The commenter noted that in setting the NAAQS, the EPA recognized that there would be greater impacts to the more exposed individuals.  The commenter contends that children living near secondary lead smelters are not only a population with increased susceptibility, but they also face elevated levels of exposure because they live near secondary lead smelters. The EPA's staff paper for the lead NAAQS shows that children living near the lead smelting facilities would still be subject to an IQ loss as high as 3.9 (at the median) to 7.3 (at the 95[th] percentile), even if the EPA had set the NAAQS at 0.02 instead of 0.15 ug/m[3].  The commenter stated that this shows that an ambient air concentration of 0.02 ug/m[3] would not achieve an acceptable level of risk for children living near a secondary lead smelter, let alone provide an ample margin of safety. The commenter stated that the EPA must set a residual risk standard that prevents the local ambient lead concentration from exceeding the CHPAC-recommended limit of 0.02 ug/m[3] as a monthly average.
      The commenter contends that in choosing the lead NAAQS, the EPA "chose to allow an IQ point loss for the children...living near lead smelting facilities, above the 1 to 2 points that is considered to be "highly significant from a public health perspective," and above the 2 points that is considered to allow an "adequate margin of safety" for the national population level of exposed children."  Therefore, replicating the NAAQS in this rulemaking fails the section 112(f)(2) test to provide an ample margin of safety to communities near secondary lead smelters.
      The commenter further stated that replicating the lead NAAQS as a standard is also problematic because it ignores cumulative, long-term impact to individuals from prior lead emissions.  Ambient lead concentrations are not the only relevant thing because it does not account for reservoirs of lead in soil and elsewhere.  The commenter contends that children can face higher levels of exposure from dust and soil than from inhaling air.
      The commenter claimed that "EPA says the standard provides an ample margin of safety because EPA has not identified any further feasible and cost-effective controls beyond the wet electrostatic precipitator which it deems too expensive."  The commenter stated that the EPA provides no explanation as to how the fact that it was unable to identify less expensive control options means the ample margin of safety requirement is met.  The commenter further noted that the EPA, in its own analysis, identified other facilities that are using HEPA filters in addition to baghouses to achieve lower concentrations of lead.
      The commenter noted that the ample margin of safety determination is "a decision about whether to set the standard lower than the acceptable risk, taking feasibility into account."  The commenter further noted that most facilities achieve emission levels well below those proposed by the EPA and that the data demonstrates that the risks can be reduced further beyond the EPA's proposed standard, taking feasibility and cost into account.
      Response: Most of this comment is addressed at page 64 above. We add that in order to assess multipathway risks associated with emissions of lead, the EPA compared modeled rolling three month average lead concentrations estimated from emissions to the NAAQS for lead. As noted above, we believe that this is a reasonable approach given that the NAAQS is a health based standard set to protect the public health, including the health of sensitive sub-populations with an adequate margin of safety. Moreover, the NAAQS for lead specifically is targeted to provide requisite protection with an adequate margin of safety to prevent neurologic effects to children with low blood lead levels living near a lead source and exposed at the level of the NAAQS.  While we conclude that the NAAQS presents an acceptable level of risk from lead in ambient air, and are requiring controls to ensure that the NAAQS is not exceeded, as part of our "ample margin of safety" analysis, we examined whether there were additional cost effective controls available to further protect public health including monitoring at a level below 0.15 ug/m[3]. For the reasons explained elsewhere in this notice and other supporting documents available in the docket, we have determined that there are no additional cost effective, technically feasible controls that would provide further risk reductions.
      In addition, the commenter states:  "EPA's staff paper for the lead NAAQS shows that children living near the lead smelting facilities would still be subject to an IQ loss as high as 3.9 (at the median) to 7.3 (at the 95th percentile), even if the EPA had set the NAAQS at 0.02 instead of 0.15 ug/m3."  As noted above, this comment may be in error.  The Staff Paper and notice of final rulemaking (73 FR at 66982) indicates a median air-related IQ loss estimated to be less than 3.7 (using the higher confidence loglinear C-R function, and less than (1.2-5.1) via the other 2 functions) for children living within 1.5 km of primary smelters.   Moreover, as noted in the earlier comment response, EPA did not rely on the risk assessment as the primary basis for its revisions to the primary lead NAAQS.
      With respect to the California benchmark for protecting children, the EPA has a hierarchy of appropriate health benchmark values.  In general, this hierarchy places greater weight on EPA derived health benchmarks than those from other agencies (http://www.epa.gov/ttn/atw/nata1999/99pdfs/healtheffectsinfo.pdf). For the reasons provided above, we believe that the lead NAAQS establishes an appropriate benchmark for addressing acceptability of risk and we therefore disagree with the commenter that we should instead use an ambient concentration of 0.02 ug/m[3] based on a one month average.
      Comment:  Commenter 98 cited the following from the preamble to the proposed rule regarding environmental risk from this source category for HAPs other than lead:

      With respect to potential for adverse environmental effects from non PB-HAP, we note that there is a lack of information about specific adverse environmental effects occurring at a given concentration of HAP for this source category.  However, given that all chronic non-cancer HQ values considering actual emissions are less than 1 using human health reference values, we believe that it is unlikely that adverse environmental effects would occur at the actual HAP concentrations estimated in our human health risk assessment.

      The commenter noted that the EPA provides no explanation as to why its conclusion regarding environmental risk from non-PB HAPs is true.  The commenter further noted that the EPA has recognized the need to look at emissions above the actual level for human health.  The commenter stated that the EPA must perform an ecological risk assessment and may not simply rely on the human health assessment without a reasoned explanation for doing so.
      The commenter noted that chemicals that are persistent in the environment or bioaccumulate in living tissue will remain or increase over time.  Therefore, additional exposure would be added to a background that is likely already unsafe for wildlife and other environmental resources.  Lack of human health risks from inhalation does not mean that the EPA can conclude that there would be no effects to wildlife or other natural resources either form inhalation or air deposition of HAP emissions, exacerbated by persistence and bioaccumulation.
      Response: First, the secondary NAAQS for lead, which is requisite to protect public welfare from known or anticipated adverse effects, is identical to the primary lead NAAQS.  Thus, in meeting the controls for lead (which also result in co-control of all other non-mercury HAP metals) emissions will be controlled to levels less than allowed by the secondary lead NAAQS.  Second, EPA is to adopt more stringent standards directed to adverse environmental effects only upon taking into consideration "costs, energy, safety, and other relevant factors".  As discussed as part of the ample margin of safety analysis, EPA has determined that these factors militate against adopting any further controls (and reached a similar conclusion based on similar factors in its section 112 (d)(6) analysis) and this same reasoning applies with respect to adopting further controls to prevent adverse environmental effects.  Moreover, without specific information about how, and at what concentration a given HAP affects a given ecological receptor, the EPA is unaware of how it could have performed a separate ecological risk assessment.  As noted by the commenter and in the risk assessment document, we generally conclude that for non PB-HAP, if all chronic non-cancer HQ values are less than 1 using human health reference values, than we believe that it is unlikely that adverse environmental effects would occur.  However, we disagree with the commenter that we do not provide a rationale for this judgment.  The risk assessment states in section 2.5:
      Human health dose-response reference 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 reference 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 scarcity of data on the direct atmospheric impact of these HAP on other receptors, such as plants, birds, and wildlife.  Thus, if the maximum inhalation hazard in an ecosystem is below the level of concern for humans (i.e., is below the human health reference value which is itself a lower reference value than would be expected for an ecologic effect), we have generally concluded that mammalian receptors should be at no risk of adverse effects due to inhalation exposures from non PB-HAP, and have assurance that other ecological receptors are also not at any significant risk from direct atmospheric impact.

      With respect to the potential for ecological risk associated with PB-HAP, we note that our multipathway analysis indicated that all chronic non-cancer HQ values were less than 1 using human health reference values.  Thus, we believe that it is unlikely that adverse environmental effects would occur considering actual emissions.  We further believe this is a reasonable interpretation of the multipathway analysis given a lack of information on the effects of PB-HAP on specific ecological receptors.
      Finally, we agree with the commenter that the potential for ecological effects should be noted when considering MACT-allowable emissions.  Thus, when HQ values are greater than 1 considering MACT allowable emissions, we note that there is at least some potential for ecological effects.
Emissions Used

