EPA has determined that CAA section 112 does not require that emissions that occur during periods of
malfuncti on be factored into development of CAA section 112 standards. Under section 112, emissions standards for new sources must be no less stringent than the level ―achieved‖ by the best controlled similar source and for existing sources generally must be no le ss stringent than the average emission limitation ―achieved‖ by the best performing 12 percent of sources in the category. There is nothing in section 112 that directs the Agency to consider malfunctions in determining the level ―achieved‖ by the best per forming or best controlled sources when setting
emission standards. Moreover, while EPA accounts for variability in setting emissions standards consistent with the section 112 caselaw, nothing in that caselaw requires the Agency to
consider malfunctions as part of that analysis. Section 112 uses the concept of ―best controlled‖ and ―best performing‖ unit in defining the level of stringency that section 112 performance standards must meet. Applying the concept of ―best controlled‖ or ―best performing‖ to a unit that is malfunctioning presents significant difficulties, as malfunctions are sudden and unexpected events. Further, accounting for malfunctions would be difficult, if not impossible, given the myriad different types of malfunctions that can oc cur across all sources in the category and given the difficulties associated with predicting or accounting for the frequency, degree, and duration of various malfunctions that might occur. As such, the performance of units that are malfunctioning is not ―reasonably‖ foreseeable. See, e.g., Sierra Club v EPA , 167 F. 3d 658, 662 (D.C.Cir. 1999) (EPA typically has wide latitude in determining the extent of data

- gathering necessary to solve a problem. We generally defer to an agency's decision to proceed on the basis of imperfect scientific information, rather than to "invest the resources to conduct the perfect study."). See also Weyerhaeuser v Costle , 590 F.2d 1011, 1058 (D.C. Cir. 1978) (― In the nature of things, no general limit, individual permit, or e ven any upset provision can anticipate all upset situations. After a certain point, the transgression of regulatory limits caused by  ̳uncontrollable acts of third parties,‘ such as strikes, sabotage, operator intoxication or insanity, and a variety of
othe r eventualities, must be a matter for the administrative exercise of case

- by

- case enforcement discretion, not for specification in advance by regulation.‖). In addition, the goal of a best controlled or best performing source is to operate in such a way a s to avoid malfunctions of the source and accounting for malfunctions could lead to standards that are significantly less stringent than levels that are achieved by a well

- performing non

- malfunctioning source. EPA‘s approach to malfunctions is consistent with section 112 and is a reasonable interpretation of the

statute.

21. Comment : Commenter 39 stated that the SSM changes are unreasonable and should be appealed.

[The commenter] relies upon control equipment to meet the emissions standards of the Subpart JJ MACT requirements at several sites. The control equipment provides the necessary emissions control and operational certainty where alternative materials are not practical or where they simply are not feasible. The SSM notice provided by EPA is in response to a court ruling that states (in part) conformance to the 40 CFR Part 63, Subpart A provisions for start

- up, shut

- down and malfunction of a control device cannot be relied upon as an affirmative defense in instances where the control
devices has failed r esulting in excess emissions.37

With any mechanical system, failures of the mechanical elements occur. Indeed, such devices must also be started up and shut down. Proper operation in accordance with and as detailed in the Subpart A requirements have been re lied upon by those operations as reasonable for reducing overall emissions. Facilities operating in accordance with the SSM provisions have done so under the premise that those operating procedures are also reasonable for providing [an] operating safeguard for restricting excess emissions.

Despite the added capital and operating expense to comply with the Subpart JJ provisions using control equipment, EPA has now made notice that ―playing by the rules‖ will not provide those same operations with assured co mpliance. This action adds unacceptable compliance risks that are unnecessarily burdensome. The change in SSM provisions has been superimposed upon operations that selected the control and HAP emissions reductions strategies years ago from a list of option s designed by, promulgated by and sanctioned by U.S.EPA.

Response: The EPA acknowledges that some facilities may use control devices to meet emission standards in Supbpart JJ. For the reasons explained above and in the response to comments section of the preamble to the final rule, EPA is removing the SSM exemption and has identified no technical or other reason not to do so. In addition, we are finalizing provisions for an affirmative defense, as discussed in the preamble.

22. Comment: Commenter 46 stated that EPA‘s Startup, Shutdown and Malfunction Provisions are arbitrary, capricious and otherwise not in accordance with law:

Section 307(d) requires EPA to provide the public a meaningful opportunity to comment. 42 U.S.C. §7607(d)(3), (5); see also Kenneco tt Corp. v. EPA , 684 F.2d 1007, 1018

- 19 (D.C. Cir. 1982). Part and parcel of this requirement is EPA‘s obligation to provide a statement of basis for its proposed Rule. 42 U.S.C. §7607(d)(3). The statement of basis must include: (a) the factual data on whi ch the proposed Rule is based; (b) the methodology used in obtaining the data and in analyzing the data; and (c) the major legal interpretations and policy considerations underlying the proposed Rule. Id . EPA‘s only purported legal basis for these revision s is to make the SSM provisions ―[c]onsistent with Sierra Club v. EPA ‖ (also referred to as ―SSM Decision‖). 75 Fed. Reg. at 80,225. EPA had identified Shipbuilding and Ship Repair as being directly affected by the SSM decision, because it incorporated by reference the vacated provisions, but not the Wood Furniture Manufacturing. Kushner Letter regarding Vacatur of SSM Exemption, July 22, 2009, available at http://www.epa.gov/compliance/civil/caa/ssm

- memo080409.pdf (―Kushner Letter‖)

. Importantly, however, EPA fails to explain how application of the standards for normal operations to SSM, where it had previously been exempted, otherwise meets the requirements of section 112. In addition, EPA provides no factual support for its proposed changes or explanation as to why its proposed changes are necessary with respect to these specific source categories. As such, EPA‘s Proposed Rule fails to meet the procedural requirements of the Clean Air Act, and the public cannot meaningfully comment on the legal or factual bases for its proposed SSM provisions.38

Response: EPA believes it provided a robust statement of basis for the proposed rule and satisfied all procedural requirements of the CAA. As to the SSM changes as they apply to Wood Furniture Manufacturing (Subpar t JJ), the commenter notes the ―Kushner Letter‖ did not list Subpart JJ in attached tables of regulations that were believed to contain SSM exemption language. The purpose of the letter was to address potential compliance issues arising from the
Sierra Cl ub court decision and EPA‘s plan for addressing those concerns, including potential future revisions to section 112(d) standards. The letter at p. 3 expressly stated ―[t]he tables attached to this letter are based on EPA‘s initial analysis and are, theref ore, subject to change‖ [footnote omitted].

In the proposed rule, EPA discussed the Sierra Club court decision, including the court‘s vacature of the SSM exemption in 40 CFR 63.6(f)(1). EPA proposed SSM changes, including a revision to Table 1 to Subpart JJ to specify that the SSM exemption in 40 CFR 63.6(f)(1), among other provisions, does not apply. Regardless of whether Subpart JJ was listed in the tables to the Kushner Letter, which were based on an initial analysis subject to change, EPA is finalizin g the SSM changes, consistent with the basis and reasoning of the court‘s Sierra Club decision.

Regarding the application of standards to SSM periods, see EPA‘s responses above.

23. Comment : Commenter 45 stated that the affirmative defense is unlawful, would h ave harmful consequences for communities, will greatly reduce the deterrent impact of the standards, is outside of EPA‘s delegated authority by limiting civil penalties, will impermissibly chill citizen enforcement, undercuts Congress‘s intent that citizen enforcement should avoid re

delving into technological or other considerations, and is equivalent to giving polluters a ―get out of jail free‖ card for serious violations:

An ―affirmative defense‖ for malfunctions...will reduce the deterrent value of the
MA CT standard and undermine or cut off the ability of people living near facilities that violate the standard to seek civil penalties.

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 civil enforcement mechanisms available to the government, and, in the HAP context, subject only to the limitation that governme nt not be ―diligently prosecuting‖ its own civil enforcement action, CAA § 304(b)(1)(B), 42 U.S.C. § 7604(b)(1)(B). EPA‘s rule proposal, by shifting this careful balance and contravening these mandates,
violates the CAA.

The affirmative defense that EPA pr oposes to allow in case of malfunctions goes directly against congressional intent in two ways. First, Congress expressed a clear intent as to how judges should determine the size of civil penalties whenever they are sought and thus, under Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc ., 467 U.S. 837, 842

- 43 (1984), flatly barred EPA from limiting when civil penalties can be assessed. In this proposal, EPA acts outside of its delegated authority to limit civil penalties available in citizen suits o r its own enforcement actions. Second, the proposal will impermissibly chill citizen participation, and the ability to win an effective, deterrent remedy, in CAA enforcement.39

The affirmative defense is fatally flawed because EPA cannot create a bright

- line test to decide when civil penalties will not be allowed. The CAA itself spells out the only limits that Congress intended to impose on citizens‘ ability to seek and recover penalties in enforcement suits under § 304. 42 U.S.C. § 7413(e). By attempting to impose additional agency

- created limits, EPA exceeds its authority.

Congressional intent on civil penalties is clear

— they are a remedy available to citizen plaintiffs, and judges have a list of factors to consider in assessing them. As such,
EPA cannot int erpret the statute to contravene that intent. By attempting to eliminate, via regulations, civil penalties in cases of malfunction where the violator demonstrates that certain factors [exist], EPA has done just that.

The CAA grants EPA minimal discretion t hat only applies to administrative penalties, 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).

However, there is no similar gra nt of authority to EPA to compromise, modify or limit civil penalties that a court may impose under section 113(e) or section 304. Section 304(a), 42 U.S.C. § 7604(a), grants courts the sole authority ―to apply appropriate civil penalties‖ in citizen suits . 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 Congress that EPA cannot contravene by rule.
EPA‘s regulation would mean that if commenters or a local community group sued a shipbuilding or repair facility or a wood furniture manufacturing facility for its violation of the NESHAP, the owner would be exempt from paying civil penalties so long as the owner satisfie d the requirements set forth in EPA‘s regulations. See Proposed Rule, 75 Fed. Reg. at 80,249 (to be codified at 40 C.F.R. §§ 63.781(d), 63.800(j)). The owner would not be subject to civil penalties regardless how the congressionally mandated factors in the statute cut.54 That is, even if the owner benefited substantially from its violation, the penalty would not harm the owner economically, and the violation was extreme, the owner would not have to pay any civil penalty.

It is improper for a court to fail t o consider the factors in CAA § 113(e)(1), or to fail to make its own determination of what civil penalties are ―appropriate‖ under CAA § 304(a).55 A fortiori it is impermissible for EPA to attempt to displace those factors or in any way alter their signif icance by creating an absolute bar to penalties if certain

agency

- created considerations are met instead.

Citizen participation in CAA enforcement also will be hampered, in violation of citizens‘ rights to protect themselves from pollution and in direct co nflict 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 civil penalties against polluters in order to p rotect themselves and achieve the Act‘s goals will be forced to engage in fact

- intensive disputes over the cause of emission violations and adequacy of responsive measures

– an outcome Congress intended to prevent with the simple straightforward40

enforcemen t and penalty provisions in the Clean Air Act. As a result, enforcement of the Act will suffer, for civil penalties provide a powerful deterrent to violators as Congress intended. Thus, the affirmative defense also runs counter to two clearly expressed int entions of Congress: (1) the burden it places on citizens makes it less likely that 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 should avoid re

- delving into ―technological or other considerations,‖
NRDC v. Train , 510 F.2d 692, 700 (D.C. Cir. 1974). Both result from the technical burden EPA imposes on citiz ens with the affirmative defense, and both render the defense impermissible.There is simply no need for an affirmative defense to penalties to be written into the regulations and cause the harm that will result. EPA has discretion to decide what cases to p rosecute, 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. Promulgating this affirmative defense is equiva lent to giving polluters a ―get out of jail free‖ card 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 polluters to evade financial penalties

– which are the real
teeth of the standards

– through this type of measure is likely to lead to them simply ignoring or factoring potential standard violations into their cost of doing business, rather than actually trying to prev ent malfunctions and violations of the standards as a way to avoid financial losses from the application of penalties.

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

1. A specific amount of compensatory damages should apply to each reported malfunction. These funds should be dedicated to enforcement, inspections, and monitoring in the local community around the specific facility, to creat e greater assurance that malfunctions will not happen again.

2. EPA should modify the regulations so that the affirmative defense cannot be used by a specific facility or company more than once within a set period of time, such as 10 years. The affirmative de fense should become automatically unavailable to a facility that has previously had a malfunction within the last 10 years, to ensure that this defense does not swallow the value of the
standards.

3. EPA should promulgate specific public reporting and notific ation requirements for malfunctions, or any emission exceedance that occurs of which an operator is aware. Specifically, EPA should require that when a facility provides EPA with a notification of a malfunction or emission standard exceedance under the reg ulations, this notice will be made publicly available on EPA‘s website within 14 days. In addition, EPA should promulgate the requirement that when such notification is made, the facility must also provide for community notification of the malfunction or e mission standard exceedance within 2 business days, through an appropriate public41 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 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.

People li ving near the facilities in these source categories, and others regulated under section 112, are on the front lines in trying to protect themselves and their families from health problems due to air pollution that no one should have to worry about simply b ecause of where they live. Attempting to take away a right granted to citizens by Congress through an agency regulation sets a dangerous precedent. EPA should work to expand and protect the ability of people harmed by air pollution to seek all appropriate and available forms of relief in court. It should not retract or weaken citizen rights and remedies, as this proposal does, by making it more difficult for people to win meaningful relief from a facility that has released toxic air pollution
into their com munity.

Response : EPA believes making available an affirmative defense to civil penalties for periods of malfunction is reasonable in light of the elimination of the malfunction exemption in the emission standards for these source categories. As discuss ed below, EPA believes this approach is consistent with the Clean Air Act and the Court's Sierra Club decision by eliminating the exemption for malfunctions while providing the opportunity for sources to avoid civil penalties by satisfying prescribed crite ria. EPA does not expect the affirmative defense to affect significantly the practice of Clean Air Act enforcement, either by EPA or citizen suit. EPA has no reason to believe the affirmative defense to civil penalties will cause sources to
violate emiss ion standards.

EPA recognizes that even equipment that is properly designed and maintained can fail and that such failure can cause an exceedance of the relevant emission standard. EPA is providing an affirmative defense for the source categories in th is rule in an attempt to balance a tension, inherent in many types of air regulation, to ensure adequate compliance while simultaneously recognizing that despite the most diligent of efforts, emission limits may be exceeded under circumstances beyond the c ontrol of the source. EPA must establish emission standards that ―limit the quantity, rate, or concentration of emissions of air pollutants on a continuous basis.‖ 42 U.S.C. § 7602(k) (defining ―emission limitation and emission standard‖). See generally S ierra Club v. EPA , 551 F.3d 1019, 1021 (D.C. Cir. 2008) ( emissions limitations under CAA section 112 must both continuously apply and meet section 112‘s minimum stringency requirements, even during periods of startup, shutdown and malfunction). Thus, EPA is required to ensure that
section 112 emissions limitations are continuous. The affirmative defense for malfunction events meets this requirement by ensuring that even where there is a malfunction, the emission limitation is still enforceable through in junctive relief. While ―continuous‖ limitations, on the one hand, are required, there is also caselaw indicating that in many situations it is appropriate for EPA to account for the practical realities of technology. For example, in Essex Chemical v.
Ruck elshaus , 486 F.2d 427, 433 (D.C. Cir. 1973), the D.C. Circuit acknowledged that in setting standards under CAA section 111 ―variant provisions‖ such as provisions allowing for upsets during startup, shutdown and equipment malfunction ―appear necessary to p reserve the42

reasonableness of the standards as a whole and that the record does not support the  ̳never to be exceeded‘ standard currently in force.‖ See also Portland Cement Association v. Ruckelshaus

, 486 F.2d 375 (D.C.Cir. 1973). Though intervening ca selaw such as Sierra Club v. EPA and the CAA 1977 amendments undermine the relevance of these cases today, they support EPA‘s view that a system that incorporates some level of flexibility is reasonable. The affirmative defense simply provides for a defe nse to civil penalties for excess emissions that are proven to be beyond the control of the source. By incorporating an affirmative defense, EPA has formalized its approach to upset events. In a Clean Water Act setting, the Ninth Circuit required this typ e of formalized approach when regulating ―upsets beyond the control of the permit holder.‖
Marathon Oil Co. v. EPA , 564 F.2d 1253, 1272

- 73 (9 th Cir. 1977). But see, Weyerhaeuser Co. v.
Costle , 590 F.2d 1011, 1057

- 58 (D.C. Cir. 1978) (holding that an inform al approach is adequate). The affirmative defense provisions give the EPA the flexibility to both ensure that its emission limitations are ―continuous‖ as required by 42 U.S.C. § 7602(k), and account for unplanned upsets and thus support the reasonablenes s of the standard as a whole.

Further, EPA‘s view is that the affirmative defense is not inconsistent with CAA section 113(e) or 304. Section 304 gives district courts jurisdiction ―to apply appropriate civil penalties.‖ Section 113(e)(1) identifies the factors that the Administrator or a court shall take into consideration in determining the amount of a penalty to be assessed, once it has been determined that a penalty is appropriate. The affirmative defense regulatory provision is not relevant to the

a mount of any penalty to be assessed. If a court determines that the affirmative defense elements have been established, then a penalty is not appropriate and penalty assessment pursuant to the section 113(e)(1) factors does not occur.

In exercising i ts authority under section 112 to establish emission standards (at a level that meets the stringency requirements of section 112), EPA necessarily defines conduct that constitutes a violation. EPA‘s view is that the affirmative defense is part of the emis sion standard and defines two categories of violation. If there is a violation of the emission standard and the source demonstrates that all the elements of the affirmative defense are met, only injunctive relief is
available. All other violations of the emission standard are subject to injunctive relief and penalties. The CAA does not require that all violations be treated equally. Further, a citizen suit claim under section 304 allows citizens to commence a civil action against any person alleged to be in violation of ―an emission standard or limitation under this chapter.‖ The CAA, however, allows EPA to establish such ―enforceable emission limitations.‖ Thus, the citizen suit provision clearly contemplates enforcement of the standards that are def ined by EPA. As a result, where EPA defines its emissions limitations and enforcement measures to allow a source the opportunity to prove its entitlement to a lesser degree of violation (not subject to penalties) in narrow, specified circumstances, as EPA did here, penalties are not ―appropriate‖ under section
304.

EPA‘s view is that an affirmative defense to civil penalties for exceedances of applicable emission standards during periods of malfunction appropriately balances competing concerns.
On the one hand, citizen enforcers are concerned about additional complications in their enforcement actions. On the other hand, industrial sources are concerned about being penalized for violations caused by malfunctions that could not have been prevented and w ere otherwise appropriately handled (as reflected in the affirmative defense criteria). EPA has utilized its43

section 301(a)(1) authority to issue regulations necessary to carry out the Act in a manner that appropriately balances these competing concerns.

The EPA disagrees that the affirmative defense provision will hamper citizen enforcement. First, injunctive relief is still available and the threat of penalties would not deter violations in cases
where all of the conditions of the affirmative defense h ave been satisfied because the affirmative defense criteria ensure that all reasonable steps were taken to prevent a malfunction that causes excess emissions. Further, litigating whether a source has met the affirmative defense will not burden a citizen gr oup any more or less than would litigating the appropriate penalty amount in the penalty assessment stage of a citizen suit enforcement action, because the section 113(e) penalty assessment criteria and the affirmative defense criteria are similar and in f act overlap. For example, the requirement that the Administrator or the court consider ―good faith efforts to comply‖ is bound to generate the type of fact

- intensive disputes that the commenter complains of. In addition, several of the affirmative defense criteria are exactly the type of criteria the Administrator or Court might consider in determining whether a source made ―good faith efforts to comply.‖ For example, to take advantage of the affirmative defense, the source must prove by a preponderance of the evidence that, among other things, the excess emissions ―were caused by an unavoidable failure of air pollution control and monitoring equipment, process equipment, or a process to operate in a normal or usual manner‖ and ―could not have been prevented through careful planning, proper design or better operation and maintenance practices‖ and ―did not stem from any activity or event that could have been foreseen and avoided, or planned for.‖

Thus, the EPA does not expect the affirmative defense provisi on to significantly alter the burden of bringing a citizen enforcement action. For those cases that do proceed to trial, even in the absence of this affirmative defense, sources generally raise equitable arguments to argue for a low penalty and citizens of ten rebut such arguments. Therefore, as a practical matter, the EPA does not expect the affirmative defense provision to materially affect the practice of CAA
enforcement.

Additionally, the affirmative defense is reasonable. The EPA‘s judgment is that the affirmative defense criteria capture the appropriate considerations in determining whether penalties are appropriate when a violation occurs as the result of a malfunction. As noted above, the affirmative defense criteria overlap to some extent with the p enalty assessment criteria set forth in section 113(e), but are not identical. For example, size of business is one of the factors listed in section 113(e), but is not reflected in EPA‘s affirmative defense. This reflects the EPA‘s view
that when a violati on is caused by a malfunction, the size of the business is not relevant to whether penalties should be excused. If the violation was unavoidable and could not have been prevented, the EPA‘s view is that it would be unfair to impose a penalty no matter the size of the
business.

