but will be considering all credible and readily available assessments. 1 For air toxics risk assessments, we identify pertinent toxicity or dose response values using a default hierarchy of sources, with IRIS being the preferred source, to assist us in identifying the most scientifically appropriate benchmarks for our analyses and decisions. The IRIS process contains internal and external peer review steps and represent EPA consensus values. When adequate toxicity information is not 63 available in IRIS, we consult other sources in a default hierarchy that recognizes the desirability of these qualities in ensuring that we have consistent and scientifically sound assessments. Furthermore, where the IRIS assessment substantially lags the current scientific knowledge, we have committed to consider alternative credible and readily available assessments. For our use, these alternatives need to be grounded in publicly available, peer reviewed information. Formaldehyde is an example of this situation. We are not using information that does not meet these requirements. We also agree with the third commenter that the issue of changing health based guideline values is a general challenge in setting health based regulations. However, we are committed to setting such regulations that reflect current scientific understanding, to the extent feasible. Facilities conducting low risk demonstrations should refer to Appendix B to Subpart DDDD ( and/ or the " Air Toxics Risk Assessment Reference Library") for guidance on choosing appropriate dose response values.

Comment: With the support of several others, one commenter pointed out that the science with respect to formaldehyde and acetaldehyde has changed since EPA's initial IRIS entries for those pollutants were completed. Consequently, the commenter believed it would be inappropriate for EPA to rely on the unit risk factors for those pollutants in the IRIS database in establishing a property line concentration threshold in the PCWP 64 rule. The commenter supported EPA's efforts in revising its formaldehyde and acetaldehyde IRIS assessment and noted that both revisions are expected to be finalized before the PCWP rule is published in 2004. Regarding formaldehyde, the commenter noted that EPA plans on using the model from the Chemical Industry Institute of Technology ( CIIT) to revise its formaldehyde IRIS assessment and encouraged this action. The commenter pointed out that the CIIT model has been recognized by several authoritative bodies ( e. g., Health Canada/ Environment Canada, Organization for Economic Coordination and Development, and World Health Organization) as providing the most scientifically defensible analysis of formaldehyde. ( Another commenter added that the IRIS risk criteria for formaldehyde clearly cause formaldehyde risk estimates to be overstated but argued that, even using the very conservative IRIS numbers, risks are still low. A third commenter urged EPA not to use the formaldehyde values in ATSDR,

stating that they are fundamentally flawed, as detailed in their comment.) Regarding acetaldehyde, the commenter recommended that EPA use a health benchmark between 27 and 390 micrograms per cubic meter ( µ g/ m3) and included their rationale in an attachment to their comment. If EPA is unable to complete its reassessments before the PCWP rule is finalized, the commenter encouraged EPA not to revert to the original IRIS unit risk factors for formaldehyde and acetaldehyde. Instead, the commenter recommended that EPA use the CIIT model ( or alternatively defer 65 to Health Canada/ Environment Canada) for formaldehyde and, at a minimum, use the IRIS reference concentration ( RfC) of 9 µ g/ m3 for acetaldehyde.

Response: We are re evaluating the dose response value for formaldehyde. Currently, the CIIT information and other recent information, including recently published epidemiological studies, are being reviewed and considered in the reassessment of our formaldehyde unit risk estimate ( URE). We plan to bring this reassessment to the Science Advisory Board in the summer of 2004.

The feasibility of delisting a subgroup of facilities based on risk is not compromised by the existing formaldehyde doseresponse value because some facilities would qualify for delisting based on this current value. We are moving forward with the final PCWP rule at this time because there is a courtordered deadline. We disagree with the statement by one of the commenters that " risks are still low" using the current IRIS number for formaldehyde. Our analysis has demonstrated that not all PCWP facilities can be considered low risk when either the current IRIS or CIIT URE for formaldehyde is employed.

While we recognize the similarities between acetaldehyde and formaldehyde with regard to suggested modes of action, the reassessment of acetaldehyde is lagging behind that of formaldehyde. The formaldehyde reassessment is further along because of the preponderance of data specific to formaldehyde and 66 the potentially greater impact of a change in potency to our regulatory decisions. Unlike for formaldehyde, an alternative,

peer reviewed, publicly available assessment does not currently exist for acetaldehyde, leaving us with the current IRIS assessment. We cannot wait for our acetaldehyde reassessment to be completed due to the court ordered deadline for the final PCWP rule. Therefore, we are relying on the IRIS values for acetaldehyde in both cancer and non cancer risk assessments for this rule.

Facilities conducting low risk demonstrations should refer to Appendix B to Subpart DDDD ( and/ or the " Air Toxics Risk Assessment Reference Library") for guidance on choosing appropriate dose response values.

Comment: One commenter stated that EPA should consider formaldehyde and acetaldehyde as carcinogens unless a reassessment classifies them as threshold pollutants. A second commenter argued that formaldehyde and acetaldehyde are properly treated as threshold pollutants. This commenter contended that the legislative history of the CAA makes clear that Congress considered " threshold pollutants" to be those for which a " no observed effect level" can be established. ( See, e. g., S. Rep.

No. 228, 101st Cong., 1st Sess. 175 176 ( 1990)). By contrast, a non threshold pollutant is one for which a no observed effect level cannot be identified, i. e., a pollutant for which adverse effects may be seen at any dose level above zero. The commenter 67 noted that EPA has historically assumed that all carcinogens are non threshold pollutants that may trigger a carcinogenic effect at any exposure level, no matter how small. However, as mechanistic data on the mode of action of carcinogenesis advances, that conservative assumption may prove not to be accurate for certain pollutants. The commenter stated that the available science strongly suggest that these pollutants act as threshold carcinogens. The commenter contended that there is a " no observed effect level" for formaldehyde below which the carcinogenic risk either does not exist or cannot be measured, as documented in an attachment to their comment. The commenter stated that acetaldehyde should be viewed similarly because acetaldehyde is similar to formaldehyde structurally and toxicologically, and is expected to behave similarly mechanistically. Because acetaldehyde is a less potent carcinogen than formaldehyde ( by an order of magnitude),

non cancer health effects ( which clearly are threshold health effects) are the likely risk driver for that pollutant. Finally,

the commenter noted that EPA's recently issued Draft Final Guidelines for Carcinogenic Risk Assessment provide that, for non linear carcinogens, EPA will calculate an reference dose ( RfD) or RfC, which are safe lifetime doses ( i. e., doses below which adverse effects will not occur). The commenter stated that this is exactly what a threshold pollutant is. Thus, EPA's revised guidelines support the conclusion that formaldehyde and 68 acetaldehyde should be treated as threshold pollutants.

Response: We agree that we should consider formaldehyde and acetaldehyde as carcinogens unless a reassessment classifies them as threshold pollutants. Currently, formaldehyde and acetaldehyde are considered probable human carcinogens. Both are under review, and their dose response values for carcinogenicity are likely to change. For this rule, we are using an alternative dose response value for formaldehyde based on a peer reviewed,

publicly available assessment. However, we do not have comparable quantitative information for acetaldehyde. Therefore,

we will use the current IRIS value. Facilities conducting lowrisk demonstrations should refer to Appendix B to Subpart DDDD ( and/ or the " Air Toxics Risk Assessment Reference Library") for guidance on choosing appropriate dose response values.

Comment: One commenter expressed concern about some of the health benchmarks that EPA plans to publish. The commenter reviewed various health studies for each pollutant and recommended several RfC values. The commenter noted that,

because IRIS does not have an RfC for methanol, EPA has indicated it plans to determine a de minimis threshold for methanol using a value of 4.0 mg/ m3 as an RfC. The commenter noted that this value is the Noncancer Chronic REL derived by CalEPA. The commenter stated that CalEPA's derivation of that REL contains some errors and inaccurate assumptions. According to the commenter, a more accurate estimate of a human safe level for 69 chronic exposure to methanol by inhalation, derived from the same mouse study data, is 171 mg/ m3, which is discussed further in their comments. The commenter stated that their discussion presents new analyses not previously reviewed by EPA and a ground breaking new approach to a hazard assessment for methanol.