      Comment:  Two commenters (90, 96) stated that the EPA's risk review is invalid because it fails to consider the reduction in dioxin and arsenic risks that would occur with the use of the proposed additional controls.  The commenters compared the dioxin concentrations and risks to background dioxin concentrations and risks for the entire US populations and concluded that dioxin emissions from secondary lead smelters produce a contribution to the environment that is "not distinguishable from background concentrations."  The commenters contend that additional controls on dioxin emissions from this source category will result in less than a 1% reduction in an exposed individual's risk.
      With respect to arsenic, the commenters stated that the average background levels of arsenic in urban air (20 to 30 ng/m[3]) result in inhalation risks between 35 and 50-in-1 million, similar to the MIR risk that the EPA yielded for the secondary lead smelters.  The commenter contends that the EPA should demonstrate how arsenic emissions from the secondary lead smelting industry would affect the extant risk from arsenic.
      Response: The EPA disagrees with the commenters that it did not consider reductions in risk after the proposed controls.  Section 3.3 of the draft risk assessment document is titled: "Post-control risk characterization" and it describes the estimated risks after potential controls are in place.  Moreover, we note that the risk estimates calculated by the EPA are those associated with emissions from the source category.  Similarly, risk reductions estimated after considering the proposed controls are based on estimated reductions in emissions from the source category.  Thus, the estimated risk reductions described in the draft risk assessment and preamble are independent of the background levels for a given HAP.
      Comment:  Commenter 98 stated that the EPA's failure to recalculate the risk assessment after changing its fugitive dust estimates is problematic given that the EPA's modeling shows that fugitive emissions are the largest contributor to risks from this source category.  The commenter further stated that because the EPA failed to "test or provide a reliable accounting for its measure of fugitive dust emissions...", it has underestimated risk and should compensate by setting a stronger standard.
      Response: We have updated the fugitive emissions based on corrections received in public comments. However, we disagree that the methodology used for calculating fugitive emissions are underestimating emissions or risk and require a stronger standard. The estimates provided by some facilities were unrealistically low and we developed the methodology to better account for fugitive emission levels as described in the proposal. See 76 FR at 28038. However, the estimates of fugitive emissions which EPA developed were overstated due to an error in the emission estimate for Exide Frisco, which was used to calculate estimates for the other facilities. The recalculated (and reduced) fugitive emission estimates led to a slight decrease in the risks due to fugitive emissions; however, we disagree that the methodology was fundamentally flawed in a way that would yield an underestimate of risk.
      Comment:  Commenter 98 stated that failing to include MACT-allowable emissions in the multipathway risk assessment is a "glaring inconsistency in the EPA's analysis that is arbitrary and capricious.  The commenter contends that relying on actual emissions does not sufficiently protect populations living near the smelters, which have a range of emissions and may exceed levels allowed by the MACT standard.
      Response: We did not have detailed enough information to perform a multipathway risk assessment considering MACT allowable emissions.  In fact, for dioxins and furans as well as for mercury there was no MACT standard in the 1997 NESHAP and thus, we would be unable to calculate MACT allowable emissions for these pollutants.  However, as noted in the proposal preamble, the proposed limit for dioxins and furans and mercury would lower multipathway risk somewhat and would also ensure that multipathway risks associated with dioxins and furans and mercury did not increase. See 76 FR at 29064.
      Comment:  Three commenters (80, 90, 91) noted that the docket did not contain the data inputs to the AERMOD and Human Exposure Model (HEM-3) and that they were thus unable to properly comment on the methods or results of air dispersion and risk modeling.  Commenter 90 supplied a list of technical documents not available that included stack test reports, survey responses, and underlying data sets.
      Response:  The EPA disagrees with the commenters.  The docket contains model input information that could be used to replicate the HEM-3 results.  This includes emissions and emissions location information. Disks with the technical documents mentioned by the commenters were sent to the Docket Center; however, CD availability was not posted because some of the test reports included in the disks contained confidential business information.

      Baseline Emissions Estimates
Fugitive Emissions Estimates

      Comment:  Commenters 90, 91, and 96 stated that the EPA's factoring approach for estimating fugitive emissions is methodologically unsound. The EPA classified each facility as Level 1, Level 2, or Level 3 based on the degree of fugitive emissions control implemented at each facility.  The commenters claimed that the EPA failed to take into account the fact that Exide Frisco itself is a Level 2 facility, meaning that the EPA effectively used the "wrong common denominator" for each facility.  This resulted in overstating emissions from Level 3 facilities and understating emissions from Level 1 and Level 2 facilities.  Commenter 80 stated that there is no description of the method the EPA used to determine scaling factors, nor how the calculation was verified.
      Response:  Although the Exide Frisco facility was classified as a level 2 facility, the enclosures at the Frisco facility were limited to the material handling area.  For this reason, the facility had many similarities to the facilities classified as level 1.  In an attempt not to overstate or understate emissions from any facilities by a large amount, a decision was made to perform the calculations as described in the Development of the RTR Emissions Dataset for the Secondary Lead Smelting Source Category document available in the docket.  We also note that the scaling factors were partly based on confidential business information that was not appropriate to publish.
      Comment:  Commenters 80 and 94 stated that the fugitive emissions estimate for the Exide Forest City facility is over an order of magnitude higher than the NEI estimate of 0.06 tons per year and that such an overestimation calls into question the reliability of the EPA's estimates.
      Response:  Because of their nature, fugitive emissions are not readily measurable. The National Emission Inventory (NEI) estimates for this source category were inconsistent and unreliable for many facilities. The estimates used for the Exide Forest City facility were developed using the same methodology that was used for the other facilities in this source category.  We note that although ambient lead data is not available near the Exide Forest City facility, a comparison of modeled and actual ambient lead concentrations for those facilities that did have ambient monitors located nearby indicated that our estimates of fugitive emissions were reasonable. See Residual Risk Assessment for the Secondary Lead Smelting Source Category and Summary of the Ambient Lead Monitoring Data near Secondary Lead Smelting Facilities, available in docket ID EPA-HQ-OAR-2011-0344.
      Comment:  Commenter 93 stated that the use of both ambient air data and TRI emissions data to estimate fugitive emissions at the East Penn Manufacturing facility is inappropriate since East Penn operates six lead-acid battery manufacturing facilities in addition to its secondary lead smelting sources.  The commenter stated that considering that East Penn has managed a reduction in emissions of HAP to levels at or below the numerical limits of all applicable standards while operating several lead-acid battery manufacturing sources in addition to its secondary lead smelting sources, the EPA's assertion that fugitive dust emissions are the largest contributor to the risk due to lead emissions is overstated.
      Response:   The absolute amount of emissions from fugitive sources is not directly measurable and therefore can only be estimated.  We acknowledge that the fugitive emissions from the secondary lead manufacturing process at East Penn may be lower than the estimates used for the development of this rule; this has been taken into account in our revised estimates.  We note that the East Penn facility is a well controlled facility that utilizes total enclosure to control fugitive emissions from the majority of the manufacturing process.  It is a facility that has demonstrated the level of control we believe is necessary to reduce fugitive lead emissions from this source category to an acceptable level. We performed dispersion modeling based on emissions from the East Penn facility. Our modeling did not include emissions from nearby facilities that are not within the same contiguous property boundary. The dispersion modeling showed that emissions from East Penn's secondary lead smelting operations yield ambient concentrations well below the NAAQS. See Table 1 in the preamble for the final rule, showing that East Penn's emissions are about 1/10[th] the NAAQS.
      Comment:  Commenter 98 stated that it is inappropriate to call the EPA's fugitive emissions estimates "actual".  The commenter claims that the EPA should measure fugitive dust emissions, such as through ambient monitoring.  If estimates are used, the commenter stated that the EPA should use actual ambient monitoring data and conservative factors to make up for uncertainty created by the failure to measure directly.
      Response:  The nature of future emissions makes them impossible to directly measure.  Based on a comparison of modeled ambient lead concentrations with actual ambient monitoring data near the secondary lead smelting facilities, we believe that our estimates of fugitive emissions for this source category are reasonable.  Therefore, we disagree that it is not appropriate to regard these estimates as "actual" emissions.  (In any case, this comment is somewhat semantic.  Whether referred to as actual or estimated actual emissions, EPA has explained above, and in detail at 76 FR 29038, why its estimates for fugitive emissions are reasonable.)
Stack Emissions Estimates
	Comment: Commenter 98 stated that the EPA should not refer to its emissions estimates as "actual" emissions for the following reasons: (1) the EPA failed to collect emission test data for all stack emissions or all pollutants; and (2) the EPA failed to account for potential malfunctions and exceedances of the standard.
Response:  We disagree that the emission estimates should not be referred to as "actual" emissions.  The emissions estimates were calculated based on the best available stack test data in all instances where stack test data was available.  If stack tests for a certain source were not available, we assigned emissions to the source based on the closest match for a similar source for which test data was available.
We disagree with the commenter that emissions that exceed standards and are violations, whether or not caused by malfunction events, should be considered as part of the risk analysis. The purpose of the risk review is to evaluate whether the emission limits -- the "standards promulgated pursuant to subsection (d)" not the non-compliance with those standards (section 112 (f)(2)(A) -- should be made more stringent to reduce the risk posed after compliance with the underlying MACT standard. To the extent that a source is violating the underlying MACT standard, no tightening of the emission standard under the residual risk rule will avoid or mitigate against such violations. In other words, a source that is violating the MACT emissions standard promulgated under section 112(d) would not be any more likely to be able to avoid such violations and comply with a different presumably more stringent standard promulgated under section 112(f). Such events are violations and subject to enforcement by the EPA, the States or citizens and an action for injunctive relief is the most effective means to address violations whether or not they are caused by malfunctions if an emissions event poses a significant health or environmental risk.
Although we disagree that emissions that result in a violation should be considered as part of the risk review, we note that we believe malfunction events in this source category do not contribute significantly to cancer or chronic noncancer risks for the source category in this rulemaking because malfunction events in this source category are inherently short-term and infrequent relative to annual operations and emissions. The commenter did not supply any data to the contrary.
Furthermore, the conservative estimates built into the acute risk assessment are sufficient to gauge worst-case potential acute health effects. The conservative estimates built in to the assessment include worst-case meteorology, emissions at ten times the maximum peak emission rate from all point sources simultaneously, and the sum of the maximum impact of each emission source, regardless of receptor location. Thus, even if we were to consider emissions that are in violation of the standard, we do not believe that they would result in any different level of control than we are promulgating here.
      Compliance Timeline
      Comment:  Commenters 90 and 96 stated that section 112(i)(3)(A) establishes 3 years for compliance for "any" section 112 standards, including those established under Section 112(f).  The commenter cites the following excerpt from CAA §112 (i):

      After the effective date of any emissions standard, limitation or regulation promulgated under this section and applicable to a source, no person may operate such source in violation of such standard, limitation or regulation except, in the case of an existing source, the Administrator shall establish a compliance date or dates for each category or subcategory of existing sources, which shall provide for compliance as expeditiously as practicable, but in no event later than 3 years after the effective date of such standard, except as provided in subparagraph (B) and paragraphs (4) through (8).

