### Summary of EPA’s Responses to Public Comments Submitted in Response to the Proposed TSCA Inventory Update Reporting Modifications Rule

U.S. Environmental Protection Agency

Office of Pollution Prevention and Toxics July 20112 Table of Contents

Acronyms ......................................................................................................5

A. General Comments .......................................................................................6

1. Justification for Proposed Modifications ..........................................................6

2. Transitioning to 2012 .................................................................................8

3. EPA’s Use of the Data ..............................................................................10

4. Guidance Document .................................................................................13

B. Electronic Reporting ....................................................................................13

1. General Comments ..................................................................................13

2. Training ...............................................................................................14

3. CDX Registration ....................................................................................15

4. Reporting Tool .......................................................................................17

5. Online Security ......................................................................................17

C. Reporting Thresholds ..................................................................................18

1. Method for Determining the Need to Report ....................................................18

2. Lowered Threshold for Processing and Use Information ......................................23

3. Reduction of 25,000 lb Threshold for Speci fic Regulated Chemical Substances ..........32

D. Chemical Substances Covered by IUR ..............................................................37

1. General Comments ..................................................................................37

2. Exempt Manufactured Water ......................................................................39

3. Remove Fully Exempt Polymers from Partially Exempt List .................................39

4. Chemical Substances Subject to an Enforceable Consent Agreement .......................39

E. Comments on Specific Data Elements ...............................................................41

1. Parent Company and Site Identity ................................................................41

2. Technical Contact ...................................................................................42

3. Correct Chemical Name ............................................................................42

4. Production Volume for Each Year si nce Last Principal Reporting Year ....................45

5. Volume Used at the Reporting Site ...............................................................51

6. Whether an Imported Chemical Substance is Physically Present at Reporting Site .......53

7. Volume Directly Exported and No t Domestically Processed or Used .......................53

8. Identify Whether A Chemical Substan ce is Being Recycled, Remanufactured, Reprocessed, or Reused ............................................................................55

9. Concentration Ranges ..............................................................................57

10. Industrial Processing and Use Information ......................................................57

a. Industrial Function Categories ............................................................57

b. Industrial Sectors ...........................................................................59

11. Consumer and Commercial Use Information ...................................................60

a. Consumer and Commercial Product .....................................................60

b. Designation of Consumer or Commercial Use .........................................62

c. Number of Commercial Workers ........................................................623 F. Definitions and Cl arification Requests .............................................................63

1. Changing the Reporting Standard for Processi ng and Use Information to “Known to or Reasonably Ascertainable ”........................................................................64

2. Modifications Affecting Importers ...............................................................72

3. Clarifications to Byproduct Reporting ...........................................................73

4. Definitions of Manufacture and Manufacturer ..................................................98

5. Definition of Site ...................................................................................101

6. Processing and Use-Re lated Definitions ........................................................103

G. Confidential Business Information ................................................................103

1. General CBI Comments ...........................................................................103

2. Chemical Identity CBI Claims ...................................................................105

3. General Comments on Upfront S ubstantiation of CBI Claims ..............................106

4. Upfront Substantiation for Processing and Use Information .................................108

5. Limitation on Confidentiality Claims for Data Elements Identified As “Not Known To or Reasonably Ascertainable” .......................................................................110

6. Reporting By Processors and Additional Data Elements ....................................110

H. Administrative Comments ...........................................................................111

1. Change Reporting Frequency ....................................................................113

2. Changes to the Regulatory Text ..................................................................113

I. Economic Analysis .....................................................................................113

1. Identification of Affected Entities ..............................................................113

2. Overall Burden, Underlying Data, Fu ture-Cycle Burden, and Methodology............. 114

3. Burden and Cost by Specific Data Element...................................................120

4. Requiring Electronic Submissions ..............................................................124

5. Modifications Specifica lly Affecting Importers ...............................................125

6. Modifying Reporting Frequency ................................................................126

7. Byproduct Reporting ..............................................................................127

8. Other Regulatory Options ........................................................................127

J. Statutory and Executive Order Reviews ...........................................................128

1. Paperwork Reduction Act ........................................................................128

2. Environmental Justice ..............................................................................129

K. Other Regulatory Options ...........................................................................130

1. Additional Exposure-Related Data ..............................................................130

2. Using TSCA Section 8(A) to Collect Exposure Data .........................................132

3. Collecting Exposure Data from Processors ....................................................132

4. Change Reporting Threshold to 10, 000 lb .....................................................134

5. Further Increase Reporting Frequency ..........................................................135

6. Utility of Data ......................................................................................136

L. Other Comments .................................................................................................1374 References ..................................................................................................139

Appendix A: Commenter Reference List by FDMSID Number .................................143

Appendix B: Commenter Reference List by Company ............................................145

Note: Each comment summary is followed by the end portion of one or more Federal Docket Management System ID numbers. The numbers id entify the comment letters used to compile the comment summary. The letters were submitted to the docket during the comment period for the proposed rule (Docket # OPPT-2009-0187). Appe ndix A provides a complete list of the

commenters and their associated ID number.5 Acronyms

ACC American Chemistry Council

CA Chemical Abstracts

CASRN Chemical Abstracts Service Registry Number

CBI Confidential Business Information

CDC Center s for Disease Control and Prevention CDX Central Data Exchange DfE Design for the Environment ECA Existing Chemicals Agreement EPCRA Emergency Planning and Community Right-to-Know Act EU European Union FDA Food and Drug Administration FIPS Federal Information Processing Standards GAO General Accounting Office HPV High Production Volume HPVIS High Production Volume Information System

IUPAC International Union of Pure and Applied Chemistry IFC Industrial Function Category

IS Industrial Sector IUR Inventory Update Reporting

MPV Moderate Production Volume MSDS Material Safety Data Sheet MSHA Mine Safety a nd Health Administration

NAICS North American Industr ial Classification System NKRA Not Known or Reasonably Ascertainable NIOSH National Institute of Occupational Safety and Health NRO Not Readily Obtainable OSHA Occupational Safety and Health Administration PAIR Preliminary Assessment Information Rule

PMN Premanufacture Notice PRA Paperwork Reduction Act REACH Registration, Evaluation, Authorization and Restricti on of Chemical Substances RCC Resource Conservation Challenge RCRA Resource Conservation and Recovery Act R&D Research and Development SSL Secure Socket Layer SNUR Significant New Use Rule SRS Substance Registry Service

TSCA Toxic Substances Control Act TRI Toxics Release Inventory UVCB Unknown, of Variable Com position, or of Biological Origin XML Extensible Markup Language6 As part of the Inventory Upda te Reporting (IUR) Modifications final rule, EPA changed the identification of the regulation from IUR to Chem ical Data Reporting (CDR). However, EPA is retaining the use of the IUR acronym throughout th is document. The read er should recognize

that where IUR is used to refer to the 40 CF R 711 regulations or to future IUR submission periods, IUR and CDR are synonymous.

A. General Comments

1. Justification for Proposed Modifications

Comment A.1: Several commenters supported EPA’s proposed reporting changes, such as the change to the reporti ng frequency, eliminating the 300,000 lb threshold for processing and use information, and required electronic report ing. Commenters stated that the changes would facilitate EPA’s ability to track chemical substa nces used and made in the United States, which would strengthen EPA’s ability to identify chemi cal substances for further assessment. Some of

these commenters noted that in addition to supporting activities under TSCA, the IUR data supported EPA activities under other statutes such as the Safe Drinking Water Act as well as

activities under othe r Federal agencies such as the NIOSH and the CDC. The IUR data is also used by states and other interested stakeholders to identify chemical substances of concern. One commenter noted that the IUR reporting is the only routine means for the entire Federal government to collect chemical substance proces sing and use data for the entire U.S. Another commenter stated that no other ongoing data collection exists for es timating the number of workers exposed to chemical substances in the U.S.

On the other hand, several commenters expressed the view that EPA has not provided adequate justification supporting the Agency’s need for the IUR data and has not sufficiently tailored the requested information to meet EP A’s goals. One commenter did not agree that the modifications will increase the “usability of collected information” or “focus reporting” on what is “most needed” by EPA. Another commenter me ntioned that the Agency does not explain how the existing IUR fails to meet these goals or w hy an IUR expansion is needed to carry out its congressionally-mandated TSCA duties. Additionally, commenter s suggested that EPA should clearly indicate how the IUR data will be utilized in programs that systematically review hazard and exposure of existing chemical substances.

Source: (0187-0042) (0187-0095 (0187- 0100) (0187-0349) (0187-0101) (0187-0064) (0187-0102) (0187-0090) (0187-0065) (0187-0244) (0187-0364)

Response A.1: EPA has an obligation under TSCA to protect human health and the

environment from unreasonable risks associated w ith chemical substances under its jurisdiction. As stated in the preamble of the proposed ru le, EPA is amending the IUR rule to improve and enhance data reporting requirements under IUR reporting beyond that required during the 2006 submission period. In 2006, submissions could be submitted on paper, on CD, or electronically. There were problems associated with many 2006 IUR data submissions that severely limited EPA’s ability to screen chemical substances for exposure and risks. Among these problems, many submissions were incomplete or improperl y completed, or identified invalid chemical identities, and/or inappropriat ely or incorrectly claimed certain data elements as CBI.7 A large number of errors were created through the scanning process and required correction by hand, which was very labor intensiv e. Consequently, EPA required over two years to validate and process the data from the 2006 IUR. The Agency had to take extra steps in order to correct the data during that period, such as accessing the or iginal submission instead of the information in the IUR database. In addition, EPA released the public database in December 2008 without information on approximately 5% of the reported chemical substances due to the high error rate experienced with the 2006 IUR data collec tion and receipt. The introduced errors included incorrectly scanned chemical identities and indications of whether a data element was claimed CBI. An incorrectly recorded CBI claim could lead to the inadvertent disclosure of confidential information. At the same time, EPA identified numerous examples of CBI claims

where the same or similar information to that cl aimed as CBI was already available to the public. In several cases, information on production volume and uses for a chemical substance or group

of chemical substances was clai med CBI on Form U, while the same or similar information was submitted voluntarily by the company without su ch a claim under the HPV Challenge Program. In those cases, EPA had previously made the information publicly available through the HPVIS or on EPA’s Existing Chemicals website. Correc t designation of reported information as nonconfidential will f acilitate reporting of this information to the public.

EPA anticipates that this final rule will (1) ensure the required information is properly reported and that the information in the Agency’s database reflects the information provided in the IUR reports; (2) increase th e usability of the collected information; (3) increase the availability of information for the public; and (4) focus reporting on information that is most needed by the Agency. Additionally, EPA believes th at the modifications to the rule will supply manufacturing and processing and use informati on the Agency did not previously possess and should be accurate and reliable enough to develop screening level assessments.

Data collected under the IUR will be used in a wide variety of programs fundamental to fulfilling the Agency’s TSCA statutory mandate. EPA believes that the IUR data is the most basic data set that will give EPA and the public at least a screening-level understanding of the volume of chemical substances produced or impor ted into the United States, how they are or may be used, and the types of expos ures (occupational, consumer, e nvironmental, etc.) potentially associated with the chemical substances. Many ch emical substances are exempted from reporting under the IUR rule, which helps tailor IUR requireme nts to EPA’s information needs. Data about production volume, exposures, and/or environmental releases are required to make some of the findings necessary to require testing under section 4, and help s EPA to prioritize chemical substances for further data gathering or risk management action. For example, data supplied by the IUR have supported a series of test rule s in the HPV Challenge Program, which were implemented to generate health and environmenta l effects data on HPV chemical substances for risk assessment purposes. The IUR supported thes e test rules by providi ng production volume and exposure information needed to make the fi ndings for these test rules. Without the IUR information, EPA might not have been able to ma ke these findings. The Agency anticipates that

the data collected under the 2012 IUR will better support the development of test rules.

The Agency’s Existing Chemicals program will use the IUR data to assess whether the Agency needs additional data about the hazards or exposures to a particular chemical substance8 under sections 4 or 8 of TSCA, and may use IUR data to inform risk management actions such as

those identified in TSCA Sections 5 and 6. EP A’s extensive use of the 2006 IUR data in the Agency’s Existing Chemicals Program is consiste nt with how EPA envisioned the data would be used when the 2003 Amendments were promulgate d. EPA used the 2006 IUR data together with other available information in developing Actio n Plans on chemical substances beginning in 2009, and noted the limitations inhere nt in those data. Any future program is expected to be similar in analytical approach regarding the use of screening-le vel hazard and screening-level exposure data to develop risk prioritizations . EPA’s future Existing Chemicals program will build on the experience of this past program, a nd the modified IUR data collected during the 2012 and future submission periods will enable the Agency to further enhance its program.

EPA’s use of IUR data is discussed in more deta il below in the response to A.2-2 and in section

A.3.

2. Transitioning to 2012

Comment A.2-1: Several commenters argued the new requirements are overly burdensome and unrealistic considering the time constraints. Commenters supported delaying the submission period in a variety of ways, includin g: (1) extending by several months and delaying the implementation of changes until the next submission period, (2) delaying the submission period until 9 to 12 months following the promul gation of the final rule, or (3) moving the submission period to 2012 and changing the prin cipal reporting year to 2011. One commenter argued that the IUR report is significantly different than a TRI report in that it is not completely site-focused but includes persons from all over the organization.

Source: (0187-0358) (0187-0065) (0187- 0292) (0187-0353) (0187-0098) (0187-0062) (0187-0091) (0187-0059) (0187-0057) (0187- 0055) (0187-0244) (0187-0355) (0187- 0360) (0187-0079) (0187-0088) (0187- 0059) (0187-0364) (0187-0340) (0187-0102) (0187-0096) (0187-0075) (0187-0078) (0187- 0060) (0187-0091) (0187-0056) (0187- 0103) (0187-0063) (0187-0101) (0187- 0073) (0187-0359) (0187-0352) (0187-0067) (0187-0081) (0187-0059) (0187-0083) (0187- 0354) (0187-0080) (0187-0104) (0187- 0090) (0187-0187) (0187-0351) (0187- 0099) (0187-0084) (0187-0061) (0187-0094)

Response A.2-1: In light of these comments, to provi de sufficient time for companies to comply with the amended reporting requirement s and to finalize the proposed modifications, EPA promulgated a rule (Ref. 1) to suspe nd the 2011 IUR submission period. In the IUR Modifications final rule, EPA supersedes the susp ension of the submission period by establishing a new sequence of submission periods, beginning with one from February 1, 2012 through June 30, 2012. EPA believes that the timing of th e 2012 submission period provide companies sufficient time to collect and submit the required data, and that steps taken by the Agency have and will provide the opportunity for companies to gain an understanding of the submission process and to prepare their internal electronic systems as needed. For example, EPA was asked by several companies and trade organizations to provide an overview of the reporting tool. Acknowledging that companies were concerned about the time needed to de velop their internal databases to collect the required informa tion, on November 30, 2010 the Agency held an informational workshop and webinar to help companies develop a bette r understanding of the CDX registration process and the e-IURweb el ectronic reporting tool. A recording of the9 workshop and a summary of the questions a nd answers are available on the IUR website ( http://www.epa.gov/iur ). EPA used stakeholders’ comments from the workshop to help ensure

the tool would address the needs of the submitters . In addition, the Agency plans to provide an opportunity, prior to finalization of the e-IURweb for stakeholders to test a pre-rele ase version of the tool. EPA also plans to conduct a training webi nar shortly after the publication of this final rule to provide detailed instruc tions on the reporting requirements and on using the e-IURweb, to complete and submit Form U. Finally, to the exte nt that the timing of the next submission period actually presents a substantial obstacle to the submission of any particular data element, notwithstanding EPA’s efforts to familiarize submitters with the draft and final reporting tool, and EPA’s post-promulgation efforts to familiarize submitters with the reporting requirements, the IUR reporting standard of “known to or reasonably ascertainable” addresses such circumstances without the need for a delay in implementation. For further discussion, see the responses to comments in section F.1.

Submitters should note that while TRI reporting is directed at facilities, EPA disagrees with one commenter’s implication that TRI reporti ng does not include persons from various parts of an organization. In fact, the TRI program’s web-based reporting software accommodates TRI facilities that rely upon a senior management offici al in a different state to remotely certify the facility’s TRI submissions.

Comment A.2-2: One commenter suggested that EP A continue under the old IUR rule for this submission period.

Source: (0187-0085)

Response A.2-2: The Agency does not agree that it should continue under the IUR rule in effect for the 2006 submission period; however , the Agency recognizes that additional time may be necessary for many submitters to become familiar with the modifications and develop processes for collecting the information. Theref ore, the Agency will be phasing in certain requirements so that the scope of exposure-related information to be collected will be increased

for the 2012 IUR data collection and then furt her increased for the 2016 data collection and subsequent reporting years. As mentioned by one commenter, the “IUR rule is one of the very few means by which the federal government can obtain and provide public access to robust information on the identity, production, processing and use of” chemical substances (Ref. 2). In order to fulfill the Administrator’s goal of enhancing EPA’s TSCA chemical management program, EPA needs to begin collecting some of the new and updated information in the 2012 reporting period. As described on EPA’s website ( http://www.epa.gov/opptintr/exist ingchemicals/pubs/enhanchems.html ), EPA’s comprehensive approach to enhancing the Agency’s current chemical management program includes requiring

information needed to understand chemical s ubstance risks and increa sing transparency and public access to information about chemical subs tances (Ref. 3). The proposed changes to the IUR are specifically identified as a key component for these aspects of the enhanced program, including required electronic reporting and the expanded ma nufacturing, processing and use information. For example, the expansion of re quiring processing and use information for all

chemical substances in 2016 addresses the identifi ed lack or insufficiency of such information for most chemical substances – including HPV ch emical substances. EPA’s efforts to understand10 and prioritize chemical substances based on ris k, using the 2006 IUR data, were instrumental in shaping the changes to the IUR requirements. See Section A.3 of this doc ument for more details

on EPA’s use of the 2006 IUR data.

In addition, requiring the use of electronic report ing will ensure that data are available in a timely manner and will reduce data entry errors, thereby increasing the usability and reliability of the data for EPA and other federal agencies. It will also help to fulfill the Administrator’s commitment to increase public access to information on chemical substances.

3. EPA’s Use of IUR Data

Comment A.3-1: One commenter stated that the current IUR was sufficient for EPA to use as a screening tool for the prioritization of chemical substances in commerce, and that EPA should use the Agency’s wide variety of regulatory tools and authorities to collect more detailed use and exposure information.

Source: (0187-0101)

Response A.3-1: EPA disagrees that the current IU R is sufficient for its purposes. Between August 2007 and mid-2009, EPA developed sc reening-level hazard, exposure, and risk

characterizations for some chemical substances produced or imported in quantities of 25,000 lb or greater a year. Based on those characteri zations, EPA developed either a risk-based prioritization (RBP) or a hazard-based prioritizati on (HBP) for individual chemical substances or a group of chemical substances that were sim ilar in some way, e.g., structure, properties, toxicity. Those prioritizations did not constitute definitive determinations regarding hazard, risk, or the sufficiency of available information for any regulatory purpose, but were rather initial

evaluations of data and understand ing currently available to EPA. EPA’s experience using the IUR information to develop the prioritizations wa s that the 2006 IUR data were not sufficient to provide the exposure-related information need ed. When EPA was deve loping RBPs for its HPV chemical substances, it needed both hazard and exposure screening-leve l information. Lacking sufficient exposure information, EPA found it nece ssary in many cases to make assumptions about exposure. Consequently, th e resulting prioritization decisi on was primarily hazard-based, as opposed to risk-based, as evidenced by EPA’s statements in many of the RBP as well as HBP documents that EPA developed (available at http://iaspub.epa.gov/oppthpv/exist chem_hpv_prioritizations.INDEX_HTML ) that further information on exposure was needed to conf irm the prioritization. Thus the exposure information provided in the 2006 IUR reporting did not provide EPA with sufficient information to prioritize chemical substances for which it generally possessed a base set of hazard data. Therefore, for some of the RBPs, the “Next Steps” indicated that additional exposure information would be necessary to validate the prioritizations before determining whether any

further action was needed. In de veloping these characterizations, EPA identified areas where the IUR data collection should be improved and enha nced. These improvements, which are reflected in the modifications to the reporting requirement s in the final rule, will allow EPA to better prioritize chemical substances for further as sessment as well as make appropriate risk management decisions for follow-up action on chem ical substances that may pose potential risks

to human health or the environment.11 EPA is considering using other regulatory tool s and authorities to collect more in-depth information, but believes the IUR (which is a TS CA section 8(a) rule) is the correct mechanism for the data collection required in this final rule. EPA also is cons idering ways to get public input

on its use of the IUR data and its chemical subs tance prioritization proces s, as suggested by the

commenters.

Comment A.3-2: A few commenters encouraged the Agency to consider convening a multi-stakeholder group that could provide inpu t on how IUR data could be used in the prioritization process, and whether there were additional data that could be collected.

Source: (0187-0078) (0187- 0100) (0187-0101) (0187-0244)

Response A.3-2: EPA appreciates those commenters who offered to participate in a stakeholder group to consider prio ritization. In the past, EPA has us ed a variety of vehicles to obtain stakeholder input as it fu rther developed both regulatory and voluntary programs. EPA will review the different options available to dete rmine the best fit for specific issues, as those

issues arise. If EPA decides to convene a st akeholder group or hold a public meeting, EPA will

communicate its intentions to al l potentially interested parties, including those who commented on the proposed rule.

Comment A.3-3: Some commenters suggested that EPA consider the prioritization approach used by Canada.

Source: (0187-0101) (0187-0051)

Response A.3-3: EPA assumes that the commenters were referring to the Domestic Substances List (DSL) Categorization that Ca nada completed in 2006. The DSL Categorization was a statutorily mandated risk-based prioritiza tion which required review of both hazard and exposure information for 23,000 chemical substances in a very short period of time. Health Canada was required to identify chemical substan ces presenting human health hazards as well as the greatest potential for expos ure to Canadians. Even though categorization was a legally mandated process with a deadline for considerati on of all chemicals on the DSL, Health Canada felt that production volume alone was not a suffici ent surrogate for exposure. In order to move beyond production volume, Health Canada sought additional information, including some of the types of data that EPA is requiring for the 2012 IUR reporting period (Ref. 4). Based on its

review of hazard and IUR data collected on HPV and MPV chemical substances, EPA also believes that using large production volume as the sole surrogate for exposure is not sufficient to identify chemical substances of highest concern. Some of the risk-based prioritizations of HPV chemical substances resulted in low priority de cisions for the HPV chemical substances that were low hazard, used in closed systems, and consumed as intermediates. On the other hand,

some of the MPV chemical substances were iden tified as potentially high or medium priority, because they had high or medium hazard and would present high or medium risk concerns if they had widespread exposure or dispersive uses. The only way for the Agency to move from prioritizations based primarily on hazard to truly risk-based prioritization is for it to receive regularly updated information on exposure and use for chemical substances being made and used

in the United States. The chemical substance manufacturing industry has indicated in several12 fora, including in comments on the proposed rule , that it supports risk-based as opposed to hazard-based prioritization. A comme nter also noted that industry strongly supports risk-based decisions and for that reason needs to provide robust production, processi ng and use data (Ref. 2).

Comment A.3-4: One commenter stated that eliminating the 300,000 lb threshold for processing and use information is contrary to the recommendations of a particular 1995 GAO Report to establish an Inventory that focuses on the highest-priority chemical substances and will

instead flood the EPA with detailed informati on on numerous additional chemical substances, not just those chemical substances that ar e high priority or HPV chemical substances.

Source: (0187-0064)

Response A.3-4: EPA notes that the commenter has misread the GAO's conclusions in the 1995 report and disagrees that EPA's decisi on to phase out the 300,000 lb threshold is inconsistent with the Agency's previous reas oning, or with the cited conclusions of the GAO report. EPA acknowledges that it s decision to phase out the re porting threshold incorporates additional information based on its experience collecting and analyzi ng the 2006 IUR data. EPA also notes that under TSCA section 8(b), EPA is charged with compiling, keeping current, and publishing a list of each chemical substance that is manufactured in the U.S., not just the highest priority chemical substances.

On July 7, 1995, the GAO issued a report: Toxic Substances: EPA Should Focus Its Chemical Use Inventory on Suspected Harmful Substances (Ref. 5). On page 1 of the report, as EPA correctly quoted in the proposal for th e 2003 IUR Amendments, the GAO concludes that "[t]he inventory could be mo re useful to EPA and othe r interested parties if it initially focused on a smaller number of the highest-priority chemical substances known to present risks to health

and the environment and was expanded as necessary " (emphasis added). GAO further noted the potential for EPA to later "assess the data obtaine d, reconsider the chemical substances and type of data included in the inventory, and make any necessary adjustments to its approach" (Ref. 5 at 10). In the proposed rule, EPA expl ained that it "still believes th at information concerning lower production volume chemical substances is valu able, especially for identifying trends and additional substitute chemicals" (Ref. 6). EPA explained that while it was proposing a 300,000 lb cutoff to reduce reporting burden, "[i]n the fu ture, EPA may find it necessary to collect information on chemicals at reporting thresholds below the thresholds pro posed in this action." EPA reiterated this point in the final 2003 IUR Amendment (Ref. 7).

Consistent with EPA’s discussion in the proposal for this rule (Ref. 8), EPA's decision to phase out the 300,000 lb reporting threshold wa s based on EPA's experience collecting and analyzing the 2006 IUR data. In 2003, EPA r easoned that the 300,000 lb reporting threshold would allow EPA to receive sufficient exposure a nd use data on HPV chemical substances while at the same time reducing reporting burden. Howe ver, based on the 2006 data, approximately 23% of the reports submitted for known HPV ch emical substances had reported production volumes below the 300,000 lb threshold and therefor e, EPA did not receive processing and use data on those chemical substances. Also, as discussed in response to comment A.3-1, when completing characterizations for HPV and MPV chemical substances which fell below the13 300,000 lb cutoff and therefore had minimal in formation from the 2006 IUR reporting period, EPA found instances where the HPV or MPV chemical substances had high or medium hazard potential and additional information on exposur e was essential for ma king a real-world prioritization decision. In order to select the highest priority ch emical substances based on risk, EPA must have sufficient hazard and exposure in formation; otherwise th e prioritization will be strictly hazard-based. Based on its experience collecting and using the 2006 IUR data, EPA believes that it is important to collect expos ure and use information on lower production volume

chemical substances so that chemical substa nces with a high or medium hazard but lower production volume (either in aggregate or at any one site) will not be overlooked in any prioritization.

4. Guidance Document

Comment A.4: One commenter stated that the Dr aft Instructions for 2011 Inventory Update Reporting as Proposed in the IUR Modifications Rule Guidance Document is confusing and inconclusive. Another suggested that EPA shoul d ensure that detailed guidance is available as early as possible and the reporti ng tool is available fo r testing also well ahead of the deadline.

Source: (0187-0103) (0187-0051)

Response A.4: EPA has revised the guidance documen t to better explain the reporting requirements for various data elements and furt her reduce the potential for confusion. See the revised guidance, Instructions for 2012 TSCA Inventory Update Reporting (Ref. 9). The Agency will also provide comprehensive training on the reporting requirements, how to register with CDX, and how to complete and submit Form U using the reporting tool. Regarding the reporting tool, EPA acknowledged through the comments recei ved, that companies were concerned about the time needed to develop their internal data bases to collect the required information. In response, EPA delayed implementation of the reporting requirement until 2012. In addition, the Agency organized an informational workshop to help companies develop a better understanding of the reporting tool on November 30, 2010. The workshop, which was recorded live as a webinar, was posted to the IUR website at http://www.epa.gov/iur along with accompanying slides, a question and answer doc ument, and the XML schemas. The comments and concerns of industry were taken into consideration as EPA developed the reporting tool.

B. Electronic Reporting

1. General Comments

Comment B.1-1: EPA received mixed comments on it s decision to require electronic reporting of all IUR submissions. In general, commenters supported electr onic reporting, but had several concerns. Some commenters suggested that the Agency develop a phased-in process for electronic reporting, in order to provide more time for companies to become familiar with the new format and to develop their own data syst ems. Some commenters wanted alternate methods, such as uploading data via an XML file into the web-based tool. The requirement to use

electronic submissions over the internet was a concern for some commenters.14 Source: (0187-0083) (0187-0080) (0187- 0065) (0187-0079) (0187-0104) (0187-0292) (0187-0369) (0187-0364) (0187-0087) (0187- 0353) (0187-0078) (0187-0050) (0187- 0063) (0187-0092)

Response B.1-1: EPA, based on its experience co llecting and managing the 2006 IUR reports, has concluded that mandatory electronic reporting is a critic al next step for collection of the 2012 data. Optional electronic reporting fo r the 2006 IUR provided the Agency with experience relating to both industry and Agency needs, and the Agency has applied this experience in the course of developing of the 2012 electronic reporting tool (e-IURweb). For example, the use of a web-based tool for th e 2012 IUR will eliminate many of the software compatibility and firewall setting issues th at were encountered during the 2006 submission period. In addition, the e-IURweb utilizes other Agency systems, such as SRS, enabling the submitter to readily select the chemical identi ty in the correct format, thereby eliminating problems relating to the previous need to type or write in the chemical name. With these enhancements, EPA believes the use of e-IURw eb will substantially reduce error rates and burden; consequently, EPA does not believe it is necessary to ha ve another optional electronic reporting period.

In addition, the Agency’s CDX service is increasingly being used by a variety of programs, as the Agency moves toward comprehe nsive electronic reportin g. EPA is continually looking for ways to improve CDX, to better addr ess submitter and Agency needs. For example, EPA has developed an eTSCA registration fo r CDX which, when fully implemented, will eliminate the need to register separately to use the e-IURweb and e-PMN systems. e-PMN registrations using the current eTSCA will be acceptable e-IURweb registrations.

The Agency believes that commenters’ concerns regarding mandatory use of the new electronic reporting tool refl ect a lack of understanding of the tool’s capabilities and enhancements. The reporting tool provides the ability to submit data in an XML format and includes enhancements to CDX that are designed to allow for multi-user capabilities and

otherwise facilitate electronic reporting.

Electronic reporting was first offered as an option for the 2006 IUR. As explained in the preamble to the proposed rule and in this doc ument, there were many problems, errors, and delays associated with paper submissions of th e 2006 IUR data, which make the continued use of paper reporting highly inefficien t and therefore undesirable. In light of th e substantial disadvantages associated with allowing paper su bmissions, and the reporting tool improvements and training opportunities outlined in this unit (and explained in greater detail in the proposed rule and in other sections of this document) EPA does not believe it is reasonable to phase in electronic reporting over another reporting cycle. However, with the additional time available because of the delay of the reporting require ment until 2012, the Agency is confident that

submitters will be able to successf ully use the e-IURweb tool to electronically report under the

IUR rule in 2012.

2. Training15 Comment B.2: Several commenters suggested that EPA provide online or in person trainings.

Source: (0187-0352) (0187- 0244) (0187-0073) (0187-0081)

Response B.2: EPA has provided training opportuniti es and guidance materials to facilitate electronic reporting, as well as product testing opportuni ties, to alleviate particular commenters’ concerns. For example, the Agency held an informational workshop and webinar on November 30, 2010. The workshop was designe d to help companies develop a better understanding of the CDX registra tion process and the e-IURweb electronic reporting tool. EPA sent emails announcing the webinar to its establ ished list serve of over 1300 companies and trade associations. In addition, an announcement of the webinar was posted to the IUR website. Industry was encouraged to send their technical staff so that questions concerning database compatibility could be addressed. The workshop, which was recorded live as a webinar, was posted to the IUR website at http://www.epa.gov/iur along with accompanying slides, a question and answer document, and a draft XML schema . In addition, EPA plans to invite several companies to test e-IURweb to identify areas needing improvements. The comments and concerns of industry representatives will be taken into consideration as EPA further develops the reporting tool. EPA also intends to hold further training and outreach sessions at which industry representatives may express remaining questions and concerns regarding the operation of the eIURweb tool, which EPA will address. Add itionally, EPA has published a revised guidance document (Ref. 9) explaining the reporting requirements and how to complete Form U using the reporting tool.

3. CDX Registration

Comment B.3-1: One commenter thought the modifi ed Electronic Signature form, particularly the need for multiple notarized si gnatures, was burdensome and unnecessary for an inventory update process.

Source: (0187-0090)

Response B.3-1: EPA understands and is cognizant of the concerns presented by industry regarding the revised Electronic Signature form. An electronic signature agreement is required for CDX registration and is necessary to submit el ectronic data to the EPA. Regarding the prior need for multiple notarized signatures, EPA has determined that requiri ng a notarized signature as part of the electron ic signature agreement is no longer necessary. EPA is also exploring an approach to eliminate the need for an individual to register multiple times with CDX to submit to various TSCA programs.