The commenter noted that EPA is currently revising its assessment for acrolein and has provided for public information a draft toxicological review and draft IRIS summary for acrolein.

The draft IRIS document states that the proposed new RfC of 0.03 µ g/ m3 replaces the previous RfC of 0.02 µ g/ m3, and that this new RfC is based on a more recent interpretation of the database.

The commenter noted the basis for the revised acrolein RfC ( Feron et al, 1978) and argued that EPA's interpretation of this study is overly conservative. The commenter stated that EPA has used the maximum uncertainty factors that could reasonably be justifiable and thereby developed an RfC that almost certainly goes beyond what is needed to protect human health. The commenter suggested that EPA should instead use the more realistic reference exposure level developed by CalEPA, which is more conservative than the Health Canada Tolerable Concentration.

The commenter noted that EPA has not published a health benchmark for phenol. The commenter agreed with EPA's proposal to use the CalEPA REL of 200 µ g/ m3 for phenol in implementing the risk based approach for wood products facilities. According to the commenter, the REL is intended to serve the same goal as an 70 RfC.

The commenter supported using a health benchmark of 110 µ g/ m3 for propionaldehyde and believed that this value would protect human health with an ample margin of safety. The commenter described how the 110 µ g/ m3 value was derived based on the TLV for propionaldehyde identified by the American Conference of Governmental Industrial Hygienists ( ACGIH). The commenter explained that this benchmark is consistent with values developed by other organizations.

Response: We are currently developing an IRIS assessment for methanol, and any new information that exists that has undergone peer review will be considered in this re evaluation.

We publish yearly in the Federal Register a list of all chemicals for which we are planning IRIS assessment activity. This notice further requests submission of pertinent data for these chemicals. In lieu of the pending IRIS assessment, we will continue to draw on other sources identified by our established default hierarchy of data sources, which have as part of their development processes external or peer review, in addition to extensive internal reviews.

A reassessment of acrolein was completed in June of 2003.

The RfC resulting from that reassessment ( i. e., an RfC of 0.02

g/ m3, with an uncertainty factor of 1,000) is what is currently on IRIS. As with all announced IRIS reassessments, time was provided for new data or relevant information to be submitted. 71 In addition, each assessment undergoes extensive internal review as well as external peer review to ensure that the data used are scientifically sound. We believe we have developed the most scientifically sound RfC that will ensure that risk assessments using this number are health protective. Facilities conducting low risk demonstrations should refer to Appendix B to Subpart DDDD ( and/ or the " Air Toxics Risk Assessment Reference Library")

for guidance on choosing appropriate dose response values.

We do not currently have plans to develop an IRIS assessment for phenol. We will continue to rely on our hierarchy of other sources when IRIS values are not available.

We do not have an IRIS file for proprionaldehyde, and an assessment is not available from the alternative sources in our default hierarchy. The hierarchy sources do not include ACGIH,

as that organization develops reference values for use in occupational exposure settings, as opposed to the ambient air exposures that are the focus of this action. Development of an IRIS assessment for propionaldehyde is currently underway. Once available, it will be used in future risk analyses. In the meantime, this HAP was not included in the assessment conducted for PCWP facilities.

Comment: One commenter stated that comparison of modeled exposures to the RfC or similarly derived health benchmark is highly protective and meets the CAA's " ample margin of safety"

requirement. Although the CAA does not explicitly define " ample 72 margin of safety," in the Vinyl Chloride case, the D. C. Circuit Court of Appeals articulated the purpose of the ample margin of safety determination as obtaining a " reasonable degree of protection" in light of scientific uncertainties and information gaps. ( Natural Res. Def. Council v. EPA, 824 F. 2D 1146, 1152 53 ( D. C. Cir. 1987)). The commenter stated that, in regulatory practice, the ample margin of safety analysis consists of a consideration of the NOEL for a pollutant and the subsequent application of factors to account for scientific uncertainty surrounding that safe level of exposure. According to the commenter, this is the approach called for by the Senate Report accompanying the 1990 CAA Amendments ( S. Rep. No. 228, 101st Cong. Sess. 171 ( 1990)), and this is exactly what is done in deriving an RfC or similar inhalation health benchmark. The commenter stated that EPA's derivation of the RfC contains multiple layers of conservatism to account for scientific uncertainty. The commenter believed that RfC values and similar inhalation health benchmarks already incorporate sufficient uncertainty factors to fulfill or exceed the ample margin of safety mandate of CAA sections 112( d)( 4) and 112( c)( 9).

Response: Today's final PCWP rule will utilize CAA section 112( c)( 9) rather than CAA section 112( d)( 4). We agree that the CAA does not define " ample margin of safety" explicitly. The CAA does, however, in section 112( f) explicitly recognize our Federal Register notice of September 14, 1989, which described our 73 interpretation of " ample margin of safety" in the case of linear carcinogens, and our approach to implementing that interpretation. While the first step identifies the presumptive limit on maximum individual risk, the second step of that 2 step approach describes the setting of the risk based standard at a level that provides " an ample margin of safety," in consideration of a number of factors. As we noted in the 1989 notice, the objective in protecting public health with an ample margin of safety under section 112 is to ensure an individual lifetime risk level no higher than one in a million to the greatest number of persons possible, and to limit to no higher than one in ten thousand the estimated risk for a person living near a plant if they were exposed for 70 years.

In assessing risk or hazard of nonlinear effects, we use the RfC or comparable value. This value represents an estimate ( with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population ( including sensitive subgroups) that is likely to be without an appreciable risk of deleterious non cancer effects during a lifetime. The RfC values and comparable values are derived from assessments of pertinent toxicological information to identify the lowest point of departure ( in human equivalent terms) from the experimental data that is also representative of the threshold region ( the region where toxicity is apparent from the available data) for the array of toxicity data for that chemical. The objective is 74 2U. S. Environmental Protection Agency. 1994. Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry. Office of Research and Development. EPA/ 600/ 8 90/ 066F. ( EPA 1994) to select a prominent toxic effect that is pertinent to the chemical's key mechanism or mode of action. This approach is based, in part, on the assumption that if the critical toxic effect is prevented, then all toxic effects are prevented. The RfC is derived from the point of departure ( POD) ( in terms of human equivalent exposure) for the critical effect by consistent application of uncertainty factors, which are to account for recognized uncertainties in the extrapolations from the experimental data conditions to an estimate appropriate to the assumed human scenario. 2 In considering the extrapolation of the ample margin of safety objective described for linear cancer risk to the management of risk for nonlinear effects under section 112( c)( 9)

( i. e., in decisions to delist a subcategory from any further regulatory action), we consider exposures relative to the RfC or comparable values for all of the emitted HAP, with specific attention to those affecting a similar physiological target organ or system, and the contribution of co located sources of the same HAP.

Comment: One commenter stated that the uncertainty factors used in deriving the wood products HAP health benchmarks are 75 particularly large. The unit risk factors for acetaldehyde and formaldehyde were calculated using the linear multi stage model,

which assumes a linear relationship between cancer incidence and exposure to the pollutant at low doses. According to the commenter, the available data on acetaldehyde and formaldehyde strongly suggest that this assumption is incorrect and overly conservative.

The commenter pointed out that EPA's health assessment of acrolein is two to three times more conservative than CalEPA's,

even though both are intended to protect sensitive individuals from any adverse effects following a lifetime of exposure. The commenter stated that EPA has developed an extremely conservative RfC for acrolein. The commenter argued that adopting a HI of 0.2 would add another five fold safety factor to this already extremely conservative RfC. The commenter noted that acrolein is the HAP of greatest importance in determining risk from PCWP facilities.