Contrary to assertions in some comments, sources will not be able to ―simply ignor[e] or factor[] potential standard violations into their cost of doing business, rather than actually trying to prevent malfunctions and violations‖. The affirmative defense provision provides that the defendant must prove the excess emissions were, inter alia, unavoidable, could not have been prevented through careful planning, proper design or better operation and maintenance practices,
did not stem from any activity or event that could have been foreseen and avoided, or planned44

for, and were not part of a recurring pattern indicative of inadequate design, operation, or maintenance. 40 CFR 63.781(d)(1) & 63.800(j)(1).EPA is not adopting commenters‘ suggestion with respect to compensatory damages or limits on the frequency of use of the affirmative defense. It is not clear that EPA has authority to require the automatic imposition of compensatory damages and even if such authority exists, EPA does no t think automatic imposition of damages is appropriate. Ensuring that malfunctions do not recur can be handled through imposition of appropriate injunctive relief. In addition, EPA‘s view is that it would not be appropriate to limit a source‘s ability to take advantage of the affirmative defense to one time over a specified period of time such as ten years given that the affirmative defense is only available when the source could not have prevented the excess emissions. With respect to commenters‘ sugges ted reporting requirements, the reporting requirements in the rules promulgated today already require malfunction reporting and the affirmative defense provisions require that parties choosing to assert the affirmative defense meet additional malfunction

r eporting requirements. Any such reports submitted to EPA are publicly available pursuant to
CAA section 114.

24. Comment : Commenter 41 believes that although EPA must take into account SSM events in establishing limits, the commenter agrees that a regulatory provision containing some form of
enforcement discretion such as an affirmative defense is needed for malfunctions. The commenter expressed concern about the burden of proof and suggested EPA establish a rebuttable presumption (rather than affirmative de fense) where it is presumed that the facility did everything in their power to minimize emissions during these events, unless the Agency proves certain facts that are enumerated in the rules. If the Agency wants to challenge these activities,
the burden of proof would be on them to show that the facility did not undertake reasonable actions to minimize emissions. The commenter also recommended the following:

1. Define ambiguous terms such as ―careful‖, ―proper‖, and ―better‖;

2. Delete reference to ―any‖ activity ;

3. Delete references to ―all‖ activities.

Commenter 46 states that to the extent EPA cannot set an achievable emissions limit or work practice standard for SSM events, e.g., because it may not be possible to identify every type of malfunction in setting emi ssion standards, the commenter did not dispute EPA‘s authority to provide an affirmative defense. The commenter says EPA did not explain why the affirmative defense does not apply to periods of startup and shutdown. The commenter stated that EPA has
clea r authority to provide an affirmative defense for malfunctions and that EPA has recognized the need to consider ―upsets‖ when establishing technology

- based standards under the Clean Water Act, citing: CMA v. EPA , 870 F.2d 177, 228

- 30 (5 th Cir. 1989); Weyer hauser v. Costle

, 590 F.2d 1011, 1057 (D.C. Cir. 1978); FMC Corp. v. Train , 539 F.2d 973, 986 (4 th Cir. 1986); as well as certain aspects of a 1999 EPA Memorandum on SIPs and SSM emissions. The commenter supported the incorporation of the definition of ―m alfunction‖ in 40 C.F.R. §63.2 and stated that a regulated entity should be able to assert a malfunction has occurred as an affirmative defense. The commenter objected to the proposed criteria for an affirmative defense and recommended changes:45

EPA asserts that the proposed criteria seek to ―ensure that the affirmative defense is available only where the event that causes an exceedance of the emission limit meets the narrow definition of malfunction in 40 C.F.R. §63.2.‖ 75 Fed. Reg. at 80,226 (emphasis adde d). The criteria outlined in the Proposed Rule to establish the affirmative defense, however, are inconsistent with this definition and must be eliminated. There simply is no justification to include criteria to establish an affirmative defense against an alleged violation that are more onerous than the requirements of the regulations.
Other criteria require ―all possible steps,‖ actions ―if at all possible‖ and repairs ―as expeditiously as possible.‖ Proposed 40 C.F.R. §§63.781(d)(1), 63.800(j)(1). These criteria are substantially more restrictive than the requirements to show a malfunction under the definition, and these more restrictive criteria would result in only a subset of malfunctions being considered eligible for the affirmative defense, if any at all, undermining the purpose of the provision.

Other criteria are more stringent than, or at least redundant of, the general duty standard and, again, should be eliminated. For example, the third criteria requires a showing that the ―frequency, amount, an d duration of the excess emissions (including any bypass) were minimized to the maximum extent practicable during periods of such emissions‖ while the eighth criteria requires a showing that ―the facility was operated in a manner consistent with good pract ices for minimizing emissions.‖ Proposed 40 C.F.R. §§63.781(d)(1), 63.800(j)(1). The general duty requires each owner or operator to operate and maintain any affected source ―in a manner consistent with safety and good air pollution control practices for m inimizing emissions.‖ The listed criteria for establishing an affirmative defense may impose a greater burden on regulated entities than would otherwise be required by the standards. At a minimum, they are redundant of the general duty standard and may

cau se undue confusion as to the applicable requirements.

EPA provides no explanation for using these onerous criteria. Although EPA cites to two memoranda addressing EPA‘s policy on how State Implementation Plans should treat excess emissions during SSM, 75 F ed. Reg. at 80,226, these memoranda are inapplicable to technology based standards. See EPA Mem., State Implementation Plans: Policy Regarding Excessive Emissions During Malfunctions, Startup, and
Shutdown , at n.6 (Sept. 20, 1999). For technology

- based sta ndards, EPA and courts have recognized that EPA must either (a) consider SSM in setting the standards or (b) provide an upset defense. Moreover, EPA provides no comparison as to the greater stringency of the affirmative defense as applied to malfunctions c ompared to the requirements for malfunction currently imposed under these source categories, particularly for Wood Furniture Manufacturing. EPA is, again, trying to impose a

one

- size

- fits

- all approach to these standards without providing any support, faili ng to give the public a meaningful opportunity to comment and rendering EPA‘s actions arbitrary and capricious.

Further, EPA provides no explanation as to why it has chosen to move away from the long

- standing upset defense at 40 C.F.R. §122.41(n), promulg ated under the Clean Water Act. Under that provision, an ―upset constitutes an affirmative defense.‖ 40 C.F.R. §122.41(n)(2). To establish the defense, the following criteria must be met:46 an upset occurred and the permittee can identify the cause(s) of the upset; the permitted facility was at the time being properly operated;
the permittee submitted notice of the upset (required within 24 hours).
the permittee took all reasonable steps to minimize or prevent the violation.

The criteria outlined in the Propo sed Rule are significantly more stringent than those provided in the Clean Water Act‘s ―upset defense,‖ imposing substantial burdens on regulated entities for actions that, by definition, are not the fault of the facility.

Thus, EPA must reconsider its SSM provisions, and reissue a proposal that provides its full legal and factual support for its determinations as to the appropriate standard to apply to SSM periods. If EPA subsequently determines to utilize an affirmative defense, then it should eliminate t he criteria in the proposal, and require the regulated entity to establish a malfunction, as defined in section 63.2 occurred. Alternatively, we suggest using the Clean Water Act‘s upset defense as a model, rather than the
1983 and 1999 EPA memoranda on ex cess emissions that do not adequately address the treatment of SSM events in technology

- based standards.

Response: EPA is promulgating the affirmative defense for malfunctions only, not for periods of startup and shutdown. As explained above, EPA believe s that malfunction events should be treated differently than periods of startup and shutdown, which are predictable and routine aspects of a source ̳s operations. Further, periods of startup and shutdown

– but not
malfunctions

-- are taken into account when establishing section 112 emissions standards. For these reasons, EPA does not believe it is appropriate to apply the affirmative defense provision to startup and shutdown periods.

Many of the conditions in the affirmative defense are modeled after the a ffirmative defense in EPA‘s SIP SSM policy, See, e.g., State Implementation Plans: Policy Regarding Excessive
Emissions During Malfunctions, Startup, and Shutdown (Sept. 20, 1999); Other conditions are modeled after a Federal Implementation Plan promulgat ed by EPA. (40 C.F.R. 50.1312). EPA‘s view is that use of consistent terms in establishing affirmative defense regulations and policies across various CAA programs will promote consistent implementation of those rules and policies. Although, as commente r notes, the SIP policy does not apply to technology

- based standards because the expectation was that technology

- based standards would contain provisions that already account for technological limitations, nothing in the policy addresses the form that
such provisions in technology

- based standards should take. As explained above, EPA has determined that including affirmative defense provisions in such standards is appropriate and reasonable. The commenters do not explain their view that the terms of the SIP policy are not appropriate to address malfunctions in the CAA section 112 context. The affirmative defense does not require a facility to prove its innocence rather than requiring an enforcement authority to prove a violation of the CAA or change the burden of proof with respect to establishing a violation. The affirmative defense applies only where a violation has been established. The burden of proof that a violation occurred remains with the plaintiff in an enforcement action. See, e.g., 40 C.F.R . 22.24. If a violation has been established and a source wishes to assert the affirmative defense with respect to penalties, the source does bear the burden of establishing that
the elements of the affirmative defense have been met. This burden

- shifting is appropriate because the source is in a better position to determine the facts required to establish the defense.47

See, e.g.

, Arizona Pub. Serv. Co. v. EPA , 562 F.3d 1116, 1120, 1129

- 30 (10th Cir. 2009) (rejecting industry challenge to EPA‘s use of an af firmative defense to address excess emissions during malfunction events.). The notification and reporting requirements are not unreasonable and are consistent with other malfunction reporting and notification requirements that have been applied without si gnificant difficulty. ( See, e.g., 40 CFR 63.6(e)(3)(iv) and 63.10(d)(5)(ii)). Section 114 of the CAA clearly provides authority to require such reports.

EPA believes the affirmative defense criteria are well

- defined and will assist EPA and the
courts i n making reasoned determinations as to the establishment of affirmative defenses. EPA and the courts have expertise and experience in evaluating and applying criteria such as those for the affirmative defense. As noted above, many of the conditions were modeled after the conditions of the affirmative defense in EPA‘s SIP SSM policy, which several states have adopted into their SIPs. We do not have any indication that parties to enforcement proceedings have had any significant difficulties applying the te rms of these SIP affirmative defenses. However, EPA believes that some of the terms or phrases in the regulatory text establishing the affirmative can be revised or streamlined to some extent. EPA is revising the affirmative defense language to delete ―sh ort‖ from the affirmative defense provisions, because other criteria in the affirmative defense require that the source assure that the duration of the excess emissions was ―minimized to the maximum extent practicable.‖ In addition, EPA is adding the phras es ―consistent with good air pollution control practice for minimizing emissions‖ to 63.781(d)(1)(viii) and 63.800(j)(1)(viii). We are also deleting the term ―severe‖ in the phrase ―severe personal injury‖ because we do not think it is appropriate to make the affirmative defense available only when bypass was unavoidable to prevent severe personal injury. We have revised several phrases in the affirmative defense provisions to refer to the ―affected source‖ which is defined in §63.2. EPA does not believe that other terms and conditions of the affirmative defense are overly subjective or extreme or need further qualification. EPA acknowledges that some of the criteria may overlap to some extent and under some circumstances, but does not believe it is neces sary to change the requirements. To the extent there is overlap, the same information can be used to meet the provisions in question. EPA is not eliminating the word ―infrequent‖ from the affirmative defense provisions, because that term appears in the d efinition of malfunction in 63.2. With respect to comments that the affirmative defense should be stated instead in terms such as a rebuttable presumption so that, once a source has claimed that its excess emissions were related to a malfunction, it will not be considered to be in violation of the standards unless the enforcement authority demonstrates that the source is not entitled to claim the malfunction, or has not taken reasonable actions to minimize emissions, EPA does not agree that the
affirmativ e defense should operate as suggested. The comment improperly seeks to shift the burden of proof from the source to EPA. It is the source, not EPA that has the information relevant to assess whether a particular event qualifies as a malfunction and meets the affirmative defense. Furthermore, the suggested approach appears to be similar to the scheme that the court vacated in the Sierra Club case, in that there would be no violation unless the enforcing party (EPA or a citizen), established that the event in question was not a malfunction.

With respect to the comment concerning operating logs, EPA believes that log entries should be made contemporaneously, which does not mean, at the exact time that the engineers are taking actions to address the malfun ction, but rather immediately thereafter. That way, more48

accurate records of the malfunction can be expected, as opposed to records reconstructed long
after the malfunction.

25. Comment: Commenter 41 noted that the requirement to do a root cause analysis j umps to the final step without considering that there may be many steps in determining causality:

For many malfunctions, the cause is immediately obvious. When a malfunction occurs, the expectation is that the facility will correct the problem as quickly a s possible and return to their operating window. A root cause analysis is typically limited to very significant events or repeat events. The proposed language assumes that all malfunctions are equally significant and need an identical degree of investigati on. For example, a root cause analysis should only be used as a last resort
when other reasonable methods fail to show what caused the malfunction or when the serious nature of an event might make such an analysis necessary. Moreover, other tools may be mo re appropriate (e.g. failure mode and effect, fault tree, etc.) or more powerful tools may be introduced in the future. The facility is the only one that can
and should decide what tool to use to determine the cause of the malfunction. If it is necessary t o do a root cause analysis (or some other detailed analysis), it may not be possible for that to be completed in 30 days. It is reasonable to develop a report of the cause and whatever corrective action was taken within 30 days if that cause was simple. Ho wever, if the event was significant and a more detailed analysis was required, a facility would need more time (e.g. 90 days) to complete that report. It should also be noted that it is impossible to eliminate the causes for certain malfunctions (e.g. Ligh tning strikes). Finally, faxing is an obsolete technology. EPA should allow notification by e

- mail or other electronic forms.

Response: EPA is revising the root cause analysis requirement to clarify that the purpose of the root cause analysis is to determ ine, correct, and eliminate the primary cause of the malfunction and that the root cause analysis itself does not necessarily require that the cause be determined, corrected or eliminated. However, in most cases, EPA believes that a properly
conducted roo t cause analysis will have such results. EPA does not assume that all malfunctions require an identical degree of investigation. EPA expects that the effort required to do a root cause analysis will vary depending on the nature of the malfunction. EPA is also revising this requirement to state that a written report must be submitted within 45 days of the initial occurrence of the malfunction. We further revised this provision to allow the source to seek an extension of up to an additional 30 days.

EPA generally accepts documents in electronic format, as long as the format is compatible with the requirements of the standards. For the affirmative defense provisions, the owner or operator of a facility experiencing an exceedance of its emission limit( s) during a malfunction must notify the Administrator by telephone or facsimile (FAX) transmission of the exceedance. However, the written reports required to demonstrate that the affirmative defense provisions have been met and requests for an extension of the deadline for these reports may be submitted electronically.

26. Comment : Commenter 46 further stated that an affirmative defense is insufficient to absolve EPA of its duty to set Section 112

- Compliant Standards:49

EPA has consistently recognized that malfunctions are inevitable. As such, EPA must account for emissions associated with malfunctions in setting the applicable standard. ―A technology

- based standard discards its fundamental premise when it ignores the limits inherent in the technology.‖ NRDC , 859 F.2d at 208. Failing to account for these inevitable failures would ―in effect hol[d] dischargers to a higher standard of technology than that demanded by the Act.‖ Id. at 207; see also Cement Kiln Recycling Coalition v. EPA , 255 F.3d 855, 872 (D.C. Cir. 2001) (noting doubts of legality of technology

- based standards that would require ―sources to comply with standards even during openings of emergency safety valves caused by events beyond the sources‘ control‖). Rather than attempt to promulgate secti on 112

- compliant standards, as described above, EPA proposes to establish an ―affirmative defense‖ for malfunctions only. This ―affirmative defense‖ is wholly insufficient to meet EPA‘s obligations under section 112.

Response : The affirmative defense is not intended as a substitute for standards under section 112. EPA has determined that CAA section 112 does not require that emissions that occur during periods of malfunction be factored into development of CAA section 112 standards.
Under CAA section 11 2, emissions standards for new sources must be no less stringent than the level ―achieved‖ by the best controlled similar source, and for existing sources, generally, must be no less stringent than the average emission limitation ―achieved‖ by the best per forming 12 percent of sources in the category. There is nothing in CAA section 112 that directs the Agency to consider malfunctions in determining the level ―achieved‖ by the best performing or best controlled sources when setting emission standards. Mor eover, while EPA accounts for variability in setting emissions standards consistent with the CAA section 112 case law, nothing in that case law requires the Agency to consider malfunctions as part of that analysis.

CAA section 112 uses the concept of ―be st controlled‖ and ―best performing‖ unit in defining the level of stringency that CAA section 112 performance standards must meet. Applying the concept of ―best controlled‖ or ―best performing‖ to a unit that is malfunctioning presents significant diffic ulties, as malfunctions are sudden and unexpected events. Accounting for malfunctions would be difficult, if not impossible, given the myriad different types of malfunctions that can occur across all sources in the category, and given the difficulties

ass ociated with predicting or accounting for the frequency, degree, and duration of various malfunctions that might occur. As such, the performance of units that are malfunctioning is not ―reasonably‖ foreseeable. See, e.g., Sierra Club v. EPA , 167 F. 3d 65 8, 662 (D.C. Cir. 1999) (EPA typically has wide latitude in determining the extent of data

- gathering necessary to solve a problem. We generally defer to an agency's decision to proceed on the basis of imperfect scientific information, rather than to "inve st the resources to conduct the perfect study."). See also, Weyerhaeuser v. Costle , 590 F.2d 1011, 1058 (D.C. Cir. 1978) (―In the nature of things, no general limit, individual permit, or even any upset provision can anticipate all upset situations.
After a certain point, the transgression of regulatory limits caused by  ̳uncontrollable acts of third parties,‘ such as strikes, sabotage, operator intoxication or insanity, and a variety of other eventualities, must be a matter for the administrative exercise of case

- by

- case enforcement discretion, not for specification in advance by regulation.‖). In addition, the goal of a best controlled or best performing source is to operate in such a way as to avoid malfunctions of the source, and accounting for malfunct ions could lead to standards that are significantly less50

stringent than levels that are achieved by a well

- performing non

- malfunctioning source. EPA‘s approach to malfunctions is consistent with CAA section 112, and is a reasonable interpretation
of the s tatute.

Further, the NRDC case cited by the commenter interprets provisions of the Clean Water Act that are different in nature than provisions governing standards under section 112 of the Clean Air Act and the discussion of technology

- based standards i s dicta. Nevertheless, EPA ̳s approach to malfunctions is consistent with NRDC and the cases cited therein; Marathon Oil Co. v. EPA

, 564 F.2d 1253, 1272 (9th Cir. 1977). The court in Marathon Oil held that EPA must formalize its approach to upsets under the Clean Water Act and the affirmative defense does so. But see, Weyerhaeuser v Costle , 590 F.2d 1011, 1057

- 58 (D.C. Cir. 1978) (holding that an informal approach is adequate).

C. ENVIRONMENTAL JUSTIC E

27. Comment : Commenter 42 commended EPA for considering envir onmental justice issues by expressing concern about the disproportionate impacts of the HAP emissions on certain social, demographic, and economic groups. However, the commenter recommended some improvements:

As stated in EPA‘s ―Interim Guidance on Conside ring Environmental Justice During the Development of an Action,‖ the agency should consider addressing existing disproportionate impacts on minority, low

- income or indigenous populations during rulemaking. [The commenter] recommends EPA conduct a full eval uation of disproportionate impacts following the guidance in EJSEAT and an evaluation of how this risk assessment could reduce impacts to those communities. EPA‘s Online Tracking Information System database appears to do this already at the facility

specif ic level and can be incorporated into the assessment to more accurately define the number of the individuals impacted by the emissions and the demographics of the impacted community. Additionally, we recommend the rule writers work with the
EPA Office of E nvironmental Justice to adequately evaluate the proposed rulemaking with regard to communities experiencing disproportionate impacts.

Response : The demographic assessments for both source categories contain information
on the cancer risk from the facili ty

- wide HAP emissions as well as the cancer risk from the source category

- specific HAP emissions. While these figures do not capture total risk, they provide estimates of the existing distribution of cancer risks across population groups, which is
the hea lth outcome of most concern related to the facilities and pollutants being regulated. While the EJSEAT and OTIS database are general tools that can be used in considering environmental justice issues, the demographic analyses we performed is superior for purposes of this rulemaking because they are more specific to these particular source categories

. We note that we are working with the Office of Environmental Justice in an ongoing effort to develop new tools for considering environmental justice in rulem akings. We also note that our ability to quantitatively assess EJ issues is evolving; over time we expect it to become more robust, sophisticated, and capable of ensuring that we are meeting our mission as an agency.51

28. Comment : Commenter 46 stated EPA shou ld consider the potential repercussions to communities of the potential loss of industry when taking into account EJ issues.