As with PMN electronic submissions, multiple people from the same site or company are able to register with CDX and participate in completing the site’s Form U. Although one individual will be designated as an authorized official who will sign and submit the completed Form U, the e-IURweb tool allows for more than one individual to edit a submission. Ultimately, EPA’s goal is to provide one el ectronic signature agreement acr oss all TSCA programs and is16 exploring the reuse of electronic signatures issued under the New Chemicals program, as well as other EPA programs.

Comment B.3-2: One respondent noted that the “Support Submitter” role was not mentioned in the proposed rule and that it is an important part of th e submittal process that

should be included in the final rule.

Source: (0187-0090)

Response B.3-2: Detailed instructions regarding s upport submitters were included in the

draft Instructions document that was in the docket for the proposed rule and will also be included

in the final Instructions documen t. To clarify, a support submitter will be a person designated by an authorized official to provi de supporting information on behalf of a company. This individual may be a corporate on-site contact, a technical contact, a paid employee of the company, an outside consultant for the company, or an auth orized representative agent for the company. Support submitters are not allowed to sign the certif ication statement requir ed for the initial IUR submission, but they may enter or modify data fo r the site for which they are authorized. When EPA receives information from a support submitter , the Agency will verify that the person had

been authorized to submit the information on behalf of an authorized official. See Chapter 6 of

the Instructions for additi onal information (Ref. 9).

Comment B.3-3: Commenters stated that there shoul d be more than one individual with an electronic signature and that multiple persons may need to be able to input and submit IUR data for a company’s U.S. site. They noted th at the actual preparer of the submission would rarely be the signatory.

Source: (0187-0358) (0187-0244) (0187- 0079) (0187-0104) (0187-0078) (0187-0081)

Response B.3-3: CDX will accommodate multiple electronic signature holders for each reporting site. As discussed in comment B.3-2, th e authorized official of each site will be allowed to authorize one or more persons to complete a Form U on behalf of their company. Although the authorized official will be required to sign the form, support registrants will be able to enter and edit data. Support registrants will only have rights to the site specific Form U

information that their authori zed officials have approved.

Also, the e-IURweb tool allows for multiple users to access and edit site information. This will allow for different people to collate diffe rent aspects of a site’s Form U. The e-IURweb tool will also allow submitters to generate a PDF document of the draft Form U prior to submitting it to EPA. See Chapter 6 of the Instructions for Reporting document for additional

information.

Comment B.3-4: One commenter stated that CDX does not allow non-US residents to register and use the system.

Source: (0187-0051)17 Response B.3-4: EPA disagrees with this comment. In the past, export restrictions on encryption technology prevented some foreign entities from using CDX. However, these restrictions are no longer in place, thereby allo wing foreign submitters to submit information to EPA through CDX. EPA provides instructions for foreign submitters in its guidance document

“Instructions for the 2012 TSCA Inve ntory Update Reporting” (Ref. 9).

4. Reporting Tool

Comment B.4-1: One commenter suggested that EPA pr ovide the ability to upload data

via an XML file to accommodate altern ative data submission file formats.

Source: (0187-0098)

Response B.4-1: The continued deployment and enha ncements to CDX has resulted in a system that can accommodate various file formats. To help facilitate the reporting of multiple chemical substances at the same time, submitters will be allowed to upload XML files into the reporting tool. The XML schema was made availa ble on the IUR website in late December 2010.

Future webinars will include a demonstration of the use of XML to upload data into the reporting tool. The XML schema is designed for companie s with existing data export systems to support

IUR submissions. Submitters should note that all XML files will need to be successfully

validated in order to be submitted to EPA.

Comment B.4-2: One respondent noted that the reporting tool would need a multi-user capability, or else EPA should distribute a reporti ng tool that allows an individual to upload a centralized report afte r review and editing.

Source: (0187-0101)

Response B.4-2: As with PMN electronic submissions, multiple people from the same site or company are able to register with CDX and participate in completing the site’s Form U. Although one individual will be designated as an authorized official who will sign and submit the completed Form U, the e-IURweb tool allows for more than one individual to edit a Form U. Ultimately, EPA’s goal is to provide one elec tronic signature agreement across all TSCA programs and is exploring the reuse of e-signatu res issued under the e-PMN program as well as other EPA programs. Regarding notarized signa tures, EPA has determined that requiring a notarized signature as part of the electronic signature agreement is no longer necessary.

5. Online Security

Comment B.5: Commenters were con cerned that securing confidential information would be an issue, and encouraged the Agen cy to thoroughly verify and demonstrate data encryption and other safeguards before requiring the use of the system.

Source: (0187-0079) (0187-0086) (0187-0081)18 Response B.5 : EPA understands the concerns expr essed by industry regarding online security and encryption of IUR data. As stated earlier in this document, EPA conducted an informational webinar on November 30, 2010 a nd plans to conduct addi tional webinars to demonstrate the use of the reporting tool and the security layers bui lt into the reporting tool to protect sensitive data. EPA is conscientious in securing the potentially conf idential data and has updated previous systems to enhance data security. T he following is a brief explanation of the how the data is protected:

1. CDX . The CDX solution has been in place for over ten years and has been implemented across several EPA programs where CBI considerations are of concern. The data

as it is entered into the e-IURw eb tool over the internet reside s in an encrypted database. In

addition this data cannot be accessed unless th e IUR submitter has both their CDX two-factor authentication and the passphrase that was gene rated for the specific Form U. The passphrase cannot be reset by the system or by the help de sk, so this data is only accessible by a CDX registrant who has been given access to a site and given, or generated, the passphrase for a particular Form U. 2. e-IURweb reporting tool . The e-IURweb reporting tool differs from the 2006 e-IUR software and the current New Chemicals Progra m reporting software (e-PMN). Specifically,

unlike the e-PMN downloadable so lution, e-IURweb was built to prevent many of the firewall and Java related issues previously encountered.

3. FIPS . The CDX solution uses the U.S. Fede ral Information Processing Standards (FIPS) certified solution that encrypts a Form U before it is transmitted to EPA. FIPS has standards concerning accep table encryption methods. For a soluti on to be FIPS certified, detailed

documentation and source codes must be submitted to the National Institute of Standards and Testing’s (NIST’s) testing laborat ories and receiv e validation.

4. SSL. The encrypted Form U is then tran smitted to EPA through a Secure Sockets Layer (SSL), a protocol that creates an en crypted connection between a browser and a Web

server for the secure transmission of data over the Internet. The data is al ways encrypted at rest

and in transit before it is stored in the TSCA CBI Local Area Network (LAN).

5. TSCA CBI LAN. The TSCA CBI LAN is th e physically isolated LAN located at EPA dedicated exclusively to store TSCA CBI. Only authorized EPA staff are allowed to access the CBI LAN to view or print documents.

C. Reporting Thresholds

1. Method for Determining Need to Report

Comment C.1-1: Several commenters believed the change to the determination method is appropriate and should be implemented for la ter reporting cycles. They noted that the new requirement is essential to effectively capture the substantial year-t o–year fluctuation in production/import volumes that was missed in past IUR reporting cycles, thereby skewing the picture of how many and which chemical substan ces are actually in commerce at a given time and what levels of production or import. On e commenter went further to say that the modification would eliminate gaps and uncerta inties in the information collected under the

current IUR that result from infr equent collections and reporting of data. Another said that this will keep manufacturers from disguising their actual output by producing certain specialty19 chemical substances only in years that ar e not currently subject to IUR reporting. Two commenters supported the change but opposed the proposal to delay implementation until a later reporting cycle, because it would further delay th e ability to obtain a ccurate annual production

information.

In contrast, others had mixed opinions or did not think the change was needed. Some commenters felt that unless the value of collecting and analyzing historical data could be clearly demonstrated such that the resource for the Agen cy and regulatory community can be justified, EPA should retain the mechanism whereby the n eed to report is based on consideration of a single reporting year. Some comment ers stated that EPA had not shown special utility for the information generated. Another commenter believe d that there is no significant incremental benefit to require reporting fr om companies that produce or import less than 25,000 lb of a reportable chemical substance fo r four out of five years.

Source: (0187-0069) (0187-0101) (0187- 0244) (0187-0073) (0187-0068) (0187-0092) (0187-0089) (0187-0079) (0187-0081) (0187- 0352) (0187-0244) (0187-0075) (0187- 0073) (0187-0359) (0187-0064) (0187-0360)

Response C.1-1: EPA has finalized this change because of the mounting evidence that many chemical substances, even larger production volume chemical substances, often experience wide fluctuations in production volume from year to year. This can result in the production volume of a chemical substance exceeding the thre shold for several years, and then falling below the threshold during the IUR pr incipal reporting year. EPA be lieves that using production volume reporting for all years since the last pr incipal reporting year to determine reporting obligations would yield a much more accurate pict ure of the chemical substances currently in commerce, ensuring proper review under EPA’s risk screening, assessment, and management activities and providing better information to the public. Respecting the comments seeking earlier implementation of the change to the de termination method, EPA acknowledges that it had the statutory authority to implement the cha nge for the 2012 reporting period. EPA’s decision to defer the change in the determ ination method to the 2016 reporti ng period is chiefly a burdenreduction measure. The Agency believes this accommodation is warranted in light of other simultaneous changes to the IUR rule which increased reporting burden.

The Agency realizes that the new multi-y ear consideration of production volume will increase reporting burden on industry, but believes that there is sufficient evidence that wide fluctuations in production volumes from year to year indicate the pa st IUR reporting was not accurately characterizing the chemical production. As EPA noted in the proposed rule preamble, production volumes of chemical substances vacill ating above and below reporting thresholds in different IUR reporting cycles resulted in a chan ge of approximately 30% in the composition of the chemical substances being reported from one IUR reporting cycle to the next. For example, EPA prepared a prioritization document for the Bu tenedioic Acid Dialkyl Esters Cluster which consists of 10 butenedioic acid dialkyl esters, seven of which were MPVs and three HPVs in 2006 (Ref. 10) Three of the chemical substances have had fluctuating pr oduction volumes above and below one million lb. In 1990 and 1994 when the HPV Challenge program was being developed, the CASRNs 68921- 51-7, 141-05-9, and 624-48-6 ha d production volumes below

one million lb and so were not included in the HPV Challenge for completion of SIDS datasets. In 1998 and 2006, CASRN 68921-51-7’s production vol umes were above one million lb, making20 it an HPV in those years. In 2002, CASRNs 141-05-9 and 624-48-6 had production volumes above one million lb. In part because of their fluctuating pr oduction volumes, neither SIDS datasets nor consistent exposure and use info rmation were available for these chemical substances. Because of this lack of exposure-rela ted information, these chemical substances were

included in a cluster for which an HBP was deve loped instead of an RBP. One commenter also submitted an analysis of the degree of fluctu ation of chemical substances and production volumes in the 2002 and 2006 IUR reporting years. This analysis found that about 32% of the organic chemical substances reported in 2002, including 400 HPVs, were not reported for 2006

and that about 26% of the chemical substan ces reported in 2006, in cluding more than 200 organic HPVs, were not reported in 2002.

In addition, in comments submitted to the Agen cy in response to other programs, industry representatives expresse d concern that short reporting dete rmination periods would drastically misrepresent the chemical substances that cu rrently are in commerce. They stated they manufactured or imported some chemical substa nces only occasionally, and that these chemical substances would not be captured if the reporting cove red too short a period. The proposed rule preamble provides a more detailed discussion of these comments (Ref. 8, 75 FR at 49664).

Comment C.1-2: One commenter stated that their company’s production volumes do not fluctuate dramatically from year to year, and that under the current rule, they are required to monitor only one year of production volumes a nd provide detailed manufacturing information for that one year. However, another commenter confirmed that the Agency is correct in its

assertion that there are wide fluctuations in manufacturing volume from year to year.

Source: (0187-0064) (00187-0069)

Response C.1-2: EPA acknowledges that while fo r some manufacturers, production volumes for a specific chemical substance does fl uctuate dramatically from year-to-year, there are others with fairly steady production. The 1-year snapshot of production volume did not provide an accurate picture of the chemical substances in comme rce, and might have provided an erroneous view of the exposure scenarios associat ed with a particular chemical substance. EPA agrees with the commenter who noted the mounting evidence that many chemical substances, even larger volume chemical substances, often experience wide fluctuat ions in manufacturing volume from year to year. This can result in the production volume of a chemical substance exceeding the threshold for several years, and then falling below the threshold during the IUR principal reporting year. Conse quently, previous IUR reporting has resulted in a change of approximately 30% in the composition of the ch emical substances being reported from one submission period to the next. This high turnover of reported chemical substances from one submission period to the next indi cates a dynamic, changing industry.

An example of the wide fluctuations in manufacturing volume is found in the Agency’s HPV Challenge Program. In this program, IUR data were used to determine the HPV chemical substances, or the chemical s ubstances with nationally aggreg ated production volumes of one million lb or more. As the HPV Challenge Progr am progressed, the Agency chose not to pursue

certain chemical substances because new IUR re porting indicated that the nationally aggregated production volume had dropped below one million lb. However, based on the latest IUR, the21 production volume for some of the chemical s ubstances the Agency was no longer pursuing had risen again to exceed one million lb.

Comment C.1-3: Some commenters felt that compan ies were not given enough notice of this change and are unprepared to respond with their information collection proce sses within the proposed timeframe. One commenter said a phased in approach is needed to adequately collect and process the increased information. Source: (0187-0244) (0187- 0090) (0187-0073) (0187-0091)

Response C.1-3: EPA agrees that some phase-in time for this change is appropriate. Therefore, the final rule provides that this new method to determine the need to report will come into effect after the 2012 IUR submission period. For submission periods subsequent to the 2012 submission period, the determination of the need to report is based on whether, for any calendar year since the last principal reporting year, a chemical subs tance was manufactured (including imported) at a site in produc tion volumes of 25,000 lb or gr eater. For example, for the 2016 submission period, it would be necessary to ex amine the annual produc tion volumes for the calendar years 2012 to 2015 for th e site. If the produc tion volume for a reportable chemical substance were 25,000 lb or greater for any calendar year during that four year period, then it would be necessary to report the chemical s ubstance, unless it was otherwise exempt. EPA believes that companies will have sufficient time to track their production volumes and believes that further phase-in time, beyond the 2016 submission period is unnecessary.

Comment C.1-4: Commenters thought that the new re quirement for determining need to report would create unnecessa ry obligations to monitor producti on volumes each year. They also thought that it would be very bur densome to require companies to collect and analyze data going back four or five years.

Source: (0187-0064) (0187-0359) (0187-0079)

Response C.1-4: While the Agency realizes that the new modification will increase reporting burden on industry, it was industry re presentatives themselves who provided further evidence that capturing production volume for only the principal reporting year is resulting in the

omission of information on chemical substances in current production (Refs. 11, 12, 13, and 14). In comments submitted to the Agency in response to other programs, the industry representatives expressed concern that short repo rting determination periods woul d drastically misrepresent the chemical substances that currently are in co mmerce. Industry representatives stated they manufactured or imported some chemical substa nces only occasionally, and that these chemical substances would not be captured if the report ing covered too short a period. Comments included statements such as “A longer time frame is necessary to capture the sporadically produced chemicals... As such, a ‘snapshot’ in time may not adequately identify the complete inventory requirements...” (Ref. 12). Another commenter agr eed a longer timeframe to report chemical substances would capture those chemical substa nces that undergo periodic manufacture based upon customer-driven demand or other factors (e.g., variation in availability or cost of raw materials, cost of substitute materials, etc. ) (Ref. 13) or chemical substances that are manufactured infrequent ly upon request (Ref. 14).22 EPA believes that most sites will be able to gather production volume information

without a substantial effort. This new requirement to consider multiple prior years in determining the need to report will not go in to effect until the 2016 submissi on period. Furthermore, in many instances, production volumes for recent past year s are tracked under standard business practices. For example, EPA believes it is standard busines s practice for a company to furnish records of recent operations in the case of a proposed sale or merger, and that companies therefore typically

retain such records so as to be prepared for such eventualities. Furthermore, persons who have submitted a PMN to the Agency’s New Chemical s program are already required to maintain records of production volume for the first 3 ye ars of production or import. They must be maintained for 5 years from the date of comm encement of manufacture or import (See 40 CFR 720.78). EPA expects that many companies would al so track production volumes for planning, marketing, and sales projection purposes. Several TSCA regulations, such as 5(a)(2) SNURs and 5(e) orders also require that production volume records be kept for five years for certain chemical substances, and several commenters indi cated that they archived these records.

Should a submitter determine, after making the efforts required under the Agency’s known to or reasonably ascertainab le standard, that no chemical substances were manufactured (including imported) above the applicable reporti ng standards at a given site, then the submitter need not report under the IUR for that particular site. Furthermore, because EPA is not changing the method of determining whether a manufactur er is subject to IUR reporting until the 2016 submission period, there should be no increase attributable to this rule change in the number of

chemical substances and sites that must be considered, and IUR reports submitted, in the 2012 submission period.

Comment C.1-5: One commenter stated the requireme nt was unrealistic and burdensome because generators of byproducts have not collected data on the production volumes of the component chemical substances contained within their byproducts because they never considered themselves to be subject to TSCA IUR.

Source: (0187-0103)

Response C.1-5: The Agency disagrees that partic ular manufacturers’ prior lack of awareness respecting the IUR’s requirements is a ba sis to revise those requirements. At this time, EPA believes the appropriate res ponse is to more prominently a nd clearly explain the reporting requirements relating to byproduct manufacturing. Th e Agency has provided such an explanation in the preamble to this rule a nd associated guidance. As noted above, the requirement (applicable to all manufacturers, including byproduct manufactur ers) to consider multiple prior years in determining the need to report will not go into effect until the 2016 submission period.

Comment C.1-6: Several commenters were in favor of the new modifications but offered some alternatives or caveats. Some said repor ting should only be require d for those years where PV threshold was triggered. One commenter sugge sted that if there are specific chemical substances for which the principal year reporti ng threshold approach is inadequate, then the Agency should consider amending the requireme nt to require reporting for those chemical substances only. One commenter stated that not all chemical substances should require the same level of detailed information to be reported. They would recommend an additional reporting23 range of between 25,000 and 300,000 lb for which EP A should require a more limited amount of information. Manufacturers should only be requ ired to report under the IUR rule if the production volume of a reportable chemical substa nce is above the thresh old during the principal reporting year only. For those ye ars during the reporting cycle wh en production volume did not exceed the established threshold, manufacturers s hould be allowed to indi cate that the production volume threshold was not reached during that period.

Source: (0187-0089) (0187-0075) (0187- 0244) (0187-0079) (0187-0091) (0187-0103)

Response C.1-6: It is precisely because of the various types of fluctuations in production

volume that the commenters enumerate that EPA believes it is essentia l to its understanding of exposure and use of chemical substances that EP A receive information based on a consistent set of reporting triggers. As noted a bove in Response C.1-2, the fluctu ation of chemical substances above and below the previous 300,000 lb reporting threshold for processing and use information resulted in the Agency receiving an inconsiste nt set of exposure and use information for many

HPV chemical substances. In order to obtain an accurate picture of chemi cal exposure, it is as important for EPA to learn that certain chemi cal substances are produced in the same amount (low or high) every year as it is to learn that some chemical substances are produced above 1 million lb one year and not at all the next year.

2. Lowered Threshold for Processing and Use Information

a. Increased Numbers of Covered Chemical Substances

Comment C.2.a: A couple of commenters asserted th at the influx of inorganic chemical substances, coupled with the threshold change fo r processing and use information, will result in

substantial increase in the amount of data being submitted to the Agency. Commenters felt that EPA staff will need significant time to comp ile, review, and analyze the data submitted.

Source: (0187-0091) (0187-0103)

Response C.2.a: In response to these and comments received during inte ragency review, EPA decided to phase in the ev entual elimination of the 300,000 lb threshold as a separate reporting threshold. For the 2012 submission peri od, all submitters of non-excluded chemical substances are required to repor t processing and use information if they manufactured (including imported) 100,000 lb or more of a chemical s ubstance in 2011. For subsequent submission periods, the reporting threshold will be the same as for other types of information: 25, 000 lb (or 2,500 lb for chemical substances subject to 40 CFR 711.8(b)). Thus, there will be no separate threshold for the reporting of processing and use information after 2012 – the applicable reporting threshold will be the sa me as for other types of information. EPA believes this is a reasonable approach because it provides new submitters with an opportunity to become familiar with the reporting requirements, and provides much needed processing and use information on additional chemical substances. Future full reporting of exposure-related information will provide EPA and others with needed additional in formation for those chemical substances with production volumes of 25,000 lb or more at a site.24 While it is true that the amount of data in the IUR reports is expected to increase substantially in 2012 and subsequent submission peri ods, EPA is better prepared now than it was for the 2006 IUR to compile, review, and analyze th e anticipated increase of data. With the new e-IURweb electronic tool, large amounts of data w ill be able to be submitted with less difficulty on the part of the submitter, and will be more readily organized, analyzed, and made available to the public by the Agency. In addition, the use of SRS for identifying chemical substances and validation process built into the e-IURweb tool will eliminate most or all of the problems EPA had with missing information (w hich necessitated phone calls and emails to submitters), and manual entry of data, which was time-consumi ng and resulted in many mistakes. Given the requirement for mandatory electronic submissi ons and the corresponding improvements to the eIURweb tool, the Agency is confident that the increase in IUR data subm issions will be easily managed for this submission period and the next , and both EPA and the public will quickly have a useable set of exposure-related IUR data.

b. Reporting Burden

Comment C.2.b-1: Numerous commenters were concer ned about the incr eased reporting burden, particularly for smaller companies, and the complexity of IUR Form U Part III. One commenter pointed out that EPA has not justif ied such additional repo rting requirements and

should assess those benefits to establis h a cost justification of the proposal.

Source: (0187-0074) (0187-0079) (0187- 0340) (0187-0355) (0187-0090) (0187-0087) (0187-0075) (0187-0056) (0187-0103) ( 0187-0083) (0187-0084) (0187-0057)(0187- 0068) (0187-0089) (0187-0061) (0187-0065)

Response C.2.b-1: EPA analyzed the potential impact s of this requirement to all submitters, including potential burden to small bus inesses, in the Economic Analysis (Ref. 15). EPA recognizes that reducing the reporting th reshold for processing and use information increases the reporting burden; how ever, phasing in the lower thre shold reduces the burden for this reporting cycle, and the cost to industry wi ll decrease in all fu ture reporting cycles.

EPA disagrees that the requirement may ha ve a disproportionate effect on smaller companies (commenters suggested that smaller co mpanies are more likely to manufacture below the 300,000 lb threshold that is eventually being eliminated). The quantity of a chemical substance that is manufactured (i ncluding imported) at a site is not necessarily dependent on the number of employees, which is the criteria by wh ich a company is considered to be small. For example, a highly automated facili ty could produce large volumes of a chemical substance with a relatively small number of employees. Additionally, as noted in the Economic Analysis (Ref. 15), the Agency determined that because the sma ll businesses affected by this final rule actually have average sales of more than $11 million, an d because any potentially affected companies with sales of $0.81 million or less (t he level at which the cost-to- sales ratio of the final rule would exceed 1%) would generally be exempt fr om reporting obligations under the IUR, small entities will not be significantly affected by this final rule.25 Comment C.2.b-2: A couple of commenters expressed co ncerns about the complexities of imported mixtures and how difficult it would be to calculate and aggregate across products for

lower volume chemical substances.

Source: (0187-0244) (0187-0065)

Response C.2.b-2: EPA recognizes that with the reduc tion and eventual elimination of the 300,000 lb threshold, importers may face an in crease in burden to iden tify more component chemical substances contained within imported mi xtures. EPA has addressed these concerns with modifications to the proposal that will reduc e burden on importers (see e.g., discussion in response C.3.b-1). EPA believes that, due to the deferral of the threshold reduction until the 2012 submission period (which involve s reporting on the processing a nd use of imports occurring in 2011) and the deferral of the threshold elimin ation until the 2016 submission period (which includes reporting on the processing and use of imports occurring in 2015), importers will have had sufficient time to conduct a reasonable inquiry as to the specific chemical substances they import in mixtures. Furthermore, the inquiry n eed only be as extensiv e as a reasonable person, similarly situated, might be expected to perform.

EPA has several reasons to expect that impor ters have a reasonable awareness of the component chemical substances contained within imported mixtures. Importers have long been responsible for certifying that their imported chemical substances, including those chemical substances present as part of mixtures, ar e in compliance with TSCA (see 19 CFR 12.119). Furthermore, importers have long been required to provide chemical specific information as to the constituents of imported mixtures under the IU R (see the definition of “importer” at 40 CFR 704.3 and the note at 40 CFR 710.4(c)(2)) and under the PMN program (40 CFR 720.30(b). Furthermore, importers are often required to report chemical specific information regarding imported mixtures, under other EPA-administered statutes, such as the Emergency Planning and Community Right-To-Know Act (EPCRA) and th e RCRA. While reporting under IUR differs in many significant respects from reporting under the EPCRA and RCRA programs, in all cases, importers are required to know the identity of the chemical subs tances they import. EPA notes that one commenter described, in detail, its practice of accounting for component chemical substances in imported mixtures. The commente r stated that “[w]ith the advent of the [Registration, Evaluation, Authorization and Re striction of Chemicals] REACH we recently implemented an application that is capable of tracking volumes of individual chemical substances in mixtures and summing them up over a period of time. The system automatically

looks at the current formulation of any product that is crossing a border and adds the volume of each component to the cumulative total for that chemical substance” (Ref. 16). EPA also analyzed the potential impact of this require ment in the Economic Analysis (Ref. 15). EPA recognizes that reducing the repo rting threshold for processing a nd use information increases the reporting burden; however, phasing in the lower threshold reduces the burden for this reporting cycle and the cost to industry will decrease in a ll future reporting cycles . Finally, EPA notes that a chemical substance that is imported solely in small quantities for research and development, as an impurity, as part of an article, or in certain other forms, see 40 CFR 720.30(g) and (h), is not subject to the IUR reporting requirements (see 40 CFR 711.10).26 Comment C.2.b-3: One commenter asserted that the reporting burden would increase for companies that manufacture chemical substances that are still undergoi ng testing by customers

and are not established as full fledged products.

Source: (0187-0068)

Response C.2.b-3: Reporting is required for each chem ical substance listed on the TSCA Inventory that is manufactured (including imported) in volumes of 25,000 lb or more during the principal reporting year. EPA does not expect that the burden will increase for chemical substances that are still undergoing testing by customers. In such ci rcumstances, as in others, the scope of reporting is still limited to information that is known to or reasonably ascertainable by the submitter. Furthermore, as a general matter EPA anticipates that processing and use

information will be especially likely to be known or reasonably as certainable by the submitter in such circumstances, due to feedback recently rece ived in connection with the customer testing.

c. Justification for Data

Comment C.2.c-1: Several commenters strongly supported EPA’s proposed change noting that the information is essential for the completion of prioritizations for IUR reportable chemical substances; is critical for evaluati ng the potential for release of and exposure to chemical substances in commerce; and that the information requested is basic, screening-level data that should be required fo r all reported chemical substances. Others gave their support, but wanted the change to take effect after the next reporting cycle. Anothe r commenter stated that this information is generally available, but di fficult to collect and comp ile since it is spread through multiple functions, including sales, marketing, supply chain, and manufacturing and therefore proposed a tiered reporting time schedul e. Other commenters had concerns about the value of the information that is repo rted in Part III. Another commenter felt that EPA should provide more specificity on its needs and explain why other, mo re tailored, options do not provide the necessary data

Source: (0187-0071) (0187-0244) (0187- 0080) (0187-0069) (0187-0349) (0187-0100) (0187-0066) (0187-0364) (0187-0101) ( 0187-0064) (0187-0088) (0187-0078)

Response C.2.c-1: EPA’s information needs have changed since the last major

amendment of the IUR rule in 2003. Production volum e changes from year to year, so chemical substances can easily fluctuate above and below a relatively high reporting threshold, such as the previous 300,000 lb threshold for reporting proc essing and use, making it difficult for EPA to collect regular exposure information on many ch emical substances. Requiring the reporting of processing and use information on an expanded list of chemical substances will assist the Agency and others in screening potential exposur es and risks resulting from industrial chemical substance operations and consumer and commercial uses of chemical substances. The information will also help to provide an accurate and readily available so urce of basic exposurerelated information for a subset of chemical substances listed on the TSCA Inventory. Furthermore, collection of this data is consistent with the Ad ministrator’s strong commitment to provide the public with more information on a greater number of chemical substances.27 As EPA discusses below and elsewhere, the 2006 IUR information did not provide useable exposure-related data for EPA’s screen ing level assessments. If EPA delayed reducing the processing and use reporting threshold until the 2016 submission period, EPA would have to wait several more years before mo re useful exposure-related inform ation is received for chemical substances for which EPA has already determined are currently in need of such information. With the phased-in approach, EPA will be able to collect much needed processing and use

information on additional chemical substances during the 2012 submission period. Requiring full reporting for all chemical substances in subs equent reporting cycles (i.e., eliminating the separate, higher, threshold for production and us e information) provides EPA with the exposurerelated information needed to continue effo rts begun with the 2012 For example, the data reported in 2006 did not provide an adequate amount of exposure- related information, especially for HPV chemical substances. When attempting to use the 2006 IUR data for its screening level exposure assessments, EPA found that numerous chem ical substances previously identified as HPVs were reported in amounts classifying th em as MPV chemical substances below the 300,000 lb cut off, and thus processing and use information was not provided for chemical substances for which EPA had a relatively complete hazard data set from the HPV challenge. For example, an RBP was prepared for the Chlor obenzenes Category, which consisted of four chlorobenzenes sponsored under the HPV Challenge (Ref. 17). Only one of the four chemical substances, 1,3-dichlorobenzene (CASRN 541-73- 1), was considered hi gh priority; however, because it was an MPV chemical substance in 2006, no exposure and use data was available from the IUR reporting, so the high priority determination was based on high human health hazard and assumptions made about exposure.

The 2006 IUR data did not provide sufficient information on MPV chemical substances for use by the Agency’s Existing Chemicals Pr ogram. Screening chemical risks generally requires a combination of both hazard and expos ure information. Because most MPV chemical substances were produced below the 300,000 lb re porting threshold, EPA did not have exposure

information available from the 2006 IUR and ther efore, developed hazard based prioritizations which were supported by a screening level hazar d characterization and c onsideration of very limited exposure and use data. The lack of in formation on exposure and use was especially problematic in those instances where the screenin g level hazard characterization identified either a medium or high hazard. Basic hazard data is easier to find in existi ng databases; however, specific exposure data is needed to make a determination risk-based. EPA believes that the gradual lowering of the reporting threshold will result in more exposure-related information on a greater number of MPV chemical substances.

By eliminating the separate reporting thre shold for processing and use information in 2016, EPA is trying to make the reporting requi rements under the IUR more consistent with those of the TRI program. Under th e TRI program, chemical substan ces of special concern listed at 40 CFR section 372.28 (e.g., mercury, lead), are required to be re ported if they are manufactured or processed in volumes of 25,000 lb or more annually or otherwise used in volumes of 10,000 lb or more annually. Though th e chemical substances on the TRI toxic chemical list may be different from those reporte d under the IUR, an analysis showed that over 80 percent of the sites that re ported under the 2006 IUR also reported under TRI in 2006. Given that there is substantial overlap in the compan ies that report and the information collected on28 activities and uses of chemical substances under both programs, EP A believes that companies are already accustomed to reporting on lo wer volume chemical substances.

Comment C.2.c-2: One commenter stated that EPA has not made public documentation of the past use of this information to address sc reening and prioritization of chemical substances.

Source: (0187-0074)

Response C.2.c-2: EPA disagrees with this comment. In 2007, the Agency began to develop and post screening-level hazard, exposure, and risk characterizations for HPV chemical substances. These documents are currently avai lable from the Agency's website. See EPA’s

archived Chemical Charact erization Documents at http://iaspub.epa.gov/oppthpv/exist chem_hpv_prioritizations.INDEX_HTML

.

More recently, the Existing Chemicals Program used the IUR database when developing

the Chemical Action Plans. For some Action Pl an chemical substances, the 2006 IUR was not a useful source of information. An example is th e Action Plan for Dyes Derived from Benzidine and Its Congeners, where the chemical subs tances of concern ar e known or reasonably anticipated human carcinogens; however, those listed were produced in amounts below the 300,000 lb threshold and so little exposure data was reported. Based on IUR data from prior reporting periods, some of the other dyes had be en reported in the 10,000 to 25,000 lb range, but

there was no 2006 IUR data available to determine whether these chemical substances were still being used in amounts beyond the small amounts used as analytical reag ents. The Action Plans

are available on EPA’s web site at http://www.epa.gov/opptintr/existin gchemicals/pubs/ecactionpln.html

.

d. Lack of Data for Chemical Substances

Comment C.2.d: Several commenters noted that th e 2010 reporting year will be over by the time the rule is finalized, and companies w ould not have had the opportunity to establish systems for collecting the information for chem ical substances in the 25,000 to 300,000 lb range. Other commenters asserted that EPA was seeking data that are limited or unavailable because

manufacturers do not know how their downstream customers use their chemical substances. One commenter asserted that the lowered threshold will not enhance the quality or integrity of the resulting IUR data due to uncer tainties in making estimates.