Response: The dose response values used to determine the criteria for defining the low risk subcategory are drawn from IRIS, as well as from certain alternative sources. The IRIS process contains internal and external peer review steps and represents EPA consensus values. When adequate toxicity information is not available in IRIS, we consult other sources in a default hierarchy that recognizes the desirability of these qualities in ensuring that we have consistent and scientifically 76 3Ibid. sound assessments. In the case of acrolein, specifically mentioned by the commenter, consultation of other sources was not necessary because the acrolein assessment was completed within the past 9 months and represents current scientific knowledge.

In those cases ( e. g., formaldehyde), where the IRIS assessment substantially lags the current scientific knowledge, we consider alternative credible and readily available assessments. As pointed out elsewhere in this section, the RfC values or comparable values have been derived with the incorporation of uncertainty factors. The uncertainty factors are to account for recognized uncertainties in the extrapolations from the experimental data conditions pertaining to the chemical's particular toxicological data set to an estimate appropriate to the assumed human scenario. 3 The size variation of the uncertainty factors across RfC values reflects the size variation of the uncertainties associated with that extrapolation.

Comment: One commenter stated that the combination of conservative air dispersion modeling techniques and a conservative human health benchmark ensure that, where a source meets the requirements for a risk based compliance option, human health will be protected with an ample margin of safety. The commenter pointed out that, for most individuals in the general population, actual exposures likely are one or more orders of 77 magnitude below the maximum exposures predicted by the tiered modeling approach. The commenter noted that EPA's tiered modeling methodology is designed to identify the highest annual property line or off site concentrations that might occur around each facility ( as opposed to actual population exposure). The tiered approach models exposures of a " maximally exposed individual" ( MEI) and incorporates a number of conservative assumptions. According to the commenter, actual average concentrations are likely to be much lower. The commenter argued that, even if the modeled concentrations were reflective of continuous average concentrations, it is highly unlikely that any individual would actually be exposed to such concentrations for a lifetime. The commenter noted that the Presidential/ Congressional Commission on Risk Assessment and Risk Management concluded that the conservatism inherent in use of the MEI " was often so unrealistic that its use impaired the scientific credibility of health risk assessment."

Response: For air toxics risk assessments, we are implementing a tiered approach. The screening level, or tier of analysis, is designed, through the use of conservative inputs, to identify situations for risks that are unlikely to be of concern.

Screening tier analyses are designed to be relatively simple,

inexpensive, and quick, , defined decision criteria, and models with simplifying conservative assumptions as inputs. More refined levels of analysis include the refinement 78 4EPA 1999 of aspects of the analysis that are thought to influence risk most or may contain the greatest uncertainty. At the refined tier, each analysis requires more effort, but produces results that are less uncertain and less conservative ( i. e., less likely to overestimate risk). 4 Appendix B to Subpart DDDD describes a process based on this air toxics approach particular to risk assessment for CAA section 112( c)( 9).

b. HAP to include in risk assessments Comment: One commenter noted that the regulatory requirements in the proposed rule focused on six HAP that are emitted from PCWP facilities: acrolein, acetaldehyde,

formaldehyde, methanol, phenol, and propionaldehyde. Those HAP represent 96 percent of the emissions from PCWP facilities. The commenter believes that any risk based compliance mechanisms may reasonably be limited to consideration of the risks from these six HAP. The commenter noted that EPA's preliminary risk analysis conducted prior to proposal narrowed the list of HAP emitted from PCWP facilities to include the following: acrolein,

acetaldehyde, formaldehyde, methanol, phenol, benzene, methylene chloride, and manganese. The commenter referred to the results of their sensitivity analysis, which was conducted based on the data used in EPA's pre proposal risk analysis. The analysis evaluated the impact of increasing or decreasing facility 79 emissions by 30 percent, using different health benchmarks than those identified in EPA's analysis, and conducting the risk assessment with the six HAP targeted in the proposed rule versus the additional HAP identified by EPA. The commenter's sensitivity analysis showed that formaldehyde and acetaldehyde made up the bulk of the cancer risk, while benzene and methylene chloride had little or no influence on cancer risk, depending on the scenario considered. Under all scenarios, acrolein contributed the most non cancer risk. The remainder of the non cancer risk was divided between acetaldehyde, formaldehyde and manganese, with manganese contributing between 5.6 and 12.2 percent of the non cancer risk, depending on the scenario. Under all scenarios, methanol, benzene, methylene chloride and phenol did not contribute at all to the non cancer risk from wood products facilities ( with one exception, where the phenol risk contribution was 0.1 percent). Based on these results, the commenter stated that there appeared to be little reason to include evaluation of methylene chloride or benzene in the risk based compliance option. However, the commenter stated that it may be reasonable to take an extremely conservative approach and include evaluation of manganese in the risk based compliance mechanisms.

Response: We agree that it is appropriate to limit the number of HAP that must be included in PCWP facility low risk demonstrations to only those HAP that result in meaningful 80 contributions to the facility risk. However, we disagree that limiting the HAP included in the low risk demonstration to the six HAP defined as " total HAP" in Subpart DDDD ( acrolein,

acetaldehyde, formaldehyde, methanol, phenol, and propionaldehyde) is appropriate. We identified the most prevalent HAP based on mass emitted for purposes of developing MACT compliance options because MACT is technology based ( i. e.,

the same technology that reduces emissions of the six HAP also reduces emissions of other organic HAP). As discussed in section IV. A of this preamble, the six HAP defined as " total HAP" in Subpart DDDD are the HAP that are most often emitted in detectable amounts from the most PCWP process units, and these HAP make up 96 percent of the mass of nationwide HAP emissions from the PCWP industry. However, the risk associated with emissions of HAP are dependent on the mass emitted and the relative toxicity of each HAP. Thus, the HAP emitted in the greatest mass may not result in the most risk because the HAP may not be as potent as other HAP emitted in lower mass. For example, methanol is the HAP emitted from the PCWP industry in the greatest mass, but because methanol is not as toxic as other HAP emitted ( e. g, formaldehyde, certain HAP metals), it does not result in as much risk as do other HAP. To ensure protection of public health, all HAP must be considered when determining which facilities are low risk.

The commenter is correct in that our preliminary risk 81 analysis conducted prior to proposal narrowed the list of HAP emitted from PCWP facilities. We acknowledge receipt of the commenter's sensitivity analysis based on the data used in our pre proposal risk analysis. Following proposal, we conducted a more detailed risk analysis to evaluate the merits of including a low risk subcategory in the final PCWP rule. This post proposal analysis considered emissions of more than 30 HAP emitted from the PCWP source category. Many of these HAP are only emitted in minute amounts that have been detected from a small number of PCWP process units. Nevertheless, we included them in our risk analysis to determine their contribution to PCWP facility risk.

We reviewed the toxicity values for each HAP and the mass of each emitted from PCWP facilities to determine if it would be appropriate to narrow the list of HAP that PCWP facilities must consider in their low risk demonstrations. Based on our review,

we determined that 95 percent of the cancer risk at PCWP facilities is accounted for by the following HAP: acetaldehyde,

benzene, arsenic, beryllium, cadmium, hexavalent chromium, lead,

nickel subsulfide, formaldehyde, and arsenic. We also determined that 95 percent of the non cancer risk at PCWP facilities is accounted for by the following HAP: acetaldehyde, acrolein,

formaldehyde, phenol, MDI, arsenic, cadmium, and manganese. We believe that inclusion of these HAP in a demonstration of eligibility of the low risk PCWP subcategory is appropriate.

Limiting the list of HAP that must be included in the low risk 82 demonstration to 13 HAP minimizes emissions testing costs, while ensuring that the HAP that drive the risk at PCWP facilities are accounted for on a site specific basis.

c. Background, multipathway, and ecological exposures Comment: Two commenters argued that multipathway exposures should not be considered for PCWP facilities. One commenter stated that, because the HAP emitted from the PCWP source category are not bioaccumulative, it is unnecessary to consider multipathway exposures. The other commenter stated that there is no policy basis for considering multipathway exposures because U. S. Government surveys and regulatory actions demonstrate that non inhalation exposure to the six HAP emitted by wood products facilities is insignificant. The commenter provided rationale for the conclusion that dietary and drinking water exposures to the six HAP are not significant. Because the six HAP emitted from the PCWP source category ( acetaldehyde, acrolein, and formaldehyde, methanol, phenol, and propionaldehyde) do not exhibit bioaccumulative characteristics, the commenter considered it unnecessary to consider multipathway exposures.