If EPA requires more stringent controls for a particular source category as a result of a demographic analysis, all sources in the source category, regardless of location may be forced to assume the additional costs and burdens unless the Agency is willing to discriminate among sources within a category. This means that many sources would be required to install additional controls ev en though the population surrounding the source is not at an increased risk (unless EPA is willing to depart from this long

standing approach to regulation under section 112).

In setting standards based on classifications related to EJ concerns, EPA will p ut existing and new businesses on notice that they must expect more stringent controls if they plan to continue to operate within these areas. Many businesses may decide to move away from areas so designated by EPA to avoid more stringent controls. This in turn would reduce economic activity in the area and employment, potentially making the areas economically disadvantaged. While EPA‘s intentions may be laudable, the communities themselves may find the repercussions to be more health threatening
than the a dded protections afforded by the pollution controls, especially if it results in greater unemployment and reduced income. EPA should consider these impacts of regulation on these communities as part of its EJ review. EPA should set a high bar for distingui shing sources, and imposing separate standards, based on potential EJ concerns, and that such standards should reflect a clear need for further protection of public health concerns.

Response : Potential impacts on the regulated industry and on employment ar e accounted for in the Regulatory Impact Analysis, which uses a standard method for estimating these impacts. These impacts, along with potential environmental and health impacts, inform the Agency‘s rulemaking decisions to the extent consistent with the C lean Air Act. In the rulemakings for these two source categories, EPA has not established any different control requirements based on the demographic analyses it performed.

29. Comment : Commenter 52 objected to consideration of demographic analyses under

sect ion 112(f). The commenter noted that although EPA conducted an ―environmental justice‖ assessment for the two rules covered by the proposal, EPA determined that those analyses did not provide a basis for imposing additional control measures in order to as sure an ample margin of safety.

Because the term ―public health‖ cannot reasonably be interpreted to include consideration of environmental justice in the § 112 context, EPA proposal to consider demographic analyses in conducting risk reviews under § 112(f ) is not a proper exercise of Agency authority.
EPA‘s proposal would unreasonably inject racial, ethnic, and other policy considerations into a program designed to provide protection for the public at large. For example, EPA suggests that the population wi thout a high school diploma should receive extra scrutiny, yet does not afford the same scrutiny to other reasonably definable educational groups, such as those with a high school diploma, those with52

college degrees, and those with advanced degrees. There is simply no principled way to identify and define those groups that should receive extra scrutiny from those that do not. In short, EPA‘s approach would inappropriately cause arbitrary policy and political considerations to trump objective scientific anal ysis. This is patently unreasonable and, as such, is not a supportable interpretation of § 112(f).

Response : In this rulemaking, EPA developed demographic analyses as part of the risk assessment for each source category; the analyses did not change the r esults or conclusions in the assessments. See also Comment above concerning Facility

- wide risk and demographic analyses and Response thereto. As stated in the Benzene NESHAP, in determining the need for residual risk standards, we strive to limit to no hig her than approximately 1

- in

- 10 thousand (100 in a million) the estimated cancer risk that a person living near a plant would have if he or she were exposed to the maximum pollutant concentrations for 70 years and, in the ample of safety decision, to protec t the greatest number of persons possible to an individual lifetime risk level of no higher than approximately 1

- in

- 1 million. These considerations are made for all people regardless of racial or socioeconomic status. However, in determining whether to req uire
additional standards under § 112(f)

, these levels are not considered rigid lines, and we weigh the
cancer risk values with a series of other health measures and factors in both the decision regarding risk acceptability and in the ample margin of safet y determination. We also consider
cost of controls in the ample margin of safety determination. While we analyzed the demographic makeup of the at

- risk populations surrounding the facilities with in source categories addressed by this rule making, we ultima tely concluded that the risks from each source category were acceptable and protected public health with an ample margin of safety. Thus, the results of our demographic analyses only served to provide information about the demographic makeup of the populat ions exposed to each of these source categories.

II. WOOD FURNITURE

A. RISK ASSESSMENT

30. Comment : Commenter 49 stated that Legacy Cabinets is now importing finished cabinets from China and shut down one of two finishing lines because of the economy. Please note Leg acy Cabinets is one of the 11 facilities with formaldehyde emissions that could result in
exceedances of the acute REL.

Commenter 40 provided improved facility data. Below is a summary of the corrected data:

Table 1. Commenter 40 Data Summary

Total NC fac ilities identified by
EPA No changes

needed Facility name

or address update Facility

emissions or

process update Name/

address and emissions/

process update Facilities

that have Closed
since 2005

Wood Furniture Manufacturing 67 30 7 8 5 17

Ship Building 053

Commenter 40 indicated that 50 of the 67 North Carolina (NC) facilities identified by EPA should be included in the risk assessment. Facilities that are closed (17) should be removed from consideration. Of the remaining 50 facilities, commenter 40 requested that the 13 facilities with
risks above threshold levels be reconsidered for cancer and non

- cancer risk, as the commenter has reported changes to emissions or processes.

Response : The EPA acknowledges receiving updated information concerning thes e facilities.

. These facilities are not driving risk in the risk assessment for wood furniture facilities

. The updated information has no effect on risk estimates for the source category because the changes to emissions are minor and correspond to very l ow risk facilities (i.e. HQ < 0.1 and MIR < 0.1 in 1 million)

. Only one facility had an increase in emissions and that facility had an MIR of 0.071 in 1 million and a maximum HQ REL = .0021. The facilities emission changes were by far
less than an order of magnitude and a corresponding order of magnitude change to the MIR and HQ risks corresponds to thresholds less than 1 in 1 million and 1, respectively. No information in the emissions database has changed as a result of these commenters.

31. Comment: Two comm enters (38 and 49) stated that the facility with the highest reportable formaldehyde emissions (Kitchen Kompact located in Jeffersonville, IN) is not a good representative wood coating manufacturing facility.

The commenters offered the following reasons:

a. the facility finishes products 4 days a week (as opposed to EPA‘s 5 day assumption ) ;
b. the facility utilizes a higher VOC product without a control device; and

c. the facility has all operations at one facility (other large facilities may spread operations

ov er several facilities).

Commenter 49 further believed that it is arbitrary for EPA to set the formaldehyde limit based on problematic data indicating that 3% (more likely 1%) of facilities had formaldehyde emissions
that could result in exceedances of the acute REL. The commenter offered the following reasons why EPA‘s conclusion that 11 facilities (about 3% of the facilities) had formaldehyde emissions that could result in exceedances of the acute REL is problematic:

a. EPA identified four facilities for emi ssions verification

– two of which had formaldehyde
emissions

– Chromcraft which no longer uses coatings that contain or emit formaldehyde and Kitchen Kompact

– which has less formaldehyde emissions than reported and is not a good representative facility. Both verification facilities are problematic and indicate that the facility data used in the risk assessment is suspect.

b. Three of the 11 facilities either no longer use formaldehyde containing products (Chromcraft) or the facilities have lower production t han EPA identified (Kitchen Kompact and Legacy Cabinets). Removing Chromcraft, only 10 or 2.5% of the facilities
had emissions that could result in exceedances of the acute REL.

c. It was clear from Table 4 that the HEM

- 3 screening results were problematic an d that the refined modeling approach that utilized aerial photographs of the facilities identified two major problems with the risk assessment:54 The REL for several facilities was lowered since the polar ring needed to be corrected due to GPS errors and;

a n evaluation of the aerial map indicated that the REL needed to be lowered in some cases by as much as 74%. Moving the ―polar ring‖ has a significant impact on the risk assessment, and while developing refined acute risks based on review of aerial maps
is better it is subjective at best.

d. Three of the 10 facilities had refined predicted acute risks greater than 3, the remaining 7 had refined predicted acute risks of less than 3, a majority of these had predicted acute risks just above 1 (1.5, 1.5, 1.6 (Lega cy Cabinets which should be changed), 1.8). The commenter suggested that these facilities be discounted as well.

After removing these data points, commenter 49 noted that there are 6 facilities (approximately 1 percent of the facilities) with acute risks greater than 1. The commenter noted that setting a standard based on 6 facilities (or 1% of all wood furniture facilities) is unjustified and arbitrary.

Response : The EPA acknowledges that there have been changes to formaldehyde
emissions since 2005. Acco rding to the comments received as well as phone conversations with several facilities, the EPA has received indications that facilities have changed and lowered formaldehyde emissions, subsequent to the 2005 NEI data. These updates, however, are not being used to replace the 2005 NEI data because data were not provided to support the assertions. Because the data are unverified, the EPA used source data from 2005 NEI to keep a verified source for purposes of risk assessment. As discussed in the preamble for this rule making , we are not adopting any new or additional requirements based on the risk assessment under section 112(f). We have found all risks to be acceptable for this rule making.

32. Comment: Commenter 39 stated that, based on EPA‘s risk analysis, imp lementation of the current Subpart JJ, promulgated on December 7, 1995, has been very effective in risk reduction. The commenter further stated that their facilities have reduced formaldehyde emissions by nearly
90% since the baselines were determined. The commenter recommended continued reliance on the Formulation Assessment Plan approach. The provisions require facilities to provide a written notification if annual usage of formaldehyde exceeds a baseline level and provide reasons for
exceedance of the ba seline.

Response : We agree with the commenter that Wood Furniture facilities have reduced formaldehyde emissions and resulting risk under the existing Subpart JJ MACT standard. As discussed in the preamble to the final rule, we also conclude that the exi sting MACT standard for Wood Manufacturing, which includes the Formulation Assessment Plan requirement, provides an ample margin of safety.

33. Comment : Commenter 40 agreed with the way in which EPA estimated cancer and non

cancer risk. However, the commenter noted that the state of North Carolina also has an air toxics program which is a ―risk

- based‖ regulatory program designed to protect public health by limiting emissions of toxic air pollutants (TAPs) from man

- made sources. Concentrations of airborne
chemic als, called Acceptable Ambient Levels (AALs), were established above which the substance may be considered to have an adverse effect on human health. North Carolina has developed AALs for 97 TAPs for cancer, chronic and acute exposures. The commenter state d55

that these may be more appropriate to use when estimating risk from North Carolina facilities and would provide consistency with the ongoing state program.

Response : For EPA to fully evaluate the NC AALs, t he documents used to set the AALs should be pro vided to the EPA to identify what studies were utilized as the basis of the dose

value for each chemical. A review of the TAP‘s regulated by NC did not identify any toxic air pollutants in which EPA did not have either a cancer or non

- cancer dose

- respons e value. The
dose

- response hierarchy established by EPA has been approved by EPA‘s SAB and represents the latest toxicity findings that have been peer reviewed and are publically available. A modification to this hierarchy is not warranted at this time

.

34. Comment : Multiple commenters (40, 42, 45, 46, 49, 50, 51, and 55) offered comments on the use of formaldehyde dose

- response values.

Commenters 42 and 45 supported the use of the Integrated Risk Management System (IRIS)
dose

- response value for formaldehyd e in the risk assessment.

Commenter 45 stated that it is not only appropriate for EPA to end its use of the CIIT Centers for Health Research risk value for formaldehyde emissions, doing the contrary would be arbitrary, capricious and unlawful. The commente r supported the IRIS value because it is more than 2,000 times greater than the CIIT value and thus more health

- protective.

Commenter 42 also provided support for EPA‘s proposal to revert to the use of the Integrated Risk Management System (IRIS) dose

- resp onse value for formaldehyde in the risk assessment. The commenter referenced the World Health Organization‘s concerns about formaldehyde. The commenter supported the continued use of the existing IRIS factors until the review process is completed. The comm enter further urged an acceleration of the IRIS review.

Alternatively, 6 commenters (40, 46, 49, 50, 51 and 55) did not support the use of outdated and overly conservative models, such as the Integrated Risk Management System (IRIS) dose

response value.

Co mmenter 46 stated that EPA must utilize the best available science in its risk assessment, which is not the IRIS value. The commenter noted that EPA has previously determined that the IRIS value ―no longer represents the best available science in the peer reviewed literature.‖ 69 Fed. Reg. 18,327, 18,333 (Apr. 7, 2004). Commenter 46 noted:

To the extent the re

- assessment [of the IRIS value] may constitute the best available science, EPA should delay the final rulemaking until the reassessment is completed

a nd it can conduct a revised assessment. It must give the public an opportunity to comment on any revised assessment and any changes to EPA‘s proposal prior to issuing a final rule.

At a minimum, EPA must weigh the risk estimates based on the CIIT values a gainst estimates that rely on the outdated IRIS value. EPA appropriately notes that the CIIT value generates estimates of maximum individual excess lifetime cancer risks that are 50 percent less than comparable estimates based on the formaldehyde IRIS valu e. Similarly, the CIIT based cancer incidence estimates are reduced by 30 percent. Based on EPA‘s use of the older IRIS value, it has proposed a new standard under56

section 112(f) to address the ample margin of safety requirement for wood furniture
manufact uring. But EPA‘s findings are insufficient to support a new standard. EPA asserts that the new standard would reduce the maximum acute hazard quotient value based on the CalEPA Reference Exposure Level (―REL‖) for formaldehyde from 7 to 3, and will reduce the maximum lifetime individual cancer risk from 20

- in

- 1 million to approximately 10

- in

- 1 million, both based on the actual emissions level. But, this is not sufficient grounds to determine that a new standard is needed to ensure an ample margin of safety, particularly where EPA only found that formaldehyde emissions from 11 facilities (about three percent) that ―could‖ result in exceedances of the acute REL, indicating a potential for acute non

- cancer risks of concern. As EPA notes these
estimates are base d on highly ―multiple conservative assumptions.‖ Indeed, EPA ―did not see a potential for any facility to cause exceedances of the acute ERPG

– 1 or
AEGL

– 1 levels.‖ Since EPA found an acceptable level of risk, these overly conservative estimates, which are n ot based on the best available science, are insufficient to justify a new standard to address ample margin of safety.

Commenter 40 stated:
EPA‘s use of the 1991 Integrated Risk Management System (IRIS) dose

- response value for formaldehyde may not be approp riate given the high level of scientific debate and inconsistency surrounding the health effects of formaldehyde. Recommendations of limiting formaldehyde use based on risk modeling results using such a conservative value may require further consideration, especially as formaldehyde is currently under review in IRIS. [The commenter] encourages EPA to accelerate its IRIS review of formaldehyde and consider delaying ―use limits‖ for the Wood Furniture Manufacturing Operations source category until the IRIS re view is completed.

Commenter 51 stated:

Contrary to IQA guidelines, EPA inappropriately applies the outdated IRIS dose

response values in determining formaldehyde inhalation exposure risk in support of the Proposed Rule. In 2004, EPA determined that ―the d ose

- response value in IRIS is based on a 1987 study, and no longer represents the best available science in the peer reviewed literature.‖ 69 Fed. Reg. 18327, 18333 (Apr. 7, 2004). EPA went on to state that ―the CIIT modeling effort represents the best ava ilable application of the
available mechanistic and dosimetric science on the dose

- response for portal of entry cancers due to formaldehyde exposure.‖ Id. This determination led to the incorporation of the CIIT dose

- response value for formaldehyde exposure in risk assessments supporting regulatory action. In the underlying risk assessment for the Proposed Rule, however, EPA reverses its position on what constitutes the best available science by stating that EPA no longer considers ―the CIIT URE value health protective, and we are again using the EPA‘s current value on IRIS, which was last revised in 1991....‖ 75 Fed. Reg. 80220, 80228 (Dec. 21, 2010).
The CIIT‘s construction of a biologically based dose

- response (BBDR) model to determine an appropriate dose

- re sponse value by utilizing a detailed understanding of formaldehyde‘s cancer mode of action (MOA) is a superior model for predicting57

cancer risk than the 1991 IRIS model. Further, current science supports the robustness
of the CIIT dose

- response model. The sensitivity of the model was questioned based on inappropriate manipulation, rebutting EPA‘s assertion that the variability of the model is ―not supportive of interpreting the CIIT model results as providing a conservative (health

- prospective) estimate of human risk.‖ Id. (citing Crump et al.

, 2008). In fact, an NAS panel has already reviewed the CIIT model and determined that it is superior to the 1991 IRIS value:

The available evidence, however, strongly suggests that the risk from formaldehyde at high do ses demonstrated in animals studies cannot be extrapolated to lower doses using the EPA‘s approach (Conolly et al. 2003; Gaylor et al. 2004). The more recent CIIT assessment results in a theoretical cancer risk well below the U.S. Department of Defense ―ac ceptable‖ risk level of 1 in 10,000, even for lifetime exposure at the
0.3

- ppm 90

- day CEGL. The subcommittee concluded that the CIIT assessment more accurately reflects the scientific weight of evidence for formaldehyde carcinogenicity than does EPA‘s appr oach (NAS, 2007, p. 131).
EPA should not ignore the NAS‘s conclusion by reverting to a twenty year old IRIS assessment value that is not supported by the best available science.

Moreover, there are substantial limitations associated with the 1991 IRIS valu e that makes its use in setting emissions standards inappropriate. Substantial research has been conducted in the past 20 years that invalidates the IRIS dose

- response value for formaldehyde exposure. The NAS is currently reviewing EPA‘s Draft IRIS
Assessm ent of formaldehyde. EPA should delay the finalization of the Proposed Rule until the NAS review is completed in March 2011, so that EPA can fully incorporate the NAS‘s findings regarding formaldehyde and risk into the emission standards for
the Wood Furni ture Manufacturing source category.

Commenter 55 stated that the decision to discontinue use of CIIT model is inappropriate. The CIIT model should continue to be used to inform formaldehyde risk assessments. The criticisms of the model by Crump and colleag ues lack foundation because the manipulations and alterations of the model on which they are based did not have an adequate basis in the underlying biology.

Commenter 49 referenced the National Academy of Science (NAS) formaldehyde re

- evaluation:

With res pect to the assessment of cancer risk from occupational and environmental exposures, [the commenter] agrees with the agency that ―formaldehyde is a unique case.‖ Since 2004, EPA has relied on the CIIT Centers for Health Research (formerly
the Chemical Indu stry Institute of Toxicology) dose

- response value for formaldehyde because if was based ―on better science than the IRIS dose

- response value.‖ The CIIT‘s risk assessment of formaldehyde incorporated both mechanistic and dosimetric information on formaldehy de, which is essential to demonstrating the underlying basis for carcinogenicity. While the agency may currently question some of the modeling assumptions used in the CIIT effort, it cannot selectively revert to an IRIS reference value that, in addition to being dated, having been established in 1991, is also currently being re

- evaluated by the (NAS) through the National Research Council (NRC).58

The NAS review is expected to be completed by March of 2011, and given that it will be considering the most recent published evidence on the possible mechanism for formaldehyde

- related carcinogenesis, it will likely substantially change the underlying basis for any and all proposed formaldehyde exposure

- related residual risk standards. Having closely monitored efforts at the International Agency for Research on Cancer (IARC) and its recent affirmation that formaldehyde be classified as a known human and animal carcinogen, causing nasopharyngeal cancer (pending IARC Monograph 100, conclusions developed October 2009 and as of yet, full documentation unpublished but summaries available at http://monographs.iarc.fr/ENG/Meetings/index1.php. In Monograph 100, IARC also cites limited epidemiological evidence for leukemia in humans is available; however
inconsistent across stud ies. While IARC affirms both genotoxicity and cytotoxicity events are critical for formaldehyde to develop nasal carcinogenicity in rats, the
mechanistic data for leukemia was not well established in the IARC discussions.

We note that formation of DNA addu cts is often described as a key event in initiating carcinogenesis. A recent study by Lu et al (see Lu et al, ―Distribution of DNA Adducts Caused by Inhaled Formaldehyde Is Consistent with Induction of Nasal Carcinoma but Not Leukemia‖, Toxicological Scien ces, 116(2), 441

- 451, 2010) explores adduct formation in a straightforward manner looking at endogenous and exogenous sources of formaldehyde. The results show that ―exogenous formaldehyde induced... adducts in DNA from rat respiratory nasal mucosa but did n ot form adducts in sites remote to the portal of entry‖ (Lu, 2010). In contrast, high amounts of endogenous formaldehyde adducts were present in all tissues examined. This study provides strong evidence supporting a mode of action for the carcinogenesis of inhaled formaldehyde in respiratory nasal epithelium, but does not support the biological plausibility that inhaled formaldehyde also causes leukemia.

[The commenter] cites all of this activity to reinforce the need to properly characterize the underlying cancer risk associated with formaldehyde exposure prior to establishing any revised proposal or final residual risk rule. Given the unique nature of formaldehyde exposure and the widespread impacts of any proposed or final rule, it is imperative that the agency consider all emerging science on the matter. To emphasize this point the commenter noted that, by the agency‘s own admission, the estimated maximum individual excess lifetime cancer risk would be reduced by 50 percent and the cancer incidence would be reduced by 30 percent if the CIIT values were used instead of the IRIS. Similarly, a finding by NAS/NRC panel that the mechanistic data does not support prior leukemia findings would dramatically alter the need for a more stringent residual risk rule.