Source: (0187-0083) (0187-0355) (0187- 0353) (0187-0085) (0187-0065) (0187-0086) (0187-0067)

Response C.2.d: EPA recognizes that submitters may not always have detailed information about how the chemical substance(s) they manufacture (including import) are used. As a result, submitters will be required only to repor t this information to the extent that it is known or can be reasonably ascertained. Base d on its experience with the New Chemicals Program, discussions with indus try about voluntary risk manage ment programs, and industry’s various self-regulation initiatives, the Agency beli eves that most submitters have at least some29 basic information about downstream uses, such as the informati on that is required by the IUR

rule.

EPA does not anticipate that the quality of the data coll ected in 2012 will significantly decrease due to the timing of the amendment to the reporting threshold. As mentioned earlier, EPA published a final rule (Ref. 1) to suspe nd the 2011 submission period to provide sufficient time for companies to comply with the updated IU R reporting requirements. This final rule was published in advance of the 2012 submission pe riod, which is February 1, 2012 to June 30, 2012. For these reasons, companies shou ld have had the opportunity to establish systems for collecting the information on their reportable chemical s ubstances. Furthermore, many of the reporting elements are the same as in past IUR submissi on periods, and EPA notes that the rule affords sufficient flexibility to account for those circ umstances in which information is truly unknown and not reasonably ascertainable. The Agency believes that the data will be of sufficient reliability for use by the Agency and others for pu rposes such as screening-level risk assessments and prioritization.

e. Alternate Approaches

Comment C.2.e-1: One commenter stated that a more efficient and significantly less burdensome approach would be to list the HPV chemical substances and any other priority

chemical substances for which such data are needed, and to which the lower threshold would apply. Others recommended that EPA use a tailored, risk-based approach to select chemical substances of concern. For example, selection sh ould be based on a chemical substance's use in children’s products, molecular structure, or demonstrated risk. Fi nally, one commenter recommended that the requirement only be impos ed upon those entities manufacturing chemical substances at the greatest volumes.

Source: (0187-0058) (0187-0062) (0187- 0079) (0187-0081) (0187-0089) (0187-0360)

Response C.2.e-1: It is precisely because EPA need s sufficient exposure information to take a risk-based approach to select chemical substances of concern that EPA has reduced the threshold for reporting processing and use. When attempting to use the 2006 IUR data for its screening level exposure assessments, EPA found th at numerous chemical substances previously identified as HPVs were reported in amounts cl assifying them as MPV chemical substances below the 300,000 lb cut off, and thus processi ng and use information was not provided for

chemical substances for which EPA had a relati vely complete hazard data set from the HPV challenge. This led EPA to believe that the thre shold was too high to pr ovide sufficient exposurerelated information on these chemical substances . Additionally, some previously MPV chemical substances were reported in amounts that classi fied them as HPV chemical substances in 2006. The 2006 IUR data did not provide sufficient info rmation on MPV chemical substances for use by the Agency’s Existing Chemicals Program. Because most MPV chemical substances were produced below the 300,000 lb reporting threshol d, EPA did not have exposure information available from the 2006 IUR and therefore, deve loped hazard-based prioritizations which were supported by a screening level hazard characte rization and considera tion of very limited exposure and use data. When the screening leve l hazard characterization for a MPV chemical

substance indicated that the h azard was low, the magnitude of exposure was generally less30 significant for the prioritization. However, when the screening level hazard characterization identified either a medium or high hazard, info rmation on the magnitude and type of exposure

would be essential for a realisti c prioritization determin ation. Basic hazard data is easier to find in existing databases; however, specific exposure da ta is needed to make a priority determination

risk-based. EPA believes that the lower th reshold will provide more exposure-related information on a greater number of MPV and HPV chemical substances.

Comment C.2.e-2: Other commenters suggested that because of the extensive effort required to gather the material on the part of the reporting en tities at the very least, the requirement should not take effect until the next reporting cycle or that a phased-in approach should be developed.

Source: (0187-0074) (0187- 0244) (0187-0073) (0187-0352)

Response C.2.e-2: As discussed earlier in this secti on, EPA has decided to take a phasedin approach to lowering the threshold for reporti ng processing and use information. EPA agrees with a phased-in approach because it provides ne w submitters with an opportunity to become familiar with the reporting requirements, and provides much needed processing and use

information on additional chemical substances. At the same time, EPA recognizes that submitters may not always have detailed info rmation about how the chemical substance(s) they manufacture (including import) are used. However, many of th e reporting elements are the same as in past IUR reporting periods, and EPA notes that the rule affords sufficient flexibility to account for

those circumstances in which information is truly unknown and not reasonably ascertainable. Submitters will be required only to re port this information to the extent that it is known or can be reasonably ascertained.

Comment C.2.e-3: One commenter suggested that EPA lower the processing and use threshold to 100,000 lb, which is consistent with one of the triggers for the small business exemption.

Source: (0187-0067)

Response C.2.e-3: EPA did consider lowering the th reshold to various levels below 300,000 lb, but greater than 25,000 lb, as discussed in more detail in Unit III.E.2. of the preamble to the final rule. As part of its decision to phase-in lowering the threshold for reporting processing and use information, EPA chose to use 100,000 lb for the 2012 submission period, because EPA believes that the 100,000 lb thres hold provides an appropriate balance between increasing the number of chemical substances with processing and use information and increasing the reporting burden on industry. For the longer term; ho wever, EPA needs processing

and use data for all chemical substances s ubject to IUR reporting. Therefore, for the 2016 submission period and beyond, full reporting of e xposure-related information will provide EPA and others with needed additional information for those chemical substances with production volumes of 25,000 lb or more at a site.31 Comment C.2.e-4: Two commenters suggested th at EPA should phase in the requirement for chemical substances manufact ured between 25,000 lb and 300,000 lb, similar to the partial exemption for inorganic chemical substances in the last reporting cycle.

Source: (0187-0244) (0187-0066)

Response C.2.e-4: EPA agrees with the suggestion that the reduced threshold should be phased in for the 2012 IUR. As EPA has discussed in greater detail in th e preamble to the final rule (Ref. 18)) and earlier in this document (see responses A.2- 2, A.3-1, and A.3-4, C.2.c), EPA's decision to eliminate the 300,000 lb reporting threshold was based on EPA's experience collecting and analyzin g the 2006 IUR data. However, EPA also agrees that a phased-in approach would provide new submitters with an opportunity to become familiar with the reporting requirements, while still providing EPA with much needed processing and use

information on additional chemical substances.

Comment C.2.e-5: Other commenters suggested that because inorganic chemical substances were previously exempt from repor ting processing and use information, the industry sector is still inexperienced w ith Part III reporting and should be given an opportunity to report under the existing thresholds befo re EPA determines th at the threshold creat es any systematic problems.

Source: (0187-0354) (0187-0073)

Response C.2.e-5: EPA disagrees with commenters who believe that inorganic chemical substances should receive additional exempti ons from reporting information for chemical substances manufactured between 25,000 lb an d 300,000 lb or that the mining industry should receive additional exemptions fr om reporting processing and use information. Manufacturers of inorganic chemicals were notified that they would need to repor t processing and use information in the 2011 IUR submission period in the 2003 IUR Amendments Final Rule (see 40 CFR 710.46(b) (2010)). The 2011 IUR submission period wa s subsequently suspended (Ref 1) and is superseded in this rule by the 2012 IUR submi ssion period. With respect to the requirement to report processing and use information, only the requirement to report on volumes of 100,000 lb to 300,000 lb is new for the 2012 submission peri od. As discussed above, EPA is taking a phased-in approach to lowering the threshold for reporting proce ssing and use information for all IUR reportable chemical substances, so that for the 2012 IUR, only submitters of chemical substances are required to reporting processing and use info rmation if they manufactured (including imported) 100,000 lb or more of a chem ical substance in 2011. Subsequent to the 2012 submission period, the reportin g threshold will be 25,000 lb.

Inorganic chemical substances may pose haza rds and/ or be produced in MPV or HPV quantities just as organic chemi cal substances are, and the manuf acturers of inorganic chemical

substances have been on notice since the 2003 IU R rule amendments that they would no longer be treated differently from organic chemical s ubstances with respect to reporting processing and

use information. For all the reasons noted in the discussion above in Unit C.2.c, EPA’s data needs include exposure information on chemical substances produced at 25,000 lb to 300,000 lb per year, and commenters have provided no reason fo r EPA to believe that this data need would32 be diminished for inorganic chemical substanc es. Commenters did not provide additional support

for the assertion that th e alternate approaches suggested in comments C.2.e-1 through C.2.e-4 would supply the information that EPA proposed to collect under the IUR. However, as noted earlier EPA will be phasing in the change in th e processing and use reporting threshold over the next two submission periods. EPA believes this is a reasonable approach because it provides new submitters with an opportunity to become famili ar with the reporting requirements, and provides much needed processing and use inform ation on additional chemical substances.

Comment C.2.e-6: One commenter said eliminating the threshold would reveal large amounts of use and exposure information for public review and competitive inspection for chemical substances produced between 25,000 lb and 300,000 lb. Many of these chemical substances are specialty chemical substances pro duced using proprietary pr ocesses or used in a proprietary manner.

Source: (0187-0096)

Response C.2.e-6: EPA disagrees that the increase in processing and use data would reveal confidential information. The type of use and exposure information made public by EPA will not change due to the lowered reporting th reshold. TSCA CBI provisions are available and are not altered by production volume.

3. Reduction of 25,000 lb Threshold for Speci fic Regulated Chemical Substances

a. Burden

Comment C.3.a: Some commenters generally supported eliminating the 25,000 lb threshold for chemical substances that are subject to certain TSCA rules and orders so that more

useful information would be received. Two comm enters suggested eliminating the threshold for other priority chemical substances identified on lists created by stat e, federal and foreign government sources. Other commenters did not support eliminating the threshold, saying that this would greatly increase the reporting burden, because it would be necessary to confirm that numerous chemical substances were not presen t at any level in mixt ures and more Form U submissions would be required. Some of these commenters felt that different thresholds for

subsets of chemical substances added an unnecessa ry layer of complexity to IUR reporting that should not be implemented without a very specific and important reason. Others did not see that the IUR reporting would provide useful informa tion on chemical substances that are already being managed and regulated under TSCA. Some commenters, while generally supporting the concept of eliminating reporting thresholds for sp ecific chemical substances subject to certain TSCA regulations, felt that many companies w ould not have sufficient time to prepare this information for the 2011 reporting cycle and they requested that impl ementation of this modification be delayed until a later reporting cycle. One commenter recommended that EPA convene an Advisory Panel to discuss the m odification further and then implement in the subsequent reporting period.33 Source: (0187-0069) (0187-100) (0187-071) (0187-0079) (0187-058) (0187-358) (0187- 0081) (0187-0101) (0187-0050) (0187- 0352) (0187-0090) (0187-0056) (0187-0098) (0187-0073) (0187-0104) (0187-0244)

Response C.3.a: The Agency believes it is likely that recordkeeping practices were already in place for a company to track the volumes of the chemical substances it is manufacturing (including importing). In response to commenters, EPA decided to take two steps

to limit the burden increase associated with IU R reporting for the specific regulated chemical substances. As a result, EPA is reducing the reporting threshold fo r these chemical substances to 2,500 lb, instead of entirely eliminating the repo rting threshold. In addition, EPA is phasing in this change to the IUR; it will not affect IU R submissions until the 2016 submission period (i.e., it applies to the submission in 2016, of records of production occurring between 2012 and 2015). EPA believes this should help to reduce the reporting burden for submitters because it provides sufficient time for companies to put in place recordkeeping proce dures to collect and report the required data for situations where the recordkeep ing procedures do not already exist. The burden of reporting will also be greatly diminished by the use of the reporting tool. The Economic Analysis contains EPA’s analysis of the bur den associated with th is reporting (Ref. 15).

EPA disagrees that the increased burden will not yield any benefits. Chemical substances that are the subject of particular TSCA rules and/or orders are of demonstrated high interest to the Agency. Receipt of up-to-date exposure and use information on these chemical substances, produced at 2,500 lb or more, will help EPA as it develops risk management strategies for those chemical substances subject to proposed rules. Additionally, EPA will use the 2016 IUR data as it monitors chemical substance production and co mpliance with the rules. The new requirement

will also contribute to the Administrator’s comm itment to increase the availability of chemical information to the public.

EPA does not believe that it is necessary to convene an Advisory Pa nel for this issue. Companies are generally aware if they are ma nufacturing or processing chemical substances subject to proposed or promulgated TSCA rule s, because many of them would have provided comments during a proposed rule comment period or may be keep ing records or taking other actions to comply with a promulgated rule or an order. As discussed further in response C.3.b-1 below, companies should be accustomed to reporting chemical specific information to EPA under IUR and other TSCA regulations and they are only required to report information that is known or reasonably ascertainable.

b. Imports and Mixtures

Comment C.3.b: Some commenters felt that the requi rement will be difficult to meet in practice, particularly for imports of mixtures. “The proposal woul d create a needle-in-a-haystack situation in which a company would need to exam ine all chemical substances and/or mixtures imported - regardless of the concen tration of the chemical substance or volume of the import - to determine if any of the approximately 1,000 regula ted chemical substances are present at any level.” Importers would have gr eat difficulty knowing that low-concentration ingredients are present in formulated mixtures, especially when they are not subject to inclusion on a label or MSDS. One recommendation is that the Agency incorporate in the IUR regulations the low-34 volume exemptions for chemical substances in mi xtures that are part of MSDS regulations. The commenter also suggested that EPA provide a general exemption for situations in which an importer, which is not the actual manufacturer of a regulated chemical substance, has not been notified by the manufacturer or othe r parties that the chemical subs tance it is importing is subject to any regulatory requirement.

Source: (0187-0050) (0 187-0101) (0187-0244) (0187-0086)

Response C.3.b: EPA recognizes that eliminating the 25,000 lb reporting threshold may, in some instances, make it more difficult for importers to determine the production information for component chemical substances in importe d products. Consequently, the reporting threshold will be 2,500 lb, instead of zero, a nd will be phased in to begin w ith the 2016 IUR. The IUR also includes a number of exemptions that address the “needle-in-a-haystack” concern expressed by the commenter. IUR reporting is not required for a chemical substa nce that is imported solely in small quantities for research and development, as an impurity, as part of an article, or in certain other forms (see 40 CFR 711.10, 40 CFR 720.30(g) and (h )). Furthermore, companies should be accustomed to reporting chemical-specific inform ation to EPA because the Agency has always sought information on individual chemical subs tances in mixtures under the IUR and other TSCA regulations. For example, TSCA section 13 requires chemical importers to certify that the chemical substance or mixture they are importing is not being imported in violation of TSCA; an importer must, therefore, have knowledge of the re gulatory status of the chemical substances he or she is importing. If an importe r does not know, or can’t reasonabl y ascertain that a particular chemical substance is present in a mixture, he or she is not required to report it. If an MSDS makes no mention of the presence of an ingred ient, and the importer do es not otherwise know that the ingredient is present, EPA would gene rally agree that the importer does not know, and cannot reasonably ascertain that he or she is im porting that ingredient. Therefore, no IUR report for that ingredient would be required. In addi tion, manufacturers and impor ters are not required to report impurities.

With respect to circumstances where the import of an ingredient below the 25,000 lb threshold is known or reasonably as certainable, but the chemical id entity of the ingredient is unknown, EPA disagrees that it is appropriate for the Agency to exempt chemical importers from the requirement to submit an IUR report, based solely on whether the s upplier has decided to notify them that the chemical import contains a chemical substance regu lated under one of the provisions listed in 40 CFR 711.8(b). This approach would likely discourage importers and their foreign suppliers from even making an inquiry in to whether an imported chemical substance is subject to a TSCA restriction, th ereby circumventing any risk prot ections EPA has already put in place under TSCA, and frustrating the IUR intention to gather basic information on all chemical substances in commerce (with certain specified exceptions). If an importer does not know and cannot reasonably ascertain that a particular ch emical substance is present in an imported mixture; he or she is not re quired to report the chemical s ubstance under the IUR. However, importers of mixtures with constituents of pr oprietary or otherwise unknown chemical identity should ask the supplier for the chemical identity to help determine whether an IUR report must be completed. If an importer knows that he or she is importing a particul ar chemical substance above the relevant threshold, but does not know the chemical id entity because the supplier is unwilling to share the chemical iden tity with the importer, it is sufficient for the importer to35 follow the procedures in 40 CFR 711.15(b)(3)(i)(A), requesting that the foreign supplier provide the chemical identity directly to EPA in a joint submission.

The IUR reporting related to mixtures and UVC B substances (chemical substances that are of Unknown or Variable composition, Comple x reaction products, or Biological materials) requires careful consideration by submitters. Whenever a submitter has manufactured or imported a combination of several chemicals, the submitter must first determine whether for TSCA purposes it is a mixture or a single UV CB chemical substance. A mixture is any

combination of chemicals that m eets the statutory definition of “m ixture” at TSCA section 3(8). Mixtures are not reported to IUR – rather the mixture's component chemical substances, the chemical substances that make it up, are partially subject to reporting, as described below. A

UVCB substance is an indefinite combination of chemicals, that does not meet the statutory definition of Mixture” at TSCA section 3(8), whose number and individu al identities and/or composition are not precisely or completely kno wn. A UVCB combination of chemicals is subject to reporting under IUR and is consider ed a single chemical substance. Generally, the

determination of whether a combination of chemi cals is a mixture or a UVCB substance is made by the time that substance has been commercialized and, as such, would be clear early in the IUR process. The following discussion is pres ented with this generality in mind.

• If you imported a mixture, you will need to re port the individual chemical components of the mixture to the extent that your total vol ume for the individual chemical substance triggers reporting (i.e., generally to the extent that such volume reaches the 25,000 lb threshold).

• If you domestically manufactured a mixture, you will need to determine whether any

chemical substances were formed from a ch emical reaction that occurred as part of manufacturing the mixture. If a chemical reaction has occurred, a chemical substance formed from the chemical reaction may be subject to reporting, based on its production volume or the applicability of other exempti ons. If a chemical reaction has not occurred, you have not manufactured any reportable chem ical substances in the production of the mixture. In such a case, the production of the mixture has not triggered any IUR reporting requirement.

• Domestic manufacturers and importers should al so consider whether the combination of chemicals they have domestically manufactur ed or imported (respectively) should be chemically identified for TSCA purposes as a single UVCB chemical substance instead

of a mixture.

EPA has developed two Inventory nomencla ture guidance documents related to the mixture-UVCB determination titled: (1) Toxic Substances Control Act Inventory Representation For Chemical Substances Of Unknown Or Va riable Composition, Complex Reaction Products And Biological Materials: UVCB Substances . Available on-line at: http://www.epa.gov/oppt/newchems/pubs/uvcb.txt (Ref. 19); (2) Toxic Substances Control Act Inventory Representation For Combinations Of Two Or More Substances: Complex Reaction

Products. Available on-line at: http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt (Ref. 20).36 c. Lists of Regulated Chemical Substances

Comment C.3.c-1: Three commenters suggested that EP A provide an up-to-date list of the chemical substances impacted at the beginning of the information collection year to ensure more accurate and complete reporting.

Source: (0187-0073) (0187-0104) (0187-0244)

Response C.3.c-1: EPA provides a list entitled “Chemi cal Substances that are the Subject of Certain TSCA Orders, Proposed or Final TSCA Rules, or Relief Granted under Civil Actions” in Appendix B of the guidance document “ Instru ctions for the 2012 TSCA Inventory Update Reporting (Ref. 9). This document, which has b een updated for the 2012 IUR, is intended to be

an information resource and is available on EPA’ s IUR website. Chemical substances are listed both by CAS Registry Numbers (for non-confidential chemical substances) or by Accession Numbers (for confidential chemical substances ) that are the subject of a rule, proposed or promulgated under TSCA section 4, 5(a)(2), 5(b)(4), or 6; an order issu ed under section 5(e)or 5(f) of TSCA; or relief that has been granted under a civil action under se ctions 5 or 7 of TSCA as of March 2011 (see 40 CFR 711.6, a nd 711.9 and TSCA § 8(a)(3)(A)(ii)).

Comment C.3.c-2: One commenter noted that EPA s hould clarify that the reduction in reporting threshold for specific regulated chemi cal substances will not impact new chemical polymers and microorganisms that are subject to TS CA Section 5(e) consen t orders or significant new use rules (SNURs). The commenter indicated that these materials are otherwise generally exempted from the IUR requirements

Source: (0187-0244)

Response C.3.c-2: EPA would like to clarify that th e commenter’s statement regarding the IUR reporting status of new chemical polymers and microorganisms subject to TSCA Section 5(e) consent orders or Section 5(a)(2) SNURs is incorrect. Polymers and microorganisms are listed as fully exempt from IUR reporti ng under 40 CFR 711.6(a)(1) a nd (a)(2), respectively. However, that exemption is superseded by th e introductory paragraph of 40 CFR 711.6 which

indicates that a chemical substan ce described in 40 CFR 711.6(a)(1), (a)(2), (a)(4) or (b) is not exempted if that chemical substance is subjec t to a rule proposed or promulgated under TSCA section 4, 5(a)(2), 5(b)(4) or 6, an ECA, a TSCA s ection 5(e) or 5(f) order, or TSCA section 5 or 7 relief granted under a civil action. Therefore, new chemical polymers and microorganisms subject to TSCA Section 5(e) consent orders or proposed or final Sect ion 5(a)(2) SNURs could be subject to IUR reporting requirements.

d. Chemical Substances Subject to Certain Proposed TSCA Rules

Comment C.3.d: EPA received mixed comments on whether the 25,000 lb reporting

threshold should also be lifted for chemical subs tances that are subjec t to proposed rules under TSCA section 5(a)(2), 5(b)(4) or 6. Commenters who supported including chemical substances subject to proposed rules thought that EPA c ould receive helpful information from IUR reporting. Those who opposed including chemical s ubstances subject to proposed rules felt that37 the need for collecting such in formation had not been established and that the proposed rules might never be finalized.

Source: (0187-0069) (0187-0349) (0187- 100) (0187-0059) (0187-0081) (0187-0098) (0187-0364) (0187- 0244)

Response C.3.d: The Agency generally agrees with the commenters who stated that if chemicals substances would typically be exempted from reporting are subject of a rule proposed under TSCA section 5(a)(2), 5(b)(4 ) or 6, the chemical substances should be reported despite the lower volumes produced. However, as discussed above in response C.3.a., EPA has decided to reduce the reporting threshold for these chemical substances to 2,500 lb instead of entirely eliminating the reporting threshold. In addition, EPA is phasing in this cha nge to the IUR; it will

not affect IUR submissions until the 2016 submission period.

The Agency disagrees with the commenter who argued that the ch ange to the 25,000 lb reporting threshold (at 40 CFR 711.8(b), prom ulgated under TSCA § 8(a))) should not be triggered by the mere issuance of a proposed rule for a chemical. The latter commenter suggested that it would be inappropriate to collect more detailed information on such a chemical substance until the proposed rule had been fully vetted and analyzed, noting that finalization can often take a number of years. However, EPA believes that the issuance of one of the proposed rules described above represents an appropriate ci rcumstance to trigger enhanced information collection under the IUR. EPA issues a proposed rule under TSCA sections 5 or 6 only after making preliminary determinations or proposed findings that a chemical substance or some specified use of a chemical substance presents some level of concern. Precisely because potential

concerns about the chemical s ubstance would be under review and because there might be an opportunity for a fuller IUR dataset would help info rm that analysis and the development of risk management actions, EPA believes it is approp riate for the reduction of the 25,000 lb reporting threshold to be triggered at rule proposal. Furthermore, those ch emical substances that are the subject of a rule proposed under TSCA sections 5( a)(2), 5(b)(4) or 6 are of demonstrated high interest to the Agency. In an effort to better understand the extent of manufacture, use, and potential exposure to such chemical substances , EPA believes it is appropriate to reduce the 25,000 lb threshold and require repo rting on these chemical substa nces during the 2016 reporting cycle if they are manufactu red (including imported) in volumes of 2,500 lb or more.

e. De minimis Threshold

Comment C.3.e: Several commenters supported the concept of a de minimis threshold,

but one of the commenters indicat ed that it would be difficult to choose an appropriate level to decrease the reporting burden while including all chemical substan ces with legitimate health and safety issues. A few of these commenters supported setting a de minimis threshold of 2,500 lb, as this is 10% of the 25,000 lb reporting threshold and is similar to the de minimis under the European Union’s REACH regulations. One commenter thought a de minimis volume should be set on a chemical-by-chemical basis for chemi cal substances for which EPA needs specific

information

. Some commenters opposed setting a new de minimis threshold, either because they felt that there should be no reporting threshold or they felt that the threshold should remain at38 25,000 lb. One commenter specifically opposed a de minimis threshold for any persistent, bioaccumulative and toxic (PBT) chemical.

Source: (0187-0079) (0187-059) (0187- 0080) (0187-0050) (0187-0092) (0187-0069) (0187-0098) (0187-352) (0187-0244) (0187-100)

Response C.3.e: EPA agrees that a 2,500 lb threshold will generally provide sufficient data for the Agency to monitor production and compliance with certain proposed or promulgated rules and/or actions. Therefore, the Agency has decided to lower the re porting threshold to 2,500 lb, instead of zero, beginning with the 2016 IUR. EPA believes that, at this time, the 2,500 lb

threshold is a reasonable de minimis threshold that is low enough to help decrease the burden on submitters, yet will provide much needed data on chemical substances of high concern to the Agency. The reduced threshold is essential to ensuring that information is available on chemical substances that could pose heal th or environmental concerns at levels of production or import below the 25,000 lb threshold. In the future, EPA may find it necessary to collect information on

these chemical substances at a reporting threshold below the 2,500 lb threshold introduced in this

action. EPA also believes that th e regulated community should be sufficiently familiar with the 2,500 lb threshold as it is similar to the threshol d that is used under the EU’s REACH regulations to submit registration dossiers. Under REAC H, a person who manufactures or imports a chemical substance in quantities of 1 tonne (met ric tonne (mt) or if c onverted to pounds, about 2,205 lb) or more per year within the European Economic Area (EEA) must register the chemical substance (Ref. 21).

EPA believes that setting a de minimis threshold on a chemical-by-chemical basis or special thresholds for PBTs or carcinogens w ould require more time and resources than are presently available. The Agency recognizes that because of this de minimis threshold, there may be some chemical substances for which the Agency will have an interest in the IUR data (e.g., for evaluating potential exposures), but for wh ich IUR data are not reported because production volume is below 2,500 lb per site. However, EPA believes the 2,500 lb threshold will be sufficient for most circumstances. To address any future need for additional exposure-related information respecting chemical substances wi th per-site production volume below 2,500 lb, EPA may propose to amend the IUR further in the future, or may evaluate whether other actions under TSCA would be appropriate.

D. Chemical Substances Covered by IUR

1. General Comments

Comment D.1-1: One commenter requested that the Agen cy provide an up-to-date list of IUR reportable chemical substances, and those in eligible for exemptions, prior to the reporting period.

Source: (0187-0104)

Response D.1-1: In general, chemical substances listed on the TSCA Inventory are required to be reported if they are manufactured (including imported) in amounts of 25,000 lb or39 greater at a single site during th e principal reporting year. Five ch emical substances or groups of chemical substances, though included on the TSCA Inventory, are largely exempt from reporting under the IUR rule. These groups are polymers, mi croorganisms, certain forms of natural gas, naturally occurring substances, and water. Refe r to 40 CFR 711.6(a) for precise definitions of these groups. Submitters should note that, with th e exception of naturally occurring substances,

these chemical substances beco me ineligible for the 40 CFR 711.6( a) exemption if they are the subject of any of the following (i.e., even t hough the chemical subs tance would otherwise exempt):

• A rule proposed or promulgated under Sect ions 4, 5(a)(2), 5(b )(4), or 6 of TSCA;

• An order issued under TSCA Sections 5(e) or 5(f); • Relief that has been granted under a civi l action under TSCA Sections 5 or 7; or • An enforceable consent agreement (ECA) under 40 CFR Part 790.

EPA provides a list entitled “Chemical Substa nces that are the Subj ect of Certain TSCA Orders, Proposed or Final TSCA Rules, or Reli ef Granted under Civil Actions” in Appendix B of the “Instructions for the 2012 TSCA Inventory Upda te Reporting” (Ref. 9). Chemical substances are listed by CAS Registry Numbers (for non-co nfidential chemical substances) or by Accession Numbers (for confidential chemical substances ). This document, whic h will be updated for the 2012 IUR reporting, is intended to be an information resource and is available in the docket for

this final rule and on EPA’s IUR website at http://www.epa.gov/iur

.

Comment D.1-2: Two commenters noted that they had submitted petitions to partially exempt aluminum and aluminum oxide prior to the 2006 IUR, and the August 3, 2006, response

letters from EPA indicated that the petitions would be revisited following the 2006 IUR. The

commenters stated that EPA has not provided any further informati on regarding the status of the petitions. The commenters maintain that thes e two chemical substances are well-understood, therefore both should be exempted from IUR requirements.

Source: (0187-0074) (0187-0066)

Response D.1-2: EPA’s initial response (dated August 3, 2006) to the petitions identified that aluminum (CASRN 1344-28-1) and aluminum oxide (CASRN 1344-28-1) we re inorganic chemical substances (Ref. 22). Prior to the 2006 IUR, inorganic chemi cal substances were exempted, for the most part, from the IUR requirements. Because EPA had not collected

information on these two chemical substan ces, the Agency did not have even basic manufacturing information and therefore denied th e petitions, with the provision that it would

revisit them once such information was collected . EPA has further consid ered these petitions, and the record of the respons e is in the public docket.

2. Exempt Manufactured Water

Comment D.2: Commenters were in favor of the Agency exempting water from reporting under the IUR rule. A commenter stated that the change would eliminate the burden associated with over-reporting.40 Source: (0187-0079) (0187-0056) (0187-0101)

Response D.2: EPA has fully exempted naturally occurring and manuf actured water and removed water from the petroleum streams partial exemption. EPA agrees this will likely result

in a burden reduction for IUR submitters.

3. Remove Fully Exempt Polymers from Partially Exempt List

Comment D.3: One commenter stated that there ar e polymers that are not captured by the criteria in 40 CFR 711.6( a)(1)(i) and (ii) or might not be recognized as being included. This commenter suggested that EPA clarify the desc ription of a polymer by adding to the end of 711.6(a)(1)(ii): "...rubber, lignin, or any other chemical substance that the EPA recognizes as a polymer for TSCA Inventory purposes." The comm enter also felt that the language in proposed 40 CFR 711.6(a)(1)(iii) did not adequately capture the curr ent polymer exemption rule requirement at 40 CFR 723.250(d)(3) that a polyme r must not be reasonably anticipated to substantially degrade, decompose, or depolymer ize after manufacture and use, even though it is

not intended to do so. The commenter recommende d that EPA modify the language at 40 CFR 711.6(a)(1)(iii) to read: "T his exclusion does not apply to a ch emical substance which has been substantially hydrolyzed, depolymerized, or chemi cally modified to the extent that the final product is no longer poly meric in structure."

Source: (0187-0081)

Response D.3: The commenter is addressing an existing requirement that has been moved, without change, from 40 CFR 710.46(a)(1 )(iii) into 40 CFR 711. In the August, 2010, proposed rule, EPA did not propose to modify this requirement, and therefore, EPA cannot change the language in this final rule without prior proposal. Any member of the public who believes that a particular chemical substance sh ould be brought within the scope of the IUR polymer exemption may petition EPA to modify the IUR rule accordingly.

4. Chemical Substances Subject to an Enforceable Consent Agreement

Comment D.4-1: Two commenters were in favor of EPA making chemical substances that are the subject of an ECA ineligible for exem ptions to the IUR. One specifically noted that the removal of this exemption would assist in addressing chemical subs tances of high concern

for infants and children.

Source: (0187-0069) (0187-0100)

Response D.4-1: EPA appreciates the support and agr ees with the commenter who noted that removal of the exemption would assist in addressing chemical substances of high concern The intent of removing IUR reporting exemptions fo r chemical substances subject to ECA is to gather data on chemical substances for which EP A has demonstrated heightened concern, just as EPA currently does with chemical substances su bject to TSCA section 4 test rules and other regulations.41 Comment D.4-2: One commenter suggested that EPA also remove the 25,000 lb reporting threshold for chemical substances under ECAs, as it proposed for chemical substances regulated by a section 5(a)(2), 5(b) (4), or 6 rule; a 5(e) or 5(f) order; or are subject to relief granted in a civil action under sections 5 or 7.