The commenters contend that the EPA did not address CAA § 112(i)'s applicability to the proposed rule.  Instead, the EPA relied on 40 C.F.R. §63.6(f)(4)(ii), which states that "the owner or operatory of an existing source unable to comply with a relevant standard established ... pursuant to section 112(f) ... may request that the Administrator grant an extension allowing the source up to 2 years after the standard's effective date to comply with the standard."
The commenters stated that CAA § 112(i)'s application is mandatory.  The commenters noted that Congress used the word "any" in defining CAA § 112(i)(3)(A)'s applicability.  According to the commenter, "A broad construction of CAA § 112(i)(3)(A) mandates that this section, and the Administrator's discretion for extension, apply to all regulations under CAA §112, including standards promulgated under subsections (d) or (f).
The commenters further noted that 40 C.F.R. § 63.6(i)(4)(ii) applies only to standards set pursuant to section 112(f) and that while the EPA's proposed revised emission standard for lead is a section 112(f) standard, the design and work practice standards for fugitive emissions are also section 112(d)(6) standards, and dioxins and furans would be wholly new standards set pursuant to section 112(d)(3).
      Response: Section 112(i)(3) establishes the compliance timeframe for any standard issued under section 112 for existing sources and provides that the compliance date shall be as expeditious as practicable but no later than 3 years following the effective date of the standard. Section 112(f)(4), however, expressly provides more specific requirements for standards issued under section 112(f) and thus for section 112(f) standards those more specific  requirements (i.e. a specific requirement for section 112 (f) standards) govern in place of the more general compliance date requirements in section 112(i)(3). Specifically, section 112(f)(4) provides that a source cannot emit an air pollutant in violation of a standard issued under subsection (f) except that the standard will not apply until 90 days after its effective date. It also provides that the Administrator may grant a waiver for a period of up to 2 years from the effective date if necessary for the installation of controls and if measures will be taken in the interim to ensure public health is protected from imminent endangerment.
      As stated in the technical documents supporting the proposed rule, we do not believe that additional controls will be required for facilities to meet the new dioxin and furan standards. However, the two year compliance date is appropriate to allow facilities the time needed to perform testing to determine whether they will need to modify existing control devices and complete such modifications, if necessary, to comply with the standard for  dioxins and THC.  See also 76 FR at 29064/1 explaining why it is possible for EPA to find at this time that sources need two years to comply with the risk-based standards for metal HAP.
      Comment:  Commenters 90 and 96 stated that a two year compliance schedule is insufficient and unrealistic based on the required controls set forth in the proposed RTR, particularly the total enclosures.  The commenters stated that for facilities that do not currently contain total enclosures, designs must consider efficient movement of materials between processing steps and the indoor work environment.  The construction must also be carefully staged around the process equipment and it is likely that the large enclosures could only be constructed during scheduled periodic maintenance downtimes which are scheduled at least six months apart.
      Response: As just stated, CAA section 112(f)(4) expressly provides specific requirements for compliance dates for standards issued under section 112(f). Specifically, section 112(f)(4) provides that a source cannot emit an air pollutant in violation of a standard issued under subsection (f) except that the standard will not apply until 90 days after its effective date. It also provides that the Administrator may grant a waiver for a period of up to 2 years from the effective date if necessary for the installation of controls and if measures will be taken in the interim to ensure public health is protected from imminent endangerment. Two years has been provided for compliance with the rule given that the two year period is necessary to install controls.
      Comment:  Commenters 90 and 96 stated that the facilities are facing obligations to attain the 2008 lead NAAQS and require time to determine the degree to which these obligations overlap with the NESHAP implementation in order to develop appropriate design and construction plans.
      Response: CAA section 112(f)(4) expressly provides specific requirements for standards issued under section 112(f). Specifically, section 112(f)(4) provides that a source cannot emit an air pollutant in violation of a standard issued under subsection (f) except that the standard will not apply until 90 days after its effective date. It also provides that the Administrator may grant a waiver for a period of up to 2 years from the effective date if necessary for the installation of controls and if measures will be taken in the interim to ensure public health is protected from imminent endangerment. Two years has been provided for compliance with the rule given that the two year period is necessary to install controls.
      Comment:  Commenters 90 and 96 stated that the EPA is engaging in numerous actions that affect other industry sources (e.g., Boiler MACT, Utility MACT, other RTR actions) that will increase the cost of compliance by increasing the demand for construction services.
      Response:  We believe that it is unlikely that any of the mentioned actions will impact the availability of the necessary services to the secondary lead smelting facilities.  The commenter provides no evidence to the contrary. Nor does the comment provide details as to how these other actions impact the compliance dates set forth in the CAA for section 112(f) standards.
      Comment:  Commenters 90 and 96 stated that it is possible that the EPA could take the position that for an area to be designated as attaining the lead NAAQS, the monitored ambient lead levels for the three years before November 2015 must be below 0.15 ug/m[3] on a three-month rolling average.  If ambient lead levels must be below the NAAQS by November 2012, then a final rule promulgated in early 2012 would not allow time for NESHAP control measures implemented by March 2014, to provide for timely NAAQS attainment.
      The commenter further stated that "an EPA position that states must demonstrate attainment of the NAAQS based on the three-month average over a three year period before the NAAQS attainment deadline would be contrary to the Clean Air Act."  The commenter asked that the EPA clarify its position with respect to the NAAQS-NESHAP compliance timeline and state that the NAAQS measures do not need to be implemented to reach the ambient standard until the attainment year.
      Response: The CAA clearly presents the compliance dates for standards promulgated under section 112(f). We also note as a point of information that the CAA requires areas to attain the various NAAQS as expeditiously as practicable, but no later than specified dates. For the 2008 lead NAAQS, areas are required to attain the standard as expeditiously as practicable, but no later than December 31, 2015. The Act not only contemplates but requires, if practicable, for areas to attain the 2008 lead NAAQS earlier than December 31, 2015.   Furthermore, no action EPA is taking in this rulemaking changes, modifies, or otherwise bears upon legal obligations to attain the lead NAAQS.
      Comment: Commenter 98 stated that the two year compliance schedule for the proposed RTR is unlawful.  The commenter stated that the two year compliance date violates the plain text of Sections 112(f)(3)-(4) which requires immediate compliance for new sources and a 90-day compliance date for existing sources.  The commenter stated that under section 112(f), individual facilities may file an application for a 2-year extension of compliance.  The EPA must then evaluate each request on a case-by-case basis.  The commenter stated that the EPA is not authorized to grant a Section 112(f)(4) "waiver" to a category of facilities without going through the case-by-case process  -  application, submission of specific information, participation by affected communities -- set out in EPA's implementing regulation.  The commenter stated that the EPA's proposal also violates section 112(f)(4) because the EPA's record included no evidence that statutory factors are met.  The commenter stated that the document entitled "Estimated Time Needed to Achieve Compliance" was not available in the publically viewable docket when checked by the commenter on July 12 and July 25, 2011.  The commenter stated that the record does not state how many sources need two years to comply, or whether faster compliance may be possible for sources like Quemetco, Inc. in City of Industry, CA that have already reduced their emissions to low levels.  The commenter further stated that even if the document provided information that any facility may need additional time, the second statutory factor bars the compliance delay proposed by the EPA because there is "no evidence in the record that the necessary "steps" will be taken during the additional two years "to assure that the health of persons will be protected from imminent endangerment."  The commenter stated that even if the compliance delay were justifiable for existing sources, extending the delay for new sources violates the plain text of the statute.  The commenter further stated that the EPA has already delayed satisfying its legal duties by failing to begin this rulemaking until 2011, and that the EPA has no lawful justification to delay the compliance date any longer.
      Response: EPA is of course aware of the requirements of section 112 (f)(3) and (4).  See 76 FR at 29064/1.  EPA is not ignoring  the requirements of this provision.  Rather, as documented in the memorandum  Estimated Time Needed to Achieve Compliance with the Proposed Revision to the MACT standard for Secondary Lead Smelters, EPA has made case-by-case findings for each existing source as to the amount of time required to comply with the risk based stack and fugitive emission standards for metal HAP.  EPA does not interpret section 63.6 (i)(4)(ii) of its regulations to mandate individual applications when all of the necessary information is already before EPA and EPA applies that information in an individualized, case-by-case manner, as done here.  Moreover, section 112 (f)(4)(B) is a direct grant of authority which can be implemented not just by regulation but by other EPA action, as done here.  As documented in the memorandum cited above, the existing sources discussed in the memorandum will need to undertake such improvements as construction of enclosures, and replacement of baghouses (with such attendant interim steps as obtaining capital, purchase and delivery of equipment, installation of equipment, and shakedown operation).  These activities simply cannot be accomplished in 90 days, and two years is a reasonable amount of time to carry them out.
      The statute likewise contains the requirement that EPA must find that "steps will be taken during the period of the waiver to assure that the health of persons will be protected from imminent endangerment" in order to extend the compliance date.  We note first that EPA does not believe that any unacceptable risk under section 112 (f) automatically equates to an "imminent endangerment", given that Congress authorized extensions of the compliance date.  We note further that existing secondary lead sources are already controlled to some degree, and will necessarily make further reductions of their emissions as they implement steps toward full compliance.  For example, fugitive emissions will be reduced as total enclosures are constructed; fugitive emissions will also be reduced as work practices are phased in.  Emissions will also be reduced during the pre-compliance period as sources upgrade baghouses and develop means of better maintaining them.   Under these circumstances, the EPA believes that steps will indeed be taken in the period before full compliance to reduce emissions and prevent an imminent endangerment.
      Finally, the commenter correctly points out that no extension of time for new sources is permissible under the statute.  The compliance date for new sources to meet the section 112 (f)(2) standards is consequently are immediately subject to the standard.
      Performance Testing
Testing Frequency