Three commenters argued that multipathway exposures should be considered for PCWP facilities. One commenter stated that,

when persistent biological toxicant or metal emissions are significant, ingestion and other pathways should be considered in the risk screening. Another commenter stated that the concentration based applicability threshold approach in the 83 proposed PCWP rule does not address non inhalation exposures or adverse effects on the environment. The third commenter stated that section 112( d)( 4) requires EPA to consider all possible ways that a pollutant could affect human health or the environment because it refers to pollutants " for which a health threshold has been established," i. e., pollutants that have no adverse health or environmental effects. ( See 5 Legislative History at 8511.)

According to the commenter, EPA has recognized repeatedly in the past that many of the pollutants emitted by the source category are re deposited from the atmosphere and then contaminate soil and water for long periods of time. The commenter added that these pollutants bioaccumulate in wildlife and food sources,

poisoning people and animals alike. ( See, e. g., 64 FR 52828,

53014 ( September 30, 1999); 64 FR 31898, 31908 31909 ( June 14,

1999); 63 FR 14182, 14193 ( March 28, 1998); 61 FR 17358, 17478 ( April 19, 1996) ( due to bioaccumulation, mercury levels may be 10,000,000 times higher in fish than in water those fish inhabit).) The commenter concluded that, to evaluate whether a pollutant is a threshold pollutant and what its health threshold and ample margin of safety must be, EPA must consider all the potential health and environmental effects of deposition,

persistence and bioaccumulation of that pollutant. The commenter argued that EPA would contravene section 112( d)( 4) by considering only health effects caused by inhalation.

Response: We agree with the last commenter that CAA section 84 112( d)( 4) requires us to include oral exposures as well as inhalation exposures when determining the applicability of section 112( d)( 4). This rule is relying not on CAA section 112( d)( 4), but on section 112( c)( 9), which also has similar requirements for determining risk applicability. Although the commenter refers to CAA section 112( d)( 4), their concern is addressed in section 112( c)( 9) also. We agree that exposures via all relevant routes need to be considered, and we have conducted a multipathway exposure assessment on those HAP emitted from PCWP facilities ( including HAP not among the six mentioned by one commenter) that we have identified as having the potential health concerns by pathways other than inhalation of ambient air. The three HAP identified, and which were analyzed for risk associated with projected oral exposures, are mercury, lead, and cadmium.

Comment: Several commenters stated that there is no legal or policy basis for EPA to consider background or multipathway ( non inhalation) exposures. The commenters noted that CAA section 112( d) requires that MACT standards be based only on emissions from the MACT regulated portion of the facility; it does not give EPA the authority to consider existing background levels. One commenter noted that section 112 can be distinguished from other statutory provisions, both in the CAA and in other environmental legislation, where EPA has clearly 85 been given authority to consider background sources.

Another commenter noted that the CAA's legislative history does not support a requirement to consider other exposures. The commenter also pointed out that the statutory provisions on which EPA would rely to implement the risk based mechanisms ( i. e.,

section 112( d)( 4), section 112( c)( 9)( B), or EPA's de minimis authority) exclusively focus on the emissions from the source in making regulatory decisions. According to the commenter, EPA has existing regulatory programs ( e. g., for mobile and area sources [ Urban Air Toxics Strategy]) in place to address HAP emissions from other sources.

The commenter argued that over control of PCWP facilities is unjustified because PCWP facilities account for very small proportions of HAP emissions nationwide   less than 1.75 percent of acetaldehyde, 1.7 percent of acrolein, and 1 percent of formaldehyde emissions, according to their industry sponsored risk assessment. Given these results, the commenter concluded that PCWP facilities cannot reasonably be considered to contribute meaningfully to background concentrations.

The commenter stated that section 112( d)( 4) does not require the complete absence of a hazard and noted that all substances have adverse effects on health and the environment at sufficiently high doses. Accordingly, section 112( d)( 4)

incorporates the concept of exposure, and the Senate Report made clear that the provision was applicable in instances where " it is 86 possible to establish a ` no observable effects level' ( NOEL)

below which human exposure is presumably " safe." In addition,

delisting criteria and the so called " trigger" component of the residual risk provision focus exclusively on emissions and whether the risk posed by any source in the category, by itself,

exceeds one in a million cancer risk.

Two commenters opposed the use of available data on background concentrations and facility specific measurement of background concentrations to determine the extent of exposures from other sources, arguing that the CAA and sound public policy warrant a focus exclusively on the emissions from the source category at hand when evaluating the applicability of a risk based compliance option. Because a HI of 1.0 ( or higher) is amply protective of public health and is warranted under EPA's statutory mandate, the commenters stated that consideration of background concentration is not appropriate.

Response: We disagree that we do not have the authority to consider background and multipathway exposures.

Commenters presumed the use of CAA section 112( d)( 4)

for the PCWP delisting. However, we are using section 112( c)( 9)

and not section 112( d)( 4). For delisting purposes, we are required to make not only a determination of a level which is " safe" to the individual exposed to the maximum concentration but 87 also a determination whether that individual and the general population are protected to a level that provides a " clear" ample margin of safety in order to have the confidence that a decision to exclude these facilities from regulation ( including residual risk) may be made. These are the same requirements that are found as the " trigger" in the residual risk program because all decisions of this type under Title III of the CAA ( sections 112( c)( 9), d( 4), and f( 2)) should be consistent and based on the same risk approaches.

We agree that imposition of costly regulatory requirements on sources that do not contribute meaningfully to background exposures is not beneficial. However, regarding the results of the industry sponsored wood products MACT risk assessment, we note that section 112( c)( 9) requires the evaluation of all facility level emission points, all HAP, and all pathways in order to satisfy that the emissions from these facilities provide protection of the population with an ample margin of safety. The wood products MACT risk assessment does not address HAP emitted from PCWP facilities that have the potential to bioaccumulate and persist in the environment ( e. g., lead, cadmium, and mercury).

We conducted an exposure assessment for these HAP to determine exposure from ingestion as well as inhalation.

The look up tables included in Appendix B to subpart DDDD were developed 88 using conservative input parameters to ensure that facilities qualifying for the low risk subcategory based on the look up tables would not pose a risk to multimedia endpoints.

As discussed elsewhere, for today's final PCWP rule, we are considering a HI limit of 1.0 to provide an ample margin of safety for protecting public health under section 112( c)( 9).

Safety factors are included to account for scientific uncertainties and their inclusion helps ensure that using a HI limit of 1.0 provides an ample margin of safety. The look up tables included in Appendix B to Subpart DDDD were developed based on a HI of 1.0. For site specific chronic inhalation risk assessments, facilities are required to ensure that the target organ specific hazard index ( TOSHI) for exceeds a value of 1.0.

Comment: One commenter stated that EPA had provided inadequate discussion of how environmental risks would be evaluated. The commenter added that the CAA requires EPA consider the environment as well as public health, and that, at a minimum, a facility would be required to conduct an assessment based on EPA's 1998 Guidelines for Ecosystem Assessment. The commenter referred EPA to Appendix A of " Generic Assessment for Endpoints for Ecological Risk Assessment" for a detailed discussion on the legal basis from " such statutes as the 89 CAA... that require EPA to consider and protect organism level attributes or various taxa including fish, birds, and plants and more generally, animals, wildlife, aquatic life, and living things."

Another commenter cited an analysis they commissioned that showed it to be highly unlikely that emissions from PCWP facilities would pose a hazard to ecological receptors at levels that are protective of human health. Thus, concern over ecological receptors would not provide a valid basis for reducing the HI below 1.0.