Source: (0187-0069)

Response D.4-2: At the present time, EPA has not concluded that the benefits of obtaining the information reported under the IUR rule for chemical substances that are the subject of an ECA (or its regulat ory equivalent, a section 4 test rule) are sufficient to justify removing the 25,000 lb reporting threshold for such chemical substances. Furthermore, EPA has concluded that the appropriate modification to the 25,000 lb IUR re porting threshold (in case of a section 4 test rule) is to reduce the reporting th reshold to 2,500 lb, for submission periods after the 2012 submission period, not to eliminate the 25,000 reporting threshold altogether (see response C.3.a). EPA will continue to consider the merits of this suggestion and whether it

should be addressed in future revisions to the IUR rule.

Comment D.4-3: One commenter argued that EPA s hould make available a current list

of affected chemical substances if the proposed lowering of repor ting thresholds and removal of exemptions for ECAs are finalized.

Source: (0187-0104)

Response D.4-3: With respect to a current list of ECAs, the list of chemical substances that are subject to ECAs is publishe d at 40 CFR 799.5000 and 799.5025; new chemical

substances are added to these lists whenever EPA and at least one other pa rty agree to an ECA.

Comment D.4-4: Two commenters were opposed to removing exemptions for chemical substances that are the subject of an ECA; one argued that information submitted under IUR would be unlikely to add value to what EPA alre ady has, and one argued that the standard for creating an ECA is different from the standard for taking regulatory action.

Source: (0187-0098) (0187-0101)

Response D.4-4: EPA disagrees with the commenters who felt that IUR data would not add value to existing information. For chemical substances that are exempted or partially exempted from reporting, EPA receives limited or no regular reporting on production or import volume, worker exposure, or downstream processi ng or use. There is no reason to assume that EPA would get this information through an ECA to conduct testing, and as noted above, the fact that a chemical substance is subject to an ECA i ndicates that EPA has a he ightened interest in it and a greater need for current manufacturing, processing, use, and exposure data. EPA also disagrees with the comment that the circumst ances leading EPA to enter into an ECA are significantly different than those that would lead EPA to promulga te a TSCA section 4 test rule.

ECAs are entered into as an alternative to a test rule, where EPA and the affected manufacturers/processors can agree on the need for and scope of testing. Under the right circumstances, negotiating an ECA can be a more efficient and timely means for EPA to gather42 data that it needs to evaluate the risks posed by the chemical s ubstance under consideration, since EPA does not have to publish formal risk or hazard-based findings, or accomplish other components of the often lengthy rulemaking proce ss. The use of ECAs is not and was never

intended to communicate a lower level of concern about a give n chemical substance, as compared to chemical substances under secti on 4 test rule. By removing IUR exemptions for chemical substances under ECA, these chemical substances are placed on equal footing, for IUR data collection purposes, with chemical substanc es subject to proposed or promulgated TSCA

section 4 test rules.

E. Comments on Specific Data Elements

1. Parent Company and Site Identity

Comment E.1: Two comments were received in support of using the company name, address, and Dun & Bradstreet Number for re porting purposes, and clarifying the meaning of "company name." Respecting the clarificati on, one commenter suggested that the word “ultimate” be removed from the phrase “ultimate domestic parent company” and that instead companies should be allowed to name their domestic company, as is understood within their particular corporate organizati on. The commenter also noted that the intended clarification was not reflected in the actual regulatory text at proposed 40 CFR 711.15(b)(2 ), which only referred to "parent company name."

Source: (0187-0079) (0187-0100)

Response E.1: During the 2006 submission period, submitters indicated that further

clarification was needed to id entify the correct company name for reporting purposes. Based on these previous comments, EPA determined that the parent company’s name, address, and D&B number is necessary to provide clarity as to which company name to use for reporting under the IUR. EPA agrees that further specification of "company name" is appropriate, and that the appropriate name for reporting should be clearl y identified in the ru le, but disagrees that "domestic parent company name" is sufficiently sp ecific. As noted in the proposed rule (Ref. 8), EPA believes that using an approach that is consistent with the TR I reporting requirements would be most clear both for reporters and user s of the data. EPA is therefore amending 40 CFR 711.15(b)(2)(i) to refer to "U.S. parent company name" and defining "U.S. parent company," at 40 CFR 711.3, to mean "the highest level company, located in the United St ates, that directly owns at least 50 percent of th e voting stock of the manufacturer ." The IUR definition of "U.S. parent company name" is consistent with the use of the term of "parent company" in Section 5 of the 2009 Toxic Chemical Release Inventory Repor ting Forms and Instructions (Ref. 23). EPA provides further clarification regarding the correc t domestic (U.S.) parent company name in the

“Instructions for the 2012 Invent ory Update Reporting” (Ref. 9).

2. Technical Contact

Comment E.2: In general, commenters were in favor of allowing multiple technical contacts on a chemical-by-chemical basis. Comm enters stated that allowing multiple technical contacts would afford maximum flexibility for co mpanies to designate who can act as a technical43 contact for a site. Several commenters stated that companies should be able to use their discretion in identifying the most appropriate contact or contacts. They believe that the technical contact need not be physically lo cated at the reporting site, and that information may be more reasonably generated by a corporate contact rather than a technical contact at the production site.

Some commenters said that th e technical contact should be an employee of the submitting

company.

Source: (0187-0364) (0187-0074) (0187- 0062) (0187-0066) (0187-0073) (0187-0078) (0187-0244) (0187-0098) (0187-0358) (0187- 0088) (0187-0079) (0187-0104) (0187- 0100) (0187-0081)

Response E.2: EPA agrees with commenters who stated that companies should use their discretion in selecting a technical contact or mu ltiple technical contacts, as permitted by the new e-IURweb tool. However, EPA believes that a technical contact must be someone who can answer detailed follow-up questions that EP A may have regarding the submission. EPA has

found that technical cont acts not at the reporting site generally are less knowledgeable about the

submission or chemical substance and therefore ma y not be able to discuss follow-up questions. Also, it has been EPA's general experience that short-term contractors have not been suitable technical contacts, because they may no longer be under contract with the submitting company when EPA contacts them a year or more after the submission is made.

3. Correct Chemical Name

a. Imported Chemical Substances and Joint Submissions

Comment E.3.a-1: There were some commenters who were in favor of using an established nomenclature system to standardi ze reporting chemical names for IUR submissions, including joint submissions.

Source: (0187-0244) (0187-0069) (0187-0349) (0187-0100) (0187-0073)

Response E.3.a-1: EPA agrees with these commenters and anticipates that the use of the reporting tool will help to make reporting easier for industry. It will also help to streamline processing of the IUR information submitted to the Agency.

Comment E.3.a-2: One commenter indicated that it w ould be difficult for an importer to require that another party complete a joint subm ission because foreign suppliers are not subject to the same Federal regulations as U.S. companie s, compliance with U.S. regulations is not their top priority, and in some cases they are slow to comply.

Source: (0187-0083)

Response E.3.a-2: EPA agrees with the commenter that the proposed joint submission procedures for importers, which re quired the importer to ensure th at a foreign supplier prepared a secondary submission on its behalf, presented implementation difficulties. This is because, as the commenter suggested, the foreign supplier may not be subject to any direct legal obligation to44 provide the information to EPA. The Agency also notes that this issue extends to the regulations at 40 CFR 711.15(b)(3)(i)(B), as there may be ci rcumstances in which the manufacture of a chemical substance is reportable under the IU R, yet the supplier of a reactant used in manufacturing that chemical substance would not have an independent le gal obligation to report the chemical identity of th e reactant under the IUR.

Therefore, the Agency has modified the regulatory requirements at 40 CFR 711.15(b)(3)(i) to reflect the primary submitter’s underlying obligation to provide what it knows or can reasonably ascertain resp ecting the identity of a chemical substance subject to reporting. The joint submission requi rement is no longer to ensure that suppliers provide secondary submissions to EPA, but to properly ask that they do so. Consistent with 40 CFR 711.15(b)(3)(i), a request for a secondary submission to EPA must be prepared using e-IURweb, include instructions for electronically submitting the info rmation to EPA, and explain how to provide a clear reference to the primary su bmission. Documentation of the requ est to the supplier must be submitted to EPA along with the re st of the primary submission.

Finally, EPA has also modified the regulatory requirements to more clearly reflect, see proposed rule (Ref. 8), that they only apply in cases where a supplier will not reveal the pertinent chemical identity information to the submitter. In the event that a manufacturer (including importer) actually knows the chemi cal identity of a chemical s ubstance subject to IUR reporting, the manufacturer must provide that information irrespective of a supplier’s confidentiality

claims. EPA has modified the substantiation question at 40 CFR 711.30(b)(1)(i) to include information about harm to the submitter’s comp etitive position “or to your supplier’s competitive position.”

Comment E.3.a-3: One commenter stated that in any case in which a foreign company would need to report information to EPA, elect ronic submission must not be required, and that the CDX access and authorization process is likely to be an insurmountable barrier to non-U.S. companies.

Source: (0187-0079)

Response E.3.a-3: : As noted in Response E.3.a-2, th e joint submission requirement is no longer to ensure that foreign suppliers provide secondary submi ssions to EPA, but to properly ask that they do so. EPA will only accept electroni c submissions from foreign suppliers using eIURweb and CDX. For the following reasons, EPA does not expect that th e electronic reporting requirement will be an insurmountable obsta cle to reporting by non-U.S. companies.

The Agency’s CDX system and the e-IURweb tool are designed to allow the foreign supplier to register with CDX a nd report their proprietary chemical identity information without revealing any of the propr ietary information to the importer. Fu rthermore, it should be noted that, as part of the electronic reporting process, submitte rs will be able to easily connect electronically from the IUR reporting tool directly to the Agen cy's SRS database in order to obtain CA Index Names and corresponding CASRNs, for all of thei r non-confidential chemical substances, and generic chemical names and Accession Numbers, for their confidential chemical substances, on the TSCA Inventory. These data can then be elec tronically copied back to the IUR reporting tool.45 The use of the SRS to obtain the chemical ident ity information for all IUR reportable chemical substances will thus be a convenient way to me et the chemical nomenclature requirement, will prevent the need to use either a fee-based service or another method to obtain this type of nomenclature, and should reduce many errors in th e reporting of chemical names for the IUR.

As stated earlier in this document, EPA w ill be conducting at least one webinar that will

demonstrate the use of the final web-based tool and provide any needed technical assistance. Also, there will be opportunities for companies, in cluding foreign ones, to gain experience with the tool and provide comments as the Agency pr ovides beta testing opportunities designed to further refine and enhance the reporting tool, including the XML schema. Foreign submitters are expected to be able to report their supporting chemical identity information using the e-IURweb reporting tool and CDX.

b. Reporting IUPAC Names As An Alternate

Comment E.3.b: A commenter recommende d allowing IUPAC names as a substitute for

CA Index Names for discrete chemical substa nces, because the IUPAC nomenclature provides the exact chemical structure and American companies should not be forced by the federal government to go through a particular fee-based se rvice to obtain names for chemical substances.

Source: (0187-0101)

Response E.3.b: The Agency disagrees that IUPAC names should be allowed as a substitute for Chemical Abstracts (CA) Index Na mes in reporting discrete chemical substances

for the IUR. Chemical substances are listed on the TSCA Inventory using CA Index Names, and only chemical substances listed on the TSCA Inventory are to be reported for IUR. The requirement for using CA Index Names is dir ectly related to positively identifying the listed TSCA Inventory chemical substance. Using a different nomenclature for the purposes of reporting for IUR could create confus ion, both for Industry and for EPA.

Additionally, there will generally be no need fo r submitters to use a fee-based service to obtain the CA Index Name and corresponding CA SRN for IUR reporting purposes. As part of the electronic reporting process for the IUR, submitters will be able to easily connect electronically from the e-IURweb reporting tool directly to the Ag ency's SRS database in order to obtain CA Index Names and corresponding CASRNs, for all of their non-confidential chemical substances, and generic chemical name s and Accession Numbers, for their confidential chemical substances, on the TSCA Inventory. These data can then be electronically copied back to the IUR reporting tool.

c. Eliminate the PMN Number As An Allowed Identifying Number

Comment E.3.c: Some commenters were opposed to removing the PMN number as an allowed identifying number, sugges ting that the Agency might be inundated with requests for Accession Numbers, and that for historical pr oducts, this may pose an extra burden for both industry and EPA. It was suggest ed that the Agency provide a cross-reference list of PMN46 numbers to Accession Numbers so that the inform ation can be easily obtained without additional burden on industry and the Agency.

Source: (0187-0358) (0187-0244) (0187-0364)

Response E.3.c: The Agency does not believe that there would be any significant burden on industry or EPA to require the reporting of Accession Numbers and to remove the PMN case number as an allowed identifying number for IUR reporting. The Agency has added PMN case numbers to the SRS listing to provide a cross-re ference list, as suggested by the commenters. The e-IURweb reporting tool allows the user to search SRS using the PMN case number to populate the pertinent chemical identification info rmation for confidential chemical substances listed on the TSCA Inventory. In the SRS, a submitte r can readily find a cross-reference list that can display the Accession Number, generic chemical name, and the PMN case number (or for an initial TSCA Inventory substance, the Inventor y reporting form number) for any confidential chemical substance listed on the TSCA Inventory. An IUR submitter can then select the correct combination of Accession Number and generic ch emical name corresponding to the confidential chemical substance intended to be reported.

There are certain circumstances where a subm itter occasionally may not be sure of the particular PMN case number and Accession Numb er the Agency has assigned to one of its confidential chemical substances, such that th e submitter would not be able to definitely determine this solely from searching in the SRS. This could happen, for example, if the chemical substance were originally reported as part of a consolidated PMN and the submitter did not learn from EPA which particular case number in the consolidated PMN number sequence corresponds to which of the several reported confidential chem ical substances. This could also happen if a certain PMN represented a mixture of two or more conf idential chemical substances, such that multiple Accession Numbers were assigned to the diffe rent chemical substances reported in that single PMN, and the submitter didn't already request the particular Accession Numbers from

EPA for the individual chemical substances co mprising that multi-component type of PMN. In such circumstances, a submitter should contac t EPA well before initiating IUR reporting, to obtain the required Accession Numbers from th e Agency. The Agency will respond to such inquiries in as timely a manner as possible. It is the responsibility of th e submitter to contact the Agency for such information in sufficient tim e to allow for the Agency to respond. Detailed instructions on how to submit an Inventory Corr espondence is available in the “Instructions for the 2012 TSCA Inventory Update Reporting” (Ref. 9).

4. Production Volume for Each Year since Last Principal Reporting Year

a. Justification for Data

Comment E.4.a: Several commenters supported the change to have submitters report the production volume for each year since the last principal reporting year. One commenter stated that the modification would eliminate gaps and uncertainties in the information collected under the current IUR that result from infrequent collec tions and reporting of data. Another felt that the requirement would keep manufacturers from di sguising their actual out put by producing certain specialty chemical substances only in years th at are not currently s ubject to IUR reporting.47 Finally, one commenter stated that because ch emical volume information is already being collected, analyzed, and made public for investor s, it should be utilized by EPA and made available to the public in a usef ul format to ensure the protection of the environment and human

health.

Other commenters stated that EPA did not provide a strong ju stification for the need for

the additional data and has not demonstrated th e practical utility of production volume for multiple years, above and beyond the usefulness of data for a single year. One commenter said EPA has not demonstrated how annual reporti ng of production would be used in a risk assessment process, other than general trend analysis. Others felt the additional information

would be of little value.

Source: (0187-0035) (0187-0069) (0187- 0349) (0187-0100) (0187-0096) (0187-0292) (0187-0101) (0187-0059) (0187-0352) (0187- 0359) (0187-0081) (0187-0055) (0187- 0090) (0187-0056) (018 7-0067) (0187-0101)

Response E.4.a: EPA is making this change because of the mounting evidence that many chemical substances, even larger volume ch emical substances, often experience wide fluctuations in manufacturing volume from year to year; however, as discussed below, EPA will be phasing in this change in 2016. Only 2010 and 2011 production volume information will be required in the 2012 submission period. Production volume information on all prior years since the last reporting year will not be required until the 2016 submission period. As discussed in Unit V. of the proposed rule, EPA uses production volume data in several important ways. The data help the Agency to establish trends in ch emical substance manufacturing; to determine the effectiveness of various Agency and other prog rams; to estimate the magnitude of consumer, worker, and environmental exposures; and to de termine the costs (and fi nancial impacts) of potential control strategies in economic analyses. As discussed in Unit III.D.2 of the final rule, the collection of annual production volume data w ould allow EPA to identify more consistently HPV chemical substances. Voluntary EPA program s such as Design for the Environment (DfE) and other pollution prevention programs would use the annua l production volume data to identify trends and program performance. Re lying on a single snapshot of annual production volume in each reporting cycle hampers EPA’s ab ility to identify the programs and techniques that are most effective, using measurable, readily identifiable production trend data.

b. Insufficient Time to Collect Data

Comment E.4.b: Most commenters stated that compan ies were prepared to compile and report information for the 2010 IUR reporting year ; some companies indicated, however, that they had not established systems to collect and compile information for 2006-2009. Several commenters recommended that EPA delay the impl ementation of the reporting requirement until the next reporting cycle to allow companies suffi cient time to prepare for the additional data

collection effort. One commenter was concerned th at the short period of time given by EPA to collect the information will result in significantl y decreased data quality and reliability. Another commenter said that most companies archive da ta after 18-24 months. Some found it confusing

that the threshold to de termine the need to report in th e 2015 cycle would change to include48 production data from previous y ears, but that the reporting of production data from previous years would take effect in the 2011 cycle.

Source: (0187-0066) (0187-0079) (0187- 0244) (0187-0104) (0187-0364) (0187-0353) (0187-0087) (0187-0096) (0187-0091) (0187- 0050) (0187-0059) (0187-0064) (0187- 0083) (0187-0354) (0187-0073) (0 187-0092) (0187-0352) (0187-0058)

Response E.4.b

. EPA acknowledges the possibility that certain information respecting past production volume, for the years between 20 06 and 2009 might not have been known to or reasonably ascertainable to a submitter in 2011. EP A notes that the applicable submission period

has since been moved from 2011 to 2012. With respect to the 2012 submission period, while submitters are free to designate as “not known or reasonably ascertainable” any information that has indeed passed out of the scope of reporting due to the passage of time, EPA has determined it is nevertheless appropriate to re duce the extent to which submitter s will need to resort to such designations, and to focus on more recent production (i.e., 2010 and 2011 production volume) in the first submission period after the finalization of this rule (i.e., the 2012 submission period). EPA believes that phasing in th e reporting of past production volumes as follows will both improve the quality of the information collect ed and reduce the burde n of collecting it.

Based on the comments received, EPA is re quiring that for the 2012 submission period, manufacturers (including importers) are required to report the total annual volume (domestically manufactured and imported volumes in pounds) of each reportable chemical substance at each site during the calendar years 2010 and 2011. For submission periods subsequent to the 2012 submission period, the total annual volume (domes tically manufactured and imported volumes in pounds) of each reportable chemical substance at each site for each complete calendar year since the last principal reporti ng year are required to be reported. EP A believes its decision to require the reporting of 2010 production vo lumes in the 2012 submission peri od is consistent with the comments noting that companies were prepared to report 2010 data, and that the Agency’s decision to phase in reporting for each complete calendar year since the last principal reporting year is warranted in light of other simultane ous changes to the IUR rule which increased reporting burden. The Agency also believes the delay to report the production volume for each year since the last principal reporting year will give companies adequate time to establish systems to collect and comp ile the required information.

c. Reporting Burden

Comment E.4.c-1: Several commenters stated th at the requirement is overly burdensome, especially for chemical importe rs and manufacturers w ho (according to the commenters) will need to analyze all products to track the volumes of all component chemical substances. Another commenter acknowledges that while the burden of reporting the data for each principal reporting year was minor, the inform ation would be of little value to the Agency. On the other hand, one commenter stated that th e requirement could increase the burden by at

least three fold. Another commenter said that in some cases, businesses have no need to capture past production volumes.49 Source: (0187-0358) (0187-0074) (0187- 0364) (0187-0355) (0187-0087) (0187-0096) (0187-0098) (0187-0062) (0187-0091) (0187- 0099) (0187-0063) (0187-0083) (0187- 0084) (0187-0101) (0187-0073) (0187- 0051) (0187-0352) (0187-0067) (0187-0055) (0187-0103)

Response E.4.c-1: EPA’s burden estimates represent the average burden across all sites for providing production volumes. As such, commen ters should be aware that their particular circumstance may not be average and, therefore, the estimate may not accurately reflect their own, individual, circumstances. However, EPA is confident that the estimate does reflect the average burden across all sites and encompasses the range of burdens faced by submitters.

In addition, some comments identified a mi sunderstanding of the reporting requirements with respect to byproducts. As described elsewher e in this Unit, accoun ting for the manufacture of a byproduct does not necessarily entail accoun ting for each individual component chemical substance in the byproduct. See the more detailed discussion of issues related to byproducts in Unit F.3. The Agency does expect that the burden of reporting this information will decrease in reporting cycles beyond 2012, as submitters put a dditional recordkeeping procedures into practice. For additional discussion of the repo rting burden, please see the Economic Analysis (Ref. 15).

Comment E.4.c-2: One commenter asserted that many companies will consider the production volume in every year to be CBI and will take the necessary steps to request CBI coverage of this information. The information will still be available to EPA for consideration, but the burden on EPA of keeping the information conf idential will increase substantially due to the potential number of CBI claims.

Source: (0187-0068)

Response E.4.c-2: As with any data element, CBI claims should only be made when warranted. While more CBI claims may increase EPA’s burden slightly, the Economic Analysis estimates the amendments will save EPA approxi mately $68,000 in the first reporting year and $175,000 in subsequent reporting cycl es through efficiencies from electronic reporting. CBI claims on production volumes are unlikely to create any significant burden beyond what is estimated in the Economic Analysis (Ref. 15) . CBI claims do, however , prevent valuable

information about chemical substance manufact ure (including import) from becoming publicly

available.

d. Retroactive Reporting

Comment E.4.d: Several commenters expressed concerns asserting that EPA retroactively is requiri ng historical data and that the requi rement for past production information was beyond the scope of EPA’s TSCA authority for IUR reporting. Another commenter said it was not feasible to accurately produce this hi storical data for the many byproducts that companies produce and send for recycling, primarily because manufacturers did not know they needed to have such data ga thering mechanisms in place.50 Source: (0187-0244) (0187-0358) (0187- 0292) (0187-0064) (0187-0099) (0187-0073) (0187-0340) (0187-0084)

Response E.4.d: EPA disagrees with commenters’ s uggestion that reporting information on past production constitutes an imposition of retroactive reporting requirements. This is

because the final rule does not establish a new le gal requirement to have taken some particular recordkeeping action in the past. Instead, it ho lds submitters to a prospective standard of reasonableness. To the extent that a particular piece of information about the past is indeed not known or reasonably ascertainable at the time th at a person is obligated to make a submission (either because of the timing of a change in the reporting requirements or for some other reason), the submitter may simply indicate that the information is “not known or reasonably

ascertainable.”

e. Alternate Approaches

Comment E.4.e: A few commenters suggested that the burden would be reduced if companies reported in ranges or provided best estimates. Other commenters suggested that reporting be limited to a subset of industries or chemical substances, based on criteria to focus on

data collection and evaluation activities that ar e more valuable to the Agency. Examples of

criteria include chemical substances with a hist ory of fluctuations in chemical manufacture and import practices or chemical substan ces that are considered hazardous.

Source: (0187-0085) (0187-0074) (0187- 0244) (0187-0080) (0187-0292) (0187-0079) (0187-0104) (0187-0353) (0187-0096) (0187- 0060) (0187-0062) (0187-0091) (0187- 0050) (0187-0059) (0187-0083) (0187- 0354) (0187-0073) (0187-0051) (0187-0092) (0187-0058) (0187-0057) (0187-0063) (0187- 0055) (0187-0075) (0187-0056) (0187- 0051) (0187-0090)

Response E.4.e: EPA disagrees that re porting production volume in ranges or estimates would provide data of comparable value. Thoug h EPA requires some of the IUR information to be reported in specified ranges, EPA sees lit tle value in allowing submitters to report the production volumes in ranges. Similarly, EPA sees little value in allowing submitters to provide

estimates that do not reflect a ll information known or reasonably ascertainable. EPA believes that a higher level of confidence in data accuracy will be achieved by requiring specific numeric

data that reflect all information known or r easonably ascertainable to the submitter.

EPA disagrees with the suggesti on that reporting be limited to a subset of industries or

chemical substances. The IUR data are used extensively in the Agency’s screening and prioritization process. As such, identifying a list of chemicals or industr ies prior to screening would not provide EPA with the data needed for its programs and defeats the purpose of collecting the data. EPA does not believe it practicable to provid e a definitive list of chemical substances with a “known history of fluctuatio ns.” The Agency does not have such a list, and believes that because year to year fluctuation could be caused by such a wide variety of circumstances, including circumstances such as economic changes and manufacturing practices, that developing and maintaining such a list is not only not practicable, but c onfining that list to51 substances with a “history” of fl uctuations would not capture the i ndustry variability that EPA is seeking.

It is important to note that EPA is interested in use and other expos ure-related data on all chemical substances that are not exempted from IUR reporting, and manufacturing exposurerelated data on partially exempted chemical substa nces. Especially since there is a multi-year gap between IUR submission periods, the mere fact th at a chemical substance is not known to be

hazardous at this time does not mean that EPA is not interested in exposures and uses of that chemical substance. Under a contrary policy, EP A would potentially need to wait several years before obtaining the basic exposure informati on necessary to determine whether a hazardous chemical substance may present an unreasonable risk (since the collectio n of screening-level exposure information would not be triggered unt il hazard data had been assessed). In summary, after considering the su ggestions, EPA believes its decision to collect multi-year production volume starting with the 2016 IUR submission period is still sound.

f. Divestitures and Acquisitions

Comment E.4.f: Commenters recommended that EP A clarify how the responsibility will be assigned for reporting chemical substa nce manufacture and import activities for entities that will be acquired or divest ed. One commenter noted that the current owner of a newly acquired facility may not have access to manufact ure/import volume information for years before they acquired the facility. Anothe r commenter indicated that exemptions should be provided for any company engaged in an acquisition or divest iture during the years si nce the last reporting cycle.

Source: (0187-0066) (0187-0074) (0187-0244)

Response E.4.f: The “Instructions for the 2012 TSCA Inventory Update Reporting” contains information regarding reporting in th e event of a change in ownership (Ref. 9). Reporting should be based on ownership of the manu facturing entity, as of the date that the report is submitted. EPA acknowledges, in any even t, that there will be submitters for whom certain information is not known or reasonably as certainable because of a change in ownership. If information is not known or reasonably ascertai nable, it need not be reported under the IUR. EPA is not persuaded that there is a justifica tion to further relax the reporting standard (i.e., exempt companies from reporting information th at could be uncovered by reasonable inquiry) merely because a company has recently undergone a change of ownership or other restructuring.

g. Imported Mixtures

Comment E.4.g: Commenters raised concerns about the time and resources needed to report component chemical substances that ar e included in imported product mixtures. One

commenter stated that the formulations of thes e imported product mixtures can change from one year to another. Thus, IT systems would need to “lock in year-by-year product composition data for imported chemical substances so that each ye ar’s total material import record can yield an accurate aggregate record of each imported chem ical substance. Other commenters said that since the same chemical substance can be presen t in multiple products, all products will need to52 be assessed and the volumes totaled to determ ine if the reporting threshold has been met. Another commenter said that many imports ar e multi-component mixtures and determining whether any single chemical substance has been imported at a volume above the threshold for reporting requires that every im port must be broken down into its component chemical substances, the volume of each chemical substa nce calculated, and the total volume of each chemical substance summed across all imports containing the chemical substance.

Source: (0187-0062) (0187-0073) (0187- 0074) (0187-0098) (0187-0358) (0187-0359)

Response E.4.g: EPA recognizes that it may be diffi cult, in certain circumstances, for importers to determine the processing and use in formation for component chemical substances in imported products. EPA also notes that the IU R rule does not requir e importers to report information that is not known or reasonably ascer tainable to them. However, EPA believes that importers are likely already accustomed to repor ting chemical-specific information to EPA, because the Agency has always sought informa tion on individual chemical substances under the IUR and other TSCA regulations. EPA believes th at instances where this information is not known or reasonably ascertainable will decline subs tantially for reporting periods subsequent to 2012 as additional recordkeeping pr ocedures are established. EPA al so notes various features of the IUR (including features that were modified or clarified based on comment from importers) that mitigate importers’ burden to report pr oduct composition information. See Response C.3.b1.

5. Volume Used at the Reporting Site

Comment E.5-1: One commenter stated that this data element was essential to improving accuracy and utility of the reported production volume information. Two commenters stated they thought there was no value in this data element and that the Agency should retain the site-limited check box because, the commenters st ated, it was more informative for screeninglevel risk assessment. Five commenters expre ssed confusion about the requirements of reporting this data element. Specific concerns included a concern about duplicative reporting for this data element and the industrial proces sing and use information for chemical substances used on-site; whether this applied to chemical s ubstances used in synthesis or al so to chemical substances that were repackaged; and the need to identify the amount of a chemical substance present on site during a specific time period.

Source: (0187-0244) (0187-0079) (00187-364) (0187-0090) (00187-0069) (00187-0056) (00187-0101) (00187-0073) (00187-0352) (00187-0094)

Response E.5-1: EPA agrees with the commenter w ho felt that reporting volumes of

chemical substance used at a site will increa se the accuracy and utility of the IUR reporting information. Reporting the volume used on-site provides valuable information related to potential exposures associated with the on-si te volumes, providing the Agency with better information for exposure assessments. The usefulness of this IUR data element has been demonstrated by EPA’s use of similar data in the New Chemicals Program. PMNs for new

chemical substances submitted to EPA under TSCA section 5 require many of the same exposure-related data elements that will be re ported under the IUR. Exposure-related data in53 PMNs include estimates of production volume, cat egories of use, percent production volume in the categories of use, maximum numbers of wo rkers exposed, and concentrations and physical

forms of the chemical substance. EPA uses thes e exposure-related data to generate screeninglevel risk assessments for regulatory deci sion making under TSCA section 5. The reporting obligation and the phrase “site us e” applies to all nonexempt chemical substances produced for commercial purposes that ar e on the TSCA inventory.

Some of the commenters have misunderstood this data element, which provides more

detailed and clearer information than did th e previous site-limited check box. Previously, submitters checked a box to indicate that a reported chemical substance was site limited – in other words, that it was both manufactured and used on the site. Some submitters misreported, identifying an imported chemical substance as site -limited (a situation that is not possible) or reporting the same chemical substance twice, once for the volume that is site limited and once

for the volume that is sent off site. Because of this confusion, EPA replaced the site-limited check box with reporting the volume of the ch emical production volume reported on the form that is used on the site. For example, if 50,000 lb of a chemical substance was manufactured and used on the same site, the submitter would re port 50,000 lb for domestically manufactured and 50,000 lb for the volume used on-site. If 70,000 lb of a chemical substance was manufactured, 25,000 lb was used on-site and 45,000 lb was shipped to a different site, the submitter would report 70,000 lb for domestically manufactured a nd 25,000 lb for the volume used on-site. If a site imported 30,000 lb and used it at the impor t site, the submitter would report 30,000 lb for imported production volume and 30,000 lb for the volume used on-site. If a site imported 100,000 lb and shipped it to an alternate site , the submitter would report 100,000 lb or imported production volume and 0 lb for the volume used on-site. As these examples illustrate, the submitter is not identifying the amount of a chem ical substance on-site during a particular time period, but rather the amount of a chemical substa nce that is manufactur ed (including imported)

and used at the same site.

Commenters also asked for clarification regard ing the activities considered to be “used at the reporting site.” For a domes tically manufactured chemical s ubstance, if the volume would have been considered to be site-limited, then the chemical substance is used on site. If the chemical substance is domestically manufactur ed, temporarily stored, and then packaged for shipment off of the site, that volume would not be considered “used at th e reporting site.” For an imported chemical substance, any use at the im porting site, including for repackaging, would be considered “used at the reporting site.”

EPA does not believe reporting the porti on of the production volume that is both

manufactured and used on site will result in dupl icative reporting. Even wi th the previous sitelimited check box, submitters provided information a bout the use of a chemical substance in both the manufacturing and industrial processing a nd use sections of the IUR Form U. The information reported under the manufacturing secti on identifies that this chemical substance is processed or used at that partic ular site and identifies the number of workers associated with the

manufacture of that chemical substance. In th e same report, the information reported under the industrial processing and use sect ion provides more details about how the chemical substance is processed or use. In the event that a chemi cal substance has a use identified by the same54 combination of use, function, and sector code by another site, the production volumes, sites, and

workers would be combined with the information describing the other sites’ processing or uses.