	Comment: Commenters 80 and 86 stated that language in § 63.543(4) implies that testing must be done on a monthly basis while § 63.543(5)(f) makes it clear that testing must be done on an annual basis; the commenter asks for clarification.  Commenters 90 and 96 stated that their understanding is that testing is required on an annual basis while the average emissions are calculated monthly based on the most recent annual stack tests; the commenters ask that the EPA confirm that this is the intent of the proposed rule.
      Response:  The commenters are correct in their understanding that testing is required on an annual basis while the average emissions are calculated monthly based on the most recent annual stack tests.

Continuous Emissions Monitoring Systems (CEMS)
      Comment:  Commenter 84 recommended that the EPA require enhanced monitoring systems for lead on both existing and new secondary lead smelting facilities.  The commenter noted that congress mandated the EPA in the CAA to use enhanced monitoring systems when available.  The commenter further contends that direct measurement of lead and other HAP metals is essential for the EPA to comply with the intent of the CAA and to evaluate residual risk and improvements in control.  The commenter noted that new proven, commercial monitoring technology for continuous measurement of lead and other HAP metals including mercury is available.
      Commenter 81 stated that the most significant and relevant observation impacting this proposed rule is that there appears to be no threshold for lead exposure below which no health effects are observed.  The commenter contends that timely feedback regarding emissions is therefore particularly important because of the potential of fumigation from relatively low stacks and the potential for secondary lead smelting facilities to produce significant dose exposures over short time periods.  The commenter stated that significant advances in continuous metals monitoring technology have been made since the last NESHAP and provides evidence that near-real-time monitoring of lead and other metal HAP is commercially available.
      Commenter 81 stated that installation of a multi-metal CEMS would eliminate the EPA concerns over the effectiveness of baghouses in capturing mercury and would eliminate the need for a BLDS as well as the need to measure mercury content in scrap metals.  The commenter further stated that installation of a multi-metal CEMS would alleviate concerns over possible arsenic emissions.  The commenter also suggested that if the EPA does not require CEMS for stacks, they should require at least two ambient near-real-time lead monitors.
      In response to the EPA's stated concerns about the costs associated with lead CEMS, commenter 81 stated that "there are costs associated with no action" and that "the real problem is not that a number of stacks might require CEMS, but that there are too many low level stacks contributing to fumigation events in the local neighborhoods."  The commenter suggested that one potential strategy would be to direct these low level stacks to a common stack that could then be monitored with a single CEMS.  The commenter contends that "most secondary lead smelters are relatively small...", so that the cost to duct emissions to a common stack "should not be too high, particularly in comparison to the cost of monitoring all stacks individually."
      Commenter 81 stated that the lack of a performance specification for a lead CEMS is not a justifiable reason for not requiring them.  The commenter noted that the lack of a published performance specification did not prevent the EPA from requiring mercury CEMS or HCl CEMS for coal fired power plants.  The commenter further noted that the performance specification and QA procedure for multi-metal CEMS are currently available on the EPA's website.  The commenter stated that modifying these performance specifications specifically for a lead CEMS could be easily completed.
      Commenter 81 noted emissions during start-up, shutdown, and/or malfunctions can represent a significant fraction of a plant's emissions.  The commenter contends that it is critical to be able to monitor emissions during SSM periods and that it is impossible to do so unless a CEMS is in place.
      Commenter 85 provided data regarding an X-ray fluorescence based multi-metals continuous emissions monitor.  The commenter also provided proposed performance specifications and on-going QA procedures for lead CEMS.  Commenter 85 also later submitted comments requesting that the EPA comment on all aspects of its original comments, citing specifically the adequacy of the presented data in demonstrating the feasibility of using the Xact as a Pb CEMS, the feasibility of the performance specifications, on-going quality assurance procedures, and the submitted traceability protocol, and any changes the agency feel may be necessary to assure the data quality of Pb CEMS.  The commenter also states that the Xact instrument cost is $141,665 with an annual operating cost of $10,693.
      Response: It is not appropriate to require lead CEMS for new or existing sources absent a promulgated performance specification for this technology. There is not a numerical standard for HAP metals other than lead; therefore, the effectiveness of a CEMS at measuring these metals is not relevant to compliance with subpart X. We also note that measuring mercury content in scrap metals is not required by this rule, so it is unclear how the presence of a CEMS capable of measuring mercury would affect a facility with respect to measuring mercury content in scrap.
      With respect to facilities reconfiguring their stacks to make their facility more amenable to CEMS and prevent emissions from shorter stacks, we note that the risk assessment considered risks from all stacks, regardless of height and the results were considered in our decision making regarding the lead emission limit. The process of developing a performance specification for a monitoring method involves a period of notice and comment. Since a performance specification was not included in the proposed rule, the public was not provided with an opportunity to comment on the performance specification provided by the commenters after the proposal. The performance specifications provided by the commenters have been provided to the appropriate EPA staff. However, we do not find it appropriate to approve the performance specifications in the context of this final rule without first providing the public an opportunity to comment. With regard to the commenter's request that the EPA respond to the specific issues raised in their late comments, we reiterate that a lead CEMS performance specification must be proposed and finalized as a rulemaking action and the issues raised by the commenter are best addressed through that rulemaking. When such a performance specification is proposed by the EPA, the public will have the opportunity to comment on the types of issues raised in the commenter's letter, such as ongoing quality assurance procedures and traceability protocols. These issues are best addressed through that rulemaking. The technical basis of the performance specification will be evaluated by EPA staff when developing the proposed performance specification for this technology. Subsequently, the application of a lead CEMS to demonstrate compliance in this rulemaking must be evaluated with respect to whether the current form of the emission standard (based on manual test data) is appropriate.
      Comment:  Commenters 90 and 96 commented on data and comments submitted by Cooper Environmental Services and Pall Corporation regarding a commercially available lead CEM.  The commenters note that Cooper Environmental Services informed the ABR that the CEM cost approximately $400,000 per stack to install, a cost that the commenters claims is extremely high and would be multiplied many times over as facilities in this industry typically have 7-8 stacks.  The commenters note further concern that the price of a lead CEM could rise if the EPA requires it as the technology is only offered by one company.
      The commenters stated that there is no discussion in the record justifying the need for advances in monitoring and surveillance on stack sources in this industry, nor is there any indication that the BLDS technology that is currently required is inadequate.  The commenters claim that Cooper Environmental Service's comments are "rife with irrelevant and incorrect information".  The commenters further noted that Cooper Environmental Service's comments regarding multi-metal CEMS are irrelevant as the EPA neither proposed multi-metal CEMS nor requested comment on their applicability.
      Response: We agree that measurement of HAP metals other than lead is not necessary for compliance with subpart X and therefore not relevant to this rulemaking. We have considered the cost estimates provided by all commenters and maintain that it is appropriate to include the requirement for lead CEMS for new sources. However, this requirement will not be effective until a lead CEMS performance specification has been promulgated.
      Comment:  Four commenters (90, 93, 95, and 96) stated that the EPA should abandon its proposal to require CEMS for new and modified sources.  The commenters stated that because the EPA has not set forth a performance specification for a lead CEM, stakeholders are unable to assess the systems and their applicability to this industry.  The commenters also argued that the EPA must assess cost-effectiveness under Section 112(f)(2)(A).  The commenters stated further stated that the EPA's analysis of technological feasibility for CEM is inadequate.  The commenters also express concern over using a different method to show compliance than the one used to set the standard.  The commenters further stated that lead CEMS should not be included in Subpart X until performance specifications and procedures are promulgated and feasibility and effectiveness on secondary lead smelters has been demonstrated.
      Response:  A performance specification for lead CEMS will be promulgated prior to the requirement becoming effective in this subpart. The process for promulgating a lead CEMS method includes proposing such a method and providing the opportunity for public comment.  In addition, EPA would consider as part of the rulemaking proceeding, whether it is appropriate to adjust the level of any standard measured by a CEM considering the more frequent measurement and hence dampening of variability over time of multiple measurements.