Response: An ecological assessment is required under Title III of the CAA, including sections 112( d)( 4), ( c)( 9), and ( f)( 2).

Therefore, delisting under section 112( c)( 9) requires consideration of ecological effects. The look up tables developed for today's final PCWP rule are intended to accommodate enough conservatism that any facility qualifying for inclusion in the delisted subcategory using them will qualify based on all endpoints, including ecological endpoints.

Assuming the assessment referenced by the first commenter included only the six HAP listed in subpart DDDD, we disagree that these six HAP should be the sole focus of an ecological assessment. It is not clear from the comment whether the commenter is suggesting that we might consider lowering the human 90 health HI values to below 1.0 in order to reflect ecological concerns or whether they are suggesting that an ecological HI value should not be reduced below 1.0. In the former case, that is not done. Human health and ecological assessments are independent assessments with their own risk management criteria.

d. Hazard index ( HI)

Comment: Two commenters stated that hazard quotients ( HQ)

for chemical mixes should not be summed to determine the HI unless the primary effects are on the same organ by the same mechanism; otherwise the risk would be overestimated. One commenter stated that section 112( d)( 4) refers to threshold pollutants, with each health threshold augmented by an ample margin of safety. These ample margin of safety values are already incorporated into RfC values. The risk criteria applied are confined to the effects upon which the RfC is based, which reflect the most sensitive target organ. According to the commenter, a decision to add risk posed by chemicals that affect the same target organ but have unknown mechanisms of action represents an unnecessarily conservative assumption that would tend to inflate the final risk estimate.

The commenters also noted that, according to the National Research Council and the Presidential/ Congressional Commission on Risk Assessment and Risk Management, additivity at low doses is more likely to overestimate than to underestimate total risk. As stated in the Commission's 1997 Final Report: " When the 91 5U. S. Environmental Protection Agency. 1986. Guidance for Conducting Health Risk Assessment of Chemical Mixtures. Risk Assessment Forum, Washington, DC. EPA/ 630/ R 98/ 002; available at http:// cfpub. epa. gov/ ncea/ raf/ recordisplay. cfm? deid= 20533. ( EPA 1986)

6U. S. Environmental Protection Agency. 2000. Supplementary Guidance for Conducting Health Risk Assessment of Chemical Mixtures. Office of Research and Development. EPA/ 630/ R 00/ 002 ( EPA 2000) individual components of a chemical mixture exhibit different kinds of toxicity or have different biological mechanisms of toxicity, they do not interact   they act independently at low doses. In that case, the dose response relationships for each chemical should be considered independently... [ By contrast]

studies in which similar chemicals with similar mechanisms and target were administered simultaneously indicate that antagonism is the usual outcome..."( Falk and Kotin 1964, Schmal et al. 1977)

Response: Our recommended approach for assessing risks from exposure to a mixture of pollutants is to utilize a dose response assessment developed for that mixture. 5,6 There are few mixtures ( e. g., coke oven emissions), however, for which such assessments are available. When mixture specific dose response assessments are not available, a component by component approach is recommended. The method for component data depends on a judgment of toxicologic similarity among components. The specific term " toxicologic similarity" represents a general knowledge about the action of a chemical or a mixture and can be expressed in broad terms such as at the target organ level in the body. In our 92 7Ibid.

8Ibid. guidance, assumptions about toxicologic similarity are made in order to choose among risk assessment methods. In general, we assume a similar mode of action across mixtures or mixture components and, in some cases, this requirement may be relaxed to require that these chemicals act only on the same target organ. 7 The primary method for component based risk assessment of toxicologically similar chemicals is the HI, which is derived from dose addition. In our guidance, dose addition is interpreted as simple similar action, where the component chemicals act as if they are dilutions or concentrations of each other differing only in relative toxicity. Dose additivity may not hold for all toxic effects. Furthermore, the relative toxic potency between chemicals may differ from different types of toxicity or toxicity by different routes. To reflect these differences, the HI is then usually developed for each exposure route of interest, and for a single specific toxic effect of toxicity to a single target organ. A mixture may then be assessed by several HI, each representing one route and one toxic effect or target organ. 8 To assess the cumulative risk or hazard associated with nonlinear effects of HAP in our analysis of PCWP facilities, HAP hazard quotients pertaining to the same target organs or systems 93 are summed to generate TOSHI. While it may be preferable to focus on the addition of HAP HQ that involve the same mechanism or mode of action, that level of information is not generally available for all of the HAP on which we are focusing. Pending the availability of such data for the HAP components of the mixture being assessed, the method employed under CAA section 112( c)( 9) is to aggregate HAP HQ by target organ to generate a TOSHI.

Comment: Two commenters supported a HI of 1.0 ( or greater)

as an appropriate benchmark for comparing exposures attributable to facility emissions, which should fully provide for the statutory mandate of an ample margin of safety. The commenters referred to the 1997 Final Report of the Presidential/ Congressional Commission on Risk Assessment and Risk Management in Regulatory Decision Making as support for their position. Specifically, the Commission supported a noncancer HI of 10.0, stating that there are few HAP with RfC values within a factor of 10 of their no observable adverse effects level ( NOAEL). Because RfC values are typically one thousandth of a NOAEL, a noncancer HI of 10.0 in those cases would still leave a margin of exposure of 100. The Commission recommended that EPA should, on the basis of screening assessments of source categories, do further risk assessment and analysis of categories where the noncancer HI exceeds 10.0. Where more detailed risk assessments yield noncancer hazard indices less than 1.0, the 94 Commission recommended that no further action be required. The


[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1415-1420]
[FR Doc No: 2016-00433]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0506; FRL-9940-47]

Certain New Chemicals; Receipt and Status Information for
November 2015

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA)
to publish in the Federal Register a notice of receipt of a
premanufacture notice (PMN); an application for a test marketing
exemption (TME), both pending and/or expired; and a periodic status
report on any new chemicals under EPA review and the receipt of notices
of commencement (NOC) to manufacture those chemicals. This document
covers the period from November 2, 2015 to November 30, 2015.

DATES: Comments identified by the specific case number provided in this
document, must be received on or before February 11, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2015-0506, and the specific PMN number or TME
number for the chemical related to your comment, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.

     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, IMD, 7407M, Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply. Although others may be affected, this action applies
directly to the submitters of the actions addressed in this document.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the Agency taking?

    This document provides receipt and status reports, which cover the
period from November 2, 2015 to November 30, 2015, and consists of the
PMNs and TMEs both pending and/or expired, and the NOCs to manufacture
a new chemical that the Agency has received under TSCA section 5 during
this time period.

III. What is the Agency's authority for taking this action?

    Under TSCA, 15 U.S.C. 2601 et seq., EPA classifies a chemical
substance as either an ``existing'' chemical or a ``new'' chemical. Any
chemical substance that is not on EPA's TSCA Inventory is classified as
a ``new chemical,'' while those that are on the TSCA Inventory are
classified as an ``existing chemical.'' For more information about the
TSCA Inventory go to: http://www.epa.gov/opptintr/newchems/pubs/inventory.htm.
    Anyone who plans to manufacture or import a new chemical substance
for a non-exempt commercial purpose is required by TSCA section 5 to
provide EPA with a PMN, before initiating the activity. Section 5(h)(1)
of TSCA authorizes EPA to allow persons, upon application, to
manufacture (includes import) or process a new chemical substance, or a
chemical substance subject to a significant new use rule (SNUR) issued
under TSCA section 5(a), for ``test marketing'' purposes, which is
referred to as a test marketing exemption, or TME. For more information
about the requirements applicable to a new chemical go to: http://www.epa.gov/oppt/newchems.
    Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to publish
in the Federal Register a notice of receipt of a PMN or an application
for a TME and to publish in the Federal Register periodic reports on
the status of new chemicals under review and the receipt of NOCs to
manufacture those chemicals.