6. Whether an Imported Chemical Substance is Physically Present at Reporting Site

Comment E.6-1: One commenter who supported the re quirement stated that these additional data will improve the Agency's ab ility to estimate the portion of the production volume that is relevant with respect to associ ated processing and use information. Those opposed questioned the need and utility for this info rmation stating that it provides no relevant information for use in risk screening purposes . One commenter stated that determining the

volume of chemical substances used in domestic vs. exported paint and coatings products will require new data collection processes and w ill not be possible for the 2010 reporting year.

Source: (0187-0069) (0187- 0065) (0187-0244) (0187-0364)

Response E.6-1: Identifying whether an imported chemi cal substance is physically at the reporting site will improve the Agency's ability to estimate the portion of the production volume

that is associated with on-site processing and use. Often, the site reporting an imported chemical substance never physically receives the chemical substance, but instead ships it directly to

another location such as a warehous e, a processing or use site, or a customer’s site. Therefore, identifying whether the chemical substance is physically at the repor ting site provides more accurate information about who might be potenti ally exposed for screening-level exposure assessments and other analyses. EPA notes that the submission period (for reporting on 2010 and 2011 production volume data) has been deferre d until 2012. EPA acknowledges that for those whose information collection systems will not be ready to collect this information until after 2012, this data element may not be reasonably ascertainable in the 2012 submission period.

7. Volume Directly Exported and Not Domestically Processed or Used

Comment E.7-1: EPA received comments regardi ng making the production volume directly exported and not domestically processed or used a required data element. Those in favor

said that it was essential to increasing the accuracy and utili ty of reporting production/import

volume information and should be included in the reporting. Those opposed felt that obtaining and tracking this information would be difficult; having this information would not significantly enhance the information the Agency requires for chemical substances used domestically and would most likely result in an increase in report ing resources not proportional to the benefit; and capturing volumes for each chemical substance in exported products (mixtures) would be

resource-intensive and internal systems would need to be si gnificantly redesigned to track. Others were in support of reporting export volumes , but felt it should be considered or required in the next reporting cycle.

Source: (0187-0358) (0187-0244) (0187- 0080) (0187-0065) (0187-0079) (0187-0364) (0187-0090) (0187-0086) (0187-0098) (0187- 0062) (0187-0069) (0187-0056) (0187- 0059) (0187-0063) (0187-0101) (0187-0073) (0187-0092)55 Response E.7-1: The comments stating that capturing volumes for each chemical substance in each exported product is difficult and burdensome indicate a misunderstanding of the reporting requirement. EPA believes that a better understanding will eliminate those

concerns. For the chemical substance that was manufactured and is being reported, the submitter is to report the volume of that chemical substanc e that is directly expo rted. If the chemical substance is processed in any wa y (e.g., combined with other subs tances to form a mixture), the chemical substance is not directly exported. Also, if a chemical is sent to a distributor who then exports it, the chemical is not directly exported. In both of these examples, the manufacturer would instead report either the pr ocessing to form a mixture or th e transfer to a distributor under the processing and use portion of the IU R reporting form. “Directly Exported” and “Domestically Processed or Used” are mutually exclusive designations; only one designation applies to any particular por tion of the production volume.

EPA’s proposal to make the production volum e that is directly exported and not domestically processed or used a required data element will increase the accuracy and value of

the IUR data. This will allow EPA to better identify the proportion of the production volume accounted for by the use reporting, given that the downstream reporting is not required for exported chemical substances. Additionally, in many cases manufacturers have a mechanism to track quantity shipped domestically versus internationally, so reporting these figures to EPA will not pose a significant burden to these parties. For reasons similar to those stated above for other reporting requirements, in sections A.2 and C.3.a, EPA disagrees th at it is necessary or desirable to delay implementation of this reporting requi rement until a later reporting period. EPA notes that if particular information is not known or reasonably ascertainable to the submitter, it need not be reported under the IUR.

Comment E.7-2: One commenter suggested that EPA c onsider an option in which export volumes are reported as a use code in Part III of Form U. This approach would better reflect how information is stored and accessible in company computer programs.

Source: (0187-0244)

Response E.7-2: EPA does not think that “export” s hould be considered a use of a chemical substance. Under the IUR rule, industrial us e is defined as “use at a site at which one or

more chemical substances or mixtures are ma nufactured (including imported) or processed.” Information reported in Part III of IUR Form U pert ains to use at a site within the United States and does not include any use at a foreign location. The Agency is asking submitters to report the

volume of the chemical substance directly exported which is not domestically processed or used

in the United States to unders tand the distribution of the total volume of the chemical substance

in commerce.

Comment E.7-3: One commenter stated that they manu facture chemical substances that are formulated into consumer products prior to distribution across Nort h America (including US, Canada, and Mexico). The commenter believes the IUR proposal is unclear as to whether a

manufactured chemical substance that under goes further processing and formulation into finished consumer products is included within the scope of the proposed reporting requirement.56 Source: (0187-0092)

Response E.7-3: For the chemical substance that was manufactured and is being reported, the submitter is to report the volume of that chemical substance that is directly exported. If the chemical substan ce is processed in any way (e.g., combined with other chemical substances to form a mixture), the chemical s ubstance is not directly exported. Also, if a

chemical substance is sent to a distributor who then exports it, the chemical substance is not directly exported. In both of these examples, th e manufacturer would inst ead report either the processing to form a mixture or the transfer to a distributor u nder the processing and use portion of the IUR reporting form. In other words, a chemi cal substance that is directly exported is not domestically processed or used, and therefore such volumes should be reported either as directly exported or as processe d or used (not both).

8. Identify Whether A Chemical Substan ce is Being Recycled, Remanufactured, Reprocessed, or Reused

Comment E.8-1: EPA received several comments on the proposal to add a checkbox indicating whether a manufactured chemical subs tance was or is expected to be recycled, including remanufactured, repr ocessed, reused, or reworked. Some commenters were supportive of adding this reporting element, but several of the commenters were concerned that the term “recycle” has been difficult to define in othe r programs, indicated confusion about EPA’s purpose in including the checkbox, and expressed doubt that this data element would yield useful

information. Others did not think the value to the information was proportional to the effort needed to collect it. Some thought that the requirement would serve as a disincentive to responsible manufacturers who recy cle their chemical substances.

Source: (0187-0100) (0187-0340) (0187- 0359) (0187-0244) (0187-0079) (0187-0098) (0187-0062) (0187-0059) (0187-0103) (0187- 0083) (0187-0354) (0187-0101) (0187- 0073) (0187-0072) (0187-0359) (0187-0081) (0187-0094)

Response E.8-1: EPA intends that this checkbox woul d be used by manufacturers to indicate whether a chemical substance they manufactured, such as a byproduct, which might otherwise be disposed of as waste, was or is expected to be recycled. EPA also included the terms remanufactured, reprocessed, reused, or re worked, intending to capture a broad array of similar, and perhaps synonym ous, activities by which a chem ical substance (that would otherwise be disposed of as waste) may be put to use. EPA is interested in the exposures from these activities, and believes that having more information about which chemical substances are being recycled will help the Agency to refine future IUR reporting requirements (i.e., if EPA knows enough about exposures from an on-site recy cling use, EPA might consider an exemption in the future).

EPA also believes that this information would help the Agency to identify where this activity is already occurr ing, and could be used to recognize companies, industries, and sectors that are using “green” practices. This informati on would also help to identify sectors where recycling is not occurring, providi ng useful data to measure the effectiveness of various EPA programs, such as the Resource Conservation Challenge (RCC) Program, and informing other57 Agency efforts to encourage prac tices that reduce waste. EPA disa grees that a precise definition of “recycle” is needed to make this data element useful for th e purposes that EPA has identified. Submitters should simply indicate, to the extent that they know or can reasonably ascertain, whether the reported volume of the chemical s ubstance that they manu factured, which would otherwise be disposed of as waste, was or is expected to be recycled, remanufactured, reprocessed, or reused, as those terms are understood by the submitter.

Comment E.8-2: One commenter indicated that many chemical substances are “reworked” in many industrial proce sses, at least at some point, so this box would be checked so often that it would provide little meaningful data.

Source: (0187-0364)

Response E.8-2: EPA agrees that the term may be in terpreted and applied too broadly to provide the type of information that EPA is trying to collect, so has removed “reworked” from the list of recycling synonyms.

Comment E.8-3: Two commenters expressed concern th at revealing whether a chemical substance they manufactured was recycled w ould reveal sensitive in tellectual property or

confidential business information.

Source: (0187-0083) (0187-0098)

Response E.8.3: In such a situation, the submitter will be able to claim the information as

confidential.

Comment E.8.4: One commenter suggested that EPA collect information about recycling under a separate rule.

Source: (0187-0062)

Response E.8.4: EPA disagrees that this would be an efficient way to collect the desired information. A separate rulemaking for one “yes or no” data elemen t would be extremely inefficient and needlessly time-consuming for bot h the Agency and industry, particularly when the IUR rule already provides a suitable vehicle to collect chemical substance manufacturing, processing, and use information.

9. Concentration Ranges

Comment E.9: The Agency received one comment in favor of eliminating gaps in the ranges used to report concentration.

Source: (0187-0079)

Response E.9: EPA agrees with the commenter and has finalized the change as proposed.58 10. Industrial Processing and Use Information

a. Industrial Function Categories

Comment E.10.a-1: The Agency received several comm ents regarding revising the list of industrial function categories for processing and use information. Some commenters were in favor of the revised categories and supported EPA’s efforts to work collaboratively with Canada to align the categories. One commenter said the improvements increase information that characterizes the frequency, rout e, and duration of exposure to chemical substances during manufacture, processing, and use of the chemi cal substances. This type of information is necessary for state pollution prevention technical assistance programs to help evaluate pollution prevention opportunities and re duced worker exposures.

Other commenters said it would require addi tional effort by the regulated community to assign the new codes, and a clear explanation of the ch anges with the repor ting instructions, e.g.,

a “read across” of old and new codes. Assi gning new codes would al so require additional definitions to ensure that activities are consistently coded across companies and providing a description for “other” will be challenging, may not provide useful information (e.g., lack of information from the downstream customers), and would require additional man-hours.

Source: (0187-0074) (0187-0080) (0187- 0079) (0187-0104) (0187-0364) (0187-0083) (0187-0101) (0187-0100) (0187-0073) (0187-0352) (0187-0094)

Response E.10.a-1: Submitters will be required to report unique combinations of processing and use (P/U) categories, industrial fu nction categories (IFCs), and industrial sector (IS) categories. In selecting th e proper IFC, submitters must determine for each reportable chemical substance which IFC best represents th e industrial use for a given P/U and IS category.

EPA worked with Environment Canada and Health Canada to develop the proposed set of IFC codes, which would be used by both the Unite d States and Canada for IUR reporting. EPA agrees with commenters who felt that harmonizati on of the categories for reporting the industrial

functions of chemical substances would facilita te the exchange of information between EPA and Canadian agencies In addition, the harmonized cate gories would faci litate consistent reporting of chemical substance use information by indus try in the United St ates and Canada.

EPA agrees with the commenters that a tabl e indicating the relati onship between the 2006

IFC codes and the new 2012 IFC codes would be us eful, along with clear definitions for each

code. The “Instructions for the 2012 TSCA Invent ory Update Reporting” contains a crosswalk between the 2006 IFC codes and proposed 2012 IFC codes to clearly identify the changes to reporting (Ref. 9). EPA also recognizes the conc ern for including the “U999 Other” IFC code. EPA will require submitters to choose from am ong the IFC codes provided at section 40 CFR 711.15(b)(4)(ii), including the "U999 Other" category.

EPA also recognizes that the requirement to report a description when the submitter selects the IFC code “Other” may be more burdens ome than for the other IFC codes, but expects any increase to be minor. The descriptive informati on is essential to enable users of the data to59 estimate potential exposures associ ated with the overall proce ssing or use of the chemical substance, of which the function is an importa nt component. The Agency’s experience with the 2006 IUR data was that the category of “other,” with no further description, was insufficient for the data to be of much use. Although EPA’s de sire is to limit the number of scenarios which must be analyzed for risk characterization, re quiring submitters to supply a written description for “Other” will help EPA evaluate and improve the list of IFC codes in the future, including those applicable to inorga nic chemical substances.

Comment E.10.a-2: One commenter cited unclear definitions of "industrial," "commercial," "function," and "use," and refe rred to problems in reporting both product- and

substance-level information.

Source: (0187-0364)

Response E.10.a-2: The terms “industrial use” and “commercial use” are adequately defined in the regulations. EPA defines industrial function as “the intende d physical or chemical

characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, or ar ticle; repackaged; or used.” This definition can

be found in 40 CFR 711.3. EPA also notes that the terms “use,” “industrial use,” “consumer use,” and “commercial use” have already been in use for IUR, and were previously defined in 40 CFR Part 710 (relocated in the final rule to 711.3). In the final rule, EPA modified the definitions

of the terms “consumer use” and “commercial use” to make them more consistent with the definitions developed collaborativel y by the United States and Canada.

Comment E.10.a-3: One commenter felt that the list of industrial function category codes is too limited and appears to apply for the most part to ch emical substances in liquid or gaseous form. This commenter recommended that, for the 2012 and future IUR reporting cycles, the Agency add an Industrial Function Category code for “Solid Manufacturing Materials” or other suitable classification, alleviating the need to address many industrial uses in the "other" category and reducing the burden on re porting entities and on the Agency.

Source: (0187-0074)

Response E.10.a-3: EPA disagrees with the sugg estion to include a “Solid Manufacturing Materials” IFC code and believes such a code will not accurately describe the

industrial function of the chemical substance. In addition, EPA believes the proposed list of IFC codes covers the majority of the industrial functi ons. This belief is based on the past experience of both the U.S. 2006 IUR and Canadian reporting. However, EPA does recognize that it did not collect such information for inorganic chemical s ubstances in the past, and therefore will use the written description for “Other” to help evaluate and improve the inclusiveness of future IFC codes, including those applicable to inorganic chemical substances.

b. Industrial Sectors

Comment E.10.b: EPA proposed to replace the five di git NAICS code with a new code

to describe the industrial setti ng. Commenters in favor of IS c odes noted that using harmonized60 codes will provide the Agency with a better unde rstanding of how chemical substances are used in downstream products and would help facili tate consistent reporting of chemical use information in the U.S. and Canada. Some felt that the change will reduce the burden and increase the usability of the data. Others felt th at harmonizing codes was essential to eliminating the extensive non-reporting or use of an unspecifi ed "other" designation in the last IUR reporting cycle. One commenter suggested that EPA ha rmonize reporting with the EU REACH program.

Commenters who did not support the change stated that many companies have already begun the process of data collection based on the former system. The commenters believe

NAICS codes are the classificati on system with which industry and regulators are most familiar, and in some cases, the IS codes are less descri ptive than the NAICS codes. Others felt that replacement of NAICS codes with IS codes is o ccurring late in the data collection process and believe that some of the IS codes appear to be for FDA-regulated activities, not TSCA-regulated activities. The commenter suggested that the chem ical substances under those IS codes be added to the partially exempt chemical substance list. Commenters also stated that the Agency should recognize that these changes will result in increased reporting burden and time.

Source: (0187-0244) (0187-0069) (0187- 0056) (1087-0059) (0187-0090) (0187-0364) (0187-0369) (0187-0080) (0187-0066) (0187- 0065) (0187-0340) (0187-0096) (0187- 0083) (0187-0101) (0187-0073) (0187-0057) (0187-0081)

Response E.10.b: EPA disagrees with the commenters th at the use of IS codes in place of the NAICS codes will present increased burden on industry. The IS codes simply group together similar NAICS codes while still prov iding the sufficient differentiation needed to

differentiate overall industrial processing and use scenarios. The IS codes span the entire range

of NAICS codes and can be translated from kno wn NAICS codes. The “Instructions for the 2012 TSCA Inventory Update Reporting (R ef. 9) contains a cross-walk tables for submitters to use to determine the proper IS code, based on the NAICS code information they may already have collected. Replacing the NAICS codes with a ne w IS code will sort the reported chemical substances into broader categories that can be used by the Agency to develop industrial exposure scenarios for priority setting and risk screening programs. Th e sectors were adapted from the EU’s ‘‘Guidance on information requirements a nd chemical safety assessment.’’ EPA evaluated reporting under the 2006 IUR and EU’s use code de scriptions to develop a code that could be used to replace the NAICS codes.

The development of the IS codes for the 2012 IUR can be found in th e technical support document discussing the replacement of the NAI CS Codes (Ref. 24). In developing the IS codes, EPA considered the level of detail requir ed for developing use and exposure scenarios, the number of 2006 IUR submissions using the code, the code definition, and the level of difficulty required in reporting more detailed codes. Submissions to the 2006 IUR reported over 340 unique five-digit NAICS codes. In the 2006 IUR, the three-code combination of P/U code, NAICS code, and IFC resulted in a large number of possible exposure scen arios that could be reported. Although not all of the NAICS codes are applicable to chemical substance manufacturing and processing, th e 2006 IUR database has over 2,300 unique combinations of P/U, NAICS, and IFC. Many of the NAICS codes re ported are from similar industries that would have similar exposure scenarios.61 EPA agrees that the new IS codes are less de scriptive than NAICS codes, but believes the reduction in specificity will not adversely affect , and will actually improve, the Agency’s ability to use the processing and use da ta for screening-level purposes. The large number of unique combinations increases the difficulty and time requi red to sort and classify chemical substances since EPA would either need to develop expos ure scenarios for each unique combination or

determine which three-code combinations have similar exposure scenarios and can be grouped together. By replacing the NAICS codes with the IS code, the number of potential three-code

combinations is reduced from in excess of 100,000 possible combinations to 7,920 combinations.

Based on information collected from the last reporting cycle, the number of combinations actually reported would be significantly less. A dditionally, the IS codes will more closely align

to the EU Sector of Use codes which will allow EP A to compare U.S. data with that collected by the European Union.

With respect to the inclusion of IS codes for FDA-regulated uses, EPA wanted the IS codes and NAICS codes to a completely correspo nd in the crosswalk between the two, so that the need for “Other” reporting is minimized. In other words, the codes that correspond to FDA activities were included for completeness. EPA di sagrees that a partial exemption from IUR is needed for chemical substances that are regulat ed by the FDA. TSCA already excludes from the

definition of "chemical substance" th ose chemical substances that are, inter alia , regulated under the Federal Food Drug and Cosmetics Act. Chemi cal substances that are food, food additives, drugs, or cosmetics covered by th at statute are not subject to TSCA, so need not be reported under the IUR rule. However, many chemical substances have multiple uses, and some of these uses may be TSCA uses. If a portion of a chem ical substance's production volume is made for

uses other than those that are excluded from the definition of "c hemical substance," that portion is covered by TSCA and, unless otherwise exem pted, is subject to IUR rule requirements.

11. Consumer and Commercial Use

a. Consumer and Commercial Product

Comment E.11.a: EPA received comments regarding revising the list of consumer and commercial product categories for consumer and commercial use information. Commenters in support of the change stated that using harmoni zed codes will (1) provide the Agency with a better understanding of how chemical substances are used in downstr eam products and would help facilitate consistent reporti ng of chemical use information in the U.S. and Canada and (2) is essential to eliminating the extensive non-reporti ng or use of an unspecified "other" designation in the last IUR reporting cycle. Some commenter s stated that providi ng a description for the product category “Other” will be ch allenging in practice and may not provide useful information, end-use type applications, and all employ ees involved may not be known. Commenters continued by stating that obtaining information from the manufacturing supply chain is already difficult, particularly when there are concerns about the protection of proprietary information, and reporting certain data on downstream uses is burdensome and ineffectual.

Source: (0187-0080) (0187- 0069) (0187-0073) (0187-0094)62 Response E.11.a: EPA agrees with commenters that support the use of harmonized

industrial sector and consumer and commerci al product use codes. EPA disagrees that information on the downstream uses of products at the category levels provided is burdensome or ineffectual. Many chemical manufacturers, such as members and partne rs of ACC who have committed to the Responsible Care initiative, ha ve product stewardship plans in place and must, (if they are to implement those plans), account for how their customers use the chemical substances. EPA anticipates that manufacturers, especially manufacturers who are implementing the ACC’s Responsible Care ini tiative, will typically know (or be able to reasonably ascertain) information respecting the revised list of product categories. EPA recognizes that submitters may not always have detailed information about how th e chemical substance(s) they make are used and to what extent they are used. However, EPA believes that industry possesses a greater knowledge than EPA about its own operations and the downstream uses of chemical substances it manufactures and sells, even if they do not cont rol their customers’ sites. The Agency believes that most submitters know (or can reasonably asce rtain) information about the downstream uses of the chemical substances they manufacture.

The revised list of consumer and commercial product categories is based on EPA’s work

with Environment Canada and Health Canada to develop a harmonized list to facilitate the exchange of information between EPA and Canadi an agencies and the reporting of chemical substance use information by industry in the United States and Canada. EPA will require submitters to choose from among the consumer and commercial product categories provided at the proposed section 40 CFR 711.15 (b)(4)(ii), including the "IS48 Other" category. In the 2006 IUR data collection, persons subject to the IUR ru le were required to re port the industrial and consumer/commercial product categories in whic h their chemical substa nces were used. The harmonized categories are similar in number and breadth to those used in the 2006 reporting and are intended to provide a comprehensive list of products in which chemical substances are used. The Agency is providing more detailed descrip tive information in the “Instructions for the 2012 TSCA Inventory Update Reporting” (Ref. 9).

EPA recognizes that the requirement to repor t a description when the submitter selects the product code “Other” may be more burdensome than for the ot her product codes, but expects any increase to be minor. The descriptive informati on is essential to enable users of the data to estimate potential exposures associ ated with the consumer or commercial use of the chemical substance. The Agency’s experience with the 2006 IUR data was that the category of “other,” with no further description, was insufficient for the data to be of much use. The requirements to describe the use when reporting “Other” will provide EPA information to categorize and assess uses which are reported as other than the harmonized categories, and inform EPA in the development of any needed new categories in the future.

b. Designation of Consumer or Commercial Use

Comment E.11.b: Commenters had mixed viewpoints re garding the need to designate whether the indicated pr oduct category is consumer use, co mmercial use, or both. A commenter in favor stated that the proposed modifications would increase th e utility and specificity of the reporting information, reduce confusion, and increas e ease of reporting, while also facilitating harmonization of reported information across No rth America. Those opposed said that (1)63 providing a description for the pr oduct category “Other” will be challenging in practice and may not provide useful information, (2) end-use type applications and all employees involved may not be known, (3) obtaining information from the manufacturing suppl y chain is already difficult, particularly when there are concerns about the protection of proprietary information, and (4) certain reporting data on downstream uses is burdensome and ineffectual.

Source: (0187-0079) (0187-0364) (0187- 0069) (0187-0101) (0187-0054) (0187-0081) (1087-0094)

Response E.11.b: The intent of the consumer and commercial use data element is to clearly identify the exposed populations. These two populations (i.e., consumers and commercial workers) are very different from each other, and the ability to distinguish uses between the two enables better exposure-based screening of chem ical substances. EPA recognizes that submitters may not always have detailed information about how the chemical substance(s) they make are used and to what extent they are used. Howe ver, EPA believes a manufacturer generally has a

certain awareness of the downstream uses of chemical substances it manufactures and sells, even

if it does not control its customer s’ sites, and can report this in formation based on what is known to or reasonably ascertainable by the submitter.

EPA also recognizes the concern for incl uding the “C909 Other” commercial and consumer use category. The revised list of consum er and commercial product categories is based

on EPA’s work with Environment Canada and H ealth Canada to develop a harmonized list to facilitate the exchange of information between EPA and Canadian agencies and the reporting of chemical substance use information by industr y in the United States and Canada. EPA is requiring submitters to choose from among the consumer and commercial product categories provided at section 40 CFR 711.15(b)(4)(ii), including the “C909 Other” category. Although

EPA’s desire is to limit the number of scen arios which must be analyzed for risk characterization, requiring submitters to supply a written description for “Other” will help EPA evaluate and improve the list of consumer and commercial categories in the future. In addition, EPA is requiring a description of the use info rmation, which will be useful for screening

purposes.

c. Number of Commercial Workers

Comment E.11.c: EPA proposed to require that submitters report the number of commercial workers reasonably likely to be exposed while using a reportable chemical substance. Most commenters indicated that they do not have sufficient information about the work practices of eventual commercial users to estimate this number; that the data received would be an estimate; and that sh aring such data with suppliers could divulge elements of trade secrecy, proprietary technology, or sensitive business informa tion related to product uses, markets, market size, or proces sing technology. It was suggested th at the Agency rely on worker

statistics from the Bureau of Labor Statistics as it conducts risk assessmen ts, or gather additional data under a separate TSCA Section 8(a) rule.

Source: (0187-0091)64 Response E.11.c: EPA is requiring this informati on to better assess the size of the commercial population in screeni ng risk assessments. In the pa st, the Agency has used the Bureau of Labor Statistics for general worker s statistics to conduct chemical-specific risk assessments; however, these worker statistics, which are industry-specific, overestimate the exposures associated with a chemical substance b ecause a chemical substance is likely to be used by only a portion of the indus try. Identifying chemical-specific worker populations for downstream activities will fill this gap for the Ag ency. The knowledge of a chemical substance’s uses in industry and the resp ective commercial popul ation potentially affected by their uses provides the Agency a more complete picture of the potential risks associated with a chemical

substance.

EPA recognizes that submitters may not always have detailed information about how the chemical substance(s) they manufacture are used and to what extent they are used in commercial enterprises. However, EPA believes that a manufact urer generally has a certain awareness of the

downstream uses of chemical substances it manuf actures and sells, even if it does not control its customers’ sites. Based on its experience w ith the PMN program, many stakeholder meetings, discussions about voluntary risk management programs, and industry’s various self-regulation initiatives, the Agency believes that most submitters can make an informed estimate for downstream uses, including the information that would be reported under IUR. To reduce the burden in reporting, the number of commercial workers need only be reported in ranges, and the ranges are the same as for manufacturing and in dustrial workers. Reporting in ranges will lessen the reporting burden when the precise number of workers for multiple end uses is not known. Although this may result in some uncertainty in the data reported, the chemical substance manufacturer or importer has fulfilled his or he r obligation by providing the information to the extent it is known or reasonably ascertainable. EPA believes that the data will be sufficiently reliable for the Agency and others to use for sc reening-level risk assessm ents and prioritization.

EPA recognizes the industry’s concern in repor ting additional data that may result in the divulgence of trade secrets or sensitive business information. To protect the confidentiality of this information, the person reporting the numbe r of commercial work ers may designate the information as confidential. However, EPA doe s not believe the addition of the two data elements to consumer and commercial product reporting (i.e., consumer/commercial product

indicator and number of commercial workers) will present such harm.

F. Definitions and Cl arification Requests

1. Changing the Reporting Standard for Proce ssing and Use Information to “Known to or Reasonably Ascertainable”

Comment F.1-1: A number of commenters requested further clarification (beyond that offered in the Draft Reporting Inst ructions) of the scope of pre-reporting inqui ry that would be required under the “known to or reasonably ascertainable by” re porting standard. Specifically, the commenters requested further clarification of how this repor ting standard would apply in the case of information reported under 40 CFR 711.15( b)(4) (“specific information related to processing and use”). The commenters also expre ssed some confusion about how this standard would differ from the “readily obtainable standard,” previously applicable to such reporting, and65 whether the change of standard indicates that “e xtensive file searches and customer surveys” would now be expected of submitters. Other co mmenters from the chemical industry expressed their understanding that the change in reporting sta ndard only altered the le vel of diligence with

which submitters must search for information within their own organization. They requested confirmation that, as under the “not readily obtainable” standard, submitters would not be required to conduct customer surveys in order to assemble data for purposes of IUR.

Source: (0187-0360) (0187-0244) (0187- 0080) (0187-0079) (0187-0355) (0187-0087) (0187-0353) (0187-0078) (0187-0098) (0187- 0062) (0187-0091) (0187-0099) (0187- 0083) (0187-0089) (0187-0084) (0187- 0354) (0187-0092) (0187-0352) (0187-0058) (0187-0067) (0187-0094)

Response F.1-1: The term “known to or reasonably ascertainable by” is defined at 40 CFR 704.3. It means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” By contrast, “readily obtainable” information doe s not even cover all the information in a submitter’s possession or control. As defined for the 2006 IUR, it was limited to what was known by certain “management and supervisory empl oyees of the submitter.” (See Ref. 7, 68 FR at 879).

Under the “known to” portion of the “known to or reasonably ascertainable by” standard,

a submitter would therefore ascertain what it knows about the processing and use of a chemical substance it manufactures (including imports), wit hout confining its inquiry solely to what is known to managerial and supervisory employees, but would also be expected to review other

information which the manufactur er (including importer) may have in its possession. In response to comments regarding the level of diligence with which submitters must search for information within their organization, this standard requi res that submitters conduct a reasonable inquiry within the full scope of their organization (not just the info rmation known to managerial or supervisory employees). The inquiry would be as extensive as a reason able person, similarly situated, might be expected to perform with in the organization. Information derived from customer surveys or other customer contacts, like any other information, would be “known to”

the submitter if it is available af ter a reasonable inquiry within the organization. The standard does not necessarily require th at the manufacturer conduct an exhaustive survey of all employees.

EPA agrees that further clar ification would be useful re garding what is “reasonably ascertainable” to submitters about processing and use information because this component of the reporting standard potentially may require subm itters to obtain inform ation previously unknown to them, for the purposes of reporting. This circumstance could arise if a submitter knows less than that what is reasonably ascertainable to it. EPA is therefore offering the following further guidance regarding the interpretation of this term.

For many of the reasons identified by i ndustry commenters (e.g., the expense and burden of surveying customers, and uncertainty as to th e extent to which customers will respond to such surveys), EPA agrees that if particular inform ation cannot be derived or reasonably estimated without conducting further customer surveys (i.e., without sending a comprehensive set of66 identical questions to multiple customers), it would not be “reasonably ascertainable” to the

submitter. Thus there is not a need to conduct new customer surveys for purposes of the IUR. However, to the extent that customer surveys are already in the submitter’s possession or control,

and to the extent that reasonable efforts to locate or analyze those surveys may result in additional processing and use information (or re asonable estimates of such information), the information is generally “reasonably ascertainable.” Also, as illustrated by the examples below in Response F.1-2, inquiry under the “reasonably ascertainable” sta ndard may entail inquiries outside the organization to fill gaps in the s ubmitter’s knowledge. Further examples of actions that would meet the “known to or reasonably as certainable by” reporting standard are provided in Response F.1-2.

Comment F.1-2: A few commenters requested that EP A specify the precise degree of effort required of manufacturers (including importers) if they must survey their customers to generate data for the IUR; e.g., how far down th e chain of commerce must such inquiries go? How persistent must the manufacturer be in seeking such information?

Source: (0187-0068) (0187-0088) (0187-0354)

Response F.1-2 : As described in Response F.1-1, EP A does not anticipate that the IUR will require manufacturers to survey customers. If particular information cannot be derived or reasonably estimated from the information avai lable to the company w ithout conducting further customer surveys, it would not be “reasonably as certainable” to the submitter for purposes of the IUR. However, where surveys have already been performed, and the results are already in the submitters’ possession or control, EPA expects that submissions will be informed by the submitters’ reasonable efforts to identify and interpret the results.

“Known to or reasonably ascertainable” in formation includes, but is not limited to, information that may be possessed by employees or other agents of th e company reporting under the IUR rule, including persons involved in the research, development, manufacturing or marketing of a chemical substance and incl udes knowledge gained through discussions, symposia, and technical publications. The sta ndard does not necessarily require that the

manufacturer conduct an exhaustive survey of all employees. Examples of types of information

that are considered to be in a person’s possession or control, or that a reasonable person similarly situated might be expected to posses, control, or know, include files maintained by the submitter; information contained in standard references, su ch as MSDSs, that contain use information or

concentrations of chemicals in mixtures; and information from the Chemical Abstracts Service (CAS) and from Dun & Bradstreet D-U-N-S®.