Bag Leak Detection Systems (BLDS)
      Comment: Commenter 90 stated that the current language in § 63.543(f), (g), and (h) require annual compliance testing for lead, THC, and D/F for all process vents.  The commenter contends that the term process vent in the proposed rule includes sources that are either not suitable for testing given their configuration or do not have emissions limits in the proposed rule.  The commenter stated that D/F and THC testing should be limited only to those sources that have emission limitations on D/F and THC.
      The commenter further stated that the Johnson Controls facility will utilize filtered roof exhausts that do not have stacks that allow measurement of velocity or meet isokinetic sampling requirements under EPA Method 29.  The commenter stated that the following sources should be excluded from the definition of process vent: roof exhausts equipped with HEPA filters, vents from buildings that are not partial or total enclosures, and building vents from non-lead bearing process areas.
      Response:  We have revised the proposed regulatory text to clarify that compliance tests need only be conducted for those sources that have emissions limitations for the applicable pollutant.  We agree that building vents from non-lead bearing process areas should be excluded from the definition of process vent and have reflected such in the regulatory text.  However, we disagree that all roof exhausts equipped with HEPA filters should be excluded from the definition of process vent.
      Comment:  Commenter 93 stated that the requirement for monthly calculation of flow-weighted average emissions is unnecessary and represents an additional burden without benefit.  The commenter argued that sources will typically schedule the annual compliance tests for all process vents at a facility in the same week, and therefore, the results produced by the monthly calculation will not change over a period of nearly a year.  Therefore, requiring the facilities to perform complicated summation calculations for multiple process vent stacks each month when the results each month will be the same provides no additional benefit or assurance of compliance with the standard.
      Response: We disagree that performing a calculation of flow-weighted average emissions is complex or represents an unnecessary additional burden.  We understand that it is possible that facilities may test different process vents at different times throughout the year.  Calculating the flow-weighted average emissions on a monthly basis will ensure that the value consistently includes the most up-to-date stack test data available.
      Typographical Corrections
      Comment: Commenter 92 requested clarification on a footnote of Table 2 that references January 2010 NEI data as being the basis for which emissions from this source category were estimated.  The commenter stated their understanding that the NEI is developed on a 3-year cycle and that 2010 is not one of the development years.  The commenter further stated that since the 2005 NEI data was used in the risk assessment, an explanation as to why an alternative year was utilized in the socio-economic analysis should be provided.
      Response:  The commenter is correct that 2010 is not a development year.  The 2005 NEI data was used for the socio-economic analysis.
      SSM and Affirmative Defense
      Comment: Commenter 98 agreed with the EPA in the removal of the unlawful malfunction exemption under the existing rules, but noted that the EPA failed to assess cancer and non-cancer chronic health risk from malfunction or other violations of the MACT standard.  Specifically;

      EPA must consider the full potential for risk from all emissions that are likely to occur, even though the standard is in place, not just the risk based on the "allowable" number of emissions.

      EPA acknowledges that malfunctions inevitably occur.  EPA has information available or can collect information on major sources' malfunction and violation history.  Research by the Environmental Integrity Project ("EIP") from 2004 found 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.

      EPA cannot ignore the additional emissions from malfunctions or other violations in calculating risk. It may not assume that malfunction or other violation-based emissions are zero when it knows that they are not and when its own proposal is likely to perpetuate the problem of malfunctions in overburdened communities. For the purpose of assessing health risk, EPA cannot presume that a facility will be in full compliance with the standard at all times, as this runs counter to past history.

      By failing to account for the heightened risk from exceedances of the MACT in its calculation, EPA fails to consider the full risk to public health and the environment from this source, especially for the maximum exposed individual and most-affected communities. This violates section 112(f)(2). The Act specifically requires EPA to base its risk analysis on the highest possible level of risk "to the individual most exposed to emissions from a source in the category or subcategory." 42 U.S.C. § 7412(f)(2)(A); § 7412(f)(1)(C). 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 risk from malfunction- and other violation-based emissions. Heightened emissions that occur during a malfunction and other types of violations pose increased acute health risks, as EPA has recognized. 76 Fed. Reg. at 29,040. Chronic cancer and non-cancer health risks may also be more severe than those calculated by EPA because of malfunction/violation emissions. For example, EPA's MIR (maximum individual risk of cancer) is based on the assumption that exposure is constant for a lifetime (unless EPA uses age dependent adjustment factors). Failing to look at the true potential for spikes will significantly underestimate the amount of emissions considered for this analysis.
      EPA has accounted for some risk beyond the "MACT allowable" emission level in its acute health risk assessment, demonstrating that it is necessary and appropriate to do so for all parts of the risk assessment. To calculate acute health risk, EPA is using a "worst-case" scenario approach that appears to include some accounting for additional health risk due to upsets, malfunctions or other exceedances of the standard. For acute health risk, EPA is using a peak hourly emissions number that is "10 times the average annual hourly emissions rate for that source." 76 Fed. Reg. at 29,040. EPA's use of a factor that accounts for risk beyond the "MACT allowable" emissions number for acute risk in some manner in the proposed rule demonstrates that EPA has found a method to account for risk from higher than allowable emissions that occur from malfunctions and violations. It must apply a similar method to assess the maximum lifetime cancer risk and chronic non-cancer health risk for the maximum exposed individual. The failure to do so violates § 112(f)(2) and is arbitrary and capricious. The fact that EPA has done this for acute health risk shows that it is possible to do and should also be done for the other health risks that EPA must address in this rulemaking.

      Commenters also urge EPA to improve its acute health risk analysis by using a similar worst-case factor for fugitive dust emissions as well as stack emissions. EPA cannot justify ignoring the potential for increased fugitive dust emissions to occur as a result of a malfunction or violation, whether or not the malfunction is combined with low-wind atmospheric conditions, as it attempts to do. 76 Fed. Reg. at 29,040. Further, accurately evaluating fugitive dust emissions is crucial because these emissions are the largest contributor to lead emission risks. See id. at 29,038.

Response: We disagree with the commenter that emissions that exceed standards and are violations, whether or not caused by malfunction events, should be considered as part of the risk analysis. The purpose of the risk review is to evaluate whether the emission limits should be made more stringent to reduce the risk posed after compliance with the underlying MACT standard. To the extent that a source is violating the underlying MACT standard, no tightening of the emission standard under the residual risk rule will avoid or mitigate against such violations. In other words, a source that is violating the MACT emissions standard promulgated under section 112(d) would not be any more likely to be able to avoid such violations and comply with a different presumably more stringent standard promulgated under section 112(f). Such events are violations and subject to enforcement by the EPA, the States or citizens and an action for injunctive relief is the most effective means to address violations whether or not they are caused by malfunctions if an emissions event poses a significant health or environmental risk.
Although we disagree that emissions that result in a violation should be considered as part of the risk review, we note that we believe malfunction events do not contribute significantly to cancer or chronic non-cancer risks for the source category in this rulemaking because malfunction events are inherently short-term and infrequent relative to annual operations and emissions. The commenter did not supply any data to the contrary.
Furthermore, the conservative estimates built into the acute risk assessment are sufficient to gauge worst-case potential acute health effects. The conservative estimates built in to the assessment include worst-case meteorology, emissions at ten times the maximum peak emission rate from all point sources simultaneously, and the summation of the maximum impact of each emission source, regardless of receptor location. Thus, even if we were to consider emissions that are in violation of the standard, we do not believe that they would result in any different level of control than we are promulgating here.
Comment: Commenter 98 noted that the affirmative defense is unlawful and unjust, would create a new unlawful loophole, would have harmful consequences for communities, undermines citizen's rights, and will greatly reduce the deterrent impact of the standards:

      Commenters support EPA's proposed removal of the start-up, shut-down, and malfunction exemption... However, EPA's proposal to promulgate an "affirmative defense" to penalties due to a malfunction would create a new unlawful loophole.   It also would have harmful consequences for local communities affected by secondary lead smelters, and will greatly reduce the deterrent impact of the proposed standards.