Commenter 50 noted that placing any further limits on formaldehyde would be premature until the NAS report on the subject has been received (end of February 2011) and the IRIS process completed. The commenter noted:
According to the proposal, ―The total es timated cancer incidence due to the actual emission from the source category is 0.005 excess cancer cases per year, or one case in every 200 years.‖ This hardly serves as a basis for further regulation. Also, six of
the 11 facilities used as the basis for concern were at ―2‖ out of a possible ―7‖ on the59

risk scale and the companies at the top of the scale at ―6‖ or ―7‖ account for less than
1

- 2% of the market. This should not be the basis for imposing further restrictions on the 98% or the industry that are performing satisfactorily. In today‘s economy, companies would need at least three years to comply if the proposed changes were approved.

Response : In 2004, the EPA determined that the Chemical Industry Institute of Toxicology (CIIT) cancer dose

- response value for formaldehyde (5.5 x 10 - 9 per μg/m 3 ) was
based on better science than the IRIS dose

- response value (1.3 x 10 - 5 per μg/m 3 ), and we switched from using the IRIS value to the CIIT value in risk assessments supporting regulatory
actions. Based on subsequent published research

, however, EPA changed its determination regarding the CIIT model, and in 2010 EPA returned to using 1991 IRIS value. The National Academy of Sciences (NAS) completed its review of the EPA‘s draft assessment in April of 2011 ( http://www.nap.edu/catalog.php?record_id=13142 ) , and EPA has been working on revising the formaldehyde assessment

. The EPA will follow the NAS Report recommendations and will present results obtained by implementing the biologically base d dose response ( BBDR ) model for formaldehyde. The EPA will compare these estimates with those currently presented in the External Review draft of the assessment and will discuss their strengths and weaknesses. As recommended by the NAS committee, appropri ate sensitivity and uncertainty analyses will be an integral component of implementing the BBDR model. In the interim, we will present findings using the 1991 IRIS value as a primary estimate, and may also consider oth er information as the science evolves. The EPA notes that risk estimates based on both the IRIS and the CIIT unit risk estimates for formaldehyde were presented in the proposal for this final rule and that the risks were acceptable in both cases.

35. Comment : Commenter 48 has previously sub mitted extensive data to the EPA under the OECD/SIDS program for the Mono

- Ethylene Glycol Ethers, Di

- Ethylene Glycol Ethers, and Tri

Ethylene Glycol Ether (High Boiling Glycol Ethers) Categories. These submissions included dossiers of robust study summarie s, test plans and SIDS Initial Assessment Reports (SIARs) for all of the common ethylene glycol ethers. These documents have been peer reviewed at various SIDS Initial Assessment Meetings (SIAMs). The EPA has access to these documents and can
review the in formation contained in them, which supports the trend toward decreasing toxicity as the size of the alkyl group or the number of ethylene glycol units is increased.

Response : 26 of the 92 facilities reporting glycol ether emissions provided speciated
emiss ions data for glycol ethers which represented approximately 10% of the glycol ether emissions emitted from the source category. This limitation as well as the limited number of acute reference values available for individual glycol ether compounds in the SIDS assessments supports the use of a conservative approach (i.e., health protective) of using the glycol ether with the lowest reference value (ethylene glycol methyl ether or EGME) as a surrogate for glycol
ethers without available reference values. A review of the 11 individual speciated glycol ethers reported to the emission inventory only 3 had SIDS data. To the extent that these studies appear in the peer

- reviewed scientific literature at the time of development of an IRIS health assessment, they would be considered along with the entire body of literature.60

36. Comment : Commenter 48 stated EPA overlooked available studies for DGBE when deriving a provision peer reviewed toxicity value (PPRTV) in 2009:

Page 80242 of the proposed rule discusses the deri vation of a PPRTV for DGBE. The EPA states, "Inhalation toxicity information for DGBE is essentially limited to the results of a single 5

- week study in rats (Gushow et al., 1984), which resulted in slight vacuolization of
the liver cells consistent with fa tty change. An uncertainty factor of 3000 was applied in deriving the PPRTV, and confidence in the provisional RfC (p

- RfC) value is low." The EPA should be aware that other studies for DGBE have also been available, and robust
summaries of these studies we re submitted to the EPA in a dossier and SIAR for the Diethylene Glycol Ethers Category in 2005. These documents were reviewed by the EPA in 2005 and also peer reviewed at OECD/SIDS SIAM 21 in 2005 with participation by the Agency. These studies include th e following: a 1992 BASF 90 day inhalation study in the Wistar rat, a 13 week dermal study in the SD rat by Auletta et al ., 1993, and finally a 2002 study in drinking water for 91 days in the F344 rat by Johnson et al. The references for
these studies are provided below. The commenter suggested that EPA should review these studies and again derive the PPRTV, taking these studies into consideration. It is likely that use of these studies may increase the confidence in the RfC value, and also reduce the
3000

- fold uncertainty factor.

Response : The EPA did not use the DGBE PPRTV value in the risk assessment supporting this proposed action. The reference concentration (RfC) for EGME from IRIS was the value used to represent the toxicity of glycol ethers without h ierarchically based non

- cancer reference values.

37. Comment : Commenter 45 stated EPA‘s sole justification for setting this formaldehyde limit at 400 lbs. per rolling 12

- month period appears to be the fact that this level is already contained in the existing M ACT as a work practice requirement:

EPA has stated that adopting this level as an emission standard would create ―either no or minimal additional costs.‖ Id. at 80,247. This number was chosen in 1995, however. Where this number came from initially is uncle ar. While it may be convenient for industry to use a level with which it is already familiar and that would incur little or no extra cost, EPA has not provided a reasoned explanation based on the required statutory health

- based criteria for choosing this l imit, rather than a more stringent limit. The record does not show why this is the appropriate limit to set as a residual risk standard in today‘s world.

EPA must complete this analysis and set an appropriately protective standard to satisfy CAA § 112(f)(2 ). Specifically, EPA must consider and address how much emissions would be reduced if EPA set a lower standard, and what level of emission standard is required to provide an ―ample margin of safety.‖ 42 U.S.C. § 7412(f)(2). EPA must address what emission s tandard would be needed to bring
the MIR down to 1

- in

- 1

- million as the statute directs. Id. EPA must address what standard is needed ―to provide maximum feasible protection against risks to health‖ by ―protecting the greatest number of persons possible‖ to a lifetime risk level no greater than 1

- in

- 1 million. 75 Fed. Reg. at 80,223 (quoting Benzene NESHAP).61

The need for this analysis is amplified by the fact that EPA has recognized numerous ―uncertainties related to the risk assessments, particularly for
fo rmaldehyde and glycol ether emissions.‖ Id. at 80,242

- 43. For example, EPA has stated that it is concerned that its risk analysis has failed to account for additional formaldehyde emissions that likely occur during curing and gluing. Id. at 80,243.
The unc ertain amount of additional risk unaccounted for provides another reason for EPA to set a more protective formaldehyde emission standard than the level chosen as a work practice standard in 1995.

Commenter 49 stated there is no approved method for estimati ng formaldehyde emissions and formaldehyde emissions from the cure process depend on multiple factors, including conditions under which the coating was applied, customer specifications, air flow, temperature, humidity, moisture content, and the elapsed tim e from coating applications. According to the commenter, elaborate, costly testing would be required to
estimate these emissions.

Response : The EPA is not finalizing the 400 pounds per rolling 12

- month period formaldehyde use limit as proposed under 112(f) of the CAA. See section IV.B of the preamble
for a discussion of the significant changes since proposal, including the decision to adopt the 400 pound per 12 month limit only as a compliance alternative because of information received concerning cost

- effe ctiveness of the proposed limit

. Also see section IV.B of the preamble regarding our conclusion under CAA section 112(f)(2) that additional standards are not necessary to provide an ample margin of safety. Section 112(f)(2) does not direct EPA to address

w hat emission standard would be needed to bring the MIR down to 1

- in

- 1

- million. On the contrary, the District of Columbia Circuit has upheld our interpretation of section 112(f)(2) that a
1

- in

- 1 million level of risk is an aspirational goal. See NRDC v. E PA, 529 F.3d 1077, 1082 (D.C. Dir. 2008). As explained by the court, ―[s]ubsection 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 sta ndards provide an  ̳ample margin of safety,‘ then the Agency is free to readopt those standards during the residual risk rulemaking.‖ Id. at 1083 (italics omitted). This statement applies to EPA‘s action in this rulemaking, with the additional step of adopt ing standards under section 112(d)(6).

Instead, as discussed in the preamble, t he EPA is promulgating a formaldehyde standard under section 112(d)(6). All wood furniture coatings and contact adhesives must be low

- or no

formaldehyde (concentration not to exceed 1 percent by weight formaldehyde) or, as a compliance alternative, formaldehyde emissions from wood furniture facilities must not exceed
400 pounds per rolling 12

- month period. The compliance options are designed to promote continuing reductions in formaldehyde emissions from wood furniture facilities without requiring equipment changes that are not cost effective. The formaldehyde limits will avoid constraining the production of wood furniture facilities while encouraging them to maintain or
decreas e levels of formaldehyde in coatings and contact adhesives. We are not estimating any quantified formaldehyde emissions reductions from the formaldehyde limits and are concluding that the existing Wood Furniture NESHAP provides an ample margin of safety un der section 112(f).62

The 400 pounds per 12 month period formaldehyde limit is based on the threshold level in Table 5 of the 1995 NESHAP, which itself was a result of negotiations with industry. In this
RTR we used the familiar numerical threshold for forma ldehyde emissions and made it a level
not to exceed. This was proposed to reduce the HQ of formaldehyde from 7 to 3 in a cost effective manner. Between proposal and promulgation, it became clear through public comments
that this limit was cost effective fo r the source category. As discussed in greater detail in section
IV of th e preamble, this limit is being finalized as a compliance alternative under section 112(d)(6).

The science is unclear as to the degree of formaldehyde curing under different
environm ental conditions. We did not receive any public comments containing or referring to

any emissions information on formaldehyde emissions from curing at wood furniture facilities that would aid in understanding and regulating cure emissions . Until there is d ata relevant to how cure formaldehyde is formed and in what quantities, we are unable to set limits for such
emissions.

38. Comment : Commenter 45 noted that ethyl benzene is the primary risk driver for cancer, but EPA did not address this pollutant:

[EPA] do es not consider or address whether this level of facility

- wide risk is acceptable at facilities where this source category is contributing so significantly. EPA must do so to complete its section 112(f)(2) duty. This is the time for EPA to
exercise its ful l authority to reduce health risk to achieve the statutory target of 1

- in

- 1 million. Its failure to consider regulatory options to address this residual risk is arbitrary and capricious. At minimum, EPA should consider whether to set an ethyl
benzene stand ard in order to reduce this residual risk. It also should consider requiring extra work practice, reporting, monitoring, and other measures for facilities that have the level of emissions putting them into this highest risk category.

Response : As discusse d in section IV.B of the preamble to the final rule, w e do not interpret section 112(f)(2) as requiring a 1 in a million MIR level as a  ̳ ̳bright line‘‘ mandated level of protection for residual risk standards. In determining the ample margin of safety, hea lth risk is one factor that we consider, from this source category covered under the rule and its contribution to facility

- wide risk, along with other relevant factors . Balancing these and other factors with the ability to achieve meaningful risk reduction benefits is a critical component of ample margin of safety determination in the residual risk rulemaking process. For the wood furniture manufacturing source category we found that risk s associated with ethyl benzene and all the other HAP emitted were ―ac ceptable‖ and the existing MACT protects the public health with an ―ample margin of safety‖, with no additional controls being adopted under section 112(f).

39. Comment : Commenter 55 stated that the use of a default low

- dose linear cancer risk assessment app roach is completely inconsistent with the strong scientific evidence of a threshold mode of action for formaldehyde:63

The only available risk assessment options for formaldehyde that are consistent with the evidence regarding its mode of action are the def ault nonlinear approach (margin of exposure calculation based on a point of departure in the range of the experimental data) or use of the CIIT BBDR model. However, the default nonlinear approach does not result in a quantitative risk estimate. Thus the CI IT BBDR model remains the most scientifically appropriate method currently available for estimating quantitative human cancer risk from exposure to formaldehyde.

The proposed EPA cancer risk assessment involves linear extrapolation through the origin from points

- of

- departure for increased tumor incidence. This default approach is not well designed to account for the dose response and dose

- dependent transitions for endogenous compounds, like formaldehyde, that have significant physiological background level s in tissues but are toxic at high exposures. Our studies integrating genomics, histopathology and pharmacokinetics (Andersen etal., 2010) indicate that at exposure concentrations below 1 ppm, inhalation of formaldehyde is not expected to cause any appreci able increase in target tissue concentrations of free formaldehyde.
Dose

- dependent transitions for mutation are present for DNA

- reactive compounds (Swenberg et al., 2008) with low dose damage adequately repaired and high doses leading to such extensive dam age that DNA integrity cannot be maintained.

Response : In 2004, the EPA determined that the Chemical Industry Institute of Toxicology (CIIT) cancer dose

- response value for formaldehyde (5.5 x 10

- 9 per μg/m3) was based on better
science than the IRIS cance r dose

- response value (1.3 x 10

- 5 per μg/m3), and we switched from using the IRIS value to the CIIT value in risk assessments supporting regulatory actions. However, subsequent research published by the EPA suggests that the CIIT model was not ap propriate and in 2010 EPA returned to using the 1991 IRIS value, which is more health protective. EPA has been working on revising the formaldehyde IRIS assessment and the National Academy of Sciences (NAS) completed its review of the EPA‘s draft in May of 2011, ( http://www.nap.edu/catalog.php?record_id=13142 ). EPA is reviewing the public comments and the NAS independent scientific peer review, and the draft
IRIS assessment will be revised and the final assessment will be posted on the IRIS database. In the interim, we will present findings using the 1991 IRIS value as a primary estimate, and may
also consider other information as the science evolves

40. Comment : Commenter 52 noted the follow ing:

Even though the HQ based on the REL is predicted to be above one for certain facilities, EPA ―did not see a potential for any facility to cause exceedances of the
acute ERPG

- 1 or AEGL

- 1 levels.‖ Thus, given the admitted conservatism of the modeling me thods and assumptions, and the admitted over

- conservatism of the REL, the fact that certain facilities are predicted to have a maximum HQ above the REL does not provide an adequate basis for concluding that additional control measures are needed to provide an ample margin of safety.

Response : The REL values provided by California EPA are not deemed by EPA to be overly conservative; by definition the values represent an acute health

- protective level of64

exposure, with no risk anticipated below those levels, even for repeated exposures to sensitive populations such as children and the elderly. It is therefore appropriate for us to utilize the RELs in concert with AEGL values which are levels at which we expect to see mild effects in the general population in order to determine what emission limits provide an ―ample margin of safety‖ (AMOS). AMOS does not define a ―rigid line(s) of acceptability‖ but requires us to use
the two

- step process laid out in the Benzene NESHAP to consider a variety of measures of ri sk to public health, costs and feasibility of controls to reduce potential risks as well as the uncertainties of our assessment, See 75 FR 80222

– 80225. Using our analytical approach with the data provided, we concluded it is unlikely that HAP emissions from this source category pose significant acute health risks and that control measures will not be necessary, based upon cost feasibility and the conservative nature of our exposure and toxicity assessment.

41. Comment : Commenter 52 noted the following:

Simi larly, as noted above, EPA asserts that the new 400 lb/yr limit is warranted because it ―will reduce the maximum lifetime individual concern risk from 20

- in

- 1 million to approximately 10

- in

- 1 million.‖ However, EPA‘s risk assessment also
reveals that the c ancer incidence associated with HAP emissions from this source category is ―1 [case] in every 200 years.‖ This rate of incidence already is so diminishingly small that there is no rational basis for EPA to impose additional
control measures in the interest of reducing it further. In short, the existing MACT standard assures an ample margin of safety with regard to potential chronic effects.

Finally, even if maximum risks at certain facilities did not have an ample margin of safety, EPA must consider target ing risk reduction measures to those facilities that present the unreasonable risk. It is unfair and unnecessary for facilities that have managed emissions in such a manner as not to pose an unacceptable risk to be required to adopt risk reduction measures . EPA could target the risk management approaches to the subset of facilities that are―high risk. If a facility wanted to undertake alternative risk reduction measures to get below the―risk threshold ‖ for either acute or cancer risks, it could choose to do so and avoid the use of reformulated coatings and adhesives. This creates an incentive for the facility to find the least cost risk reduction strategy while still meeting an acceptable risk level.

Response : No new requirements are included in the final r ules for these source categories to address or reduce residual risk, so these comments are not germane. To the extent the commenter has concerns with actions taken in future residual risk reviews, those concerns
should be raised at that time

42. Comment : Comme nters 39 and 49 commented on the acute HQ.

Commenter 49 stated that similar to formaldehyde, it was clear from Table 4 that the HEM

- 3 screening results were problematic and that the refined modeling approach that utilized aerial photographs of the faciliti es identified two major problems with the risk assessment 1). The REL for several facilities was lowered since the polar ring needed to be corrected due to GPS errors and 2) an evaluation of the aerial map indicated that the REL needed to be lowered in som e cases by as much as 70%. The commenter noted that it is arbitrary that EPA used the REL for EGME65

as opposed to using the REL for EGBE (delisted HAP) which accounted for 25% of the glycol ether emissions from wood furniture manufacturing, especially since it appears that from Table 4 (Glycol Ether Speciation Profile) that EGME is not used at all in the industry.

Commenter 39 noted that the high acute HQ of 10 is due to EPA's use of the REL for ethylene glycol methyl ether, the most protective reference val ue for this category of compounds, to estimate risk from individual compounds in the group. This extremely conservative assumption significantly overestimates the risk from glycol ether emissions.

Response : We acknowledge that refining our screening asses sments of potential acute impacts utilizing aerial photography in some cases lowered the estimated maximum Hazard Quotient for acute non

- cancer impacts. We also acknowledge that the use of the most health

protective glycol ether REL as the threshold value for all glycol ethers without acute REL values more likely overestimates these potential acute impacts than underestimates them. This approach was utilized because of the large amount of the reported glycol ether emissions which were reported as ―unspeci ated‖. Approximately 70% of facilities reporting glycol ether emissions were unspeciated. There are no AEGL or ERPG values available for any glycol ethers; this further limits our ability to interpret the potential acute impacts of glycol ethers.
Noneth eless, even though our maximum estimated acute HQ from glycol ether emissions remains above 1, we believe it is unlikely that glycol ether emissions from this source category pose significant acute health risks based upon the conservative nature of our exp osure and toxicity assessment.

43. Comment : Commenter 48 stated the CalEPA Reference Exposure Level for EGME is an inappropriate choice of REL for EGPE. EGME is the lowest molecular weight member of the ethylene glycol ether series:

The REL for EGME is based o n decreased testes weight and degenerative changes in the testicular germinal epithelium. A CalEPA REL also is available for ethylene glycol ethyl ether (EGEE), and is also based on testicular degeneration. These types of reproductive organ effects are uni que to EGME and EGEE, but no such effects have been seen in other, higher members of the ethylene glycol ether series starting with EGPE. Based on the observed reproductive organ effects for EGME and EGEE, these glycol ethers were discontinued as commercia l products by the major U.S. manufacturers many years ago. Since the reproductive toxicity effects are limited to EGME and EGEE, and these substances are no longer available in industrial commercial quantities, it is inappropriate to use the REL for EGME t o characterize EGPE and the higher molecular weight members of the ethylene glycol ether series.

The c ommenter derived an REL for EGPE following the methodology of CalEPA. The commenter provided a comment attachment containing the derivation of a proposed REL of
4.3 mg/m

3 for EGPE.

Unlike the 0.060 and 0.070 mg/m 3 RELs calculated for EGME and EGEE, respectively, based on testicular degenerative effects, the proposed 4.3 mg/m 3 REL for EGPE is based on observed hematological changes. No testicular degenerati on has been observed for EGPE. The findings for EGPE are more consistent with the hematological changes observed for EGBE, for which an acute REL of 14 mg/m 3 has66

been assigned based on irritative effects. In both cases, the hematological effects are
seen i n rats and mice, which are more sensitive to hemolysis than human beings. An REL of 4.3 mg/m 3 for EGPE based on hematological effects is consistent with the effects seen in higher glycol ethers, such as EGBE, and serves as a conservative lower boundary for the ethylene glycol ethers series.

Response : 26 of the 92 facilities provided speciated emissions data for glycol ethers which represented approximately 10% of the glycol ether emissions emitted from the source category.
This limitation as well as the li mited number of acute reference values available for individual glycol ether compounds in the SIDS assessments supports the use of a conservative approach (i.e., health protective) of using the glycol ether with the lowest reference value (EGME) as a

surr ogate for glycol ethers without available reference values. A review of the 11 individual speciated glycol ethers reported to the emission inventory only 3 had SIDS data. To the extent that these studies appear in the peer

- reviewed scientific literature at the time of development of an IRIS health assessment, they would be considered along with the entire body of literature.