The following hypothetical examples illustrate the anticipated applic ation of the “known to or reasonably ascertainable standard,” in the specific contex t of the collection of processing

and use data under the IUR. Because the standard applies on a case-by-case basis, however, these examples cannot substitute for a complete anal ysis of a submitter’s particular circumstances:

Company XYZ discovers that it has no know ledge of how a particular reportable chemical substance (Substance #1) is processe d or used by its customers. Company XYZ usually maintains marketing data documenting custom ers’ use of its chemicals, in line with the67 reasonable business practices typical of comparable manufacturers, but it irrevocably lost these

data for Substance #1 due to an inadverten t computer malfunction. Company XYZ has many customers, but it expects that it could substa ntially reconstruct this missing information by briefly contacting its largest cust omer and asking that customer what Substance #1 is generally used for. Company XYZ contacts this customer, reports on the basis of the processing and use data that the customer was willing to provide . Company XYZ has likely fulfilled its duties under the reporting standard. Compa ny XYZ would not have fulfille d its duties under the reporting

standard if it had not endeavored to supplement the information it already knew.

Company XYZ has never maintained inform ation on how a particular reportable chemical substance (Substance #2) is processed or used by its customers. However, it is typical for comparable manufacturers to collect such in formation as part of their reasonable business practices. Company XYZ has many customers but it expects that it could substantially fill this data gap by reviewing the public web site of its largest customer. Company XYZ reviews this web site, and reports on the basis of the inform ation contained in the web site. Company XYZ has likely fulfilled its duties under the repor ting standard. Company XYZ would not have fulfilled its duties under the reporting standard if it had not endeavored to supplement the information it already knew.

Company ABC maintains seasonal marketing data on changes in use patterns for a particular chemical substance (Substance #3). Co mparable manufacturers typically only maintain

such data on an annual basi s, in line with reasonable business practices. Company ABC irrevocably loses its summer marketing data for Substance #3, due to an inadvertent computer malfunction. Company ABC expects that it coul d substantially recons truct the missing summer marketing data by contacting its largest custom er and asking the customer what it used or processed Substance #3 for in the past summ er. Nevertheless, instead of attempting to

reconstruct the summer data in this manne r, Company ABC reports on the basis of the processing and use data that it already knows (regarding the winter, spring, a nd fall of the year). Company ABC has likely fulfilled its duties under the reporting standard . Company ABC would not have fulfilled its duties under the reporting sta ndard if it designated the information as “not known or reasonably ascertainable” simply because one of the seasonal marketing reports was missing.

Company ABC has never maintained inform ation on how a particular reportable chemical substance (Substance #4) is processed or used by its customers. However, it is typical for comparable manufacturers to collect such in formation as part of their reasonable business practices. Company ABC has one major customer and ten minor customers. Company ABC asks its major customer to supply information about ho w Substance #4 is processed and used, but that customer is unwilling to supply this informa tion. Company ABC reasonably expects that the only remaining way to substantially fill this data gap would be to send a survey to its ten minor customers. Company ABC reports that the information is “not known or reasonably ascertainable” to it. Company ABC has likely fulfilled its duties under the reporting standard.

Comment F.1-3: A number of commenters objected to the “known to or reasonably ascertainable by” standard on the grounds that it was subjective or too vague to be appropriately applied to the collection of processing and us e information outside of the submitter’s direct68 control. Other commenters objected to the sta ndard’s reference to what a reasonable person similarly situated “might” be expected to posse ss, control, or know. They suggested that the

standard be amended to what a reasonable person “should” be expected to know.

Source: (0187-0074) (0187-0104) (0187- 0364) (0187-0355) (0187-0086) (0187-0075) (0187-0056) (0187-0083) (0187-0354) (0187-0081) (0187-0094)

Response F.1-3 : EPA does not agree that the “known to or reasonably ascertainable” standard is subjective or excessive ly vague. The standard is set fo rth in EPA’s statutory authority to collect information under Section 8(a) of TS CA, and EPA’s definition is consistent with Congressional intent to establish an object ive standard: “The conf erees intend that the ‘reasonably ascertainable’ standard be an objec tive rather than a s ubjective one. Thus, the manufacturer or processor must provide inform ation of which a reasonable person similarly situated might be expected to have know ledge” (Ref. 25, H.R. Rep. 94-1679 at 693). Thus, whether a particular level of diligence meets this standard does not depend on the submitter’s subjective view of a reasonable person “should” be expected to know. It turns on an objective question: the level of diligence that a reasonable person, similarly situated, might be expected to undertake. EPA believes it is appr opriate to define the standard consistently for all persons reporting under Section 8(a) of TSCA, and that the existing defi nition appropriately reflects Congressional intent. Finally, EPA does not thin k the standard of objective reasonableness will

be unfamiliar to submitters. It is included in a wide variety of legal standards under state and federal law, and in the 2006 IUR it applied to all aspect s of the information collection other than processing and use information.

Comment F.1-4: A number of persons questioned EP A’s rationale to propose changing the reporting standard for proces sing and use information from “readily obtainable” to “known to or reasonably ascertainable.” Some persons noted that the “readily obtainable” standard aligns with the standard in use for PAIR reporting. Othe rs suggested that confusion about the scope of reporting obligations, but not the “r eadily obtainable” standard itsel f, was responsible for the low levels of processing and use information provi ded in the 2006 IUR. Finally, several questioned the appropriateness of citing, as a point of comparison for the IUR, the successful application of the “known to or reasonably ascertainable by” standard in the New Chemicals program.

Source: (0187-0244) (0187-0079) (0187- 0364) (0187-0355) (0187-0090) (0187-0062) (0187-0056) (0187-0354) (0187-0101) (0187-00 67) (0187-0081) (0187-0089) (0187-0061)

Response F.1-4: As noted in the proposed rule (Ref. 8), only 12% of the IUR submissions contained complete information on th e industrial processing and use of the chemical substances they manufactured or imported a nd only 3% contained complete information on processing and use of their chemical substanc es. Although the informati on collected was very useful, EPA believes more complete information is needed to support re gulatory decisions and the decisions would be fairer to the regulated community if the completeness of the information were improved.

The standard set forth in Sec tion 8(a) of TSCA, which author izes the IUR data collection, is that EPA may require information to be provided to the extent that it is known to or reasonably69 ascertainable by the person repor ting the IUR data. Although the lesser standard of “readily obtainable” applies to the coll ection of information under the PAIR regulation, 40 CFR Part 712, the Agency’s particular experience implementing the IUR program has lead it to the conclusion that the “readily obtainable” standard did not provide sufficiently complete data to give confidence when screening the uses of chemical substances for regulatory purposes (Ref. 8, 75 FR at 49673).

As noted by several persons commenting on the proposed rule, the “known to or reasonably ascertainable” standard has been effec tive in obtaining information needed to assess

new chemical substances. The effectiveness of th is standard in the new chemical substances

context derives not from the circumstances in whic h the information is collected but rather from the submitter’s duty to gather all information reasonably available within the organization, including reasonable estimates. By contrast, the previous “readily obtainable” standard limited inquiry to what was known by certain “man agement and supervisory employees of the submitter” (Ref. 7, 68 FR at 879). None of th e purported distinctions between IUR and PMN reporting cited by the commenters led EPA to concl ude that it would be inappropriate to hold both IUR and PMN submitters to the same standard of reasonable inquiry. Even if the analysis of existing uses for an IUR submission presents diffe rent challenges than the analysis of potential uses for a PMN submission, it is appropriate for EPA to hold both the IUR submitter and the

PMN submitter to a reasonable effort at confro nting those challenges. Finally, EPA does not have a basis to assume, as one commenter sugges ted, that existing chemical substances are of inherently lesser concern than new chemical substances—many thousands of chemical substances were included in the initial compila tion of the TSCA Inventory, which did not include a review process similar to th e PMN review process. Conseq uently, EPA may know much less about these “grandfathered” chemical substances than it does about chemical substances that

have since been added to the TSCA Inventor y after going through the PMN review process. EPA therefore does not see any reason to hold IUR submissions to a lesser reporting standard than pre-manufacturing notices.

Lastly, EPA does not believe that the scope of the reporting obligations led to confusion in reporting. The scope of the reporting obliga tions for the 2006 IUR were clearly defined by regulation at 40 CFR 710.43 and fu rther explained in the 2006 IU R Instructions for Reporting. Additional information was also provided on the NAICS codes and descriptions of the industrial function categories were given in the 2006 IUR Inst ructions. Few, if any, persons reporting IUR information in 2006 had any difficulty in disti nguishing the 300,000 lb th reshold which required reporting of industrial processing and use information, or that imported chemical substances

were to be included in manu factured volumes. Rather, it appeared to EPA that the incompleteness in the reported data arose from application of the lesse r reporting standard of “readily obtainable” to reporting of industrial processing and use information and information on

commercial and consumer uses of chemical substances.

Comment F.1-5: Some commenters, particularly t hose representing chemical substance processors and distributors, expr essed concern that moving from a “readily obtainable” (RO) to a “known or reasonably ascertainab le” (KRA) standard would have an adverse effect on the quality of data reported unde r the IUR. These persons were concerned that under the new standard, manufacturers will begin reporting unreliable processing and use information based on70 “best guesses,” whereas the manufacturers prev iously would have simp ly stated that the information was “not readily obtainable” (NRO ). In contrast, comme nters representing environmental and pollution prevention interest s expressed the view that the old readily obtainable standard operated as a loophole to reporting, and that it limited the usefulness of the processing and use data colle cted under the 2006 IUR.

Source: (0187-0244) (0187-0355) (0187- 0086) (0187-0062) (0187-0083) (0187-0081) (0187-0069) (0187-0349) (0187-0100)

Response F.1-5: EPA believes that changing the re porting standard from RO to KRA will improve the completeness of the information reported. As noted in the proposal for modification of this regulati on (Ref. 8, 75 FR at 49672), improvement in reporting is needed because 13% of the reports contained no information on the processing and use of the reported chemical substance and 46% of the reports contained no information on the consumer and

commercial uses of a chemical substance.

Improvement in the completeness of the reported information will result from more complete searches within the organization. Unde r the KRA standard, it is expected that the person responsible for the IUR subm ission will collect or direct th e collection of all information reasonably available within the organization to complete the IUR submission, and not limit the reporting to information known by particular management or supervisory employees.

The KRA standard does not require (nor does EPA encourage) the submission of unfounded guesses when data, and reasonable es timates of data, are unavailable after a reasonable inquiry. Neither, as a general matter, does the standard re quire that the person submitting the IUR information conduct new surveys of his customers to ascertain the uses of the chemical substance for which the information is reported. EPA believes submitters will be capable of distinguishing between reasonable esti mates of processing and use data (required to be submitted under the IUR) and unfounded guesses (neither required nor encouraged by EPA under the IUR). Additional guidance on the reporti ng standard is provided in the “Instructions for the 2012 TSCA Inventory Update Reporting” (R ef. 9). Because the IUR now requires a more thorough search for processing and use inform ation, but neither compels nor encourages submitters to submit unfounded guesses at such data, EPA believes the completeness of the reported information will be improved and the quality will not be degraded.

Comment F.1-6: Many commenters believed that furt her characterizatio n of the burden and expected benefits of switching from the “r eadily obtainable” to th e “known or reasonably

ascertainable” standard was needed. Commenters noted that while KRA is not itself a novel reporting standard for the IUR, the RO standa rd for the processing and use information was introduced at the same time as the underlying obl igation to report processing use information under the IUR. Thus, they suggest that the a dditional burden of repor ting processing and use information under the KRA standard has not yet been adequately evaluated. The commenters also expressed their expectation th at manufacturers’ efforts to emba rk on a more intensive effort to survey their customers were unlikely to yield much additional use information.71 Source: (0187-0360) (0187-0079) (0187- 0090) (0187-0087) (0187-0075) (0187-0088) (0187-0056) (0187-0099) (0187-0354) (0187-01 01) (0187-0068) (0187-0081) (0187-0089) (0187-0061)

Response F.1-6: EPA disagrees that the change from RO to KRA, for processing and use information, requires further economic analysis. As EPA explains on page 4-37 of the Draft Economic Analysis for the proposal (Ref. 15), EPA’s burden estimates were based on an industry survey conducted for the 2002 IUR Ec onomic Analysis. This survey assessed the burden of manufacturers reporting processing and use information at the KRA standard. Because EPA did not lower the reporting standard to RO until after it had conducted the economic analysis, the KRA standard is already incorporated into the baseline of EPA’s economic analysis.

Furthermore, EPA disagrees that the KRA sta ndard requires an economic analysis of the expected burdens and benefits of manufacturers survey ing their customers. While manufacturers may be required to report proces sing and use data based on customer surveys they have already performed, EPA does not anticipate that the IU R will trigger any obligation to conduct such surveys. See Response F.1-1. EPA need not incor porate into the economic analysis a discussion

of actions that the IUR is not expected to trigger.

Comment F.1-7: Two commenters asserted that, even if is appropriate to move to the KRA standard for processing and use informati on, the change in reporti ng standards should be deferred to the next reporting cycle. The commenters argued that processing and use information for 2010 has already been assembled under the RO st andard, and that it would be inefficient to

revisit the information to ensure it meets the KRA standard.

Source: (0187-0096) (0187-0088)

Response F.1-7: EPA disagrees that a multi-year “phase-in” period is needed for manufacturers to prepare to report under the KRA standard. Reporting under the RO standard was limited to information known to managerial and supervisory employees. (Ref. 7, 68 FR at 879). EPA does not expect that the change in re porting standard will entail a duplication of already-completed searches to re-identify what is known to managerial and supervisory employees. Rather, it may require a reasonably extensive inquiry into what is known by other employees, if one has not already been performed.

EPA acknowledges that the KRA standard now al so encompasses information that is not known, but is nevertheless reasonably ascertainab le. However, given that EPA has moved the submission period to start on February 1, 2012, EPA does not agree that an additional delay is

needed for submitters to acclimate themselves to the new standard. Because the KRA standard is tied to the objective test of wh at a reasonable person similarly situated might be expected to possess, control, or know, it already addresses context-specific consid erations, such as the amount of time available to the submitter for pr eparatory inquiry. Because the standard already addresses context-specific timing considera tions, EPA does not believe those same timing

considerations can be consid ered as grounds for delaying im plementation of the standard.72 Comment F.1-8: Several commenters expressed c oncern that additional material reportable under the KRA standar d, but not previously reportable under the RO standard, would be material claimed as CBI by their customers. The comments expressed reluctance to take on the responsibility of asserti ng their customers' CBI claims. Commenters also requested

clarification of how the IUR would accommodate the assertion of their customers’ CBI claims.

Source: (0187-0088) (0187- 0091) (0187-0056) (0187-0094)

Response F.1-8: The Agency recognizes that there ar e circumstances when the release of information about a particular use could harm the competitive position of the submitter’s customer. Submitters may assert CBI claims base d on harm to a customer's competitive position. Furthermore, EPA has modified the substantiati on question at 40 CFR 71 1.30(d)(1)(ii) to include information about harm to the submitter’s competitive position “or to your customer’s competitive position.” If a submitter believes that particular processing and use information is not publicly known from any sour ce and might be CBI from its customer's perspective, the

submitter should consult with its customer and make a claim consistent with the discussion and the general standards for making CBI claims.

Comment F.1-9: One commenter raised the question of whether it was appropriate to apply the KRA standard to the processing a nd use information for inorganic chemical

substances. The commenter noted that EPA’s f actual basis for changing reporting standards was based on the level of processing and use info rmation provided in the 2006 IUR for organic chemical substances (inorganic chemical substa nces were exempted from reporting obligations for processing and use information in that year).

Source: (0187-0354)

Response F.1-9: EPA acknowledges that previous y ears’ IURs have not required the reporting of processing and use information for inorganic chemical substances. However, the comments do not supply a factual basis for EPA to presume that IUR reporting of inorganic chemical substances, under the “r eadily obtainable” standard, would be any more complete than past IUR reporting of organic chemical substanc es under that standard. Furthermore, the impact

of the basic structural framework of the RO st andard (e.g., limitation of reporting to what is already known, limitation of inquiry to managerial and superv isory employees) is likely to be independent of the particular type of chemical substance be ing manufactured. EPA believes it appropriate to apply the KRA standard uniformly among all manufacturers.

2. Modifications Affecting Importers

Comment F.2-1: More guidance for joint reporting procedures was recommended, specifically for submitting electroni cally via e-IURweb and CDX.

Source: (0187-0244) (0187-0364)

Response F.2-1: EPA understands the concerns rega rding the reporting of proprietary chemical substances requiring joint submissions with foreign suppliers. The reporting tool was73 specifically designed to address this process. e- IURweb generates a unique identifier when the primary submitter reports a jointly imported chemical substance. The unique identifier is sent to the foreign submitter so that their report can be linked to the domestic submitter's report. In addition to a unique identifier, the reporting tool is designed to presume that all foreign submitter

data in Section 4.D. of Form U is claimed as CBI, protecting it from in advertently being made viewable to any unauthorized personnel. Additi onal details on submitting a joint report is provided in the “Instructions for the 2012 TS CA Inventory Update Reporting” (Ref. 9).

Comment F.2-2: One commenter stated that they ha ve no contractual means to require foreign suppliers of already purch ased materials to either register with CDX or file a joint submission electronically.

Source: (0187-0369)

Response F.2-2: EPA agrees with the commenters that its proposed joint submission procedures for importers, which re quired the importer to ensure th at a foreign supplier prepared a secondary submission on its behalf, presented implementation difficulties. This is because, as the commenters suggested, the foreign supplier may not be subject to any direct legal obligation to provide the information to EPA. The Agency also notes that this issue extends to the regulations at 40 CFR 711.15(b)(3)(i)(B), as there may be ci rcumstances in which the manufacture of a chemical substance is reportable under the IU R, yet the supplier of a reactant used in manufacturing that chemical substance would not have an independent le gal obligation to report the chemical identity of th e reactant under the IUR.

Therefore, the Agency has modified the regulatory requirements at 40 CFR 711.15(b)(3)(i) to reflect the primary submitter’s underlying obligation to provide what it knows or can reasonably ascertain resp ecting the identity of a chemical substance subject to reporting. The joint submission requi rement is no longer to ensure that suppliers provide secondary submissions to EPA, but to properly ask that they do so. Consistent with 40 CFR 711.15(b)(3)(i), a request for a secondary submission to EPA must be prepared using e-IURweb, include instructions for electronically submitting the info rmation to EPA, and explain how to provide a clear reference to the primary su bmission. Documentation of the requ est to the supplier must be submitted to EPA along with the re st of the primary submission.

Finally, EPA has also modified the regulatory requirements to more clearly reflect (Ref. 8, proposal at 75 FR 49666), that they only apply in cases where a supplier will not reveal the pertinent chemical identity information to th e submitter. In the event that a manufacturer (including importer) actually knows th e chemical identity of a chem ical substance subject to IUR reporting, the manufacturer must provide that information irrespective of a supplier’s confidentiality claims. EPA has modified the substantiation question at 40 CFR 711.30(b)(1)(i)

to include information about harm to the submitt er’s competitive positio n “or to your supplier’s competitive position.”

3. Clarifications to Byproduct Reporting

a. General Comments on Byproducts74 Comment F.3.a-1: One commenter stated that EPA has wrongly interpreted the act of finding a useful purpose for what would otherw ise be a waste product, otherwise known as recycling, as somehow changing and transfor ming the byproduct into an intentionally

manufactured chemical substance.

Source: (0187-0103)

Response F.3.a-1 : The premise of the comment is incorrect. Whether a byproduct is manufactured for commercial pur poses depends on the circumstances by which it came into being. See 40 CFR 704.3. The particular commerci al purposes to which a byproduct may be put after it comes into being (e.g., recyc ling) are irrelevant to whet her it was manufactured for commercial purposes in the first place. However, post-manufacturing use may affect whether or not the manufacturer of the byproduct can ex ercise a reporting exemption under 40 CFR 711.10(c). See also 40 CFR 720.30(g) and (h).

The requirement to report for IUR begins w ith concluding that a ch emical substance is manufactured for a commercial purpose. As is stated in the 40 CFR 711.3 definition, manufacture means “to manufacture, produce, or import for a commercial purpose...” Manufacture for a commercial purpose is defined in 40 CFR 704.3 to include “...substances that are produced coincidentally duri ng the manufacture, processing, us e, or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that subs tance or mixture. Such byproducts and impurities may, or may not, in themselves have commercia l value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.”

Byproducts that are manufactured for a comm ercial purpose may be exempted from reporting by the byproduct exemption found in 40 CFR 711.10(c) (referring to 40 CFR 720.30 (g) or (h)), which specifically identifies activiti es for which reporting is not required. Some recycling activities ma y affect the byproduct manufacturer’s eligibility fo r the reporting exemption at 40 CFR 711.10(c).

Comment F.3.a-2: Another commenter cited inequity with imported byp roducts versus domestically manufactured scrap (i.e., scrap metals, where reporting is required for imported materials but not for domestic scrap that is, for instance, simply melted and reformed). The proposal may also result in confusion about who reports what, i.e., whether the importer or the recycler is responsible.

Source: (0187-0351)

Response F.3.a-2 : Under TSCA section 3, importing a chemical substance into the customs territory of the United States counts as manufacturing the chemical substance. Contrary to the views of the commenter, EPA believes it would be inequitable to provide a special exemption for byproducts that happened to be manufactured by way of import. Furthermore, EPA notes that importers of metal scrap (lik e any other manufacturers of metal scrap) may75 potentially avail themselves of byproduct repo rting exemptions at 40 CFR 711.10(c). Importers are responsible for reporting what they import. If recyclers manufacture separate chemical substances from an imported chemical substance, then the recyclers are responsible for reporting such separate chemical substance. EPA be lieves the distinction between importers’ and recyclers’ reporting respons ibilities is clear.

Comment F.3.a-3: Regarding the general public’s risk of exposu re to byproducts, one commenter from the metals industry indicated th at, when byproducts are to be further processed for recovery of chemical components, such bypro ducts are essentially non-i solated intermediates, with a very limited potential fo r exposure to the general public . Any significant exposure to the general public would involve the extracted components, which are reportable by the treatment/recovery facility. Anot her commenter stated that repor ting recycled spent catalyst solutions does not serve environmental or public health interests because there is no significant potential for exposure of the public to these byproduc ts, and because exposure is extremely low.

Another commenter gave the example of electrowinning cells at copper mining operations, which accumulate chemical substances high in metals other than the primary metal being produced. These chemical substances are t ypically shipped to other sites engaged in the production of those other metals, a nd where the other sites may extr act the metal in a manner that changes its chemical form somewhat. The commente r stated that the only potential exposure is associated with transportation from the mining to the recycling site. The commenter stated that the Agency’s interpretation that changes in th e specific metal substance during the extraction process results in the need to report byproducts by the original mining site that otherwise would not be reported due to the byproduct exemp tion at 40 CFR 720.30(g)(3). The commenter concluded that this would imposes a significant burden on those companies

Source: (0187-0073) (0187-0104) (0187-0072)

Response F.3.a-3: EPA disagrees that byproducts in general should receive the same regulatory treatment as non-isolated intermedia tes. Not only do non-isolated intermediates not leave the manufacturing facility, such chemical substances are not accumulated and do not leave the equipment in which they are manufactur ed. Byproducts, like many other chemical substances, often are accumulated, leave their ma nufacturing or processing equipment, and are shipped off the manufacturing si te. In the rare situ ation when a byproduct is an actual nonisolated intermediate, the repor ting requirements associated w ith non-isolated intermediates would apply.

Byproducts that are shipped fr om the manufacturing site to a processing site such as a recycler would have similar expos ure scenarios to any other chem ical substance that is in a similar physical form and shipped from a manufactur ing site to a processing site. EPA disagrees that such exposures are, in fact, necessarily limited or that there are not additional exposures associated with the manufacturing, processi ng, or use of such chemical substances.

Comment F.3.a-4: One commenter noted that, at the ou tset of the Draft Q&A Document (Ref. 26), EPA indicates that the document “does not establis h any legal obligations beyond those that already exist pursuant to TSCA a nd its implementing regulations.” This commenter76 stated that it does not view EPA’s statements in this document as independently binding on any party, regardless of the fact that EPA is pr oviding an opportunity to comment on the guidance document in parallel to a rulemaking pr oceeding on a separate binding regulation.

Source: (0187-0354)

Response F.3.a-4: Consistent with the disclaimer la nguage quoted, the purpose of the Agency’s guidance documents is to articulate EP A’s interpretation of the applicable regulations and to assist industry in understanding the scope of potential reporting ob ligations under the IUR

rule.

b. Concern that New Byproduct Reporti ng Requirements are Being Added

Comment F.3.b-1: In general, some commenters assert ed that EPA’s explanation of the IUR’s byproduct-related reporting requirements reflect new require ments, inconsistent with current byproduct exemptions. To one commenter, the Agency is attempting to make a significant change without invoki ng appropriate rulemaking pro cedures, which the commenter states is fundamentally unfair to the regulated community and does a disservice to the broader objectives of EPA concerning recycling. Commen ters indicated that the guidance document offers interpretations that are c onfusing, using new principles that have no basis in the history of TSCA IUR regulations and that th is restrictive interpretation of the exemption as it applied to recycled chemical substances di d not exist prio r to 2006 IUR.

Source: (0187-0354) (0 187-0104) (0187-0072) (0187-0244)

Response F.3.b-1: EPA is clarifying, not enlarging, the report ing requirements for byproducts, which have been in place for d ecades. The definitions of “Byproduct” and “Manufacture for commercial pur poses” (referencing bypr oducts) at 40 CFR 704.3 have been in place since 1983 (Ref. 27) and have been applicab le to the IUR since the IUR’s inception in 1986. See 51 FR at 21447 (incorporating definiti ons from 40 CFR 704.3) (Ref. 28). The reporting exemptions for byproducts at 40 CFR 720.30( g) and (h)) (cross re ferenced at 40 CFR 711.10) have also been in place since 1983 (Ref. 29) and have also been applicable to the IUR since the IUR’s inception (Ref. 28). While this final rule is modifying the applicable definition of “manufacture,” the pertinent por tion of the revised definition (providing that manufacture includes “the extraction, for commercial purpos es, of a component chemical substance from a previously existing chemical substance or comp lex combination of chemical substances”) is consolidated from materially identical language f ound in the previously applicable definition of “

manufacuture” and “manufacturer” at 40 CFR 704.3. This specification of the scope of

“manufacture” has been in force for IUR purposes since 1988. See 51 FR at 21447 (1986 incorporation of definitions from 40 CFR 704.3 into the IUR) (Ref. 28) and 53 FR at 51716 (1988 revision to 40 CFR 704.3) (Ref. 30).

In 1983, EPA promulgated a rule that made clear (for subsequent IUR and PMN purposes) that the reporting ex emption for the manufacture of byproducts is only potentially applicable to the manufacture of the byproduct a nd would in no case apply to the manufacture of component chemical substances extract ed from the byproduct. 40 CFR 720.30(g)(3).77 Furthermore, it has been the Agency’s position since at least 1991 that, in order for byproduct manufacture to qualify for the 40 CFR 720.30(g)(3) exemption, “the component to be extracted must be already existing as a distinct chemical substance in the waste stream” (Ref. 31). When the chemical substance present in the byproduct a nd the chemical substance extracted from the byproduct are distinct chemical substances, ne ither the manufacture of the byproduct nor the

manufacture of the extracted chemical substa nce qualify for the 40 CFR 720.30(g)(3) exemption.

The guidance docketed with this final rule, which explains existing byproducts reporting requirements under the IUR, is consistent with pa st guidance issued in connection with the IUR and TSCA New Chemicals Program. For exampl e: In a 2002 response to public comments on a previous proposed amendment to the TSCA Invent ory Update Rule (Ref. 7), EPA explained that “distillation, extraction, refi ning, and similar activities may result in the manufacture of a

chemical substance.” In a 2006 letter to the Aluminum Association, EPA described a

circumstance in which the extraction of alum inum from aluminum dr oss byproduct constituted the reportable manufacture of aluminum, while cautioning that if the aluminum is “chemically changed during the extraction process,” then not only the extracted aluminum but also the dross byproduct would be reportable under the IUR (R ef. 32). In 2008, EPA provided similar guidance by letter to IPC, anot her trade group (Ref. 33).

Due to the 2003 expansion of the IUR repor ting requirements to inorganic chemical substances, many companies have recently beco me aware of their status as chemical manufacturers when they recycle their waste ma terials. Instead of disposing of those waste materials, the manufacturers return them to commerce by recycling the materials – either themselves or through a third party. Recycling ma y be beneficial for many reasons: it conserves resources, may reduce the expense of purchasing new raw or starting materials, may reduce the reliance of the United States on foreign suppliers of raw materials, reduces the need for landfill or other disposal sites, and re turns a waste to commerce. However, many recycling activities fit the TSCA and IUR rule definition of manufacture, and are likely to be c onsidered “manufacture for a commercial purpose.” EPA has finalized th e draft IUR guidance documents that were published with the proposed rule. These doc uments include examples of many common manufacturing scenarios to assist individuals in determining whether their company is manufacturing a chemical substance that needs to be reported under the IUR (Ref. 9 and 26).

Comment F.3.b-2: One commenter stated that ge nerators of byproducts have not collected data on the producti on volumes of the component ch emical substances contained within their byproducts because they never considered themselves to be subject to TSCA IUR.

Source: (0187-0103)

Response F.3.b-2: As a result of questions receiv ed during the 2006 IUR submission period, EPA identified the need for specific gui dance regarding byproduct chemical substances. As described in the preamble to the proposed ru le, EPA drafted such guidance and will make it available for the 2012 IUR. In addition, EPA has met with various industr y representatives and associated groups to help ensure that those potenti ally subject to the IUR are educated as to the requirements of the rule.78 Although the need to report fo r byproduct chemical substances is not a new requirement, EPA recognizes that there were many comments and concerns raised about byproduct chemical substances, as stated earlier in this section, and that there ma y be byproduct manufacturers that remain unsure of their reporting ob ligations under the IUR. In pa rticular, the Agency recognizes that this may be an issue for those bypr oduct manufacturers who r ecycle byproducts by sending them off-site to a recycler. The Agency is co mmitted to helping byproduc t manufacturers report according to the IUR requirements and views th e 2012 reporting cycle as an opportunity for the Agency and byproduct manufacturers to work together. Among other things, the Agency will use this opportunity to determine whether additional guidance tailored to these manufacturers is needed. In addition, EPA intends to provide traini ng specific to byproduct reporting and to make available Agency personnel to answer questions on an individual basis.

EPA also intends to continue to work w ith industry and the interested public. EPA encourages recycling. The Agency intends to examine the collected information related to byproducts, recognizing the importance of recycling, to identify whether there are segments of byproduct manufacturing for which EPA can determine that there is no need for the IUR information for the 2016 or other future reporting cycles.

Comment F.3.b-3: Some commenters stated that Congress intended to exempt byproducts and/or recycled pr oducts. One commenter stated that byproducts are produced coincidentally, as the unintended consequence of the manufacturing of another product and do

not have a commercial intent – that they are not generated for commercial purposes. This

commenter does not believe that TSCA’s inte nt and mandate is to regulate byproducts as

manufactured chemical substances.

Source: (0187-0101) (0187-0103)

Response F.3.b-3: EPA disagrees with these comments . The legislative history of TSCA addresses the issue of Congressi onal intent regarding the inte rpretation of manufacture “for commercial purposes,” in TSCA sec tion 5(i). The legislative history provides that this term is not restricted to only chemical s ubstances manufactured or proc ess “for sale.” The 1976 House Committee Report states that “By the use of th e term ‘for commercial purposes’ the Committee

does not intend to restrict covera ge to chemical substances manuf actured or processed ‘for sale’. Any commercial purpose, such as use as a chemi cal intermediate in a manufacturing process, is sufficient to bring the manufacturi ng or processing of a chemical substance within the ambit of section 5” (Ref. 34, H.R. Report No. 94-1341 at 437-438). EPA’s regul ations at 40 CFR 704.3 reflect the Agency’s longstanding view that byproduc ts, because they are pa rt of the manufacture of another chemical product for a commercial purpose, are themselv es manufactured for commercial purpose, irrespective of their inherent commercial value.

c. Identity of Byproduc t Chemical Substances

Comment F.3.c: Commenters expressed concern with the need to definitively identify their byproduct chemical substances , especially those that are a pot entially fluctuating mixture of chemical substances or for which the bypr oduct manufacturer may not know the exact composition of the byproduct produced. A commente r stated that it would need to initial79 thousands of requests for new CASRNs, noting th at mixtures do not typically have CASRNs.

Given the lack of a commercial interest in some byproduct components, according to one commenter, “it is not reasonable to expect companies to have speci fic or detailed information on the individual components of the by-product mixture, much less the volumes of each component.” One commenter noted that the am ount of resources and time to identify, characterize, and report these byproduct streams can, in some instances, outweigh the economic benefit to recycle or reclai m the chemical substances.