      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 government 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 the EPA proposes 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 the EPA from limiting when civil penalties can be assessed. In this proposal, the EPA acts outside of its delegated authority to limit civil penalties available in citizen suits or its own enforcement actions. Second, the proposal will impermissibly chill citizen participation, and the ability to win an effective, deterrent remedy, in CAA enforcement actions.
      The affirmative defense is fatally flawed because the EPA does not have the authority 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 CAA § 304, 42 U.S.C. § 7604. See 42 U.S.C. § 7413(e). By attempting to impose additional agency-created limits, the EPA exceeds its authority. The commenter goes on to say:

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 interpret 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 that 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 grant 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.

      If a local community group sued a covered facility for a violation of the emission standards, the owner might argue that it is exempt from paying civil penalties so long as the owner satisfied the requirements set forth in the EPA's proposed affirmative defense regulations. See 76 Fed. Reg. at 29,061-62 (proposing 40 C.F.R. § 63.552). The owner must not be able to evade civil penalties that apply when the congressionally mandated factors in the statute are met. 210 See 42 U.S.C. § 7413(e) (listing factors). It is improper for a court to fail to consider these factors, or to fail to make its own determination of what civil penalties are "appropriate" under CAA § 304(a), and the EPA should not ask a court to ignore its legal duty.  A fortiori it is impermissible for the EPA to attempt to displace those factors or in any way alter their significance by creating a bar to penalties if certain agency-defined considerations are met instead.
      Citizen participation in CAA enforcement also will be hindered, in violation of citizens' rights to protect themselves from pollution and in direct conflict with congressional intent. The affirmative defense would likely be used on a routine basis by polluters seeking to avoid penalties, just as the malfunction exemption was. As a result, citizens who seek the assessment of civil penalties against polluters in order to protect themselves and achieve the Act's goals may 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 straightforward enforcement and penalty provisions in the Clean Air Act. As a result, enforcement of the Act could suffer, for civil penalties provide a powerful deterrent to violators as Congress intended. As the Supreme Court explained: "To the extent that they [civil penalties] encourage defendants to discontinue current violations and deter them from committing future ones, they afford redress to citizen plaintiffs who are injured or threatened with injury as a consequence of ongoing unlawful conduct." Friends of the Earth, Inc. v. Laidlaw Envtl. Servs., 528 U.S. 167, 186 (2000).  Thus, the affirmative defense also runs counter to two clearly expressed intentions 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, 724 (D.C. Cir. 1974). Both result from the technical burden the EPA imposes on citizens with the affirmative defense, and both render the defense impermissible.
      In addition to these problems, 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 prosecute, to consider settlements, and to request civil penalties in a case-by-case manner, as long as it acts consistent with the Clean Air Act to protect clean air as its top priority, see 42 U.S.C. § 7401. Promulgating this affirmative defense is equivalent to giving polluters "get out of jail free" cards for serious emission exceedances and MACT violations. Polluters are likely to claim that any violation of the standard is due to a malfunction in order to evade the requirements. Allowing polluters to evade financial penalties  -  which are the real teeth of the standards  -  through this type of measure is likely to lead to polluters simply ignoring or factoring potential standard violations into their cost of doing business, rather than actually trying to prevent malfunctions and violations of the standards as a way to avoid financial losses from the application of penalties.

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

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

      2.   The 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 defense 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.   The EPA should promulgate specific public reporting and notification requirements for malfunctions, or any emission exceedance that occurs of which an operator is aware. Specifically, the EPA should require that when a facility provides the EPA with a notification of a malfunction or emission standard exceedance under the regulations, this notice will be made publicly available on the EPA's website within 14 days. In addition, the EPA should promulgate the requirement that when such notification is made, the facility must also provide for community notification of the malfunction or emission standard exceedance within 2 business days, through an appropriate public forum that is designed to reach residents who live near the facility, including but not limited to a notice on the facility's own website (if it has one), a written notice to the local municipality 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.

      Commenters urge the EPA not to adopt an affirmative defense that undermines citizen right and remedies under the Clean Air Act. People living near secondary lead smelters are exposed to unacceptably high levels of hazardous air pollution that no one should have to face simply because of where they live. Attempting to take away a right granted to citizens by Congress through an agency regulation sets a dangerous precedent. The 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. The EPA 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 facilities that have released toxic air pollution into their communities for years.
      Response: As the EPA explained in the preamble to the proposed rule and in the response to comment document, the 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. The EPA included an affirmative defense in the final 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 control of the source. The 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 Sierra 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, the 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 injunctive relief. While "continuous" limitations, on the one hand, are required, there is also caselaw indicating that in many situations it is appropriate for the EPA to account for the practical realities of technology. For example, in Essex Chemical v. Ruckelshaus, 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 preserve the 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 caselaw such as Sierra Club v. EPA and the CAA 1977 amendments undermine the relevance of these cases today, they support the EPA's view that a system that incorporates some level of flexibility is reasonable. The affirmative defense simply provides for a defense to civil penalties for excess emissions that are proven to be beyond the control of the source. By incorporating an affirmative defense, the EPA has formalized its approach to upset events. In a Clean Water Act setting, the Ninth Circuit required this type 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 informal 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 reasonableness of the standard as a whole.
      Further, the EPA's view is that the affirmative defense is not inconsistent with CAA section 113(e) or 304. Section 304 gives district court's 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 amount 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 its authority under section 112 to establish emission standards (at a level that meets the stringency requirements of section 112), the EPA necessarily defines conduct that constitutes a violation. The EPA view is that the affirmative defense is part of the emission 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 the EPA to establish such "enforceable emission limitations." Thus, the citizen suit provision clearly contemplates enforcement of the standards that are defined by the EPA. As a result, where the 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 the EPA did here, penalties are not "appropriate" under section 304.
      The 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 prevented and were otherwise appropriately handled (as reflected in the affirmative defense criteria). The EPA has utilized its 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 have 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 citizen group any more or less than would litigating the appropriate penalty amount in the penalty assessment stage of a citizen suit enforcement action, because the 113(e) penalty assessment criteria and the affirmative defense criteria are similar and in fact 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 provision 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 often 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 penalty 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 the EPA's affirmative defense. This reflects the EPA's view that when a violation 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.
      The 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 the EPA has authority to require the automatic imposition of compensatory damages and even if such authority exists, the EPA does not think automatic imposition of damages is appropriate. Ensuring that malfunctions do not recur can be handled through imposition of appropriate injunctive relief. In addition, the 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' suggested 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 reporting requirements. Any such reports submitted to the EPA are publicly available pursuant to CAA section 114.
      Comment: Commenter 111 stated that the affirmative defense provisions do not cure the EPA's failure to set emission standards that are achievable during SSM events and are not a substitute for setting emissions standards for these periods. The commenter further state that the proposed standards with the affirmative defense do not represent emission limitations achieved by the best-performing existing sources, nor do they meet the criteria for establishing beyond-the-floor emission standards and that the affirmative defense is not a permissible substitute for setting standards for periods of malfunction and is insufficient to meet the EPA's obligations under CAA §112.  Commenter 87 requests the EPA set aside the proposed affirmative defense for periods of malfunction and establish a work practice standard for these periods.
      Response: The affirmative defense applies to malfunction events and not to periods of startup and shutdown. The affirmative defense is not intended as a substitute for standards under section 112  -  the applicable standard applies during malfunctions, but a source may assert an affirmative defense in an enforcement action for penalties for emissions in excess of the standard. Elsewhere in this document, we address the commenter's concern regarding whether the EPA has met its obligation under section 112 in addressing emissions during startup and shutdown.
      Comment: Commenter 96 and 90 advised that the EPA should promulgate work practice standards for emissions during startups, shutdowns and malfunctions, rather than requiring compliance with the proposed emissions standards during these events.  The EPA has not demonstrated that the best-performing units can achieve the proposed MACT emission standards during SSM events.  The commenter stated that "the unpredictability and variability of emissions during SSM events makes measuring their emissions infeasible using current measurement methods..."  Commenter 90 suggested that the standards should require the development and implementation of an emissions minimization plan that would be a dynamic document maintained at the facility.
      Response: Work practice standards have been included in the final rule for startup and shutdown periods where a facility will not be able to demonstrate compliance with the D/F and THC limits based performance testing during these periods. See section III.A.3 of the final rule preamble for a discussion of these work practice standards and the impracticality of performance testing for THC and D/F during periods of startup and shutdown. No exemption for startup periods was requested or determined to be necessary for the lead emission standard.
      Comment: Commenter 90 provided additional support for incorporating work practice standards for periods of SSM.  According to the commenter:

      EPA claims that its approach to SSM is required by Sierra Club v. EPA, 551 F.3d
      1019 (D.C. Cir. 2008), cert. denied, 2010 U.S. LEXIS 2265 (2010). In this decision, the D.C. Circuit vacated the exemption in 40 C.F.R. § 63.6(f)(1) and (h)(1) for SSM periods, and in light of this decision, EPA proposed emissions standards in the RTR Proposed Rule that apply at all times, including periods of SSM. 76 Fed. Reg. at 29,072.