IV. Receipt and Status Reports

    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that the information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI.
    For the 54 PMNs received by EPA during this period, Table 1
provides the following information (to the extent that such information
is not claimed as CBI): The EPA case number assigned to the PMN; The
date the PMN was received by EPA; the projected end date for EPA's
review of the PMN; the submitting manufacturer/importer; the potential
uses identified by the manufacturer/importer in the PMN; and the
chemical identity.

                        Table 1--PMNs Received From November 2, 2015 to November 30, 2015
----------------------------------------------------------------------------------------------------------------
                                    Projected end
     Case No.       Date received   date for EPA     Manufacturer/           Use(s)           Chemical identity
                                       review          Importer
----------------------------------------------------------------------------------------------------------------
P-16-0049........      11/23/2015       2/21/2016  CBI.............  (S) Foam stabilizer    (G) High oleic algae
                                                                      and rheology           oil ethoxylate.
                                                                      modifier in
                                                                      dishwashing and car
                                                                      washing detergents.
P-16-0050........      11/23/2015       2/21/2016  CBI.............  (S) Foam stabilizer    (G) High lauric
                                                                      and rheology           algae oil
                                                                      modifier in            ethoxylate S2014.
                                                                      dishwashing and car
                                                                      washing detergents.
P-16-0051........      11/23/2015       2/21/2016  CBI.............  (S) Foam stabilizer    (G) High lauric
                                                                      and rheology           algae oil
                                                                      modifier in            ethoxylate S5223.
                                                                      dishwashing and car
                                                                      washing detergents.
P-16-0052........       11/2/2015       1/31/2016  CBI.............  (G) Printing ink.....  (G) Polyamid resin.
P-16-0053........       11/2/2015       1/31/2016  CBI.............  (G) Printing ink       (G) Acrylated
                                                                      applications.          polycarbonate
                                                                                polyol.

P-16-0055........       11/3/2015        2/1/2016  Henkel            (S) Accruable          (S) 1,3-Butadiene,
                                                    Corporation.      component in           homopolymer,
                                                                      adhesive and Sealant   hydrogenated, 2-
                                                                      formulations.          hydroxyethyl-
                                                                                terminated, bis[N-
                                                                                [3-
                                                                                (trimethoxysilyl)pr
                                                                                opyl]carbamates].
P-16-0056........       11/2/2015       1/31/2016  CBI.............  (G) Oil production...  (G) Dialkylamino
                                                                                alkylamide salt.
P-16-0057........       11/2/2015       1/31/2016  CBI.............  (G) Oil production...  (G) Dialkylamino
                                                                                alkylamide salt.
P-16-0058........       11/3/2015        2/1/2016  CBI.............  (S) Chemical           (G) Beta amino fatty
                                                                      intermediate.          ester.
P-16-0059........       11/3/2015        2/1/2016  CBI.............  (S) Chemical           (G) Dialkylamino
                                                                      intermediate.          alkylamide.
P-16-0060........       11/3/2015        2/1/2016  CBI.............  (S) Chemical           (G) Beta amino ester
                                                                      intermediate.          derivative.
P-16-0061........       11/3/2015        2/1/2016  CBI.............  (G) Friction reducer.  (G) Acrylamide-
                                                                                substituted
                                                                                ammonium chloride
                                                                                polymer.
P-16-0062........       11/3/2015        2/1/2016  Colonial          (S) Viscosity control  (S) Tetradecanoic
                                                    Chemical, Inc..   in hard surface        acid, compd. with
                                                                      cleaners.              1,1'-iminobis[2-
                                                                                propanol] (1:1)
                                                                                (9Cl).
P-16-0065........       11/3/2015        2/1/2016  CBI.............  (G) Component of       (G) Propanoic acid,
                                                                      electrocoat.           polyhydroxyalkyl-,
                                                                                compds. with
                                                                                aminoalkanol-
                                                                                quaternized
                                                                                bisphenol A-
                                                                                (aminoalkanol-
                                                                                blocked aromatic
                                                                                polyisocyanate-
                                                                                polyether polymer)-
                                                                                epichlorohydrin
                                                                                polymer carboxylate
                                                                                salts.
P-16-0066........       11/3/2015        2/1/2016  CBI.............  (G) Component of       (G) Propanoic acid,
                                                                      electrocoat.           polyhydroxyalkyl-,
                                                                                compds. with
                                                                                aminoalkanol-
                                                                                quaternized
                                                                                bisphenol A-
                                                                                (aminoalkanol-
                                                                                blocked aromatic
                                                                                polyisocyanate-
                                                                                polyether polymer)-
                                                                                epichlorohydrin
                                                                                polymer carboxylate
                                                                                salts.
P-16-0067........       11/3/2015        2/1/2016  CBI.............  (G) Component of       (G) Propanoic acid,
                                                                      electrocoat.           polyhydroxyalkyl-,
                                                                                compds. with
                                                                                aminoalkanol-
                                                                                quaternized
                                                                                bisphenol A-
                                                                                (aminoalkanol-
                                                                                blocked aromatic
                                                                                polyisocyanate-
                                                                                polyether polymer)-
                                                                                epichlorohydrin
                                                                                polymer inorganic
                                                                                salts.
P-16-0063........       11/3/2015        2/1/2016  CBI.............  (G) Component of       (G) Propanoic acid,
                                                                      electrocoat.           polyhydroxyalkyl-,
                                                                                compds. with
                                                                                aminoalkanol-
                                                                                quaternized
                                                                                bisphenol A-
                                                                                (aminoalkanol-
                                                                                blocked aromatic
                                                                                polyisocyanate-
                                                                                polyether polymer)-
                                                                                epichlorohydrin
                                                                                polymer.
P-16-0064........       11/3/2015        2/1/2016  CBI.............  (G) Component of       (G) Propanoic acid,
                                                                      electrocoat.           polyhydroxyalkyl-,
                                                                                compds. with
                                                                                aminoalkanol-
                                                                                quaternized
                                                                                bisphenol A-
                                                                                (aminoalkanol-
                                                                                blocked aromatic
                                                                                polyisocyanate-
                                                                                polyether polymer)-
                                                                                epichlorohydrin
                                                                                polymer carboxylate
                                                                                salts.
P-16-0068........       11/3/2015        2/1/2016  CBI.............  (S) Chemical           (G) Dialkylamino
                                                                      intermediate.          alkylamide.
P-16-0069........       11/3/2015        2/1/2016  CBI.............  (G) Fuel use.........  (G) Glycerides, C14-
                                                                                18, C16-18
                                                                                unsaturated, from
                                                                                fermentation.
P-16-0070........       11/5/2015        2/3/2016  3M Company......  (S) Emergency          (S) Boron sodium
                                                                      shutdown coolant in    oxide (B5NaO8),
                                                                      boiling water          labeled with boron-
                                                                      reactors.              10.
P-16-0071........       11/5/2015        2/3/2016  CBI.............  (G) Fabric treatment.  (G) Fluorinated
                                                                                polyurethane
                                                                                emulsion.
P-16-0072........       11/5/2015        2/3/2016  CBI.............  (G) Temperature        (G) Phenyl methyl
                                                                      resistant coating.     siloxane resin.
P-16-0073........       11/5/2015        2/3/2016  CBI.............  (G) Coating additive.  (G) Styrene-acrylate
                                                                                polymer.
P-16-0074........       11/6/2015        2/4/2016  CBI.............  (G) Adhesive for open  (G) Isocyanate
                                                                      non-descriptive use.   terminated
                                                                                polyurethane.