Source: (0187-0292) (0187-0073) (0187-0104) (0187-0099) (0187-0103)

Response F.3.c: The comments reflect a misperception th at characterizing the identity of complex chemical substances, as are found in or comprise many byproducts, necessarily involves a detailed analysis of the “individual components of the ch emical substance.” In reality, a byproduct may be listed on the TSCA Inventory as a single chemical substance that represents, for TSCA purposes, what may be a complex com position of chemical substances. In this way, the chemical identity of a byproduct may repr esent a chemical process stream. Complex chemical substances are listed (or can be listed) on the TSCA Inventory as chemical substances of Unknown or Variable composition, Complex reaction products and Biological materials (“UVCB” chemical substances). As described by the commenters, the byproduct “mixture” is often complex and varies over time, making the identification of the individual components a very difficult task. This descri ption itself indicates that the proper identification of such a reaction product is as a UVCB chemical subs tance (Ref. 19). As stated in EPA’s on-line guidance, “Each combination of chemical substan ces resulting from a reaction is considered by the Agency to be either (1) a mixture, com posed of two or more well-defined chemical substances to be named and listed separately, or (2) a reaction product, to be listed as a single chemical substance, using one name that collectiv ely describes the products, or, failing that, the reactants used to make the products” (Ref. 20). Situations may exist where the byproduct chemical substance is actually a mixture, but as further described in the aforementioned guidance, “A combination of products resulting fr om a chemical reaction is considered a mixture provided that all of the component product chem ical substances are unambiguously identified and are represented as forming each time the reaction is run.”

Approximately one third of the chemical s ubstances included on the TSCA Inventory are

UVCB chemical substances. UVCB chemical s ubstances in some cases include a TSCA Inventory definition to further de scribe the chemical substance. Here are some examples of

UVCB chemical substances. Please s ee EPA’s on-line guidance (Ref. 19):

Dust, iron-ore, sinter

CASRN 69012-53-9 Definition: Dust generated dur ing the making, breaking and ha ndling of sinter which is recovered through the use of po llution abatement equipment.

Gold, dross

CASRN 69029-68-1 Definition: A scum formed on the surface of molten gold.80 Electrolytes, copper-manufg., spent

CASRN 69012-54-0 Definition: Spent copper sulfate electrolyte consisting of copper sulfate and sulfuric acid resulting from the electrolytic refining of copper.

These chemical substances should be reporte d by the byproduct manufacturer as they are listed by EPA on the TSCA Inventory. As a single UVCB chemical substance, this type of byproduct material does not need to be further analyzed by its manufacturer to determine the precise, detailed composition. Because byproducts woul d typically or generally be identified for TSCA purposes as single UVCB chemical substances, the Agency does not believe that the identification and reporting of byproducts would be significantly burdensome. As a general matter, if there is to be appropriate stewards hip of potential chemical substance risks, EPA

believes that chemical substance manufacturer s, processors, and users should know and

understand the identities of chem ical substances they handle.

d. Determining When a Byproduct Is Manufactured

Comment F.3.d-1: Commenters stated that clarificat ion is needed regarding purification

and extraction and when a chemical substance is considered manufactured versus purified. Commenters asserted that where there is no change in chemical identity, only a change in purity,

a chemical substance should not be considered manufactured, regardle ss of the method of purification. Commenters refere nced the Draft Q&A Document (Ref. 26, General Examples A and C, pg. 6),

Other commenters requested clarification on proposed requirements that (a) exclude simple physical separation or purif ication of a chemical mixture, without any chemical synthesis and (b) amend the definition of “manufacture” to add language concer ning extraction of a previously existing substance. Considering TS CA Section 5 and IUR requirements, and the

distinction between chemical transformation and physical separation or purification of a chemical substance, commenters indicated that such definitions could be interpreted to encompass, for example, the disti llation of a reaction solvent for reus e in a given process. If such a solvent does not undergo any chemical change, but only beco mes contaminated during the reaction process, its “extraction” away from other chemical substances in the mixture should not

constitute “manufacture” of the solvent. These commenters conclude that if the Agency does intend for each such physical separation step in a chemical process to constitute “manufacture,” this would constitute a profound change in reporting requirements. The same solvent molecule

could be “manufactured” numerous times without a ny change in its chemical identity. Such an expansion in the scope of the definition of “manufacture” would constitute a ve ry substantial change in reporting requ irements and burden.

Regarding the issue of chemical changes in byproduct processing, one commenter noted that routine metal recycling often involves minor, often transitional, chemical changes as part of the process, making many forms of beneficial recycling unqualified for the exemption. Since many metal compounds in a byproduct would dissoc iate in solution to form metal ions, the removal of this ion (which is in reality a compon ent of the byproduct) is not recognized as valid “extraction” activity under the exemption. This commenter in dicated that such an interpretation81 represents the Agency’s attempt to narrow the scope of the commercial byproduct exemption to the greatest degree possible.

Another commenter noted that providing info rmation on byproducts produced in some sectors would be essentially im possible, providing these examples: "when metals are reclaimed from secondary materials of mining and manuf acturing processes -- e.g., when metal oxide pollution control dusts are reduced to metallic form, or when precipitation is used to recover metals from soluble metal compounds in wastewater."

Source: (0187-0078) (0187-0099) (0187- 0098) (0187-0244) (0187-0354) (0187-0073) (0187-0058) (0187-0354) (0187-0079)

Response F.3.d-1: There are numerous examples of chemical substances separated/extracted from various sources, such as air, mined substances, petroleum refinery streams, and byproduct/waste streams that are cons idered manufactured and therefore, reportable for the TSCA Inventory. The separation techniques are quite varied such as solvent extraction, distillation, and crystallization The rules implementing TSCA Sec tions 5 and 8(a) clarify the statutory definition of “manufact ure” by defining “manufacturer” to include persons who extract

a chemical substance from another chemical s ubstance or mixture of chemical substances. “Manufacturer” means a person who imports, produ ces, or manufactures a chemical substance. A person who extracts a component chemical s ubstance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance (40 CFR 711.3 and 704.3).

Much of the commenter’s confusion regardi ng the differences between purification and extraction appears to concern wh ether extraction or purification involves a change in chemical identity; the potential for a change in chemi cal identity is closely linked with the proper

identification of the manufactured chemical subs tance, as described in the previous comment response. As described in response F.3.c, byproduc ts are typically identified for TSCA reporting and Inventory purposes as complex chemical s ubstances or process streams having chemical names that best describe the typically indefi nite compositions of the byproducts in somewhat generic single substance names (i.e., UVCB na mes). The extraction of component chemical substances from certain complex byproduct mi xtures or process streams, such as UVCB chemical substances, is not considered purif ication, because the complex byproduct mixture and

the extracted chemical substance do not have the same chemical identity. For example, a manufacturing process involving the use of solvent A results in the manufacture of a spent solvent. As a variable, complex mixture of solv ent A, finished product, unreacted reactants, individual byproduct chemical substances, and ot her impurities, the spent solvent is considered

to be a UVCB chemical substance. It is not unusual for the manufacturer to extract solvent A

from this UVCB chemical substance. In such a cas e, the extracted solvent A is considered to be manufactured, and therefore is reportable for purposes of IUR. When the spent solvent is a byproduct whose only commercial purpose is the extr action of a component chemical substance, solvent A, the byproduct exemption at 40 CFR 720.30( g)(3) can be applied and the spent solvent byproduct does not need to be reported. The extr acted solvent A is neve rtheless reportable for purposes of IUR.82 As another example, tall oil is a byproduct fr om the pulping of pine trees representing a complex combination which is composed of nu merous chemical substances—the most common of which are rosin and fatty acids, with lesser amounts of terpenes and sterols. Each species of pine tree yields a different precise composition of tall oil, and the co mposition of the tall oil could be influenced by the climate and local te rrain. This byproduct, tall oil, is used as the

feedstock for fractional distillati on, to form a variety of useful fractions (rosin, TOFA, distilled tall oil, heads and pitch). “Manufacture” of a chemical substance includes, by definition, the

distillation/extraction of that chemical substance (40 CFR 704.3) . Note, however, that if a chemical substance is manufactured as a byproduct that is used for a non-exempt commercial purpose, it is subject to IUR reporting.

Where there is no change in chemical identity but rather just a change in purity (an impure chemical substance correctly identified for TSCA purposes as “substance A,” for example, undergoing purification to a more pure form of “substance A”), the Agency agrees with the commenter that, for purposes of IUR, the ch emical substance is not being manufactured. The chemical substance that appears on the TSCA Inventory may actually represent a category consisting of the same chemical substance in various degrees of purity. For example, if a company manufactures a specific, discrete chemical substance at 90% pur ity and it is correctly

identified as that discrete chemical substan ce (not having a UVCB name), then increasing the purity of the chemical substance (such that it retains its chemical identity) is considered purification and, for purposes of IUR, such purification is not considered manufacture.

Comment F.3.d-2: One commenter questioned the Draft Q&A Document at Question 9 (Ref. 26), with respect to recycl able aluminum chips being reported under IUR. This commenter

indicated that "in no case should the machining of metal articles and the resultant chips or shavings, or other physical proce sses, be an activity that companies need to consider for IUR reporting."

Source: (0187-0050)

Response F.3.d-2: The aluminum chips left from the machining of aluminum articles would be considered to be a byproduct that is ma nufactured in the course of machining the metal articles. There is the potential need for IUR repo rting of aluminum if someone, for example, was to melt down the chips into anothe r physical form (such as an ingot or billet), as this could be considered introducing the aluminum into commerce and could represent the

extraction/manufacture of aluminum from th e byproduct chips (which could contain some impurities). In this case, the person who melts down the aluminum may have to report the

reformed aluminum for IUR. As a much less likel y activity, if the aluminum chips were to be used directly as a chemical feedstock for manuf acturing another chemical substance, this would

appear to represent a non-exempt use of a byproduct, causing the generation of the chips to be subject to reporting.

e. Duplicative Reporting83 Comment F.3.e-1: Commenters also argued that th ere would be duplicative reporting by the byproduct manufacturer and th e recycler/processor who extr acted a component chemical substance from the byproduct mixture.

Source: (0187-0101) (0187-0099)

Response F.3.e-1: EPA does not agree that such re porting is duplicative, because a byproduct manufacturer would potentially report the UVCB name for the byproduct composition, while the subsequent recycler of the byproduct would potentially report the specific chemical identity of the chemical substance th ey chemically manufacture from the byproduct. Generally, reporting will fall into one of followi ng two scenarios. If the chemical substance

manufactured from the UVCB byproduct is already present as a constituent of the UVCB byproduct, then the byproduct manufacturer need not report the byproduct that is sent for such processing/recycling. If the chemical subs tance manufactured from the UVCB byproduct is distinct from any chemical s ubstance present in th e UVCB byproduct as a constituent, then the separate reporting by the byproduct manufacturer and the processor/ recycler reflects a change in chemical composition. Either way, there is no du plication of reporting be tween the manufacturer of the UVCB byproduct and the processor/recycler. As a general matter, if there is to be appropriate stewardship of potential chemical substance risks, EPA believes that chemical substance manufacturers, processors, and user s should know and understa nd the identities of chemical substances they handle.

Comment F.3.e-2: Some commenters stated that doubl e counting of chemical substances

would occur when the volume of a metal in a byproduct is reported and then again when that metal is extracted from the byproduct. The comme nters stated that ma ny byproduct mixtures in the metals industry are processed to recover the metal values and indicated that the metal value should be considered a component chemical s ubstance (i.e., that if Nickel (II) hydroxide (Ni(OH) 2 ) is present in a byproduct mixt ure, then the elemental chemical substance Nickel (Ni)

should be considered the com ponent chemical substance).

Source: (0187-0104) (0187-0072) (0187-0354) (0187- 0103) (0187-0073)

Response F.3.e-2: EPA disagrees that reporting bot h the byproduct chemical substance and the extracted elemental metal are duplica tive. Although the commenter stated that many byproduct mixtures in the metals industry are pro cessed to recover “the metal values,” which is somewhat of a generic term, the IUR requires repor ting of the specific chemical identity of what is recovered; that is, if the recovered chemical substance is a metal oxide that is used as an intermediate to form elemental metal, then both the specific metal oxide and elemental metal should be reported by their manufacturer(s).

As stated in the response to comment F.3.b-1, many byproduct chemical substances are UVCB chemical substances, and therefore are different both from an extracted component

chemical substance and from an elemental me tal manufactured from a component chemical substance. EPA disagrees with the example provided in the comment summary. Under TSCA, Ni(OH) 2 and elemental Ni are two different chemical substances, with separate listings on the TSCA Inventory. If the byproduct contains Ni(OH) 2 but not elemental Ni, only Ni(OH) 2 is84 considered a component chemical substance of the byproduct. The manufacture of elemental Ni from either the Ni(OH) 2 –bearing byproduct (or Ni(OH) 2 itself) results in a potential need to report under IUR. That is, if the extracted compone nt chemical substance is an oxide and used as an intermediate to form an elemental metal, then both the oxide and elemental metal are subject to reporting by their manufacturer (s). Note that information pe rtaining to manu facture of a chemical substance need only be reported to th e extent that the information is known to or reasonably ascertainable by the submitter.

A second example of a meta l-containing byproduct is:

Electrolytes, copper-manufg., spent

CASRN 69012-54-0 Definition: Spent copper sulfate electrolyte consisting of copper sulfate and sulfuric acid resulting from the electrolytic refining of copper.

This spent material is a UVCB chemical substa nce that is likely to be recycled. If the only commercial purpose for this spent material is to extract the component chemical substance copper sulfate, then the spent material is exem pted from reporting (but the copper sulfate is subject to reporting). On the othe r hand, if the spent material is used directly to manufacture elemental copper, then both the spent material and the elemental copper are subject to reporting under the IUR by their respective manufacturers, because elemental copper is not a component chemical substance in the spent material byproduct . In this case, the spent material should be reported under the IUR as “Electrolytes, c opper-manufg., spent” according to the TSCA Inventory UVCB chemical substance listing, not as just a component chemical substance in the spent material (that is, it shoul d not be reported as copper sulf ate (or as copper) and sulfuric acid).

Comment F.3.e-3: Commenters stated that raw ma terials that are recovered from byproduct streams for reuse in the same chem ical process should not be reported as

manufactured chemical substances. The chemical substance is simply recovered and reused, and is the same molecule provided by a supplier. As an example, a commenter noted that unreacted raw materials that are recycled a nd reused in a process may be counted multiple times, especially when they have already been accounted for by th e original manufacturer. A commenter provided an example of the recovery and reuse of a solvent, with the potential that a site appears to be the largest U.S. manufacturer of the solvent, when in fact the manufacturer has not manufactured any new molecules of the solven t but rather reused the solvent originally purchased. The commenters stated that counting the volume of chemical each time it when through the process cycle is not a true reflection of the amount of these chemical substances in commerce, and this situation may discourage recycling because th e amount of resources and time to identify, characterize, and report these streams may outwei gh the economic benefit to recycle or reclaim

the chemical substances. The commenter was con cerned that the Agency’s efforts to provide increased transparency to the publ ic may unfairly and inappropriate ly stigmatizes a manufacturer by making it appear to be a manufacturer of larg e volumes of chemical substances, when it is actually using good environmental and economic practices associat ed with the reuse of raw

materials. The commenter also noted that this can unnecessarily cause th at manufacturer to the85 subject to HPV testing as well as section 4 test rules and section 8(a)PA IR reporting, potentially resulting in the manufacturer being subject to these additi onal compliance requirements.

Source: (0187-0099) (0187-0360)

Response F.3.e-3: EPA disagrees with this comment, and does not believe that the IUR provides for inappropriate repe titive counting of chemical s ubstances regenerated from a byproduct in cyclical manufacturing process. Cyc lical or looping processe s either extract or

manufacture chemical substances from other ch emical substances during each cycle, thereby introducing the desired recovered chemical substances back into commerce during each cycle or loop. The situation where a chemical substa nce is separated from a complex, unknown and variable composition subs tance (a.k.a., a UVCB chemical substa nce) – even if that separated

chemical substance is one of the raw material s to the manufacturing process – is manufacturing and, because it is used as a feedstock, is ma nufactured for a commercial purpose. If the UVCB chemical substance is a byproduct, it may be exempt from reporting due to the byproduct exemption at 40 CFR 720.30(g), but the extracted component chem ical substance (i.e., the raw material that is separated from the chemical s ubstance) is considered to be manufactured and therefore potentially reportable.

For example, EPA has been presented with th e following scenario: An excess of reactant A is mixed with reactant B, to form a mixtur e of product C and excess reactant A. The unreacted A and product C (along with possibly some byproduc ts) are separated in a distillation column, with reactant A being returned to the proce ss. In this case, a UVCB chemical substance containing product C and excess reactant A (and possibly other chemical substances) is

manufactured in the reactor. This chemical s ubstance is not isolate d, and therefore can be

considered a non-isolated intermedia te. A distillation column is used to separa te (or extract) the

unreacted A from the manufactured chemical substa nce. The resulting reactant A is used for commercial purposes (as a feedstock), and theref ore is subject to IUR reporting (assuming other requirements, such as production volume, are me t). Product C is also manufactured (and subject to reporting). Note that the UVCB chemical substa nce resulting from the reactor may need to be reported if it is stored, thereby negati ng its non-isolated intermediate status.

EPA also disagrees with the commenter that th is is not a true refl ection of the amount of

these chemical substances in commerce becaus e the Agency believes that the company is manufacturing the subject chemical substance and notes that potential ex posures to the desired

chemical substances continue to exist during each recovery cycle. In addition, if the company is not already tracking this type of activity, it will now have additional information to provide support to its claims of using good environmen tal and economic practices. Making use of the recycling checkbox data element on its IUR submi ssion will enable the pub lic also to identify such practices.

Comment F.3.e-4: Commenters stated that raw mate rials that are regenerated from byproduct streams (i.e., by chemical reaction or ot her means) for reuse in the same chemical process should not be reported as manufactur ed chemical substances. Commenters provided examples of the pulping cycle used by many pape r manufacturers and the regeneration of metal acetate catalyst. One commenter suggested that, instead of reporting the volumes manufactured86 in these “looping” manufacturing operations wher e a byproduct is produced and used onsite to regenerate chemical substances in a loop or cy cling process, the annual net volume of reportable chemical substance(s) in the cycling proce ss should be reported. The commenter further recommends that the net volume of a regenera ted chemical substance in a loop or cycling process is the amount formed based on use of added makeup chemical substances. The

commenter felt that such a cha nge to reporting would be more representative of the actual amount of chemical substance being generated and meaningful from an environmental and health perspective.

Source: (0187-0099) (0187-0360)

Response F.3.e-4 : EPA disagrees with these comments and does not believe that the IUR provides for inappropriate repetitive countin g of chemical substances regenerated from a byproduct in a loop or cycling pr ocess. Cyclical or looping pr ocesses either extract or

manufacture chemical substances from other ch emical substances during each cycle, thereby introducing the desired recovered chemical substances back into commerce during each cycle or loop. Each manufacturing cycle re sults in potential exposures to the extracted and reused

chemical substances.

EPA disagrees with the commen ter’s suggestion that a more representative view of the amount of chemical substance being manufactured at the submitter’s site would be to report the

amount of chemical substance the manufacturer purchases (i.e., the volume of the makeup chemical substance). Reporting the amount of ch emical substance purchased would result in double counting, since that volume of chemical substance should have been reported by the manufacturer of that purchased chemical substance.

f. Effect of Byproduct Reporting On Recycling

Comment F.3.f-1: One commenter stated that many waste streams (and even articles) and byproduct chemical substances will need to be listed on the TSCA Inventory before recycling can occur. The commenter noted that us e and recycling possibilities associated with these streams are not necessarily known at the tim e the material is generated, and therefore the manufacturer may not have reported the chemi cal substance under the TSCA section 5 PMN regulations. Therefore, if a recycling option becomes availa ble for a non-listed chemical substance, the manufacturer will be forced to continue to treat it as a waste and not recycle the

chemical substance. One commenter stated that such a situation exists for spent catalyst

solutions.

Source: (0187-0354) (0187-0072)

Response F.3.f-1 : EPA is aware that there may be situations where a company identifies a way to recycle or otherwise bring into comm erce a byproduct chemical substance that is not listed on the TSCA Inventory because it has traditi onally been treated as a waste or in such a manner that it has been otherwise exempted from listing on the TSCA Inventory and/or reporting

under IUR. Manufacturers in such situations shou ld contact EPA for help in properly identifying the byproduct and to determine whether it should be added to the TSCA Inventory.87 Comment F.3.f-2: Several commenters raised concer ns that the requirement for IUR reporting of byproducts that are se nt for recycling would have the unintended consequence of discouraging recycling and sustai nability efforts. For example, if a manufacturer sends a byproduct to a landfill, as opposed to sending it for recycling, th e company would not be subject to IUR reporting for that byproduct. It may be less expensive to dispose of byproducts in a landfill than to have them recycled or reuse d. This would create an economic disincentive for companies to recycle, which is counter to the longstanding Agency policy of encouraging recycling and reuse. One commenter stated th at the Draft Q&A Document (Ref. 26) sends a message that recycling is for other “educationa l” programs of the Agen cy and that the TSCA program does not acknowledge that the reportin g burdens of TSCA do discourage recycling of waste streams, just as they did in 1977 wh en the commercial byproduct exemption was first

established. Commenter stated that EPA should ex empt all byproducts that are sent for recycling in order to encourage rather than discourage recycling.

Source: (0187-0101) (0187-0094) (0187- 0354) (0187-0072) (0187-0084) (0187-0099)

Response F.3.f-2: EPA believes that commenters’ concern that reporting under IUR would be a disincentive to recy cle reflects certain misunderstandi ngs of the IUR requirements. The Agency expects that revised byproduct guidan ce materials, as well as EPA’s responses to the comments concerning, for instance, byproduct chemical identification requirements, will help to alleviate the majority of those concerns. EP A believes that many factors play into whether a company chooses to recycle, including the value of the recovered materials, the expense of disposal, desire to maintain or build a “green” reputation, technical limitati ons or flexibility, state and local requirements or incentives, and the incentives offered or requirements imposed by other federal laws (such as RCRA). EPA strongly believes that the benefits of recycling usually outweigh the burden associated with IUR for th ese materials, and, just as with any other

chemical substance whose manufacture must be reported under the IUR, production volume, worker exposure and other IUR data collected on byproduct chemical substances supports the Agency’s mandate to protect human health and the environment.

EPA intends to continue to work with indus try and the interested public. EPA encourages recycling. While the 1977 language cited by the commenter (Ref. 35, 42 FR 39186) suggests that the byproduct exemptions at 40 CFR 720.30(g) were proposed, in part, to encourage recycling, it does not immediately follow that further expansion of the exemptions at 40 CFR 720.30(g) is appropriate, simply because such an expansion would potentially further encourage recycling. The Agency intends to examine the collected in formation related to byp roducts, recognizing the importance of recycling, to id entify whether there are segmen ts of byproduct manufacturing for

which EPA can determine that there is no need for the IUR information for the 2016 or other future reporting cycles.

g. The Relationship between IUR and Other EPA Regulations

Comment F.3.g-1: Citing the original TSCA I nventory language from 1977, one commenter noted that the primary origin of the commercial byproduct exemption was EPA’s decision, at the outset of the TSCA program, to create a regulatory structure for chemical88 management that would encourage recycling ac tivity. This commenter al so noted that RCRA, not TSCA, is the lead Agency program addressi ng the recycling of solid and hazardous wastes. The Agency’s stated intent in establishing the exemption was “to encourage conservation and recycling of the energy and resources contained in the waste material that might otherwise be discarded because of reporting burdens under TSCA” (Ref. 35, 42 FR at 39186). This commenter noted that the Agency did not take any further regulator y action on commercial byproducts in later stages of the TSCA I nventory regulations. In 1983, however, it did incorporate the commercial byproduct exemp tion language from the Inventory Reporting Regulations into the new chemical review regul ations at 40 CFR § 720.30(g). In addition, this commenter requested that EPA initiate a cross-pr ogram review of the appropriate roles of the TSCA and RCRA programs regarding the management of recycled materials, and that in the interim the Agency should not pursue publishing the IUR byproduct guidance document that was

offered for comment.

Source: (0187-0354) (0187-0101) (0187- 0072)

Response F.3.g-1: There is a distinction between the IUR, the PMN rule, RCRA, and the TRI requirements. As these have all been desi gned for separate purposes, EPA does not believe that it is necessary to conduct a program review of the appropriate ro les of TSCA and RCRA regarding recycled materials. Rather, EPA belie ves that a better understanding of the goals and requirements of the various programs should help the reader determine re porting obligations, if any, under TSCA and RCRA. In broad terms, the purpose of TSCA sections 8 (governing the IUR) and 5 (governing PMN reporting) is to underst and the universe of chemical substances in commerce in the United States. (Section 5 also provi des EPA with the ability to control for risks of new chemical substances before they are placed into commerce.) The IUR requires reporting of manufacture, processing, and use informati on for chemical substances in commerce and exemptions exist for those chemical substances or manufacturing activities for which EPA has a

low current interest in the IUR information. With limited exception, such as those included in 40 CFR 720.30, all chemical substances in commerce in the United States are to be listed on the TSCA Inventory; companies can tr igger the addition of a chemical substance to the Inventory by filing a PMN and meeting certain other requirements (Ref. 36).

RCRA is focused on waste – it is concer ned with the generation, transportation, treatment, storage, and disposal of hazardous wa stes and the management of non-hazardous solid

wastes. RCRA is also focused on waste minimi zation, phasing out land disposal of hazardous waste, corrective action for releases, and recyclin g. EPA notes that while RCRA or other statutes may exempt a certain chemical substance fr om reporting requirements based on certain treatments or disposals, RCRA exemptions in most cases are not relevant to TSCA reporting obligations. It is important to note that finding a commercial use for a chemical substance previously treated as a waste under RCRA can re lieve the manufacturer of that chemical substance from some RCRA requirements, but ma y then subject that manufacturer to TSCA reporting requirements. Also note that 40 CFR 720.30(g) provides IUR exemptions for certain uses of byproducts. In certain circumstances, reporting under both RCRA and TSCA may be required. As noted earlier, the purposes fo r reporting under RCRA and the TSCA IUR are different, and therefore the requi red data sets are different. While the data sets are not duplicative, EPA recognizes that there may be lim ited circumstances where particular elements89 of the data sets overlap. EPA strives to re duce such overlap, while ensuring that it is administratively feasible to coll ect and collate the data that ar e needed for TSCA purposes. The TSCA program is continuing its work with the federal RCRA program -- to maintain coordination between the two programs. It is im portant to note that the application of RCRA regulations varies state-by-state, and recent changes to RCRA regulations have not been adopted by all states. Therefore the overlap between RCRA reporting and IUR reporting may vary depending upon the state in which a submitter’s site is located.

A similar situation exists for some sites that meet the requirements to report under both TRI and IUR. The TRI reporting requirements ar e governed by section 313 of EPCRA, section 6607 of the Pollution Prevention Act (PPA), an d the regulations at 40 CFR part 372. TRI’s program goal is to provide communities with in formation about toxic ch emical releases and waste management, and the TRI reporting requi rements are designed to address that goal. Because the IUR program goals differ, the speci fic information collected under each program is not the same. Where a person must report for bot h for the same site, EPA and the public will have a broader picture of the exposure scenarios at that site, including environmental releases from that site; while the two information colle ctions may be complementary, neither is an adequate substitute for the other. See comment response F.3.g-2 for further discussion.

A better understanding of both the RCRA pr ogram and the TSCA IUR requirements associated with byproducts and recycled chemical substances will help the reader determine any reporting obligations. Below is a discussion and some background information; additional

discussion is included in the IU R reporting guidance (Ref. 9). For purposes of IUR and PMN, the

term byproduct could refer to a chemical substance th at, under RCRA, is considered a secondary material (i.e., one of a number of categories of materials regulated under RCRA), and includes by-product

, sludge

, spent material, and scrap metal . The IUR term is defined as:

Byproduct means a chemical substance produced w ithout a separate commercial intent during the manufacture, processing, use, or disposal of anothe r chemical substance(s) or mixture(s). (40 CFR 704.3)

The four RCRA terms are defined as:

Spent material means any material that has been us ed and as a result of contamination can no longer serve the purpose for which it was produced without processing. (40 CFR 261.1)

Sludge means any solid, semi-solid, or liqui d waste generated fr om a municipal, commercial, or industrial wastew ater treatment plant, water su pply treatment plant, or air pollution control facility exclusive of the tr eated effluent from a wastewater treatment plant. (40 CFR 260.10)

By-product means a material that is not one of the primary products of a production process and is not solely or separately pr oduced by the production process. Examples are process residues such as slags or distillation column bottoms . The term does not include a90 co-product that is produced for the general public 's use and is ordinarily used in the form it is produced by the process. (40 CFR 261.1)

Scrap metal means worn or extra bits and pieces of metal parts, such as scrap piping and wire, or worn metal items, such as scrap automobiles and radiators.

RCRA regulations make additional distinctions that affect the status of the chemical substance under question. For in stance, a by-product can be a characteristic waste or a listed

waste , and a material can be reclaimed or used or reused . Under RCRA Subtitle C regulations, a

material is considered recycled if it is used, reused, or reclaimed. (40 CFR 261.1)

A characteristic waste is a waste that has not been speci fically listed and exhibits one of four characteristics - ignitability, corrosivity, reactivity, or toxicity

. (40 CFR 261 Subpart C) ( http://www.epa.gov/epawaste/hazard/ wastetypes/characteristic.htm )

Listed wastes have been determined to be hazardous by EPA. These wastes are incorporated into lists published by the Agency. ( http://www.epa.gov/epawaste/ hazard/wastetypes/listed.htm )

A material is reclaimed if it is processed to recover a usable product, or if it is regenerated. Examples are rec overy of lead values from sp ent batteries and regeneration of spent solvents. In addition, for pur poses of §§261.2(a)(2)(ii ), 261.4(a)(23), and 261.4(a)(24) smelting, melting and refining furnaces are considered to be solely engaged in metals reclamation if the metal recovery from the hazardous secondary materials meets the same requirements as those specified for metals recovery from hazardous waste found in §266.100(d)(1)–(3) of this chapte r, and if the residuals meet the requirements specified in §266.112 of this chapter. (40 CFR 261.1)

A material is used or reused if it is either:

(i) Employed as an ingredient (including us e as an intermediate) in an industrial process to make a product (for example, distillation bottoms from one process used as feedstock in another process). Ho wever, a material will not satisfy this condition if distinct components of the ma terial are recovered as separate end products (as when metals are recovere d from metal-containing secondary materials); or

(ii) Employed in a particular function or application as an effective substitute for a commercial product (for example, spen t pickle liquor used as phosphorous precipitant and sludge conditioner in wa stewater treatment). (40 CFR 261.1)

A recent RCRA publication states that “cert ain hazardous secondary materials, if recycled, are not solid wastes and, therefore, are not subject to RCRA’s ‘cradle to grave’ management system. The basic idea behind this pr inciple is that recycling of these materials often closely resembles industrial manufacturin g rather than waste management” (Ref. 37). Effectively, these materials, provided some rather stringent conditions are met, are not subject to91 RCRA’s hazardous waste management requirements . However, some of the same facts and conditions that would qualify a recycling activ ity for an exemption from RCRA hazardous waste management requirements may trigger TSCA repor ting requirements, due to the fact that the activity meets the TSCA definition of manufact uring a chemical substance for a commercial

purpose.

See the IUR reporting guidance for additi onal information regarding reporting requirements for byproducts. In addition to an ex tension of the discussion in this comment response, current and potential differences be tween RCRA and TSCA regarding some specific situations, such as those identified in the para graph describing when a material is reclaimed (specifically associated with me tals recovery), are addressed. As EPA is made aware of other situations or points of confusion, clarifying information will be added to the IUR guidance

materials.

Comment F.3.g-2: Commenters noted that many byproducts, such as recycled spent catalyst streams, are already managed by waste tr ansport and recycling fa cilities regulated under RCRA, TRI, and other federal a nd state laws and regulations. On e commenter specifically noted that byproducts shipped off site by mining companies are already reported under the TRI program, so there is little or no benefit to requi ring that similar information be reported again under the IUR program.