B. FORMALDEHYDE LIMIT

44. Comment : Five commenters (39, 43, 49, 50, and 52) disagreed with the 400 lb/year formaldehyde limit.

Commente rs 49 and 52 noted that limiting formaldehyde emissions from the wood furniture manufacturing operations source category is not supported by EPA‘s risk analysis and is therefore arbitrary. Commenter 49 noted that the total estimated cancer incidence due to actual emissions is 0.005 excess cancer cases per year or one case in every 200 years.

Commenter 43 further stated that the limit is not necessary because formaldehyde emissions are likely to decrease further during the 2

- year compliance period, without any further regulations.

Commenter 52 added that EPA is not justified in adopting this standard under §112(f)(2)(A) or §112(d)(6). On a related note, Commenter 50 questioned the authority of EPA to establish a 400

- pounds per year limit on formaldehyde emis sions:

Such a limit could result in as little as 40,000 gallons of now compliant finish to be the maximum usable quantity. This forces the use of alternative finishes, many of which do not provide performance necessary to meet existing industry performanc e standards (ANSI/KCMA
A 161.1

- 2000), add cost ($500,000 to $1 million annually according to one estimate), and sometimes are more difficult to work with in the manufacturing process. The proposed 400

- pound limit on formaldehyde emissions should not be app roved as a limit, but should remain as currently referenced in the existing regulation. Justification for the arbitrary limit of 400 pounds is lacking.

Commenter 49 noted that EPA chose the 400 lb/year Formaldehyde limit based on Table 5 of the
MACT standa rd (List of VHAP of Potential Concern Identified by Industry) or 0.2 ton per year. Currently, facilities that exceed their baseline level would need no further explanation to permitting authorities if the exceedance is no more than 15% above the baseline, or if the usage is below the level in Table 5. According to the commenter, EPA did not note the number of facilities that utilize the formaldehyde limit versus the baseline exceedance option. Without this67

data it is not known if facilities use the 0.2 ton per year limit. The commenter assumed that most facilities comply via the exceedance of baseline option and not the 400 lb/year limit.

Commenter 39 stated that an absolute limit on total formaldehyde emissions will impose a significant production constrain t. Take for example, a large cabinet manufacturing facility using a coating containing only 0.25% formaldehyde. If operations involve the use of 25,000 gallons of coating per year, formaldehyde emissions from this operation would total 500 pounds (assuming a density of 8 pounds per gallon). Where a smaller operation can use a much higher formaldehyde content coating and still stay below the 400 pound threshold based on lower annual coating consumption. Larger facilities would need either to curtail operatio ns, install costly controls, or replace the coating with an even lower formaldehyde content material at a considerable cost per ton of formaldehyde reduced.

Commenter 39 also stated that EPA improperly presumed that a ―one

- size fits all‖ approach to

coat ings and adhesives is feasible in the manufacture of wood furniture/cabinet products. EPA failed to take into account the performance, quality and customer requirements of these manufactured goods.

The coatings and adhesives used for cabinet manufacture a re specialized and may contain higher amounts of formaldehyde due to unique customer and environmental requirements.

Based on the data in the October 19, 2010 EPA Memorandum Impacts of Implementing a Limit on Formaldehyde Usage in the Wood Furniture Manufa cturing Operations Source Category , the difference in price between coatings with formaldehyde and those that are formaldehyde

- free is $3.02 per gallon. The commenter assumed a 1% formaldehyde content in the lower priced coating and a coating density of 8 pounds per gallon. The $3.02 per gallon additional cost for a formaldehyde

- free coating would reduce formaldehyde emissions by 0.08 pounds for a cost of $37.75 per pound of formaldehyde eliminated or $75,500 per ton.

The commenter also evaluated the replac ement cost for a topcoat containing 0.25% formaldehyde with a material containing only 0.005% formaldehyde. The price differential of $3.58 per gallon resulting in a cost of over $365,000 per ton of formaldehyde eliminated.

The commenter also noted the hi gh cost of replacement of contact adhesives. Based on the relatively low formaldehyde content in the current materials used, an incremental cost of only $1 to $2 per gallon could result in a cost exceeding $20,000 per ton.

Response : Based on information r eceived in the comments and further inquiry of the impacts of the proposed limit of 400 pounds formaldehyde per rolling 12

- month period , EPA has revised the standard to require the formaldehyde content of coatings and contact adhesives to be
less than or e qual to 1 percent by weight with an alternate compliance option of the 400 pounds per rolling 12

- month period formaldehyde use limit, as explained in the preamble. This approach is promulgated under the technology review requirements under the CAA
section 112(d)(6)since the risks were deemed acceptable under the residual risk requirements under section 112(f)(2) of the CAA. This technology rule will not limit production or result in68

significant costs for high production facilities and will encourage furth er reductions in the future without compromising the integrity of product.

The EPA believes that most facilities will be able to cost effectively comply with the 1 percent by weight formaldehyde limit. 9 This level of formaldehyde will be sufficient to crea te the

cross

- linking nucleation that provides durability to wood furniture products in many cases. By also having a formulation restriction as an alternative to the 400 pound per year limit, there are options for facilities so that there will not be restri ction s of production.

45. Comment : Commenter 44 asked that the final rule clarify that affected sources may rely on the absence of a reported formaldehyde content value in the relevant MSDS as a sufficient basis upon which to report ―no formaldehyde‖ in the re spective finishing material or contact adhesive. This would be inconsistent with EPA‘s prior position on this issue in Plastic Parts and
Products NESHAP.

Response : As required by the final rule, s ources will maintain certified product data sheets (CPDSs) f

rom coating manufacturers that state the concentration of all chemicals within the coatings and contact adhesives. If formaldehyde is not listed on the CPDS, it may be assumed
that it is not part of the formulation.

46. Comment : Commenters 49 and 50 disagree d with the additional recordkeeping and reporting requirements.

Commenter 50 stated that imposing complicated additional recordkeeping and reporting requirements on 150 U.S. based cabinet manufacturers simply because their plants emit some formaldehyde is an overreach and an example of the type of regulatory excess both the President and Congress are trying to discourage.

Commenter 49 stated that the additional recordkeeping and reporting requirements will further burden an industry already facing overseas competition, even though EPA found the risks from this source category acceptable.

Response : The recordkeeping and reporting provisions being finalized are necessary to determine compliance with the 1% formaldehyde content limit or alternatively the 400 lb /12 month formaldehyde usage limit. As discussed in the preamble for this rulemaking, the cost associated with reporting and recordkeeping is low. It is expected that any reporting and recordkeeping resulting from this rule is already occurring routinely w ithin the industry. The commenters did not provide any specifics or data concerning recordkeeping and reporting
burdens. W ithout a description of how this record

- keeping and reporting will create an additional

9 One of the major manufacturers of wood furniture coatings, Valspar, does not carry any products that have greater than 1 percent formaldehyde leading to the conclusion that coatings greater than 1 percent form aldehyde are mostly unnecessary in the industry. http://www.valsparwood.com/valsparwood/msds/msds.jsp . Also through conversations with facilities, we have not encountered facilities that definitively have more than 1% formaldehyde concentrations within their coatings. See Estimated Cost Impact for Wood Furniture Manufacturing Industry to Comply with Proposed Formaldehyde Limit on Coating Operations Wood Furniture Manufacturing RTR for info rmation regarding formaldehyde concentrations in Kitchen Kompact‘s coatings in the docket for this action.69

burden and/or a reason why it is not necessary to keep track of emissions information, EPA has no reason to modify the provisions

.

47. Comment : Commenter 51 stated that the best available science indicates that formaldehyde in outdoor air does not present a risk to human health.

The World Health Organiza tion (WHO) found that ―[i]n ambient air, formaldehyde is quickly photo

- oxidized in carbon dioxide. It also reacts very quickly with the hydroxyl radicals to give
formic acid. The half

- life estimated for these reactions is about one hour depending on the

en vironmental conditions.‖ (WHO, 2010, at 103). Further, WHO concluded that because levels in ambient air are low, outdoor air does not contribute significantly to indoor pollution. Id. at 108. Therefore, EPA‘s proposed cap on formaldehyde use is an unnecess ary restriction that will not reduce residual risk, if any, to public health.

Response : Everyone is exposed to small amounts of formaldehyde in air and some foods and products. Nasal and eye irritation, neurological effects, and increased risk of asthma a nd/or allergy have been observed in humans breathing 0.1 to 0.5 ppm. Eczema and changes in lung function have been observed at 0.6 to 1.9 ppm.

The Department of Health and Human Services (DHHS) has determined that formaldehyde is a known human carcinogen based on human and animal inhalation studies. 10 The EPA considers formaldehyde as a ―Probable Human Carcinogen‖ in IRIS; http://www.epa.gov/iris/subst/0419.htm. The International Agency for Research on Cancer (IARC) classifies formaldehyde as a human carc inogen; http://monographs.iarc.fr/ENG/Monographs/vol88/index. Ambient modeling of formaldehyde in the National Scale Air Toxics Assessment (NATA) at major urban centers indicate that formaldehyde exposures over the long term for
excess cancer risks could b e up to 100 in a million with a national average of 20 in a million based upon the current IRIS Unit Risk Estimate (URE). Monitoring at the National Air Toxics Trends Sites for formaldehyde are in good agreement with the NATA, refer to the following
websit e; http://www.epa.gov/ttn/atw/nata2005/compare.html. The dispersion modeling for wood furniture manufacturing and shipbuilding does not incorporate photochemical decay. The EPA conducted a sensitivity analysis and determined this
feature in AERMOD 11 does n ot have a significant effect on near

- field exposures and is most relevant for population exposures in the far field especially for pollutants with half

- lives less than 30 minutes. The rate of decay is also very dependent temporally with less reactivity occ urring during evening hours as well as during colder seasons. For more information on the sensitivity analysis, please refer to Section 4.6: Sensitivity Analysis

– Atmospheric Chemistry in ―the EPA‘s Risk and Technology Review (RTR) Risk Assessment Methodo logies,‖ that was reviewed by the EPA‘ s SAB; http://www.epa.gov/ttn/atw/rrisk/rtrpg.html . Based upon the rate of decay for formaldehyde varying from 1 hour to 16 hours and the fact that the MIR loca tion for

10 This is according to the Agency for Toxic Substances and Disease Registry.
ht tp://www.atsdr.cdc.gov/toxfaqs/tf.asp?id=219&tid=39

11 AERMOD was developed by the American Meteorological Service (AMS)/EPA Regulatory Model Improvement Committee (AERMIC). This is the preferred model by EPA for modeling point, area and volume sources of

c ontinuous air emissions from facilities.70

this source category is located within 300 meters of the emission source, we find that photochemical decay will not have an effect on the MIR.

Comment : Multiple commenters (39, 49, 51, and 52) offered comments related to the cost
estimate for meet ing the new formaldehyde standard.

Commenter 51 noted that EPA does not adequately support its cost estimate. The commenter
stated that EPA provided no data or analysis to support its assumption that facility operations are
the same or that the use of no

- or low

- formaldehyde coatings and adhesives would be suitable for use by all facilities.

Commenter 51 further noted that EPA‘s ―cost analysis‖ consists of price information, from one supplier, of thirteen no

- or low

- formaldehyde coatings that the Agency c onsiders to be suitable
for use in wood furniture manufact uri ng operations. See U.S. EPA, M emo: Impacts of Implementing a Limit on Formaldehyde Usage in the Wood Furniture Manufacturing Operations Source Category (Oct. 19, 2010 ). The commenter noted that E PA does not analyze whether the available coatings can be used in all applications or would meet industry performance standards.

Commenters 39 and 51 noted that EPA does not list any no

- or low

- formaldehyde contact adhesives in its analysis.

Commenter 52 s tated that the technical and cost analyses EPA puts forth in support of the 400 lb/yr limit are not backed up by any critical analysis or actual data. According to the commenter, this analysis amounts to the assertion that, ―because some facilities are doi ng it, all facilities should be able to do it. This is an empty  ̳analysis‘ that provides no support for the proposed 400 lb per year limit. On top of that, EPA also asserts that the new standard can be met  ̳at little or no extra cost.‘‖ The commenter state d that a much more robust cost analysis would be needed to justify imposing an additional emissions limitation.

Moreover, commenters 49 and 51 noted that EPA does not address the additional costs incurred due to the potential need for new equipment, the si gnificant expenses to adapt to a new finish material, or costs resulting from an increase in business.

Response : Based on information received in comments, we have adopted a 1 percent by weight formaldehyde limit with a 400 pounds formaldehyde per rolling 12

- month period alternative compliance limit that allows wood furniture manufacturers to use their discretion to reformulate to lower formaldehyde coatings and contact adhesives while not necessitating the expense of production line reconfiguration. As di scussed above, we have updated the cost effectiveness analysis for the proposed formaldehyde limit and concluded that the 400 pound per 12 month limit as proposed would not be cost effective 12

.

Using low

- formaldehyde coatings and contact adhesives reflect s developments in technology and was described in the proposal as the method to achieve compliance with the

12 For further detail, see memo to the docket, Estimated Cost Impact for Wood Furniture Manufacturing Industry to Comply with Proposed Formaldehyde Limit on Coating Operations Wood Furniture Manufacturing RTR , dated July 15, 2011.71

proposed 400 pounds formaldehyde per rolling 12

- month period . A limit of 1 percent formaldehyde in coatings and adhesives allows facilities the flex ibility to use coatings and adhesives that are suitable for a range of different products, from cabinets to home furnishings, without compromising their quality, cost, or production. 13 Also, in many cases

, the 1 percent formaldehyde limit will allow flexibi lity in different types of line configurations. 14

Although we did not list any low

- formaldehyde contact adhesives in the proposed rule making, does not mean they do not exist. 3M‘s Fastbond Contact Adhesive 30NF is an example of many that do not contain for maldehyde.

48. Comment : Commenter 51 stated that EPA has not demonstrated that the formaldehyde cap will reduce residual risk. Instead, EPA‘s cap will unnecessarily limit wood furniture production and EPA should not adopt the proposed standard.

Commenter 39 a greed that a review of the facility data compiled by EPA fails to show that emissions of formaldehyde correspond to a high cancer risk or that a reduction in emissions of formaldehyde will result in a reduction of this risk. Of the 385 wood furniture manuf acturing facilities evaluated by EPA, only 141 facilities emit formaldehyde, and of the 141 formaldehyde

emitting facilities, only 26 emit more than EPA‘s proposed threshold of 400 pounds per year.

Commenter 39 further referenced EPA‘s December 2010 Draft Residual Risk Assessment for the Wood Furniture Manufacturing Source Category. Within that memo, 63 facilities were identified as having a cancer Maximum Individual Risk (MIR) of greater than 1

- in

- 1 million. Of these 63,
less than one

- third have formaldeh yde emissions exceeding the 400 pound per year threshold, with only 9 facilities out of the 25 with the highest MIR emitting formaldehyde above the 400 pounds level, compared to six of the top 25 having no formaldehyde emissions reported.

Response : EPA is not promulgating the 400 pound/year formaldehyde limit based on risk
reduction . With this limit now being a compliance alternative to the 1% formulation limit of formaldehyde, risk reductions cannot be determined and no quantifiable risk reductions are being claimed as a result of either the 400 pound per 12 month limit or the 1% by weight formaldehyde
content limit . It is the EPA‘s belief that the promulgated formaldehyde limits maintain the same
level of risk as the existing NESHAP

.

C. GLYCOL ETHERS

49. Comment : Multiple commenters (39, 48, and 50) noted that EPA overestimated the health risk from glycol ethers by using ethylene glycol methyl ether as the representative glycol ether. Given that the use of glycol ethers other than ethylene glycol methyl e ther is the norm for the industry, the risk associated with this class of compounds is overstated in EPA's analysis and no additional regulation of glycol ethers is warranted. Both commenters referred to Table 4 in EPA‘s October 22, 2010 memorandum Review of Glycol Ether Emissions Associated with Wood

13 It is necessary for some facilities to minimize levels of formaldehyde in the coating formulation to promote cross

linking nucleation. This process directly affects the quality and durability of the wood furniture. See notes from the
Marsh Furniture Site Visit in the docket for this action for reference.

14 For additional information, please see memo to the docket, Meeting with Kitchen Cabinet Manufacturers Association (KCMA) , dated August 17, 2011.72

Furniture Manufacturing Source Category . The table contains a summary of speciated glycol ethers that are less toxic than ethylene glycol methyl ether, resulting in EPA‘s overestimation of
the health risk from these compounds.

Commenter 39 offered another assessment approach for glycol ethers:

A more reasonable assessment of glycol ethers would be the example based on data from all facilities of a large wood furniture manufacturing company. Glycol ether
emissio ns in 2010 totaled 3.76 tons, of which over 95% of the emissions were ethylene glycol monobutyl ether, with the remainder comprising diethylene glycol phenyl ether, diethylene glycol butyl ether and phenoxyethanol. Based on the preponderance of ethylene gl ycol monobutyl ether in these emissions, a risk assessment using the significantly higher REL for ethylene glycol monobutyl ether (REL = 14 vs. REL for in ethylene glycol methyl ether of 0.093 ref: http://www.oehha.ca.gov/air/pdf/acuterel.pdf) would conclu de that the risk from glycol ethers is approximately 150 times lower than EPA's analysis shows. Even if the REL for another glycol ether

- Ethylene Glycol Monoethyl Ether, REL 0.37

- were used, the risk associated with glycol ethers would be reduced by a f actor of 4.

Commenter 48 offered another option. The commenter recommended that the HQs derived for Propyl Cellosolve® by the EPA be recalculated using the proposed REL for EGPE. The attached proposed REL (included in their comment) for EGPE demonstrates t hat sufficient information exists to derive an REL for EGPE, which would be more appropriate for risk management than
the REL for EGME.

Response : As we acknowledged in the proposal, the use of the EGME REL in our acute risk screening assessments provided us with a conservative ( i.e. , health

- protective) estimate of potential acute health risks from glycol ethers when the exact speciation profile of emitted glycol ethers was uncertain. For this source category, approximately 70 percent of facilities reportin g glycol ether emissions reported them without any speciation information. Since there are no AEGL or ERPG values available for any glycol ethers, this further limits our ability to interpret the potential acute impacts of glycol ethers. Since this uncerta inty remains, the EPA is not
convinced that the use of less health

- protective assumptions (such as those recommended by the commenters) represents any improvement in the assessment of potential acute impacts. Even so,
because of the health

- protective natur e of our assessment, we do not believe that these estimated

worst

- case acute glycol ether impacts warrant the adoption of additional control measures.

50. Comment : Commenter 50 stated that the industry meets current Occupational Safety and
Health Administratio n (OSHA) regulations on ethy l benzene and glycol ethers emissions in the workplace, including curing and gluing operations. Imposition of different regulations by EPA would be confusing and possibly contradictory. According to limited data, such emissions a re de
minimis.

On the other hand, commenter 45 asked that a residual risk standard be set for glycol ether emissions. California has listed glycol ethers as a toxic air contaminant and EPA should consult the California EPA data and reference values for gly col ethers in order to address these emissions, and the risk they create.73

Response : EPA‘s responsibility to protect public health generally does not cover occupational exposures within the work place ; that is the specific jurisdiction of OSHA, as the

comme nter notes. Under the authority of the Clean Air Act, EPA develops residual risk rulemakings to ensure that hazardous air pollutant emissions from plants are at levels that provide an ample margin of safety to protect public health under section 112(f)

. As such, o ur risk assessment s are designed to characterize the exposures of the public, not those of industrial workers. Ultimately, the regulations of OSHA, which are protective of industrial workers, combined with the regulations of EPA, which are prot e c tive of public health , work together to provide appropriate protection for all. This approach does not create confusion or contradiction since the success of each regulatory approach is measured by its ability to provide protection for

a different segme nt of the population.

With respect to glycol ethers, EPA is aware of glycol ether reference values developed by California EPA and has taken them into account in our risk assessments for this rule, as appropriate within our stated hierarchy of accepted do se

- response values. See the risk assessment documentation for further details on this hierarchy and how it is used. Based on the results of
our risk assessment s, the existing Wood Furniture NESHAP was determined to provide an ample margin of safety, and n o additional regulation was warranted.

D. SPRAY GUNS

51. Comment : Commenter 49 suggested that the EPA either define the term ―conventional‖ or mention the types of spray guns that are to be used to assist the regulated community in complying with this rule. The commenter suggested specific items, mentioned in the Paint Stripping and Miscellaneous Surface Coating Operations rule (Subpart HHHHHH): High

volume low

- pressure(HVLP) spray guns, electrostatic applications, airless or air

- assisted airless

spray guns, or air

- assisted airless equivalent technologies.

Commenter 43 suggested that the EPA exclude the following components from the definition:
handheld non

- refillable aerosol containers, touch

- up markers, marking pens, and the application of paper film or plas tic film which may be pre

- coated with an adhesive by the manufacturer.
These items are allowed by the miscellaneous metal parts and products NESHAP (subpart MMMM).