P-16-0075........       11/6/2015        2/4/2016  Fritz             (S) Oil field          (S) Poly[oxy(methyl-
                                                    Industries,       additive.              1,2-ethanediyl)],
                                                    Inc..                                    alpha-[2-
                                                                                (bis(phosphonomethy
                                                                                l)amino]methylethyl
                                                                                ]-omega-[2-
                                                                                [bis(phosphonomethy
                                                                                l)amino]methylethox
                                                                                y]-, sodium salt
                                                                                (1:4).
P-16-0076........       11/6/2015        2/4/2016  Itaconix Corp...  (S) Chelant in         (G) Itaconic acid
                                                                      detergents.            copolymer.
P-16-0077........       11/6/2015        2/4/2016  CBI.............  (S) Use per FFDCA:     (S) 5-Octenoic acid,
                                                                      Food/flavors,          methyl ester, (5Z)-
                                                                      cosmetics, fragrance   .
                                                                      uses, scented papers
                                                                      detergents, candles,
                                                                      etc..
P-16-0078........       11/6/2015        2/4/2016  CBI.............  (G) Organic light-     (G) Amine-alkyl-
                                                                      emitting diode         polyaromatic
                                                                      material.              hydrocarbon
                                                                                polymer.
P-16-0079........      11/10/2015        2/8/2016  CBI.............  (G) Coating resin for  (G) Polyarylate.
                                                                      organic
                                                                      electrophotographic
                                                                      photoconduct.
P-16-0085........      11/10/2015        2/8/2016  CBI.............  (G) Emulsifier.......  (G) Poly
                                                                                alkylimidazoline.
P-16-0081........      11/10/2015        2/8/2016  CBI.............  (G) Emulsifier.......  (G) Poly
                                                                                alkylimidazoline.
P-16-0082........      11/10/2015        2/8/2016  CBI.............  (G) Emulsifier.......  (G) Poly
                                                                                alkylimidazoline.
P-16-0080........      11/10/2015        2/8/2016  CBI.............  (G) Emulsifier.......  (G) Poly
                                                                                alkylimidazoline.
P-16-0084........      11/10/2015        2/8/2016  CBI.............  (G) Emulsifier.......  (G) Poly
                                                                                alkylimidazoline.
P-16-0083........      11/10/2015        2/8/2016  CBI.............  (G) Emulsifier.......  (G) Poly
                                                                                alklyimidazoline.
P-16-0086........      11/11/2015        2/9/2016  CBI.............  (G) Coating component  (G) Mixed metal
                                                                                oxide-halide
                                                                                complex.
P-16-0087........      11/11/2015        2/9/2016  CBI.............  (G) Anti-static agent  (G) Dicarboxylic
                                                                      for thermoplastic      acid, polymer with
                                                                      resin.                 aminoalkanoic acid
                                                                                and polyether
                                                                                polyol.
P-16-0088........      11/12/2015       2/10/2016  Shin Etsu         (G) The composition    (G) Fluorined
                                                    Silicones of      including the new      organopolysiloxane.
                                                    America.          chemical substance
                                                                      hardens by heating.
P-16-0091........      11/12/2015       2/10/2016  Lawter..........  (S) Printing ink       (S) Rosin, polymer
                                                                      resin-litho/offset     with
                                                                      printing.              dicyclopentadiene,
                                                                                glycerol, maleic
                                                                                anhydride,
                                                                                pentaerythritol,
                                                                                soybean oil and 1-
                                                                                tetradecene.
P-16-0092........      11/13/2015       2/11/2016  CBI.............  (G) Industrial         (G) Polymeric
                                                                      coatings, open non-    polyamine.
                                                                      dispersive use.
P-16-0093........      11/13/2015       2/11/2016  CBI.............  (G) Ingredients for    (S) 2-Cyclohexen-1-
                                                                      consumer products      one, 2-methyl-5-
                                                                      dispersive use.        propyl-.
P-16-0094........      11/13/2015       2/11/2016  Shin Etsu         (S) Stain-proof        (G)
                                                    Silicones of      coating agent for      Perfluoropolyether
                                                    America.          touch panel.           modified
                                                                                organosilane.
P-16-0095........      11/16/2015       2/14/2016  CBI.............  (G) Flame retardant    (G) Phenol-
                                                                      additive.              formaldehyde resin.
P-16-0097........      11/16/2015       2/14/2016  CBI.............  (G) Polymer for        (G) Amine salted
                                                                      coatings.              polyurethane.
P-16-0096........      11/16/2015       2/14/2016  CBI.............  (G) Polymer for        (G) Amine salted
                                                                      coatings.              polyurethane.
P-16-0098........      11/18/2015       2/16/2016  Univation         (S) Catalyst for       (G) Compound of
                                                    Technologies,     polyethylene           Silica gel, metal
                                                    LLC.              polymerization.        alkyls, and
                                                                                chromium.
P-16-0099........      11/20/2015       2/18/2016  CBI.............  (G) Aquerous coatings  (G) Polyethylene
                                                                                glycol polymer with
                                                                                aliphatic
                                                                                polycarbodiimide,
                                                                                Bis(alkoxysilylprop
                                                                                yl) amine blocked.
P-16-0100........      11/20/2015       2/18/2016  CBI.............  (G) Component of       (G) Substituted
                                                                      coatings.              heteropolycyclic
                                                                                derivs.
P-16-0101........      11/20/2015       2/18/2016  CBI.............  (G) Material for       (G) disubstituted
                                                                      highly dispersive      alkanal.
                                                                      use in consumer
                                                                      products.
P-16-0102........      11/21/2015       2/19/2016  CBI.............  (G) Coating component  (G) Polyester
                                                                                acrylate.
P-16-0104........      11/24/2015       2/22/2016  CBI.............  (S) Intermediate for   (S) 2-
                                                                      pesticide              Pyridinecarboxylic
                                                                      manufacturer.          acid, 4,5-dichloro-
                                                                                6-(4-chloro-2-
                                                                                fluoro-3-
                                                                                methoxyphenyl.
P-16-0105........      11/24/2015       2/22/2016  CBI.............  (G) Fertilizer         (G) Alkyl polyol
                                                                      component.             salt.
P-16-0106........      11/30/2015       2/28/2016  CBI.............  (G) Bonding agent....  (G) 1,3-Diazetidine-
                                                                                2,4-dione, 1,3-bis
                                                                                [(isocyanatophenyl)
                                                                                methyl] phenyl]-,
                                                                                polymer with 2-
                                                                                (chloromethyl)oxira
                                                                                ne and 4,4'-(1-
                                                                                methylethylidene)bi
                                                                                s[phenol],
                                                                                alkoxypropanol-
                                                                                blocked.
----------------------------------------------------------------------------------------------------------------

    For the six TMEs received by EPA during this period, Table 2
provides the following information (to the extent that such information
is not claimed as CBI): The EPA case number assigned to the TME, the
date the TME was received by EPA, the projected end date for EPA's
review of the TME, the submitting manufacturer/importer, the potential
uses identified by the manufacturer/importer in the TME, and the
chemical identity.

                        Table 2--TMEs Received From November 2, 2015 to November 30, 2015
----------------------------------------------------------------------------------------------------------------
                                    Projected end
     Case No.       Date received   date for EPA     Manufacturer/           Use(s)           Chemical identity
                                       review          Importer
----------------------------------------------------------------------------------------------------------------
T-16-0001........       11/2/2015      12/17/2015  CBI.............  (G) Oil Production...  (G) Dialkylamino
                                                                                alkylamide salt.
T-16-0002........       11/2/2015      12/17/2015  CBI.............  (G) Oil Production...  (G) Dialkylamino
                                                                                alkylamide salt.
T-16-0003........       11/3/2015      12/18/2015  CBI.............  (S) Chemical           (G) Beta amino fatty
                                                                      Intermediate.          ester.
T-16-0004........       11/3/2015      12/18/2015  CBI.............  (S) Chemical           (G) Dialkylamino
                                                                      Intermediate.          alkylamide.
T-16-0005........       11/3/2015      12/18/2015  CBI.............  (S) Chemical           (G) Beta amino ester
                                                                      Intermediate.          derivative.
T-16-0006........       11/3/2015      12/18/2015  CBI.............  (S) Chemical           (G) Dialkylamino
                                                                      Intermediate.          alkylamide.
----------------------------------------------------------------------------------------------------------------

    For the 32 NOCs received by EPA during this period, Table 3
provides the following information (to the extent that such information
is not claimed as CBI): The EPA case number assigned to the NOC; the
date the NOC was received by EPA; the projected date of commencement
provided by the submitter in the NOC; and the chemical identity.