      When setting standards in the early 1990's under CAA § 112(d), EPA used its New Source Performance Standards (NSPS) program as a model. The § 112 standards were acknowledged by EPA to be "essentially equivalent to [§ 111] performance standards" and that "unpredicted and reasonably unavoidable failures of air pollution control systems" would occur. 58 Fed. Reg. at 42,762, 42,777 (Aug. 11, 1993). To address this situation, EPA adopted an exemption similar to the one in the NSPS Program for SSM events and imposed a "general duty" to minimize emissions. Thus, EPA acknowledged, as early as 1993, that SSM events are not appropriate for inclusion in a MACT standard and that an alternative approach should be used to address these situations. While the D.C. Circuit in the Sierra Club vs. EPA case ruled that sources cannot be exempt from complying with MACT standards, the court noted that Congress recognized in some instances that it may not be feasible to prescribe or enforce an emission standard under § 112, and so § 112(h) "work practices" or "operational" standards are available in certain situations. See Sierra Club v. EPA, 551 F.3d at 1028.

      The D.C. Circuit also has recognized that standards based on what sources achieve must account for the limitations inherent in the technology used to reduce emissions. For example, in a case reviewing NSPS under § 111 of the CAA, Portland Cement Ass'n v. Ruckelshaus, 486 F.2d 375, 398 (D.C. Cir. 1973), the court acknowledged that " 'start-up' and 'upset' conditions due to plant or emission device malfunction, is an inescapable aspect of industrial life and that allowance must be made for such factors in the standards that are promulgated." Id. Furthermore, in National Lime Ass'n v. EPA, 627 F.2d 416 (D.C. Cir. 1980), the court noted that "a uniform standard must be capable of being met under most adverse conditions which can reasonably be expected to recur." Id. at 431 n.46. The D.C. Circuit acknowledged this same principle almost 20 years later when reviewing emission standards for new sources in the medical waste incinerator rule under § 129 in Sierra Club v. EPA, 167 F.3d 658 (D.C. Cir. 1999). In that case, while the court did not find the record sufficient to support EPA's approach for new sources, the D.C. Circuit did not object to a standard-setting approach which would account for the performance of technology under the "worst reasonably foreseeable circumstances." See id. at 665. Furthermore, the D.C. Circuit reiterated the principle in National Lime that "where a statute requires that a standard be 'achievable,' it must be achievable 'under the most adverse circumstances which can reasonably be expected to recur.' " Id. at 665 (citing National Lime Ass'n v. EPA, 627 F.2d 416, 431 n.46 (D.C. Cir. 1980)). 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." 76 Fed. Reg. at 29,061. Considering that EPA's proposed MACT standards are supposed to apply at all times, the implication is that periods of malfunction also are covered by the MACT standards that apply during normal operations. This approach directly conflicts with the statutory requirement that the MACT standard be "achievable." EPA has failed to recognize what Congress acknowledged in enacting §112: that it is likely that even best performers will experience malfunctions. It is possible for pollution control equipment to fail in various ways. Power failures do occur, fabric filters fail, scrubber pumps fail even at best performers and despite the best efforts of companies to prevent and minimize such events. Industry can and does work to minimize such periods, but they do occur. Further, manufacturers of such equipment routinely make emission guarantees for normal operations and although they sometimes oversize equipment to account for some of the variability described above, it is very doubtful that vendors would provide sufficient numerical guarantees for equipment under such situations. Given that the MACT floor data does not consider malfunctions and that the statute requires that the MACT standard be "achievable," EPA should, if it is determined that it is appropriate to amend the MACT at all, set work practice requirements to address periods of malfunctions as well.

      Response: We have included work practice standards for periods of startup and shutdown for THC and D/F.   With respect to standards for lead, EPA believes that the standards that otherwise apply are also appropriate for startup and shutdown because the bag leak detection systems used to determine compliance with the emission standard for lead operates properly during these periods.  With respect to malfunctions, we do not find it appropriate to make a blanket determination that work practices should be applied for periods of malfunctions (which do not always cause situations that will satisfy the criteria of section 112(h) regarding technical and economic practicality of measuring emissions). We have included an affirmative defense to civil penalties for malfunctions in the final rule that addresses situations that are beyond the control of the owner or operator, reflecting the caselaw in this area, as stated in response at pages 117-121 of this document.
      Comment: Commenter 90 stated that the EPA's basis of cost for implementation of the affirmative defense is not supported, and in their estimate is significantly less than what would be expected. The EPA's estimate of the number of occurrences per year of 2-3 seems low as well.
       Response:  We believe that the cost estimate for implementation of the affirmative defense is reasonable.  The commenter provided no specific data to support their claims.