Response : The existing Wood Furniture Manufacturing Operations MACT standards define ―conve ntional air spray‖ as:

―a spray coating method in which the coating is atomized by mixing it with compressed air and applied at an air pressure greater than 10 pounds per square inch (gauge) at the point of atomization. Airless and air assisted airless spr ay technologies are not conventional air spray because the coating is not atomized by mixing it with compressed air. Electrostatic spray technology is also not considered conventional air spray because an electrostatic charge is employed to attract the coa ting to the workpiece.‖ 40 CFR 63.801(a).74

Many of the above suggestions for specific coating applications are clearly included or excluded by the definition of conventional spray provided in the 1995 NESHAP. The technologies listed above such as touch

- up m arkers, marking pens, and manufacturer pre

- coated adhesive film are not affected by the restriction on use of conventional spray guns because they do not have a spray, i.e. , they are not ―a spray coating method.‖ Even if certain technologies are allowed un der other rule makings such as subpart HHHHHH, the commenter did not explain why these applications are appropriate for this rule making. Examples of compliant spray technology under the Wood Furniture NESHAP include, but are not limited to

, HVLP spray

gun s, low

- volume low

- pressure guns (LVLP), electrostatic applications, airless and air

- assisted airless spray guns. Low

- capacity HVLP cup guns may be used for small batch operations.

52. Comment : Commenter 49 suggested that EPA clarify in the rule that faciliti es with controls can continue to use conventional spray guns. Any emissions would be controlled via the
control device.

Commenter 50 noted that several RTOs, which rely on rich VOC waste streams, are being operated in the industry. To impose air

- assisted

- a irless guns reduces RTO efficiency and requires
more fossil fuel to be consumed.

Response : The proposed rule has been revised to continue to allow use of conventional spray guns when the overspray is routed to a functioning control device. The efficiency of the control device sufficiently reduces excess emissions associated with the decreased spray efficiency of conventional spray guns. 15

53. Comment : Commenters 39 and 50 noted that EPA offered an incorrect premise that all applicator improvements to increas e transfer efficiency of the sprayed material will result in reduced emissions simply due to higher transfer efficiencies. The premise does not consider the
low

- use application considerations required for trials, touchups, and product repairs.

Commenter 3 9 noted:

HVLP and equivalent high efficiency applicators require larger volumes of premixed materials for application and are best utilized where large quantities of materials are intended (usually volumes larger than one gallon to as much as 30 gallons) a nd in production quantity applications where large surface areas are coated. Under large volume spray applications, the high transfer efficiency equipment results in reduced material consumptions resulting in lower operating costs and lower emissions. Unde r high volume application conditions, there are both economic and environmental advantages for operations to use high transfer efficiency equipment.

15 A typical transfer efficiency of an HVLP gun is 65

- 85 percent compared to 25

- 45 percent for conventional guns under similar conditions. This is a difference of 40 percent spray efficiency. When compared to an estimate of 90 percent efficiency of a control device, the control device more than com pensates for the 40 percent reduction in efficiency of guns. For more information on transfer efficiencies of spray technologies see the memo to the docket, Impacts of Prohibiting the Use of Conventional Spray Guns in the Wood Furniture Manufacturing Opera tions Source Category , dated October 29, 2010.75

However, for low use applications such as low volume color stains, trial materials, small touchups and rep airs, mixing large batches for use in high transfer efficiency equipment will result in increased material consumption and waste, increased cleanup solvent consumption and waste, and, for catalyzed top coat materials, material loss through restricted pot l ife. The proposed applicator changes would result in an inability to properly mix small batch work coatings (stains, sealers, topcoats, etc.), resulting in more wasted raw material, increased cleanup material use, waste, and emissions and an unnecessary in crease in generated waste volume.

Arguably, the use of low volume conventional spray equipment such as cup guns, etc., affords the industry a small volume spray alternative that would otherwise require a part to be re

- finished or scrapped entirely. Failed finish repairs with minimal rework and reapplication to the part and in some instances salvage of an otherwise scrapped production part makes production and environmental sense. Indeed small quantity applicators (generally those with a restricted volume o f 1.0 U.S. quart or less) may actually result in lower VOC and VHAP emissions due to the restricted use and inherent limited production capability of the application equipment itself.

Such an overreaching requirement for all spray equipment to be of the H VLP spray type or equivalent is not reasonable and does not consider the other adverse environmental impacts discussed above.

Commenter 50 expressed some of the same concerns as Commenter 39.

Response : First we note the commenter agrees with the EPA that with large volume spray applications, which the commenter defines as larger than one gallon and in production quantities, high transfer efficiency equipment results in reduced material consumption, lower operating
costs and lower emissions 16 . In addition, w e find that t he application technology is available for small batches of coating to be applied with non

- conventional spray guns such as HVLP cup guns. The use of HVLP cup guns will allow for smaller batch mixes. This prevents unneeded coating material goin g to waste. With the higher spray efficiency associated with non

conventional spray guns, a greater portion of the spray is coating the piece of wood. This means that there is less overspray leading to fewer emissions. Other touch

- up applications such as

t ouch

- up markers and handheld non

- refillable aerosol containers may still be used under the
standard. For more information see Use of Non

- Conventional Spray Technology in the Wood Furniture Manufacturing Industry , dated August 3, 2011 and Impacts of Prohibi ting the Use of Conventional Spray Guns in the Wood Furniture Manufacturing Operations Source Category

, dated October 19, 2010 , in the docket for this action.

54. Comment : Commenter 52 argued that EPA lacks authority to ban conventional spray guns
in the wood furniture manufacturing source category:

The proposed rule‘s ban on conventional air spray guns is without rational basis and lacks justification under §112(d)(6). The Agency attempts to justify the ban on the possibility that conventional air spray guns may be more widely used in the future. To the Agency‘s reasoning, a ban would prevent a possible future resurgence in this

16 For more information please see Impacts of Prohibiting the Use of Conventional Spray Guns in the Wood Furniture Manufacturing Operations Source Category , dated October 19, 2010, in the docket for this action

.76

technology. However, EPA offers no information justifying their concern about their potential for future use, relying instead on the unsupported assertion that it might happen. Moreover, EPA refutes even this slim justification by also asserting that affected sources will save money by shifting away from conventional technology. In short, this proposed rule would be regulation for the s ake of regulation. As such, it is not a supportable exercise of §112(d)(6) authority.

Response : EPA fully justified the prohibition on use of conventional air spray guns in the preamble to the proposed rule as well as a supporting memo

, Use of Non

- Convent ional Spray Technology in the Wood Furniture Manufacturing Industry , dated August 3, 2011 . We explained that conventional air spray guns have lower transfer efficiencies and higher emissions than other spray gun types, so requiring use of other spray gun types such as air assisted airless would prevent higher emissions resulting from use of conventional air spray guns. Conventional air spray is defined at 40 CFR 63.801 as, in short, a spray coating method in which the coating is applied at greater than 10 psi, specifically excluding airless, air assisted airless, and electrostatic spray technology. While it is generally accurate to describe this provision as a prohibition on use of conventional air spray guns (with the remaining exception for use of contr ol devices), it would be equally accurate to describe it as a requirement to use spray guns in which the coating is applied at 10 psi or less or else that are airless, air assisted airless, or electrostatic. We also explained that the cost of discontinuin g use of conventional spray guns was believed to be minimal, and in fact may result in a net cost savings.

Based on comments received from other commenters, we have made an adjustment to the prohibition on conventional air spray guns by preserving the exis ting exception that allows conventional air spray gun use when a control device is used for the emissions, as discussed above and in the preamble.

Contrary to Commenter 52‘s assertion, EPA is not required to prove whether conventional air spray guns will b e more widely used in the future in order to justify greater restrictions on their use. EPA‘s prohibition on conventional air spray guns, with an exception for use of control devices, is justified under Clean Air Act section 112(d)(6) as a measure to limi t HAP emissions, with little to no costs (and possibly net savings) for affected sources.

55. Comment: Commenter 43 noted that EPA has assumed, without presenting supporting evidence, that conventional spray guns are now ―rarely used.‖

We were unable to locat e in the Federal Register notice or in the rulemaking record a numerical estimate of the number of conventional spray guns (expressed in total numbers or as a percentage of all spray guns) that are currently in use. The
commenter is therefore concerned tha t EPA‘s figures underestimate the importance of conventional spray guns, especially because they are used for specialized, low volume application. The commenter believes that EPA should provide more information about the current usage of conventional spray guns in the wood furniture manufacturing subcategory before taking further steps towards a prohibition.

Second, it appears that EPA has assumed that there are no issues of feasibility with the prohibition against conventional spray guns. However, some fac ilities use guns77

that operate above 10 pounds per square inch (psi) for applications where the use of
lower

- pressure guns is not feasible.

Third, the commenter was concerned that EPA has underestimated the useful life of conventional spray guns and the rep lacement cost of such guns. In the analysis of the impacts of prohibiting the use of conventional spray guns, EPA assumed that conventional guns have an expected life of up to two years. The commenter stated that some companies have reported that the usefu l life of their spray guns easily exceeds five years with routine maintenance practices such as replacement of worn packings, nozzles, and fluid needles. Similarly, the commenter believes that the average cost of an air

- assisted spray gun is higher than EP A‘s estimate of $500.

Response : In the notice of proposed rulemaking, EPA presented its understanding of the limited and declining use of conventional spray guns , and the availability of alternatives thereto, in the wood furniture industry and solicited co mment on a proposed ban. The EPA received
further information regarding the number of conventional spray guns from a few sources within the industry. 17 18 The information f rom these sources indicates that the vast majority of facilities

are no longer using any conventional spray guns and of those relatively few that are, about two

thirds use them in conjunction with control devices which would continue to be allowed under
the final rule. Given the information provided, we still believe that the small number of wood
furniture facilities still using conventional spray guns without control devices are doing so mostly for touch

- up work and because they did not feel compelled to make a change within a working system

. 19 20 21 In this RTR rulemaking , EPA is adopting a re striction on use of conventional spray guns based on our determination that more efficient, lower

- emitting spray technologies are available and at reasonable cost

. Based on the limited number of conventional

guns currently in use , the EPA believes it is re asonable to expect that conventional guns will be replaced after their useful life within the three

- year compliance period of the final rule. The few

, if any, that remain after three years will have very limited useful life left

. A commenter asserted
that  ̳some‘ companies have reported a useful exceeding five years with certain routine maintenance practices, but commenter did not provide any specifics as to how many companies and spray guns this applies to, whether these facilities or spray guns are unusual , and the costs of the routine maintenance practices. Without such information, EPA is not revising its estimated useful life of conventional spray guns, except to note that to the extent that any such spray guns have a useful life beyond 3 years from the effective date of this rule, they will be few in number and very limited in remaining useful life. The EPA also maintains that non

- conventional spray

guns are technically feasible and applicable for touch

- up work. See Response to Comment #5 4
above. The co mmenter asserts that the cost of an air

- assisted spray gun is higher than EPA‘s
estimate of $500 but failed to identify a different cost figure or provide any supporting information, so EPA is not revising its cost estimate for a replacement air

- assisted s pray gun

.

17 An email from Dick Titus of KCMA describing the frequency of conventional spray guns within a sector of the industry is in the docket for this action.

18 An email from Bryan Starnes of Linwood Furniture describing their current use of conventional spra y guns is in
the docket for this action.

19 Please see the Notes from Linwood Furniture Site Visit in the docket for this action for more information.

20 An email from Dick Titus of KCMA describing the frequency of conventional spray guns within a sector of the industry is in the docket for this action.

21 An email from Bryan Starnes of Linwood Furniture describing their current use of conventional spray guns is in
the docket for this action78

E. SSM PROVISIONS

56. Comment : Two commenters (43 and 46) voiced concern with EPA‘s proposal to amend several Subpart JJ provisions in response to Sierra Club v. EPA , in which the U.S. Court of Appeals for the D.C. Circuit vacated two of the MACT gene ral provisions that address SSM events. The vacated provisions are 40 CFR 63.6(f)(1) and 63.6(h)(1). Both commenters
referenced the Kushner Letter, written by Adam Kushner, Director of EPA‘s Office of Civil
Enforcement

.

Commenter 43 noted that Table 1 to S ubpart JJ indicates that neither of the vacated provisions has been incorporated into Subpart JJ. The commenter cited the Kushner Letter, which explains the potential impact of the SSM litigation and provides two lists of Section 112(d) rules. The first

ca tegory identifies MACT standards that will be ―immediately affected‖ by the Court‘s decision because the rules specifically incorporate the vacated provisions. The second category lists rules
that have a source

- category specific SSM provision which will no t be affected by the Court‘s decision. The commenter noted that Subpart JJ is not identified in either list.

Commenter 43 suggested that it would be more appropriate to address the decision in the following ways:

EPA [should] first develop a comprehensive rulemaking response that explains how EPA will address the Court‘s vacatur of 40 CFR 63.6(f)(1) and 63.6(h)(1). This process would involve a detailed review by EPA of the Court‘s decision and, as appropriate, proposed amendments to the MACT general provis ions that would conform to the outcome of the case. Because the vacated provisions impact several different MACT standards, they should be assessed first on a broader scale before any changes to the individual source category standards are proposed.

Commen ter 46 noted that the Wood Furniture Manufacturing provision was not affected by the SSM Decision (Kushner Letter). Commenter 46 also noted:

EPA has previously found a case

- by

- case basis consideration of potential
enforcement to be a less desirable route t o address malfunctions. 37 Fed. Reg. 17,214, 17,214 (Aug. 25, 1972). As the Supreme Court has found, ―a reasoned explanation is needed for disregarding facts and circumstances that underlay or were engendered by the prior policy.‖ FCC v. Fox Television Sta tions, Inc. , 129 S. Ct. 1800, 1811 (2009) (citation omitted). EPA failed to provide any explanation as to why it now believes a

case

- by

- case affirmative defense is a more appropriate route.

Response: EPA intends to propose a comprehensive rulemaking respon se to address the Court‘s vacatur of 40 CFR 63.6(f)(1) and 63.6(h)(1). Our proposal will be comprehensive, in that it will address 63.6(f) and (h), and the related provisions of 63 Subpart A that address planning, monitoring, recordkeeping, and reporting o f emissions related to startup, shutdown, and malfunction under the various MACT standards. Further, EPA intends to address most of the MACT standards in that proposal to ensure that MACT standards conform to the court‘s decision.79

While EPA is developing this more comprehensive response, EPA was and is simultaneously required to meet deadlines on o 7 ther MACT standards, deadlines imposed by the Act itself, consent decrees, court orders, and the like. EPA opted to address the court‘s decision on SSM in MAC T rules being proposed and promulgated, while still developing a more comprehensive proposal, in a good faith effort to put the court‘s decision into practice expeditiously.

It is EPA‘s intention to propose that affirmative defense be included in the gene ral provisions and make it available to all sources subject to a MACT standard in part 63. Thus, the decision to include affirmative defense in actions prior to our comprehensive response is intended to be congruent with our action to remove startup, shut down, and malfunction exemptions in those rules. EPA considered it unreasonable to remove startup, shutdown, and malfunction exemptions without providing affirmative defense available to the sources, when our intention is to provide it in the near future in subsequent action applicable to those sources.

F. RULE TEXT CORRECTION S

57. Comment : Commenter 49 recommended EPA add the following language from other
MACT standards for consistency and burden reduction :

A. What Source Categories and Subcategories Are Affec ted by the Final Rule?

The final rule applies to you if you own or operate a [miscellaneous metal parts and products] surface coating facility that is a major source, or is located at a major source, or is part of a major source of HAP emissions. We define a [miscellaneous metal parts and products surface coating] facility as any facility engaged in the surface coating of any [miscellaneous metal part or product]. If application of coating to a substrate occurs, then surface coating also includes associated activities, such as surface preparation, cleaning, mixing, and storage. However, these associated activities do not comprise surface coating if the application of coating does not occur. Coating application with handheld, non

- refillable aerosol containers , touch

- up markers, marking pens, or the application of paper film or plastic film which may be

pre

- coated with an adhesive by the manufacturer is not a coating operation for the purposes of the final rule. You will not be subject to the final rule if your [miscellaneous metal parts and products] surface coating facility is located at an area source. An area source of HAP is any facility that has the potential to emit HAP but is not a major source. You may establish area source status by limiting the source ‘s potential to emit HAP through appropriate mechanisms available through your permitting authority. The final rule does not apply to surface coating or a coating operation that meets any of the criteria listed below:

A coating operation conducted at a sou rce where the source uses only coatings, thinners and/or other additives, and cleaning materials that contain no organic HAP, as determined according to the procedures in the final rule.80 Surface coating that occurs at research or laboratory facilities, or is part of janitorial, building, and facility maintenance operations, or that occurs at hobby shops operated for noncommercial purposes.

Coatings used in volumes of less than 189 liters (50 gallons (gal)) per year, provided that the total volume of coating s exempt does not exceed 946 liters (250 gal) per year at the facility.

B. Determination of Mass Fraction of Organic HAP

(a) Determine the mass fraction of organic HAP for each material used.

You must determine the mass fraction of organic HAP for each coa ting, thinner, and cleaning material used during the compliance period by using one of the options in paragraphs (a)(1) through (5) of this section.

(1) Method 311 (appendix A to 40 CFR part 63). You may use Method 311 for determining the mass fraction of organic HAP. Use the procedures specified in paragraphs (a)(1)(i) and (ii) of this section when performing a Method 311 test.

(i) Count each organic HAP that is measured to be present at 0.1 percent by mass or more for Occupational Safety and Health Admini stration (OSHA)

- defined carcinogens as specified in 29 CFR 1910.1200(d)(4) and at 1.0 percent by mass or more for other organic HAP compounds. For example, if toluene (not an OSHA carcinogen) is measured to be 0.5 percent of the material by mass, you do no t have to count it. Express the mass fraction of each organic HAP you count as a value truncated to four places after the decimal point (for example, 0.3791).

(ii) Calculate the total mass fraction of organic HAP in the test material by adding up
the indiv idual organic HAP mass fractions and truncating the result to three places after the decimal point (for example, 0.763).

(2) Method 24 (appendix A to 40 CFR part 60). For coatings, you may use Method 24 to determine the mass fraction of nonaqueous volatile matter and use that value as a substitute for mass fraction of organic HAP.

(3) Alternative method. You may use an alternative test method for determining the mass fraction of organic HAP once the Administrator has approved it. You must follow the procedu re in § 63.7(f) to submit an alternative test method for approval.‖

(4) Information from the supplier or manufacturer of the material. You may rely on information other than that generated by the test methods specified in paragraphs (a)(1) through (3) of t his section, such as manufacturer‘s formulation data, if it represents each organic HAP that is present at 0.1 percent by mass or more for OSHA defined carcinogens as specified in 29 CFR 1910.1200(d)(4) and at 1.0 percent by mass or more for other compound s. For example, if toluene (not an OSHA carcinogen) is 0.5 percent of the material by mass, you do not have to count it. For
reactive adhesives in which some of the HAP react to form solids and are not emitted to the atmosphere, you may rely on manufacture r‘s data that expressly states the organic HAP or volatile matter mass fraction emitted. If there is a disagreement between such information and results of a test conducted according to paragraphs (a)(1) through (3) of this section, then the test method re sults will take precedence81

unless, after consultation, you demonstrate to the satisfaction of the enforcement agency that the formulation data are correct.

Response : The language recommended by the commenter is unnecessary for the Wood
Furniture NESHAP or this RTR rulemaking

, and the commenter did not provide specific reasons to do so, so EPA is not including it

.

III. SHIPBUILDING
A. RISK ASSESSMENT

58. Comment : Commenter 45 stated that EPA has failed to fulfill its section 112(f)(2) duty to fully assess and determin e whether the risk from this source category is ―acceptable.‖ EPA concludes that this category creates an MIR of 20

- in

- 1 million based on allowable emissions, and
10

- in

- 1 million based on estimated ―actual‖ emissions. EPA does not justify its conclusion on the record that this level of risk is acceptable. It simply lists the numbers and different factors, without explaining how it is analyzing these factors or why they have led EPA to reach its conclusion. EPA recognizes that disparities in risk exist, with individuals in certain demographic groups, including African Americans and people with income below the poverty level, more likely to experience a higher level of risk. As discussed above, EPA cannot simply rely on the old Benzene presumption that any lev el of risk under 100

- in

- 1 million is acceptable. And, the fact that 4,000 people is a ―relatively low‖ number ( i.e ., the number estimated to be exposed to
cancer risks of 1

- in

- 1 million or greater) does not justify EPA‘s proposal of inaction to protect
the se people. Section 112(f)(2) requires EPA to set standards for the maximum exposed individual. The individuals in this group of 4,000 are the very people whom the law requires
EPA to be concerned about.