    Table 3--NOCs Received From November 2, 2015 to November 30, 2015
------------------------------------------------------------------------
                                     Commencement
    Case No.       Received date         date             Chemical
------------------------------------------------------------------------
P-97-0141.......       11/17/2015       10/22/2015  (G) Acrylate
                                                     polymer.
P-04-0313.......       11/10/2015       10/14/2015  (G) Aminoraizie
                                                     modified cresol
                                                     novolac resin.
P-06-0142.......        11/6/2015        11/4/2015  (S) Castor oil,
                                                     polymer with
                                                     ethylenediamine,
                                                     1,6-hexanediol,
                                                     .alpha.-hydro-
                                                     .omega.-
                                                     hydroxypoly(oxy-1,4-
                                                     butanediyl), 3-
                                                     hydroxy-2-
                                                     (hydroxymethyl)-2-
                                                     methylpropanoic
                                                     acid, 1,1'-
                                                     methylenebis[4-
                                                     isocyanatocyclohexa
                                                     ne] and soybean
                                                     oil, compd. with
                                                     triethylamine.
P-08-0167.......       11/20/2015        11/9/2015  (S) Butanedioic
                                                     acid, polymer with
                                                     1,4-butanediol.
P-12-0169.......       11/18/2015       10/28/2015  (G) Fluoro-modified
                                                     acrylic copolymer.
P-13-0931.......       11/11/2015       10/28/2015  (S) 2-propenoic
                                                     acid, 4-
                                                     phenoxybutyl ester.
P-14-0105.......       11/20/2015       11/10/2015  (G) Methylene
                                                     diisocyanate
                                                     polymer with diols
                                                     and triols.
P-14-0142.......       11/23/2015        9/23/2015  (G) Formaldehyde
                                                     polymer with
                                                     modified phenol and
                                                     amine, alkoxylated.
P-14-0480.......        11/2/2015        10/7/2015  (G) Carboxlic acid
                                                     polymer with
                                                     isocyanate,diols
                                                     and acid,alc and
                                                     amine blocked.
P-14-0581.......       11/11/2015       10/23/2015  (G) Alkyl
                                                     alkylphosphinate.
P-14-0623.......        11/2/2015        5/11/2015  (G) Aliphatic
                                                     polyester.
P-15-0139.......       11/16/2015       10/26/2015  (S) D-glucitol, 1-
                                                     deoxy-1-
                                                     (methylamino)-, n-
                                                     c8-10 acyl derivs.
P-15-0269.......        11/3/2015       10/27/2015  (G) Substituted
                                                     carbomonocycle,
                                                     (alkylidene)bis-
                                                     ,polymer with
                                                     haloalkyl
                                                     heteromonocycle and
                                                     alkylidene)bis(subs
                                                     tituted
                                                     carbomonocycle)]-
                                                     bis[heteromonocycle
                                                     ], reaction
                                                     products with
                                                     carbon dioxide.
P-15-0272.......       11/19/2015       11/11/2015  (G) Formaldehyde,
                                                     reaction products
                                                     with aniline and
                                                     aromatic mono- and
                                                     di-phenol mixture.
P-15-0292.......       11/13/2015       10/22/2015  (G) Butanedioic
                                                     acid, polymer with
                                                     substituted-
                                                     acrylamide,
                                                     styrene, and
                                                     acrylates.
P-15-0306.......        11/2/2015        9/26/2015  (S) Phenol, 1, 1-
                                                     dimethylpropyl
                                                     derivs;
P-15-0319.......       11/19/2015       11/18/2015  (G) Butanedioic
                                                     acid, 2-methylene-,
                                                     alkyl ester.
P-15-0324.......       11/19/2015       11/18/2015  (G) Magnesium
                                                     alkaryl sulfonate.
P-15-0505.......        11/3/2015        10/4/2015  (S) Hexanedioic
                                                     acid, polymer with
                                                     1,4-
                                                     cyclohexanedimethan
                                                     ol, dimethyl
                                                     carbonate, 2,2-
                                                     dimethyl-1,3-
                                                     propanediol, 2-
                                                     ethyl-2-
                                                     (hydroxymethyl)-1,3-
                                                     propanediol,
                                                     hexahydro-1,3-
                                                     isobenzofurandione,
                                                     1,6-hexanediol, 3-
                                                     hydroxy-2-
                                                     (hydroxymethyl)-2-
                                                     methylpropanoic
                                                     acid and 5-
                                                     isocyanato-1-
                                                     (isocyanatomethyl)-
                                                     1,3,3-
                                                     trimethylcyclohexan
                                                     e, compound with 2-
                                                     (dimethylamino)etha
                                                     nol.
P-15-0530.......       11/19/2015       11/17/2015  (G) Alkoxylated
                                                     fatty alcohol
                                                     citrate.
P-15-0531.......        11/4/2015       10/27/2015  (G) Siloxanes and
                                                     silicones, di-Me
                                                     ethers with
                                                     polyalkylene glycol
                                                     monoallyl ether.
P-15-0541.......        11/3/2015       10/13/2015  (S) Hexanedioic
                                                     acid, polymer with
                                                     1,6-
                                                     diisocyanatohexane,
                                                     2,2-dimethyl-1,3-
                                                     propanediol, 1,6-
                                                     hexanediol and 5-
                                                     isocyanato-1-
                                                     (isocyanatomethyl)-
                                                     1,3,3-
                                                     trimethylcyclohexan
                                                     e.
P-15-0571.......       11/11/2015       10/15/2015  (G) Potassium salt
                                                     of organic acid.
P-15-0572.......       11/11/2015       10/15/2015  (G) Mixed salts of
                                                     organic acid.
P-15-0603.......       11/18/2015       10/22/2015  (S) Ethanesulfonyl
                                                     fluoride, 1,1,2,2-
                                                     tetrafluoro-2-
                                                     [(1,2,2-
                                                     trifluoroethenyl)ox
                                                     y]-, polymer with
                                                     1,1,2,2-
                                                     tetrafluoroethene,
                                                     hydrolyzed, lithium
                                                     salts.
P-15-0621.......       11/25/2015       11/16/2015  (G) Aromatic
                                                     polyester.
P-15-0655.......       11/30/2015       11/23/2015  (G) 2-Ethylhexanoic
                                                     acid, compound with
                                                     alkylamino
                                                     cyclohexane 2-
                                                     Ethylhexanoic acid,
                                                     compound with
                                                     cyclohexylamine.
P-15-0670.......       11/18/2015       11/12/2015  (S) 1,2-
                                                     Ethanediamine,
                                                     n1,n2-bis(2-
                                                     aminoethyl)-,
                                                     acetate (1:4).
P-15-0670.......       11/18/2015       11/12/2015  (S) 1,2-
                                                     Ethanediamine, n1-
                                                     (2-aminoethyl)-,
                                                     acetate (1:3).
P-15-0670.......       11/18/2015       11/12/2015  (S) 1,6-
                                                     Hexanediamine,
                                                     acetate (1:2).
P-15-0670.......       11/18/2015       11/12/2015  (S) Ethanol, 2-[(2-
                                                     aminoethyl)amino]-,
                                                     acetate (1:2).
P-15-0670.......       11/18/2015       11/12/2015  (S) 1,2-
                                                     Cyclohexanediamine,
                                                     acetate (1:2).
------------------------------------------------------------------------

    Authority: 15 U.S.C. 2601 et seq.

    Dated: January 5, 2016.
Pamela Myrick,
Acting, Information Management Division, Office of Pollution Prevention
and Toxics.
[FR Doc. 2016-00433 Filed 1-11-16; 8:45 am]
BILLING CODE 6560-50-P