      Request for Comment Period Extension
      Comment:  Several commenters requested more time to review the proposed package.  Three commenters (70.1, 72, 73) requested a 60 day extension, one commenter (80) requested a 58 day extension, and one commenter (71) requested a 45 day extension.
      Commenters 70, 71, and 73 stated that the period for comments is insufficient to allow them to fully review the proposed rule and docket materials, and develop meaningful comments to assist the Agency in finalizing its proposal.  Commenter 72 stated that the proposal raises a host of complicated issues that warrant careful consideration in order to comment meaningfully.  Commenter 73 stated that an extension is warranted because not all documents on which the EPA relied in drafting the proposed rule were located in the docket on May 19.  The commenter further noted that the comment period included Memorial Day and Independence Day, effectively shortening the time available to conduct the necessary analyses.  Commenter 74 notes that the comment period for the EPA's proposed rule and that for the EPA's First External Review Draft Integrated Science Assessment for Lead share a common deadline.  The commenter contends that it is not reasonable to review both of these lengthy documents on the same time frame.
      Response:  The EPA granted a 21 day extension of the comment period. The 21 day extension was the longest that the EPA could grant while still providing enough time to meet the court-ordered deadline for signature of this final rule.  See also response at pages 127-127 below, explaining in more detail why further extensions were inappropriate and unnecessary.
      Miscellaneous
      Comment: Commenter 80 provided comment on the Draft Summary of Ambient Lead Monitoring Data near Secondary Lead Smelting Facilities document (EPA-HQ-2011-0344-0041).  The commenter stated that two of the monitoring sites listed for the Buick Resource Recycling Facility are not ambient, but are located within the facility fenceline and should not appear in the table.  The commenter also notes that the listed maximum 3-month concentration of 2.46 ug/m[3] at site 29093016 in 2008 resulted from an upset condition at the facility, not typical operation.
      Response:  We have added footnotes to the applicable tables of the technical document clarifying the commenter's points.
      Comment: Commenter 78 and 83 stated that they support the proposed rule as published.
      Response: We acknowledge the commenters' support.
      Comment:  Industry respondents (90, 95, 96) commented on the EPA's statement in the preamble to the proposed rule that "No new secondary lead smelters have been built in the last 20 years, and we anticipate no new secondary lead smelting facilities in the foreseeable future, although there is one facility currently in the process of expanding operations."  The commenters note a secondary lead smelting facility that is currently operating in Puerto Rico.  Additionally, JCI is currently constructing a battery recycling facility in Florence, S.C., and Exide Technologies holds an active Title V permit for a facility in Columbus, GA.  The commenters contend that the EPA's failure to accurately and completely describe the industry is grounds for withdrawal and re-proposal of the rule.
      Response:  The commenters are correct in their statements regarding these facilities.  However, we note that the JCI facility in Florence, SC and the Exide facility in Columbus, GA are not operational.  Therefore, `emissions' (non-existent) from these two facilities could not have affected any revised emissions limits in the proposed rulemaking.
      With regards to the Puerto Rico facility, the EPA contacted The Battery Recycling Company requesting information in an effort to determine the potential impacts of the proposed rule on this facility.  The stack test data obtained by the EPA revealed that stack emissions of lead from this facility are below the limit proposed by the EPA and therefore would not have affected the EPA's stance that its proposed emissions limit for lead for this source category is technologically feasible and represents a level that is achieved in practice by a well-performing fabric filter. The data received can be found in docket ID: EPA-HQ-OAR-2011-0344-0124 and EPA-HQ-OAR-2011-0344-0125. With regards to total hydrocarbons and dioxins and furans from rotary furnaces, EPA is not setting section 112 (d) standards in this rule because of an absence of data to represent performance of rotary furnaces and is now preparing to send out section 114 information requests to obtain additional data.   We have conducted analyses to evaluate the cost impacts of the proposed rule on the aforementioned facilities and have revised the technical document describing the cost impacts accordingly.  None of the data or information collected from these facilities alters the decisions made by the EPA in this rulemaking.  As such, we do not believe that this issue merits delay of this rulemaking.
      Comment:  Commenter 75 requested that the EPA issue a supplemental notice of rulemaking for the secondary lead smelting NESHAP.  The commenter claims that there are "significant problems with the proposed rule that undermine EPA's proposed MACT floors and its Risk and Technology Review (RTR)."
      First, the commenter notes that the proposed rule fails to consider emissions from The Battery Recycling Company's secondary lead smelter in Puerto Rico.  The commenter notes that, with regards to risk, the EPA is required to consider emission from all members in the source category.  The commenter further notes that the MACT floors proposed by the EPA for THC and D/F must be based on the best-performing 5 sources and that the EPA's failure to consider emissions from the Puerto Rico facility prejudices these standards.
      Second, the commenter states that the proposed rule is flawed because its risk review is based on a overestimation of dioxin emissions at the Exide Frisco facility.  The commenter notes that Exide conducted a stack test in October 2010 demonstrating emissions 69 times lower than the estimate used by the EPA in its risk assessment.
      Third, the commenter states that a supplemental notice of proposed rulemaking would allow the EPA to take into account additional stack testing data submitted by the industry.
      Response:  We do not believe that it is appropriate to issue a supplemental notice of rulemaking for this source category.  We received data from the overwhelming majority of the industry in the ICR developed for the proposal. However, we did obtain data from the Battery Recycling Company after the proposal and the data did not change any of the substantive conclusions of the rulemaking. As noted in the final rule preamble, we have deferred standards for organic HAP and dioxin for rotary furnaces. We will collect data from the Battery Recycling Company and the JCI facility currently under construction in South Carolina (if it is operational) and use those data to develop appropriate emission standards for those pollutants. The test data for dioxins and furans from the Exide Frisco facility mentioned by the commenter were not made available to the EPA until June of 2011, despite the testing being conducted in October 2010. The EPA requested these data from Exide repeatedly before the proposal and did not receive them. As noted by the commenter, the data showed that the multipathway risks from dioxins and furans are below 1 in a million. However, the overestimated risk used in the proposal did not lead to any emission standards for dioxins and furans being proposed under section 112(f). These data thus did not substantively change any decisions made for this rulemaking making it unnecessary to reopen the comment period. There were two additional stack tests mentioned by the commenter. First, the commenter mentioned that RSR's Middletown, NY facility was performing additional testing on their rotary furnace for THC or dioxins and furans. However, the facility provided additional test data for lead and confirmed that they did not perform additional testing for THC or dioxins and furans. The additional lead test data showed that the tested furnace was meeting the lead emission standard promulgated in this final rule. The second test cited by the commenter occurred at the Exide Reading facility but was not provided to the EPA until late November 2011, too late to be incorporated into the MACT floor calculations (although, as noted, inclusion of those data might have made the standard slightly more stringent). The concerns presented by the commenter have been addressed elsewhere in this document.
      Comment:  Commenters 86, 92, and 98 recommended that the EPA adopt a consolidated emissions reporting rule for HAPs.  According to the commenters, "The lack of a federal requirement to collect the basic information on how many HAPs are released from stationary sources into the surrounding community is a serious impediment to any attempt to evaluate total HAP exposure and risk in a sound technical manner."
      Response:  We agree and the EPA is currently considering how to collect such data.
      Comment:  Commenter 98 stated that the EPA should commit to review and update its residual risk determination in this final rule  at the same time as it is next required to review its § 112(d) technology-based standard (i.e., 8 years from promulgation of the final rule).
      Response:   This comment is beyond the scope of this rule.
      Comment:  Commenter 130 stated that the EPA finalized far less prescriptive design standards and work practices for the primary lead processing source category than it proposed for the secondary lead smelting category.  The commenter believes that the less prescriptive work practices and design standards should be applied to the secondary lead smelting rule.  Specific proposed work practices that were proposed for secondary lead include the water application rate in pavement cleaning, the requirement to wash building roofs, and the requirement to conduct all maintenance activities within enclosures. The primary lead rule does not require these work practices.
      Response:   We have revised the list of required work practices to remove redundancy or potential workplace hazards based on a number of comments received on the proposed rule for the secondary lead smelting source category. The specific water application rate for pavement cleaning, and the requirement to wash building roofs which EPA proposed are not included as requirement in the final rule.  The proposed requirement to perform all maintenance activities within enclosures has been modified to ensure that maintenance activities that could generate lead dust are conducted in a manner that minimizes emissions of fugitive dust. However, the final list of work practice standards will ensure that fugitive dust is not generated outside of total enclosures, thereby ensuring the public is protected with an ample margin of safety.
      Comment:  Commenter 130 discussed the requirement for total enclosures to be maintained at a negative pressure of at least 0.02 mm of Hg with an in-draft velocity of 300 feet per minute with continuous multiple negative pressure monitoring units fitted with backup power supplies.  The commenter compared the final primary lead standard to the proposed secondary lead standard.  The primary lead standard is less prescriptive than the proposed secondary lead standard, and the commenter stated that there is no reason that the design standards for enclosures need to be more prescriptive.
      Response:  We believe that monitoring of building differential pressure is the most accurate means by which to ensure that the enclosure building is under negative pressure at all times. This method provides direct measurements that the building is indeed maintained at negative pressure and thus not emitting contained material. Some commenters stated that specifying doorway velocities could require substantial additional in-draft, which could cause strain to building structures, wind chill problems for workers, and pilot lights being extinguished. We agree with these comments and have therefore removed the proposed requirement to measure in-draft velocity at the openings of the total enclosures, but have retained the continuous differential pressure monitoring requirement. However, we have altered the differential pressure requirement from 0.02 mm of mercury to 0.013 mm of mercury to be consistent with the EPA Method 204's criteria for verification of a permanent or temporary total enclosure. Because fugitive lead emissions are the predominant contributor to overall risk for the secondary lead source category, EPA concluded that total enclosures with continuous monitoring of negative pressure were appropriate for this category.
      Comment: Commenter 130 compared the bag leak detection system requirement in the proposed secondary lead rule to the requirement in the final primary lead rule.  The EPA proposed to remove the 1997 NESHAP exemption in the secondary lead rule for bag leak detection system on baghouses fitted with secondary HEPA filtration.  In the final primary lead rule, EPA included this exemption.
      Response:  We agree with the commenters that baghouses equipped with HEPA filters do not need bag leak detection systems as well. Measurement of pressure drop across a HEPA filter provides the needed information to determine that the filter is performing effectively so a bag leak detection system would be redundant.
      Comment: Commenter 130 noted that a comment by the ABR was included in the primary lead rule docket opposing the proposed requirement that new primary lead processing facilities install and operate continuous emission monitoring systems for lead.  The comment also explained why the EPA should not include a similar requirement in the secondary lead smelting rule.  The ABR comment to the primary lead proposed rule stated that without setting a performance specification at the time of proposal, there is no way for the commenter to meaningfully assess the system and the potential applicability.  There is no assurance that the CEM technology will be sufficiently sensitive and robust to provide reliable data on emissions for secondary lead smelter stacks.  Additionally the requirement to install a CEMS would impose a cost burden that would be greater than any incremental environmental benefit.
      Response: We have considered the cost estimates provided by all commenters and maintain that it is appropriate to include the requirement for lead CEMS for new sources. However, a performance specification for lead CEMS will be promulgated prior to the requirement becoming effective in this subpart. The process for promulgating a lead CEMS method includes proposing such a method and providing the opportunity for public comment.  In addition, EPA would consider as part of the rulemaking proceeding, whether it is appropriate to adjust the level of any standard measured by a CEM considering the more frequent measurement and hence dampening of variability over time of multiple measurements.
      Comment: Commenter 127 submitted late comments in response to late-filed additional comments from the Pall Corporation.  The commenter is concerned that EPA is not providing a complete record of supporting materials in the docket, in that minutes of a meeting between EPA and Pall in September 2011 are not docketed.  The commenter noted that the comments provided by Pall do not include any explanation as to why the information was not submitted before the end of the comment period.  The commenter does not believe there is sufficient information in the EPA's proposal and supporting documentation regarding the feasibility, performance specifications or quality assurance procedures of a Pb CEMS.  The cost noted by the Pall Corporation in the late-filed comments is incomplete and misleading in that it does not include all installation costs.
      Response: While the commenter is correct that the additional comments submitted by the Pall Corporation were received after the close of the public comment period, that does not bar the EPA from considering those comments, just as it did not bar the EPA from considering the multiple comments submitted by ABR after the close of the public comment period.  The additional comments submitted by the Pall Corporation essentially emphasized their request that the agency respond to their original comments rather than raising new issues (with the exception of new cost information). The updated cost information provided by the Pall Corporation did include caveats that certain costs were excluded, as mentioned by the commenter. The EPA has considered both the cost estimate provided by the commenter and by Pall Corporation. The costs submitted by the commenter ($400,000 per device) were the values that the EPA used to determine whether it was appropriate to require these devices for new sources. We deemed that it was appropriate. Whether the costs remain at $400,000 or are indeed lower, we maintain that it is an appropriate requirement. With regard to comments on the feasibility of a Pb CEMS, the EPA has included the requirement for new sources to install a CEMS only after the performance specifications for a lead CEMS method have been promulgated.  The EPA will conduct an investigation into the feasibility and cost effectiveness of a Pb CEMS before as a part of the rulemaking process for the performance specification. That rulemaking will involve a public comment period during which the commenter may inform the EPA of any potential problems with the performance specification that is proposed.  The total cost of installing and operating a CEMS will be considered in the evaluation. Notes from the September 2011 between the EPA and Pall Corporation were posted in the docket well before the signature date of the final rule, see EPA-HQ-OAR-2011-0344-0128.