Response : We do not consider the 1

- in

- 1 million MIR l evel as a  ̳bright line‘ mandated level of protection for establishing residual risk standards. In determining the ample margin of safety ( i.e. , the level of the standard), health risk is one factor that we must consider, along with
other factors such as co st and technological feasibility. Balancing these and other factors with the ability to achieve meaningful risk reduction is a critical component of the residual risk rulemaking process. We considered reducing risks further but concluded that the technolog y required, such as a portable or permanent enclosure big enough to accommodate an entire ship or even a section of a ship to capture and control air emissions, would be cost prohibitive for this industry. Although our additional analysis of the demographi cs of the exposed population shows some disparities in risks between demographic groups for both categories, the EPA has determined that no group is exposed to an unacceptable level of risk. In general, the contribution of the source category to elevated f acilitywide cancer or noncancer risks is low throughout the facilities in this source category. The primary processes driving the facilitywide cancer and noncancer risks are welding and abrasive blasting which are not regulated under this source category

.

Comment : Commenter 45 stated that EPA has determined that maximum individual cancer risk at the facility

- wide level is 200

- in

- 1 million based on estimated ―actual‖ emissions. This means that the risk is likely to be higher based on allowable emissions. (a llowable up to 2 times greater than estimated ―actual‖). The allowable level is the level of maximum individual82

exposure. Further, of the 41 facilities with facility

- wide MIR of 1

- in

- 1 million or more, 15 have shipbuilding and ship repair operations that c ontribute over 50 percent to the facility

- wide risks. Yet, EPA does not propose to take any action to address that risk. EPA should investigate ways to reduce this residual risk. It does not consider or address whether this level of facility

- wide risk
is a cceptable at facilities where this source category is contributing so significantly. EPA must do so to complete its section 112(f)(2) duty. Its failure to consider regulatory options to address this residual risk is also arbitrary and capricious. At minimu m, EPA should consider whether to set a residual risk standard in order to reduce this high level of facility

- wide risk. It should consider requiring extra work practice, reporting, monitoring, and other measures for facilities
that have the level of emiss ions putting them into this highest risk category. In sum, EPA must address what standard is needed ―to provide maximum feasible protection against risks to health‖ by ―protecting the greatest number of persons possible‖ to a lifetime risk level no greater than 1

- in

- 1 million. (quoting Benzene NESHAP), and its facility

- wide risk analysis has failed to complete this essential step.

Response : We examined facilitywide risk to provide additional context to the source category risks. Facilitywide risks are driv en by estimated emissions from abrasive blasting and welding sources at Shipbuilding and Ship Repair facilities. These sources are not part of the Shipbuilding and Ship Repair (surface coating) source category. As discussed in the preamble to the proposed actions for this source category [75 FR 80237], we intend to list welding and
abrasive blasting operations as a major source category under section 112(c)(5) of the CAA.

59. Comment : Commenter 45 stated that EPA has identified that some of the high cancer risk from these facilities is driven by hexavalent chromium emissions from welding and abrasive blasting operations. It also has found that the high TOSHI is driven by manganese from these operations. Commenters support EPA‘s proposal to list welding and abras ive blasting operations as a source under section 112(c)(5), 42 U.S.C. § 7412(c)(5), to address these significant amounts of HAP emissions. The commenter urged EPA to do so promptly now that it has information showing that it is necessary to list this sour ce category. The commenter also noted that California has developed a child reference dose value for manganese that EPA should consult in developing regulations for this new source category( See http://www.oehha.ca.gov/public_info/public/kids/schools070306. html; and http://www.oehha.ca.gov/public_info/public/kids/pdf/Mn

- PCPFinal

- 070306.pdf .).

Response : EPA intends to list welding and abrasive blasting operations that occ ur at shipbuilding and ship repair facilities as a major source category under Section 112(c)(5) of the
CAA. EPA may consider the use of CAL

- EPA‘s child RfD values for ingestion risks, only for those pollutants that meet EPA‘s criteria as a PBT. A review of the methodology from EPA‘s Air Toxics Risk Assessment Reference Library; Appendix D: ―Methodology for Identifying PB

HAP Compounds,‖ Table 1 did not identify manganese as a PB

- HAP; http://www.epa.gov/ttn/fera/data/risk/vol_1/appendix_d.pdf . A review of criteria utilized by EPA to assess persistence, bioacculmulative, and toxicity indicate that manganese does not readily bioaccumulate in the environment and is most toxic thru the i nhalation pathway.

60. Comment : Commenter 53 provided support for the Agency‘s proposal to re

- adopt the existing provisions of the Shipbuilding and Ship Repair (Surface Coating) NESHAPs (40 CFR Part 63 Subpart II) have been effective in providing an ample marg in of safety to protect public83

health and prevent adverse environmental effects, as determined by the Agency‘s risk and technology review.

The commenter (53) also expressed support for the Agency‘s proposal to re

- adopt the existing provisions of the Shipbu ilding and Ship Repair (Surface Coating) NESHAP for the purpose of meeting the requirements of Section 112(f)(2) of the Clean Air Act and Amendments.

The commenter stated that they continue their research and development activities to improve their portfol io of coatings used in the global shipbuilding and ship repair industry. Among these products are improved anti

- fouling and foul

- release technologies, and sealers/tie coats to enable their effective use. The commenter‘s R&D programs also target reductions of VOC and VOHAP contents of their marine and protective coating products to meet the sustainability expectations.

Response : We appreciate the commenter‘s support on our approach to evaluating residual risk for the shipbuilding and ship repair source categ ory.

61. Comment : Commenter 42 stated that with respect to the Shipbuilding and Ship Repair standard, we are concerned that EPA based its decision that no additional controls are needed and that the existing standard provides an ample margin of safety in part due to ―the uncertainty and lack of data associated with one potential risk reduction option identified, and the technological infeasibility of the other option identified‖. The commenter urged EPA to obtain the necessary data regarding the two options to make a more informed decision, including contacting air quality agencies that currently regulate the source category. We compliment EPA on its intention to list welding and abrasive blasting operations at shipbuilding and ship repair facilities as a major source category under section 112(c)(5), but encourage EPA to determine the extent to which this action will address the risks remaining at these facilities before deciding that relying on this strategy is sufficient.

Commenter 45 stated that EPA‘s propos al fails to satisfy the ―ample margin‖ requirement. EPA bases this conclusion in part on the fact that it has ―not identified any data regarding the availability, use, performance, and emissions associated with the use of lower overall VOHAP
content or low er toxicity VOHAP content.‖ Id. EPA‘s conclusion is incorrect based on the use of the California standards in place. It is unclear why EPA did not simply contact the four identified California air quality districts that have more stringent emission limits to attempt to gather these
data. See Part IV.A.1, infra . This is the 8

- year residual risk rulemaking and now is the time to collect and consider those data. EPA may not defer or ignore this responsibility, or the fact that
stricter standards are in use tha t it must address. EPA also cannot justify a failure to set a residual risk standard on a lack of data. EPA has failed to explain how the existing section 112(d) standard could provide the required ―ample margin of safety.‖ Commenter 45 also stated that

s t andards in other jurisdictions are more stringent than the existing MACT. For shipbuilding and ship repair, EPA has recognized that four California air quality districts have implemented stronger standards. Where other jurisdictions have implemented strong er standards this provides evidence that for the purposes of CAA § 112(d)(6) more stringent limitations are achievable and
have been achieved.

However, for the shipbuilding and ship repair category, EPA states that there are differences between coating lim its in the four air districts, and that the 1995 MACT standard includes cold84

weather limits which are not present in the California standards due to its moderate climate. Neither of these points is a valid reason for EPA not to further analyze and adopt st ronger standards based on these California examples. While it may not be appropriate to adopt the California standards in full on a national basis, EPA gives no rational justification for not analyzing how to take these models and use them to create an app ropriate national standard under CAA § 112(d)(6). EPA concludes that ―we do not have data to determine whether these
lower

- VOC content coatings could be applied nationwide.‖ Gathering and analyzing that data, starting with any information already compiled by the California districts, is precisely what the section 112(d)(6) rulemaking is designed for. A lack of data is not a lawful basis for EPA to decline to adopt a stronger MACT standard.

Response : The EPA researched current technologies for the shipbuild ing and ship repair surface coating industry, and did not find any cost effective options that would make the current standard more stringent. Related to the marine coating limits in the MACT rule, we reviewed the general use and 22 specialty coating VOHAP limits and the lower limits that some states and air districts have adopted over the past decade for some of the specialty categories. Furthermore, we requested comment on the availability and feasibility of using lower VOHAP coatings but did
not receive any data or information during the comment period. Following proposal, we did contact a shipyard in Maine, and found that the use of lower VOHAP coatings, such as those required to meet the limits set by some of the California air quality districts, is not feasible in climates that are not as moderate and, therefore, necessitate greater thinning of paint.

As noted by the commenter, some jurisdictions have implemented more stringent standards that have resulted in changes to formulations being used in those locations. However, temperature and humidity issues experienced by other locations would make painting operations having to comply with the more stringent limitations more difficult, more expensive, and in some
cases unachievable.

There are many different coatings, and in some cases groups of specific coatings, comprising each of the marine coating categories. Over the past several years, there have been changes to some formulations with HAP solvent reductions and solvent replacements, but those
are coatin g and manufacturer specific and not reflective of the entire marine coating category. 22

B. WELDING AND ABRASIVE BLASTING

62. Comment : Commenter 54 stated that the National Shipbuilding Research Program (NSRP) was created by U.S. shipyards at the Navy‘s request to reduce the cost of building and maintaining U.S. Navy warships. NSRP is a collaboration of several major U.S. shipyards focused on industry

- wide implementation of solutions to common cost drivers. The program targets solutions to consensus priority issues identified by the Navy shipbuilding community and industry by undertaking R&D efforts that exhibit a compelling business case to increase warship affordability by improving U.S. shipbuilding and ship repair efficiency. The NSRP is comprised

22 See following memos to the docket on cost effectiveness of control technologies: Cost Analyses for Add

- on Controls for Surface Coating Operations at Shipbuilding and Ship Repair Facilities , dated September 2, 2010 and Affordability of Add

- on Controls for Shipbuilding and Ship Repair Source Category

, dated October 18, 201 0.85

of ten ―Ship Pr oduction Panels,‖ one of which is the Environmental Technology Panel (ETP), which focuses on environmental compliance issues as they relate to the shipbuilding/repair industry and its customers.

The U.S.EPA published an Advance Notice of Proposed Rulemakin g (ANPRM), entitled ―Risk and Technology Review, Phase II, Group 2‖ in the Federal Register on March 29, 2007 (72 Fed. Reg. 14734). The ANPRM stated that entities potentially affected by this action include facilities containing any one or more of the 22 m ajor source categories subject to the 12 National Emission Standards for Hazardous Air Pollutants (NESHAP), commonly referred to as Maximum Achievable Control Technology (MACT) standards. ―Shipbuilding and Ship Repair Operations‖, North American Industry C lassification System (NAICS) code 336611, and MACT code 0715, was included in this as a source category (U.S. EPA, 2007).

The commenter recognized the potential impact that this proposed ruling could have on the shipbuilding industry, and took a proactive approach to work with the U.S. EPA in a collaborative effort to support the development of a final rule. Early in this process, the U.S.EPA and the NSRP ETP recognized that this approach would be mutually beneficial in supporting both the U.S. EPA‘s missio n to ensure that human health and the environment are protected from potentially hazardous air pollutants with an ample margin of safety, as well as the commenter‘s goal to ensure that any regulatory decisions made in support of the U.S. EPA‘s mission woul d be based on scientifically defensible data, and not default conservative assumptions.

In response to the ANPRM published in 2007, the commenter submitted a series of comments expressing concern that the use of the proposed conservative default values and assumptions associated with such things as HAP emissions, metal speciation, facility air emissions modeling, and health risk calculations to fill identified data gaps would overestimate the actual risk from shipyard welding operations. Since submitting th ose comments, the NSRP ETP has worked towards improving the data available to the U.S. EPA to reduce the need for default values and assumptions. The commenter did this by completing several research projects primarily focused on collecting actual welding emissions data. The NSRP ETP worked closely with Mr. Tom Driscoll from U.S. EPA‘s Measurement and Policy Group, to coordinate U.S. EPA reviews of sampling and analysis plans used to guide these research projects. The purpose of this was to: (1) Address any comments and/or concerns that the U.S. EPA may have with the scientific approach developed to collect and analyze weld fume samples prior to completing the project; and (2) Ensure that the resulting data would be of a level of quality that could be accept ed by the U.S.EPA for use in the rulemaking process. Upon completion of each research project, the commenter provided Mr. Driscoll with a Final Summary Report, which documented the research activities and provided the final data. The commenter‘s intent was for this data to be used in later stages of the residual risk process, and ultimately be reflected in the Proposed Rule.

However, when the Proposed Rule was published in the Federal Register, Vol.75, No. 244, on December 21, 2010, it stated that, ―...this M ACT standard only includes the surface coating operations that occur at these facilities during shipbuilding and ship repair...‖ (p. 80235); and ―We therefore intend to list welding and abrasive blasting operations that occur at shipbuilding and ship repair facilities as a major source category under Section 112(c)(5) of the CAA. We request additional information on the HAP emitted by these activities. Once we have this information, we will be in a better position to identify the appropriate scope of the majo r source86

category to be listed‖ (p. 80237).‖ In response to this request, the commenter prepared this data package to be officially submitted to the docket for consideration in the potential development of any future major source category that may be devel oped for or may include shipyard welding operations.

The intent of this letter is to summarize how the data generated from the commenter‘s past efforts can be used to support the potential development of a new major source category, and to explain why ship yard welding operations differ greatly from other manufacturing processes that use welding heavily in their processes to the point that a uniform approach to regulation of shipyard welding with other, heavier welding operations may not be possible.

Summary of commenter efforts:

1. Submitted June 28, 2007

- Response to Comments on the March 29, 2007 ANPRM (72 Fed. Reg. 14734):

The commenter prepared and submitted comments to the Air and Radiation Docket (EPA

- HQ

OAR

- 2006

- 0859) on June 28, 2007. The commenter believes that these comments are applicable to the potential development of a major source category for shipyard welding operations, and are requesting that they be reviewed and considered if such a category is developed (provided as Appendix A of this let ter).

2. Completed July, 2008

- Control Technology Demonstration and Weld Fume Evaluation (CTC, 2008a):

Under this project, it was determined that actual welding process and material usage data would be critical to verifying current weld fume emissions. As such, the team researched and selected the most commonly used process/electrode combinations, and evaluated the fume generation rates, and the concentration of hazardous air pollutants emitted to characterize weld fume emissions. The differing welding pro cesses and electrode types were selected by researching actual industry usage data. One survey based on data from 12 reporting shipyards (Serageldin, January 2005) found that the most common shipyard welding processes are Flux Cored Arc Welding (FCAW) (55% of the welding) and Shielded Metal Arc Welding (SMAW) (29%). This same study found that 90% of rods are mild steel (including 71T and 7018), and that only 1%
stainless steels are used.

Another study which had 16 reporting shipyards (Harris, 2000) found th at the welding processes used are 64% FCAW, 14% Gas Metal Arc Welding (GMAW) and 10% SMAW. This study found that the most common rods/wires used with SMAW are E7018, E6010/E601 1, E11018;
the most common for FCAW is E71

- T1; and the most common for GMAW are ER70S

- 3,
ER100S

- 1, and ER120S

- 1. They also found that 85% of shipyard welding is on mild steels. A survey of five shipyards participating as active members of this project team was conducted during October 2007 to determine the quantity and types of elect rodes that they used during a

recent one

- year timeframe. For these shipyards, 77% of the welding was FCAW, 15% was SMAW, 7% was GMAW and 1% was GTAW. Less than 1% of the welding was done using
stainless steel electrodes.87

In these shipyards, 99% of the FCAW welding is done with electrodes 71T

- 1C and 81T1; 85% of SMAW welding is done with 7018 electrodes; and 85% of GMAW welding is done with
E70C

- 6M electrodes. Based on these studies, it is seen that FCAW, SMAW and GMAW are the three welding processes used mo st frequently in the shipyards; thus, these were the processes selected for this project. The most commonly used electrodes were selected for use with these processes and included the stainless steel electrodes E309, E310, and E316, along with the
carbon s teel electrodes E7018, E71T, E81T1, and E70C

- 6M.

After addressing comments and recommendations provided by the U.S. EPA‘s Measuring and Policy Group on the project Sampling and Analysis Plan, testing was completed at two shipyards, and the data was evaluat ed independently for each testing event. The fume generation rates for these process/electrode combinations were calculated using the average of 5 separate welding runs, completed in a specially modified American Welding Society (AWS) welding
fume chamber. The total fume generated was collected in filters and analyzed through gravimetric analysis. The Total Metals: Chromium (Cr), Hexavalent Chromium (CrVI), Manganese (Mn), Nickel (Ni), and Lead (Pb), emissions factors were the result of a single sample. The samples were collected on glass or quartz fiber filters in the modified AWS fume chamber, and were analyzed according to Occupational Safety and Health Administration (OSHA) or National Institute of Occupational Safety and Health (NIOSH) methods.

The emis sions factors for Total Chromium were higher for the stainless steel electrodes (SMAW 309L, 310

- 16, FCAW 309L, and 316L) than for the carbon steel electrodes. Total Cr emissions factors ranged from 92 to 551 μg/g of electrode consumed for the stainless steel electrodes, but was less than 5 μg/g for the carbon steel electrodes. The lowest chromium emissions factor for a stainless steel electrode was generated by the GMAW process. As for Cr(VI), emissions factors were again higher for the stainless steel electrodes than for the carbon steel electrodes. Cr(VI) emissions factors ranged from 5 to 375 μg/g for the stainl ess steel electrodes, and were 2 μg/g or lower for the carbon steel electrodes. The lowest Cr(VI) emissions factor for a stainless steel electrode was generated by the GMAW process. The ratio of Cr(VI) to Cr was only calculated
for the stainless steel elec trodes because the amount of Cr and Cr(VI) in the carbon steel electrodes was low, and in some cases was below limits of detection. For the three processes, using four electrodes, Cr(VI) accounted for ~5% to ~86% of the total chromium, which varied by

proc ess; again with the GMAW process having the lowest value, followed by FCAW, then finally SMAW with the highest. Emissions factors for total nickel were also highest for the

sta inless steel electrodes, ranging from 29 to 229 μg/g, while the carbon steel electrodes ranged from 0.3 to 4 μg/g. Manganese emissions factors ranged from 79 to 925 μg/g and were consistently high for all process/electrode combinations that were evaluated. Total lead emissions factors were low for all process/electrode combinations, ranging from less than 0.2 to 4.7 μg/g. It should be noted again here that these values are the result of two independent samples, collected for each process/electrode combinati on, at two different shipyards.

The single point emissions factors were then compared to emissions factors values published in the U.S. EPA‘s, ―AP

- 42, Fifth Edition, Compilation of Air Pollutant Emissions Factors, and Volume 1: Stationary Point and Area So urces, January 1995‖ (AP

- 42), and the ―Shipbuilding and Ship repair

– Residual Risk, Proposed Emissions Factors for Stainless Steels, Mild Steels, and Alloys Steels, Presented during their July 26, 2005 Conference Call (as the data used for
stainless steel s and mild steels) (Residual Risk Proposed)‖. For Total Cr, Cr(VI), Mn, and Ni, the88

calculated emissions factors for the stainless steel electrodes evaluated were generally consistent (either slightly above or below), or a great deal less than the publishe d values. For SMAW 309L, total Cr, Mn and Ni were all less than the Residual Risk Proposed emissions factors, while there are no SMAW 309L factors provided in AP

- 42 for comparison. However, Cr(VI) was found to be higher than the Residual Risk Proposed emis sions factors. For SMAW 310

- 16, Cr, Cr(VI), and Mn are all significantly less than the AP

- 42 published emissions factors, but were found to be generally consistent for Pb. These were all found to be generally consistent with the Residual Risk Proposed emis sions factors. For FCAW 309L, total Cr, Mn and Ni were all a great deal less than the Residual Risk proposed emissions factors, while Cr(VI) appeared to be consistent. There were no FCAW309 factors provided in AP

- 42 for comparison. For GMAW316L, the emissi ons factors measured in this study were generally a great deal less than those published in the AP

- 42 and in the Residual Risk proposed emissions factors for Cr, Cr(VI), Mn, and Ni. For all of the process/electrode combinations evaluated, the emissions fac tors for Pb were a great deal less (ranging from <0.2 to 3 μg/g) than the default value of 215 μg/g provided for all of the selected process/electrode combinations in Residual Risk proposed values. With the four carbon steel electrodes evaluated, the emiss ions factors determined for Cr, Cr(VI), Ni and Pb were generally consistent with or less than, the AP

- 42 and the Residual Risk proposed values. With regard to Mn, the measured emissions factors for SMAW 7018M were approximately half of the AP

- 42
and the Re sidual Risk proposed values. For GMAW70C

- 6M, the emissions factors calculated under this project were approximately twice the values for those listed under 70S in AP

- 42 and the Residual Risk proposed emissions factors (70C

- 6M was not listed in either of th ese documents). For the remaining two electrodes, FCAW71T

- 1C and FCAW81T1, the Mn values measured in this project were consistent with the published values.

Also as part of this project, the NSRP ETP demonstrated and evaluated two, commercially available, portable welding emissions control technologies. The objective of this testing was to determine the capture (ability to capture the fume at the source) and control (filters‘ ability to remove the contaminant from the exhaust air) efficiency of both units. The first technology tested was a low vacuum, high volume portable system designed for medium duty extraction and filtration of welding fumes. The capture efficiency ranged from ~73% to ~100% over the various runs, with an average of 95%.

A total of 20 sam

ples were collected from the exhaust air stream of the unit, three (3) produced a detectable concentration of Mn, two (2) produced a detectable concentration of Ni, while all 20 produced results below the limit of detection for Cr, Cr(VI), and Pb. Shipyard welders commented that this type of unit would work best for fixed

- site welding operations and would not be as suitable for long, linear welds, and not at all be suitable for using on

- board a vessel due
to its size. The second unit demonstrated was a smal ler, more portable, high vacuum, low volume unit, with two different extraction attachments, a bell

- shaped nozzle, and a fume extraction gun. The capture efficiency with the bell

- shaped nozzle ranged from ~42% to ~89% with an average of 60%. The fume gun w as determined to be ineffective for use in a shipyard environment. When the air velocity was set to a high enough velocity to capture the weld fume, the shielding gas was pulled away from the point of the weld, resulting in a poor quality weld. A
total of 24 samples were collected from the exhaust air stream of the unit; one (1) produced a detectable concentration of Mn, and one (1) produced a detectable concentration of Ni, while all 24 produced results below the limit of detection for Cr, Cr(VI), and Pb.89

The general conclusion that were reached as a result of this research project were:

Based on industry research, the primary welding process used by the shipbuilding and ship repair industry is FCAW, followed by SMAW and GMAW. This is significant
because t he analytical data generated in this project demonstrated that FCAW and GMAW generally produce fewer emissions as compared to SMAW.

Based on industry research the majority (~85 to 99%) of shipyard welding is completed using mild steel as opposed to stainle ss steel. This is significant because the analytical data generated in this project demonstrated mild steel generally produces fewer Cr(VI) emissions as compared to stainless steel. This is an important fact, considering the Cr(VI)
is a known human carcino gen and the primary risk driver for estimated offsite cancer
risks.

Several discrepancies were found between the emissions factors generated under this project, and the Proposed Residual Risk emissions factors; most notably for Pb, Cr, Mn. It is requested that the data used to develop the Proposed Residual Risk emissions factors be evaluated for accuracy and applicability for use in the development of shipyard emissions factors as we strongly believe that the introduction of specifically developed
factors w ill enhance the ability to accurately characterize emissions for any potential welding rulemakings.

The capture and control efficiency of the control technologies was demonstrated, and their limitations were discussed. However, a full scale assessment of t heir applicably for use in a shipyard environment was not completed. Due to the unique nature of shipbuilding and ship repair activities, it is recommended that a technology assessment be completed to determine if control technologies could be implemented at a reasonable

cost.

3. July 29, 2008

- Evaluation of Welding Electrodes to Determine the Mass Fraction and Decay Rate of Hexavalent Chromium :

Under this project the team selected three commonly used welding process/electrode combinations, SMAW 310

- 16, FC AW 309 and FCAW 71T

- 1. The 310 and 309 electrodes are both stainless steel, while the 71T

- 1 is mild steel. Even though shipyards perform much more welding on mild steels than on stainless steels, two of the three electrodes chosen were stainless
steel beca use their higher chromium content made them more representative of ―worst case‖ risk conditions for Cr(VI) emissions. These process/electrode combinations were evaluated for fume generation rates and concentrations of hazardous air pollutants using the sam e procedure as referenced under the first project. However the testing under this project was completed in a high bay testing facility as opposed to a shipyard, and three (3) data points were collected for each process/electrode combination as opposed to o ne (1), which were then averaged to generate the emissions factors. As with the first research project, the mild steel electrode FCAW 71T

- 1 produced fewer Cr(VI) emissions at 0.08 μg/g, as compared to the two stainless steel electrodes,
FCAW 309 and SMAW 310

- 19, which produced Cr(VI) emissions at 31.4 and 388 μg/g, respectively. The ratio of Cr(VI) to Cr varied based on the various weld ing process/electrode combinations. The fume generated from the SMAW 310

- 16 electrode contained the greatest ratio90

of Cr(VI) to Cr at 72%, followed by FCAW 309 at 25% and FCAW 71T

- 1 at 3%. As discussed under the first project, the metal

- specific emissions factors were compared to the AP

- 42 and the Proposed Residual Risk emissions factors. When comparing the SMAW 310

- 16 developed emissions factors to the Proposed Residual Risk emissions factors, they are generally consistent. However, when they are compared to the factors listed in the AP

- 42, with a quality rating of C, the developed emissions factors are a great deal lower for Cr(VI), Cr, and Mn, and are consistent for Ni. The developed emissions factors for FCAW 309 are a great deal less for Cr, Mn, and Ni, and are generally consistent for Cr(VI). There were no AP

- 42 values available for FCAW 309 for comparison. For FCAW 71T

- 1, the developed emissions factors are generally consistent with the Proposed Residual Risk emissions factors as well as with the AP

- 42 listed values, with the exception of Ni, in which case the developed emissions factor is a great deal less that the Proposed Residual Risk emissions factors.

The decay rate testing was completed on fume collected from the SMAW 310

- 16 electrode by allowing the sample to set out on untreated filters, exposed to ambient conditions in a laboratory environment (temperature ~70 °F, relative humidity of 50%) for specified time intervals of 3, 6, 9, 12, 15, 18, 24, and 48 hours after sampling. At the designated ti me interval the sample was placed in a buffer solution to inhibit the conversion of Cr(VI) to Cr. A decay rate constant of 0.012 was calculated for Cr(VI) in SMAW 310

- 16 weld fume. The data from this study demonstrated that 25% of the initial Cr(VI) decaye d within 24 hours and about 44% of the initial Cr(VI) decayed within 48 hours. The Cr(VI) half

- life was estimated to be approximately 58
hours.

The general conclusions that were reached as a result of this research project were:

Mild steel, which is the st eel primarily used in shipbuilding welding processes, generally produces fewer Cr(VI) emissions as compared to stainless steel. This is an important fact, considering the Cr(VI) is a known human carcinogen and the primary risk driver for estimating offsite cancer risks.

Based on the data obtained, it appears that FCAW generally produces fewer Cr(VI) emissions (0.08 and 31.4 μg/g) as compared to SMAW (388 μg/g). This is significant considering that FCAW is used to a greater extent as compared to SMAW.

Several discrepancies were found between the emissions factors generated under this project, and the Proposed Residual Risk emissions factors, and those published in the AP

42. Most notably for SMAW 310

- 16, and FCAW 309. It is requested that the data used to develop the Propos ed Residual Risk emissions factors be evaluated regarding its accuracy and applicability for use in the development of emissions factors.

There is documented evidence that the concentration of Cr(VI) reduces over time as it transforms into Cr(III). This is significant because it demonstrates that not all of the Cr(VI) generated during shipyard welding will reach the fence line due to its natural conversion to Cr(III). Based on this, the risk to public health will decrease as the distance from the point of o rigin increases, based on the fact that the amount of time that the Cr(VI) is present in the environment increases as well.91

It is requested that the natural decay of Cr(VI) in the environment be taken into account in any future regulatory decision.

4. Dece mber 30, 2009

- Developing Emissions Factors for Electrodes Commonly used within the Shipbuilding Industry for use in Regulatory Reporting Procedures :

The third project expanded on the work completed under the previous two projects. The same procedure was used to collect and analyze the weld fumes while simulating typical shipyard processes, but the number of samples collected for each process/electrode combination was increased to six (6) as opposed to three (3), to increase the scientific defensibility of the results. An alternate approach was used to select five welding process/electrode combinations for evaluation. The selection was based on: overall volume of use in the shipyards; lack of current high quality emissions factors listed in the AP

- 42; and, the composition of Cr(VI) and Mn as the primary constituents that drive the estimation of shipyard offsite public health risks. The process/electrodes selected for evaluation were as follows: FCAW 308, FCAW 309, SMAW 11018, SMAW 309 and SMAW 7018. The aver age (mean of 12) total fume emissions factors for the two stainless steel FCAW electrodes, 308LT1 and 309LT1, were 5.5 and 6.27 mg/g, respectively.

The average total fume emissions factor for the stainless steel SMAW electrode, 309L

- 16, was 10.4 mg/g. The total fume emissions factors for the two mild steel SMAW electrodes, 7018M
and 11018

- M, were 20.5 and 17.3 mg/g, respectively. For the metals Cr, Pb, Mn, and Ni, the reported emissions factors represent the average of six data points. The average Cr emissi ons factors for the two stainless steel FCAW electrodes, 308LT

- 1 and 309LT1, were 426 and 696 μg/g, respectively, and for the stainless steel SMAW electrode, 309L

- 16, the average was 716 μg/g. The average Cr emissions factor for the carbon steel SMAW elect rode 7018M was 6 μg/g. As expected, these values are lower than those for the stainless steel electrodes. The average Cr(VI) emissions factors for the two stainless FCAW electrodes, 308LT

- 1 and 309LT1, were 12 and 37 μg/g, respectively, and for the stainle ss steel SMAW electrode, 309L

- 16, the average was 252 μg/g. The average Cr(VI) emissions factor for the carbon steel SMAW electrode, 7018M was 1.2 μg/g. It should be pointed out that the Cr(VI) emissions factor of 71 +/

- 35 μg/g for the
SMAW11018

- M electro de is statistically higher than the Cr emission factor of 21 +/

- 3 μg/g. It is not possible to obtain a Cr(VI) value higher than the total Cr value.

The project team investigated several potential sources for this discrepancy in the data, but a
definite c ause for this could not be determined. The project team suspected that the Cr(VI) value is incorrect, due to the fact that it is a mild steel electrode, and would be expected to emit low amounts of Cr(VI). However, because this could not be confirmed, the project team recommended that both the Cr(VI) and Cr values be disregarded for the SMAW11018

- M electrode. The Cr(VI)/Cr emissions factor ratio for the two stainless steel FCAW electrodes,
308LT

- 1 and 309LT1, were 3 and 5%, respectively, and for the stainle ss steel SMAW electrode,
309L

- 16, it was 35%. The average Pb emissions factors for all of the electrodes ranged from 0.8 to 3.3 μg/g. The average Mn emissions factors for the two stainless steel FCAW electrodes,
308LT

- 1 and 309LT1, were 440 and 416 μg/g, r espectively, and for the stainless steel SMAW electrode, 309L

- 16, it was 736 μg/g.92

The average Mn emissions factors for the two carbon steel stick (SMAW) electrodes, 7018M and
11018

- M, were 771 and 1004 μg/g, respectively. The average Ni emissions factors for the two stainless steel FCAW electrodes, 308LT

- 1 and 309LT1, were 56 and 131 μg/g, respectively, and for the stainless steel SMAW electrode, 309L

- 16, it was 64 μg/g. The average Ni emissions factors for the two carbon steel stick (SMAW) electrodes, 701 8M and 11018

- M, were 1 and 46 μg/g, respectively. This controlled study, which proceeded following a review of the approach by the EPA, and all corresponding data help to conclude that this is an appreciable reduction for emissions of these potential HAPs (which are risk driving constituents) when compared to the speciation ratios used in the rulemaking process. The analysis specifically concluded that the CrVI speciation is much closer to the 5% demonstrated in the study when contrasted to the 33% speciati on offered as a default factor in the rule. We believe that the continued use of any default values for the speciation of CrVI at 33% would be unlikely.

Moreover, the continued use of default speciation assumptions for the assessment of CrVI
emissions woul d adversely affect the conclusions of any regulatory decisions when those decisions are based on assumed speciation when given the findings from this actual testing. The welding material supplier ESAB provided comparative testing, using the same electrodes evaluated under this project, but collected and analyzed the fume in a different manner. It was determined that the two methods resulted in comparable data, within one order of magnitude. It is important to note that the ESAB data was generated from the a nalysis of one composite sample, while this study is representing the average of the analysis of six individual samples. In addition, ESAB used different techniques for sample preparation and analysis.

The emissions factors developed under this study were then compared to those developed under those previous two projects, as well as to the AP

- 42, and to the Proposed Residual Risk
emissions factors. It should be noted that not all electrodes were included in all of the research projects, and not all of the e valuated electrodes and metal species were included in AP

- 42 or the Proposed Residual Risk emissions factors. Based on the electrodes that were able to be compared, the following observations were made:

The emissions factors generated in the various studie s represented in these comparisons are consistent from study to study (within the same order of magnitude) for all metals.

The ratio of Cr(VI) to Cr varied significantly between the FCAW (3% and 5% Cr(VI)) and SMAW (21% and 35% Cr(VI)) processes.

The Resid ual Risk Proposed Cr emissions factor of 3000 μg/g for both FCAW electrodes appears to be high relative to the data generated in all of the various studies.

The Residual Risk Proposed Pb emissions factor of 215 μg/g for all stainless steel electrodes appea rs to be high relative to the data generated in the various studies.

The Residual Risk Proposed emissions factors for Cr(VI), Mn, and Ni appear to be consistent (within the same order of magnitude) with the emissions factors generated in
these studies.93

The general conclusions that were reached as a result of this research project and the collection
of actual data were:

Mild steel generally produces fewer Cr(VI) emissions as compared to stainless steel. This is an important fact, considering the Cr(VI) is a known human carcinogen and the primary risk driver for offsite cancer risks.

Based on the data obtained, it appears that FCAW generally produces fewer Cr(VI) emissions (0.08 and 31.4 μg/g) as compared to SMAW (388 μg/g). This is significant considering tha t the FCAW is used to a greater extent as compared to SMAW.

Several discrepancies were found between the emissions factors generated under this project, and the Proposed Residual Risk emissions factors, and those published in the AP

42; most notably for Cr and Pb emissions factors. It is requested that the data used to develop the Proposed Residual Risk emissions factors be evaluated regarding its accuracy and applicability for use in the development of emissions factors.

This project focused on electrodes that currently did not have published high quality
emissions factors. It is recommended that these emissions factors be considered for use in filling these data gaps.

The commenter worked closely with the U.S. EPA through the coordination of Mr. Tom Drisco ll of U.S. EPA‘s Measurement and Policy Group during the collection of this data. Most recently, the commenter participated in a meeting with U.S. EPA representatives at RTP, NC on January 19th, 2011. The presentation given by the commenter was provided as an attachment. As a result of this meeting, the commenter took the action to prepare and submit these comments to support the U.S. EPA in any potential regulatory action taken to address welding as a major source category. The commenter was also requested to participate in a project with the U.S. EPA in the submission of the emissions factors generated under these projects to ―WebFIRE‖, which will be rolled out as a result of the U.S. EPA Emissions Factors Improvement Program. The commenter requested that if any future regulatory actions are taken to address welding as a major source category, that this be coordinated with the appropriate points of contact from the U.S. EPA‘s Emissions Factor Program to ensure consistency and defensibility of the data being used.

Response : The EPA thanks the commenter for this information. The information and data provided by the commenter will be reviewed and considered during the development of the future MACT for welding and abrasive blasting operations.

63. Comment : Comment er 52 determined that a new source category for welding and abrasive blasting operations is unreasonable because such operations are already part of an existing source category. In the proposed rule, EPA announced its intent to list welding and abrasive bl asting operations that occur at shipbuilding and ship repair facilities as a major source category under § 112(c)(5). The possibility of creating a new source category appears to be based at least in part on the facility wide risk assessment, which purport s to show significantly higher risk than from surface coating operations alone. The additional risk is tied to chromium emissions from welding and blasting.94

In comments on the October 21, 2010 RTR proposal, the commenter explained that once EPA
establishe s a MACT standard for a particular source category, the Agency has the authority under § 112(d)(6) to ―review and revise as necessary (taking into account developments in practices, processes, and control technologies), emissions standards promulgated unde r this section no less often than every 8 years.‖ In other words, EPA does not have unfettered discretion to revisit a prior MACT determination once that determination has been issued. Rather, EPA may revise a prior determination only ―as necessary‖ accord ing to explicit statutory criteria. These comments were directed at EPA‘s proposal to adopt new emissions standards under §§ 112(d)(2) and (3) for specified ―significant emission sources within the [subject] categories for which standards were not previous ly developed.‖

Whereas, in the October 2010 RTR proposal, EPA proposed to ―gap fill ‖ existing standards by invoking §§ 112(d)(2) and (3), in the case of the current RTR proposal EPA attempts to accomplish the same ―gap filling ‖ by an alternate route

– i.e

. , by purporting to identify a new source category within shipbuilding facilities (welding and abrasive blasting operations) and adopting a separate MACT standard for the new source category. This approach to ―gap filling‖ is unjustified and in contraventi on to § 112(d)(6).

The MACT standard for shipbuilding and ship repair operations is applicable to ―shipbuilding and ship repair operations at any facility that is a major source.‖ While welding and abrasive blasting are included in the defined source categ ory, the current MACT standard does not include any emissions limitations or control requirements applicable to these activities. The preamble to the proposed standard explains why:

Over 99 percent of HAP emissions at shipyards are organic solvents assoc iated with paints and cleaning. Other activities that collectively contribute the remaining 1 percent include welding, metal forming/cutting, and abrasive blasting. The proposed standards will affect operations involving the use of paint and organic solven ts.

Thus, it is clear that EPA included welding and abrasive blasting in the shipbuilding and ship repair source category, but chose not to regulate emissions from these activities under the MACT standard because the emissions from these activities represe nted only a very small fraction of total HAP emissions from the source category.

With this context, the assertion in the RTR proposal that a new source category needs to be created to regulate HAP emissions from welding and abrasive blasting operations at shipbuilding and ship repair facilities is unfounded. Since these activities are already within the defined source category, § 112(d)(6) provides the only authority for EPA to adopt § 112(d) standards for
these activities.

Response : We disagree with the c ommenter‘s assertion that EPA included welding and abrasive blasting in the shipbuilding and ship repair (surface coating) source category. The listed source category only addresses surface coating operations at shipbuilding and ship repair
facilities. As noted previously, we examined facilitywide risk to provide additional context to the source category risks. For this source category, the emissions from welding and abrasive blasting were concerned in the context of facilitywide risk. The EPA believes tha t welding and95

abrasive blasting will be a source category that is relevant to multiple industries, and is therefore more appropriate to address outside of just the shipyard and ship repair source category.

C. ENVIRONMENTAL JUSTIC E

64. Comment : Commenter 45 stat ed EPA recognizes that there are ―disparities in risks‖ for certain minority and lower

- income individuals. For shipbuilding and ship repair, African Americans and people below the poverty level face a cancer risk of at least 1

- in

- 1 million at a higher rate than their representation in the population. EPA must consider potential ways to address the disproportionate impact on minority individuals and communities in deciding whether the likelihood of cancer risk is ―acceptable‖ and whether there is action that could provide an ―ample margin of safety‖ for these individuals and communities. Indeed, EPA has recognized this since the Benzene NESHAP although it has failed to take action to address this. (citing Benzene NESHAP factors, including ―overall incidence o f cancer or other serious health effects within the exposed population. . . other quantified or unquantified health effects‖). These additional factors are supposed to be used in addition to the MIR. It is neither acceptable nor just
to avoid the need to r educe the correlation between race or income level and a disproportionate risk of cancer from toxic air pollution. EPA‘s proposals for inaction, in the face of the recognized disparities, contradict the Administrator‘s professed commitment to ―fair treatme nt‖ (EJ Guidance, infra note 30, at 3). With the knowledge it has, EPA must, at minimum, consider the amount of background pollution faced by, and baseline health of, racial minorities and communities affected by these two source categories, including for the types of health effects that these HAP emissions have potential to exacerbate. These types of health data are readily available for EPA to factor into its analysis and to use in proposing a regulatory response to the disproportionate risk found. It wou ld be arbitrary and capricious to propose to take no further action at all after finding these disparities for both source categories.

The commenter support s the EPA‘s effort to gather demographic data. Merely looking at these numbers in a simplistic manne r, however, is no substitute for a true environmental justice analysis. EPA should develop and undertake an actual analysis of the location and community effects of these source categories. It has sufficient data on the locations of these facilities to
und ertake an analysis of the effect of their emissions on the maximum exposed individual, the history of pollution faced in the most affected community, and to consider how to set a just standard in view of these lasting harms.

Response : The demographic anal ysis found that African

- Americans and people below the poverty line may be somewhat disproportionately impacted by facilitywide air toxics emissions; however, emissions from the source category itself contribute minimally to these impacts. The EPA also fou nd the overall level of risk from both source categories to be acceptable and to provide an ample margin of safety for all populations in close proximity to
these sources. As noted previously, the EPA‘s ability to quantitatively assess impacts on
environme ntal justice communities is evolving.