Source: (0187-0104) (0187-0101) (0187-0072)

Response F.3.g-2: The TSCA IUR collects significantly different types of information than the TRI program. TRI generally requires the reporting of, releases of a relatively small set of chemical substances compri sing the TRI list that are either manufactured, processed, or otherwise used in quantities ex ceeding certain thresholds. The IUR program is concerned with developing data related to the manufacture, pr ocessing and use of all non-exempt chemical substances in commerce, to support screening- level risk assessments of these chemical substances. One major reason that TRI byproducts re porting is not an adequate substitute for IUR byproducts reporting is that the universe of chemical s ubstances subject to TRI is substantially narrower than the universe of chemical substances subject to IUR. Furthermore, the particular kinds of data collected under the TRI are not the same as thos e required under the IUR, because the two programs are designed to serve different purposes. For example, TRI entries may, in certain circumstances, aggregate quantitie s of several chemical substances that fall within a broad category of chem ical substances; this informa tion would not achieve the IUR’s purpose of gathering information on the specific chemical substances on the TSCA Inventory. Such aggregate reporting is par ticularly likely to occur in the case of metals (e.g., copper and copper compounds can be reported in one report as a single category), so the reporting of mining byproducts under the TRI is especially unlikely to be an adequate substitute for IUR reporting, which would collect disaggregated informati on on the metal and each individual compound. To take another example, the IUR required reporting of the physical form of a chemical substance (e.g., dry powder, wet solid, liquid, etc.), which TRI does not. The physical form of a chemical substance is often a meaningful input to conducting a screening- level risk assessment for that chemical substance, an important component of EPA’s implementation of TSCA. Because of the

difference in the chemical substances that are subject to the two programs, and because of the92 differences in the information reported respecting each chemical substance the Agency does not agree that concurrent reporting under TRI warrant s the elimination of byp roducts reporting under

IUR.

Regarding the relationship between RCRA and IUR obligations, please see above Response F.3.g-1. Regarding “other federal and stat e laws and regulations,” EPA is not aware of any other comprehensive source of the informati on that Congress has mandated that EPA collect and keep current, respective the TSCA Inventory. If we receive information concerning specific alternatives to collecting this in formation through IUR, we will c onsider whether any revisions to IUR would be appropriate.

To illustrate the similarities and differences between the two programs, below is a summary comparison of reporting in 2006 for Asar co’s Amarillo Copper Refinery, in Amarillo, TX. Note that any specific discussion within th is example is necessarily restricted to non-CBI data, which is more of an issue for public dissemination of IUR data than for TRI data.

Under IUR, ASARCO reported the manufacture of four chemical substances in volumes of 25,000 lb or more. Under TRI, the same facility reported two specific ch emical substances and eight compound categories. Each of the four chem ical substances reported under IUR could fit within a compound category repo rted under TRI (note that th is is because, under certain circumstances, TRI reporters have an option to separately report the elemental metal (e.g., copper) or to report it as part of the categor y (e.g., copper compounds)). For example, copper was reported as manufactured under IUR, and copper compounds were reported as produced and imported under TRI. Because copper was only re ported as manufactured for IUR, one can conclude that all copper imported for TRI should be copper compounds , otherwise the IUR report would have indicated both manufacture and import for copper. One could also conclude

that all of the other copper compounds were manufactured under 25,000 lb, were impurities, or were byproducts with no commercial purpose or an exempted commercial purpose, because no copper compounds were reported under IUR for this site. Note that the requirement to report imported chemical substances is different under IUR and TRI, and certain volumes that would be reported as imported for IUR would not be reported as imported for TRI.

IUR collects data on production volume; TR I collects data on maximum amount on-site and the volume released. For TRI reporting, in the case of a compound category, the volume reported is the weight of the copper only and is, not the full we ight of the copper compound. The maximum amount of copper in the copper comp ounds onsite was substan tial, reported as between 50 and 100 million lb. Under IUR, copper was reported by a number of sites in an aggregated national production volume of over one billion lb. Because of CBI concerns, EPA is not able to publicly identify the sp ecific amount reported by any one site.

The TRI data indicate that the category of copper compounds was used on-site, sold or distributed, and produced or imported as a bypr oduct and/or impurity. A small portion (94 lb (copper weight only)) was transf erred offsite for land treatment, and another small portion (803 lb (copper weight only)) was sent offsite for meta ls recovery. There is no indication of the total amount produced or imported. As an inorganic ch emical substance, IUR reporting of processing and use information was not required for 2006, but will be required for the first time in 2012.93 Therefore, the Agency does not have IUR data identifying industrial processing and use or consumer or commercial use of copper, includi ng possible use in products intended for use by

children.

IUR data identify that copper was manufactured in four different physical forms – dry powder, water or solvent wet solid, other solid, and liquid. The number of manufacturing sites is determined from the number of reporters, and the number of processing and use sites will be determined when such information is reported for the 2012 IUR. In addition, the number of reasonably likely to be exposed manufacturi ng workers was reported for the 2006 IUR, and will also be reported industrial pr ocessing and use workers and commercial workers for the 2012

IUR.

Comment F.3.g-3: One commenter noted that treating byproducts sent for recycling as manufactured chemical substances and requi ring reporting under IUR may have unintended effects on other EPA rules, including that some manufacturers may stop reporting these byproducts under RCRA and TRI because they are now considered by EPA to be chemical

substances in commerce.

Source: (0187-0103)

Response F.3.g-3: EPA disagrees with the commenter that the requirement to report byproducts will cause significant confusion re garding a company’s RCRA and TRI reporting obligations. As described in response F.3-g-1, su bstantial differences ex ist between the reporting requirements. As stated in th at response, there are circumstances under which a chemical substance is reported for bot h IUR and RCRA or IUR and TRI, and manufacturers should carefully review the respective regulations to determine their reporting obligations.

h. Identifying the Need to Report a Byproduct

Comment F.3.h-1: Some commenters stated that the byproduct generator cannot determine what component chemical substances will be extracted from the byproduct and in what quantities. One commenter not ed that the manufacturer of the by-product mixture may have no reason to be aware of the recycler’s plans and thus will not know wh ether these secondary components will simply be disposed of (in which cas e, they are not subject to IUR reporting) or will be subject to recovery in a process involving a chemical reaction (in which case, they would be subject to reporting under EPA’s by-products reporting policy). One commenter identified that the answer to question 7 in the Draft Q&A Document (Ref. 26) has the potential to create a situation in which generators of byproducts (e.g., wastes) sent to reclaimers are responsible for knowing the processes used by the reclaimers.

Source: (0187-0073) (0187-0103) (0187-0058) (0187-0079) (0187-0099)

Response F.3.h-1 : EPA considers it the responsibility of the byproduct manufacturer to try to determine how the byproduct would be used if shipped to another company or organization: whether it would be used as a chemical substance, thus making the byproduct subject to reporting, or whethe r its use would be covered by the byproduct exemption under94 720.30(g)(3). In addition, the Agency believes that much of the industry confusion is due to misunderstandings of the proper identification of their byproduct chemical substances (see comment and response F.3.c-1). For instance, qu estion 7 in the Draft Q&A Document (Ref. 26) addresses the issue of spent catalysts sold to metal reclaimers who “extract the metals out of the spent catalysts.” The spent metal catalyst byprodu ct is reportable unless the extracted chemical substances are component chemical substanc es of the byproduct. The byproduct manufacturer needs to determine its IUR reporting obligations based on whether the recy cler is extracting a component chemical substance or reacting a chem ical substance in the byproduct to extract a different chemical substance (e.g., an elemental me tal), to the extent such information is known to or reasonably ascertainabl e by the byproduct manufacturer.

Comment F.3.h-2: Some commenters stated that the byproduct exemption is for byproducts for which the only commercial purpose is to extract component chemical substances, including instances such as ex tracting an elemental metal fr om a metal compound or complex that exists as a component chemical substan ce in the byproduct. A commenter stated that the regulatory language does not necessa rily indicate that chemical reaction or conversion would negate the exemption.

Source: (0187-0058) (0187-0079) (0187-0099)

Response F.3.h-2 : In general, a byproduct, as defined at 40 CFR 704.3, is excluded from the IUR reporting requirements at 40 CFR 720.3 0(g)(3) when used to extract component chemical substances from it for commercial purpo ses. Note that a component chemical substance that is extracted or separated from a byproduct must be a chemi cal substance that is actually present in the byproduct. Any me thod of extraction of the component chemical substances, including by means of heat or a chemical reaction (a reaction carried out on another component of the byproduct), is to be regarded as “manufactur e of that chemical substance” for the purposes of this rule. (See the definition of manufacturer at 40 CFR 704). Thus, the IUR exclusion does not apply to the component chemical substances extracted from the byproduct for commercial purposes since they are consid ered to be manufactured.

It should be noted a byproduct is typically identified for TSCA reporting and Inventory purposes as complex chemical substances or proc ess streams having a single chemical name that best describes the typically indefinite compos itions of the byproducts using somewhat generic nomenclature (these are UVCB substances, described above in response F.3.c.). Because an extracted chemical component necessarily has a different chemical identity from the byproduct, the extraction cannot be thought of as a purif ication of the byproduct, but rather as the

manufacture of a chemical substance that is different from the byproduct composition.

Comment F.3.h-3: One commenter stated that, alt hough it “does not believe byproducts sent for recycling are ...chemicals reportable under the IUR rule, if EPA insists that data is needed on the recycling of byproduc ts, the reporting should be provi ded by the recycler, not the byproduct generator. In a letter from EPA to IPC on November 30, 2007, EPA stated, ‘When a manufacturer recycles a byproduct , the manufacturer needs to consider whether any obligations arise under TSCA...’ (Emphasis added.) (Ref. 38). Manufacturers do not recycle the byproducts they generate, recyclers do. The regul ation clearly states th at excluding byproducts95 when component chemical substances are extracted from it applies to the byproduct, not the component chemical substances. The component chemical substances are extracted, processed, and resold on the market by the recycler and ther efore, the reporting requirements should be the responsibility of the recycler. Fu rthermore, recyclers will have data on the processing and use of the component chemical substances that are ex tracted, since they would be selling the final chemical product. Recyclers s hould be required to report on th e byproducts they recycle under the IUR rule, not the generator of the byproduct.”

Source: (0187-0103) Response F.3.h-3 : EPA agrees with the comment that the recycling of byproducts into chemical substan ces that are different from the byproduct should require the reporting of the diffe rent chemical substances by th e recycler. In this case, the recycler is considered to be a manufacturer of the different chemic al substances, regardless of the production method used (e.g., extraction or chem ical reaction). Furthe rmore, the byproduct manufacturer is responsible for reporting the manu factured byproduct if it is to be used for a nonexempt commercial purpose, including as a chemical feedstock or reactant.

Comment F.3.h-4: One commenter stated that, in th e Draft Q&A Document (Ref. 26), EPA does not clearly state that bypr oducts sent for recycling are s ubject to the IUR rule and that the definition of an IUR reportable chemical substance does not incl ude byproducts sent for recycling. The commenter states that the definitio n in the guidance documen t states that an IUR reportable chemical substance is: “[A] chemical substance that is domestically manufactured or imported into the US, is listed on the TSCA I nventory, and is not exempted by 40 CFR 711.6 in TSCA,” and that electronics manufacturers do not consider the byproduc ts or the component chemical substances contained within byproducts as , “a chemical substance that is domestically manufactured or imported into the U.S.”

Source: (0187-0103) Response F.3.h-4 : EPA disagrees with this statem ent. The guidance document, titled “Q&A Document: Recycling and th e TSCA Inventory of Chemical Substances Premanufacture Notification and Inventory Update Reporting Requirements” (Ref. 26) clearly discusses issues associated with recycling and IUR requirements. A byproduct sent for recycling may or may not need to be reported, depending upon the recycling activ ities. As described in the preamble to the proposed rule, the guidance document, the preamble to the final rule, and other places in these comment responses, the need to report when a bypr oduct is recycled is not definite, but rather is dependent upon the circumstances surrounding the byproduct and how it is used in commerce.

i. Requests for Byproduc t-Related Exemptions

Comment F.3.i-1: One commenter urges EPA to excl ude the reporting of all byproducts from the IUR rule, regardless of whether they are disposed of or sent for recycling.

Source: (0187-0103)

Response F.3.i-1: As noted for other circumstance s where commenters have suggested an across-the-board exemption, EPA presently has no informed basis to conclude that byproducts that are manufactured for a commercial purpose, and that were not el igible for the byproduct96 exemption based on 40 CFR 711.10 (activities for wh ich reporting is not required), are not of

current interest to EPA. There is no reason for EPA to believe that e xposures or hazards of byproduct chemical substances are generally lower than for chemical substances that are the target of the manufacturing activ ity. The fact that some companie s may not have realized that they need to report these chemical substances, or that they are chemical manufacturers when they produce a byproduct chemical substance, is no t an appropriate basis to grant a reporting exemption. EPA cannot meet its mandate to prot ect human health and the environment if it

excludes whole classes of chemical substances from IUR reporting obligations without carefully considering whether IUR reporting is needed for each chemical substance proposed to be

excluded.

The Agency also intends to examine the co llected information related to byproducts, recognizing the importance of recy cling, to identify whether there are segments of byproduct manufacturing for which EPA can determine that th ere is no need for the IUR information for the 2016 or other future reporting cycles.

Comment F.3.i-2: One commenter requested a generic or general partial exemption from IUR reporting for the byproduct “recycled spent me tal catalyst solutions” in accordance with 40 CFR 710.46(b)(2)(iii). The commenter’s petition pertains to whether spent metal catalyst streams, as a general category, “[ are] . . . of low current intere st” and therefore entitled to a partial exemption on those separate grounds. See 40 CFR 710.46(b)(2)(iii)(A), redesignated at 40 CFR 711.6(b)(2)(iii)(A). The commenter also aske d to be notified if EPA determines that a specific chemical identity is needed instead of the more generic “recycled spent metal catalyst solutions” identity.

Source: (0187-0072)

Response F.3.i-2 : The IUR has a petition process for adding a chemical substance to the partial exemption list. Reporting exempti ons under 40 CFR 720.30(g )(3) relate to the commercial purposes of a byproduct after it is manufactured. Requests for partial exemptions under 40 CFR 711.6(b)(2)(iii)(A), by contrast, are re viewed based on the “tot ality of information available” to screen the risks of a particular chemical substance. EP A is not substantively responding to it in this response to comment. EP A will respond to the petition pursuant the procedures at 40 CFR 710.46(b)(2)(iii).

Note also that, as is stated in 40 CFR 711.6( b)(2)(iii)(C), requests must be submitted no later than 12 months pr ior to the start of the reporting year. For the 2012 IUR, the reporting year is 2011 and therefore the request needed to ha ve been made by January 1, 2010. Because this petition was submitted too late for considera tion for the 2012 IUR, the Agency will instead consider this request for the 2016 IUR. Because EPA has not yet completed its review of the petition, EPA has not yet determined whether it will promulgate the amendment to the IUR sought by the petitioner.

Comment F.3.i-3: One commenter felt that the scra p recycling industr y should not be subject to IUR reporting for elemental metals on two levels:97 (1) Bulk scrap metals are a low priority with respect to risk and should be exempt from reporting requirements. (2) Reporting of scrap metals by industry faci lities would provide litt le, if any, additional useful information to EPA because the processi ng of scrap metals and the downstream use of specification-grade scrap metal commodities ar e already sufficiently known to EPA.

The commenter thought that it was inappropriate that removal of the IUR exemption for inorganic chemicals made every metallic element reportable whether they are toxic or not. The

commenter contrasted the IUR requirement for metals reporting with the EPCRA exemption from reporting for solid metals listed in 40 CFR 302.4 with diameters above 100 microns (0.004 inch) and stated that the EPCRA exemption “stro ngly suggests that bulk elemental solid metals do not pose a hazard.”

To address the above concerns, the co mmenter suggested the following possible

modifications that would have the effect of exempting the scrap recycling industry from IUR reporting for scrap metals: 1. Modifying the definition of “processor” at 40 CFR 710.3 to disallow “upgrading” of a “processor” to a “manufacture[r] ” solely because of importing. 2. Adding bulk scrap elemental metals to the TSCA Inventory while simultaneously adding an exemption from reporting requirement s for bulk scrap elemental metals at 40 CFR

710.46. 3. Classifying bulk scrap elemental metal as an “article” to allow it to meet the “article” exemption at 40 CFR 710.50(b) for chemical substa nces imported as part of an “article.”

Source: (0187-0351)

Response F.3.i-3 : Regarding the commenter’s genera l desire for an exemption for bulk scrap elemental metals, EPA has provided a proc ess whereby any person may request that EPA amend the chemical substance list in paragraph (b)(2)(iv) of 40 CFR 711.6 to provide a partial exemption from IUR reporting for a chemical substa nce. In addition to pr oviding instructions for the submission of such a petition and considerations that should be addressed, EPA has indicated that petitions must be submitted to EPA no later than 12 months prior to the start of the next principal reporting year. Ther efore, EPA recommends that the commenter review the requirements for such a request and prepare a petit ion for EPA's consideration well in advance of the 2016 reporting cycle.

EPA does not agree with the commenter’s suggestion that the exemption at 40 CFR 302.4 (for solid metals with diameters above 100 micr ons) represents a conclusion that bulk elemental solid metals never pose a chemical hazard. Th e 100 micron cutoff is not based on a general hazard determination, but rather it represents th e particle size below wh ich notification of the release of a reportable quanti ty is required under the regula tion under EPCRA or CERCLA. The cutoff size was deliberately set ten times larger th an the maximum size considered by EPA to be respirable dust to ensure that releases cont aining small particles of metals would result in notification. The primary purpose of emergency notification is to en sure that releasers notify the various levels of government of potential hazards so that necessary response actions can be taken to protect human health and the environmen t (Ref. 39, 50 FR at 13461). The exemption at 4098 CFR 302.4 addresses exposure to substances in respirable dust unde r accidental release

conditions. It does not cover all potential routes of exposure to a chemical substance under occupational and general populati on exposure conditions that are the subject of IUR reporting. Additionally, as noted in previ ous responses, the purpose of IUR reporting is to update the TSCA Inventory which includes chemical substances curre ntly in commerce and is not limited to those

chemical substances which have been determined to be hazardous or toxic. Regarding the commenter’s suggestion to modify the “processor ” definition, the Agency does not believe it is appropriate and sees no compelling reason to modify either the 40 CFR 710.3 definition of processor (or, for the revised IUR, the appl icable 40 CFR 704.3 definition) along the lines suggested by the commenter. This is because under TSCA, manufacture includes import. The statutory definition of “manufacture” includes “t o import into the customs territory of the United

States.” The commenter did not ar ticulate an adequate rationale to justify differentiating certain importers from other manufacturers, simply becau se they are importing a chemical substance for purposes of processing it.

Regarding the commenter’s suggestion for a generic TSCA Inventory listing for bulk scrap metals, a scrap metal material having an uncertain or unknown co mposition could perhaps become listed via new chemical substance reporting under section 5 if such a material is to be imported for a non-exempt commercial purpose. However, it would not be appropriate under TSCA for the Agency to preemptively add such a listing to the TSCA In ventory. Such an action would potentially convert a “new chemical subs tance” into an “existing chemical substance”

without the benefit of the new chemical substance reporting and review process specified under

section 5 of TSCA.

Regarding the commenter’s suggestion to classify bulk scrap metals as “articles” so that they would be covered by the articles exemp tion at 710.50(b) (finalized as 40 CFR 711.10(b)), EPA does not agree, based on the information s upplied in the comment, that bulk scrap metal qualifies as an article. For purpos es of the IUR, the term “arti cle” is defined at 40 CFR 704.3. An article must be “formed to a specific shape or design during manufacture, ” and it must have “end use function(s) dependent in whole or in part upon its shape or design during end use.” EPA does not agree, and the commenter does not contend, that the end use of imported scrap metal is dependent on the particular shape or design of the individual pieces of scrap metal. To the contrary, EPA believes that the e nd use of scrap metal is metallurg ical recycling, a process that eliminates rather than depends upon the shape or design or the individual metal pieces. Finally, EPA does not agree that it would be appropriate to enlarge the defi nition of article to encompass scrap metal. The definition of “article” is long-standing and the modifications requested by the commenter (essentially to abandon the traditiona l structure-function test) would likely have unwarranted, far-reaching, and unintended consequences.

4. Definitions of Manufacture and Manufacturer

Comment F.4-1: Several commenters asserted th at the definition of manufacture included in the proposed rule was inconsistent wi th past definitions, over-broad, and confusing.

Source: (0187-0089) (0187-0079) (0187- 0065) (0187-0244) (0187-0098) (0187-0081)99 Response F.4-1: EPA disagrees, except with respect to minor typographical errors noted

below. EPA consolidated existi ng definitions into a single “m anufacture” definition to reduce confusion. EPA also added a very short clarifyi ng definition that “a ma nufacturer is a person

who manufactures a chemical substa nce,” to direct the reader to the relevant language in the definition of “manufacture,” and to avoid confusion with an existing definition of

“manufacturer” in 704.3. The definition of “man ufacture” is consistent with established regulatory and statutory definitions, and is suffi ciently flexible to accommodate the actual allocation of knowledge between toll manufacturers and cont racting companies. EPA has separately addressed the comment s received relating to the extr action of component chemical substances. (See the discussion on reporting byp roducts and recycling elsewhere in this document.)

The first part of the definition of manufacture in the final rule is as follows: “Manufacture means to manufacture, produce, or import, for commercial purposes. Ma nufacture includes the extraction, for commercial purposes, of a com ponent chemical substance from a previously existing chemical substance or complex combina tion of substances.” It is similar to the

definitions of “manufacture” and “manufacturer” used for past IUR reporting. For example, the

definition of manufacturer in effect for th e 2006 IUR reporting period is in 40 CFR 704.3: “Manufacturer means a person who imports, produ ces, or manufactures a chemical substance. A person who extracts a component chemical subs tance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical

substance.” The two similar de finitions of “manufacture” in effect for the 2006 IUR reporting period were found in 40 CFR 710.3 (“to manufac ture, produce, or import for commercial purposes,” and 40 CFR 704.3 (“to manufacture fo r commercial purposes”). The Part 711

definition of “manufacture” is also consistent with the establis hed definition of “manufacturer” used for purposes of PMN reporting, at 40 CFR 720.3. Existing Part 704.3, which was not modified in the final rule, also includes a definiti on of manufacture: “M anufacture means to manufacture for commercial pu rposes,” and a definition of “manufacture for commercial purposes” that makes clear that byproducts produced during manu facturer are also “manufactured for a commercial purpose.”

The definition of “manufacture” in the final rule is also similar to and consistent with

TSCA’s definition of “manufact ure” at Section 3: “’manufacture’ means to import in the customs territory of the United States, produce, or manufacture,” and Se ction 8: (“For purposes of this section, the term “manuf acture” . . . mean[s] manufacture . . . for commercial purposes.”) Finally, EPA disagrees with one commenter’s s uggestion that a new definition of “produce” is necessary to clarify that producti on involves a chemical substance that is “chemically different” from the chemical substance in the starting ma terials. “Chemically different” is itself an undefined term, so it would not bring additiona l clarity to a new definition of “produce.” Furthermore, the difference between one chem ical substance and another (and hence, the question of whether a chemical substance is bein g produced) already has a basis in the statutory definition of “chemical substance” at TSCA 3(2) , and in the differences between the entries of the TSCA Inventory.

The second part of the definition, as noted in the preamble to the proposed rule, adds an explanation, derived from the definition of “m anufacturer” in Part 720, of the conditions under100 which a contract manufacturer would be cons idered to “manufacture,” and therefore be responsible for IUR reporting. Persons contra cting with a toll manufacturer and toll

manufacturers are now considered to be co-manufacturers of wh at is produced at the toll

manufacturer’s site. Consistent with 40 CFR 711.22(c), such part ies should coordinate amongst themselves to submit a single report, rather than duplicative indi vidual reports, respecting what they have co-manufactured. The joint submi ssion mechanism, under 40 CFR 711.15(b)(3)(i), is

not available to co-manufacturers. The join t submission mechanism addresses distinct circumstances: those in which one party is the manufacturer/importer, and a second party (not a manufacturer of the chemical substance in quest ion) possesses confidential information needed to determine the chemical identity of what the first party has manufactured/imported. In the final rule, EPA uses the term “co-manufactured” ra ther than the proposed term “jointly manufactured.” This change of terminology is intended to avoid confusion between the reporting provisions at 40 CFR 711.22(c) a nd those at 40 CFR 711.15(b)(3)(i).

EPA also notes that it made minor changes to the definition of “ma nufacture” to correct a typographical error in the definition as proposed and to address a comment that the definition used confusing syntax. The words “and” and “then” were added to make cl ear that the conditions in paragraph (1), and the conditions in paragra ph (2) (up to the comma), must both be satisfied

before a chemical substance will be consid ered “jointly manufactured” by the producing manufacturer (i.e., the toll manuf acturer) and the person contracti ng for such production (i.e., the contracting company).

Comment F.4-2: One commenter pointed out that th e IUR definition of manufacture is circular, including “manufacture” as an example of an activity that constitutes “manufacture.”

Source: (0187-0099)

Response F.4-2: EPA notes that the statutory definition is also circular. It is nevertheless evident that the statutory definition of manuf acture encompasses both the import of a chemical substance and the domestic produc tion of a chemical substance (Ref. 34, H.R. Report, No. 94- 1341 at 420). The IUR’s regulatory definition of “manufacture” follows TSCA in including a circular reference to “manufacture, ” to foreclose potential mis-inte rpretation that there is a third type of manufacturing (other th an import and domestic production) that is outside the scope of

the IUR.

Comment F.4-3: Another commenter suggested that a se parate definition of “produce” is

necessary.

Source: (0187-0099)

Response F.4-3: . EPA disagrees with one commenter’ s suggestion that a new definition of “produce” is necessary to clarify that pr oduction involves a chemical substance that is “chemically different” from the chemical substa nce in the starting materials. “Chemically different” is itself an undefined term, so it would not bring additional clar ity to a new definition of “produce.” Furthermore, the difference betw een one chemical substance and another (and hence, the question of whether a chemical substa nce is being produced) alre ady has a basis in the101 statutory definition of “chemical substance” at TSCA 3(2), and in the differences between the entities of the TSCA Inventory.

Comment F.4-4: Regarding toll and contractor manuf acturer situations, one commenter supported the assignment of responsibility as pr oposed while others s uggested that the toll manufacturer should be primarily or solely responsible for IU R reporting, or expressed concern that the rule would compel c ontracting companies to submit information on behalf of toll

manufacturers. Some also indica ted that the contracting company should be responsible, or that reporting responsibility in toll s ituations should be allocated case-by-case among the companies involved. Some commenters also suggested that EPA should “acknowledge the complexity of contractual mechanisms and not offer a blanket, ‘one size fits all’ requirement for reporting responsibilities.”

Source: (0187-0100) (0187-0089) (0187-0065) (0187-00769) (0187- 0089) (0187-0101) (0187-0083) (0187-0065) (0187-0059)

Response F.4-4 : EPA agrees that a dive rsity of contractual arra ngements may exist, and notes that there was nothing in the proposed ru le to prevent toll and contracting manufacturers from sharing information and agreeing between th emselves that one or the other will undertake all or a portion of the work associated with IU R reporting for a given chemical substance, though

comments indicated that there was some confus ion caused by EPA’s assignment of “primary” responsibility for reporting to the contracting manufacturer (s ee 40 CFR 711.22(c)). EPA expects that in most instances, a person that contracts with a toll manu facturer will generally know more about the particular chemical substances, and will usually be a better position to report on industrial processing and use of a chemical substa nce, and on commercial and consumer uses of products containing the chemical substance. Si milarly, EPA expects that the toll manufacturer will generally be in a better position to repor t on the number of workers and other information about their plant. In light of the contracting company’s control over the “total amount produced and the basic technology for the plant process,” a nd based on EPA’s expectations of the relative knowledge of the contracting company, EPA init ially indicated, in proposed section 711.22(c), that the contracting company would be “prima rily responsible” for IUR reporting. However, given the confusion introduced by indicating that one party or the other is “primarily” responsible for reporting, and not wishing to interfere in contractual agreements to the contrary,

EPA has decided not to allocate “primary” responsibility to e ither party in the final rule. Conforming changes have been made to 40 CFR 711.22(c) in the final rule. However, the enforceability of the rule requires EPA to speci fy the persons who are legally responsible for reporting. In fairness, EPA has chosen to make both parties responsible for reporting on the chemical substances they have co-manufact ured, as specified in the proposed rule.

5. Definition of Site

Comment F.5-1: Several commenters asserted th at the proposed revision to the definition of “site” would force different companies that are at the same site to report together.

Source: (0187-0244) (0187-0079) (0187-0081)102 Response F.5-1: EPA disagrees with this assertio n. In the proposed rule, EPA added explanations to accommodate manufacturing und er contract and for portable manufacturing units, and clarified that an importer’s site must be a US address. Th e definition of site used in the past, at 40 CFR 710.3, was not otherwise significan tly changed. The old definition states that “Site means a contiguous property unit. Property divided only by a public right-of-way will be considered one site. There may be more than one manufacturing plant on a single site. ...” This portion of the definition was retain ed, with slight wording change (“More than one plant may be located on a single site.”), in the proposed rule.

The statement “More than one plant may be lo cated on a single site” is meant to guide companies that have multiple plants at one site to sum production volumes and other IURreportable data across all of their plants at one site and produce one report for each reportable chemical substance at each site (not at each plant). The definition does not require different companies located at the same site to report together.

Comment F.5-2: Two commenters suggested that EPA define site in the IUR reporting instructions, rather than in the CFR, to increase flexibility.

Source: (0187-0101)

Response F.5-2: EPA disagrees that the definition of “site” should be left to guidance. IUR rule reporting is required for each pers on that manufactures or imports any non-excluded

chemical substance at an individual site. The definition of “site” therefore affects the legal obligations of submitters under the IUR. For this reason, the CFR (as opposed to a non-binding guidance document) is the appropriate place to defi ne ”site.” Furthermore, “site” for the purposes of the IUR rule was previously and very si milarly defined in the CFR, at 40 CFR 710.3.

Comment F.5-3: One commenter expressed concern th at persons engaged in portable manufacturing might not be awar e of IUR reporting requirements, and that EPA would need to undertake significant outreach efforts to inform them. Another stated that while the proposed changes do not materially impact their compa ny, they thought submitters in other industries could be adversely impacted by the changes, especi ally as they relate to mobile manufacturing.

Source: (0187-0059) (0187-0244)

Response F.5-3: EPA agrees, in part, that expanded outreach efforts to reach as many affected stakeholders as possibl e may be beneficial. Several outre ach efforts have already been undertaken and will be expanded in the near fu ture. EPA notes, however, that its proposed modification to the site definition was prompted by inquiries from the operators of portable manufacturing units in the most recent IUR data co llection. This indicates th at at least some of the affected community is already awar e of IUR rule repo rting requirements.

Comment F.5-4: One commenter noted that its he adquarters location (physically separated from its manufacturing site) controls import transacti ons, and therefore completes the IUR report for its imports. The commenter noted ot her circumstances in which headquarters and manufacturing operations are located at the same site, yet maintain separate D&B numbers. The103 commenter suggested that for the sake of cons istency, the IUR definition of "site" should be revised so that when a compa ny maintains two operations with separate D&B numbers at the same site, those two operations would be deemed to constitute separate sites. The commenter stated that reporters with a colocated headquarters situation will be unnecessarily burdened as compared to others.

Source: (0187-0364)

Response F.5-4: EPA disagrees with the suggestion to revise the defini tion of "site" to include the D&B number as part of the definition. EPA recognizes that there are many different ways that companies organize their corporate st ructure and manage thei r property. However, the commenter did not clearly explai n the potential inconsistency or concern that would require further modifying the proposed definition of "sit e," and EPA disagrees that a change along the lines the commenter sought is warranted. For pur poses of the IUR, EPA believes that it is preferable to aggregate all manufacturing (inc luding import) activities that a particular manufacturer conducts at a single site, even if the manufacturer operates several fa cilities with

different D&B numbers at the sa me site. Reporting for IUR is site-specific because EPA is interested in potential exposures associated with each particular site. For chemical substances that are domestically manufactured, the site is the physical location where the chemical

substance is manufactured. Becau se importing could be considered to occur at any of several physical locations (e.g., at the bord er, or at any of perhaps severa l locations within the importer’s organization), EPA has specified, for clarity and consistency, how to determine the site for imported chemical substances. The change sugge sted by the commenter would cause companies with one D&B number for all facilities at one ph ysical property to be treated differently from companies with more than one D&B number for di fferent facilities at one contiguous property. If the definition of site depended on D&B number, the company with more than one D&B number at one contiguous property would potentially have to file separate IUR reports for the same chemical substance that is, for example, imported by a corporate headquarters, and is domestically manufactured by th e same company next door. EPA generally considers the burden of filing multiple reports to be greater than filing one report, so using the D&B number to define site, as the commenter suggests, would tend to create a greater burden to companies "with a colocated headquarters situation,” not less. Furthe r, using the D&B number to define site would not further EPA’s interest in receiving data on the greatest possible proportion of chemical substances manufactured (includi ng imported) in the United States . In some cases, as described in the example above, a company would have to make two separate reports for the same chemical substance manufactured and/or importe d at the same conti guous property (i.e., EPA would get the same information, but split into two reports). In other cases, one or both of the entities located on the same contiguous prope rty with separate D&B numbers may not manufacture or import enough of a given chemical substance to trigger reporting requirements, even though reporting requirements would be tri ggered for the whole volume if the two volumes were added together. In this case, EPA would not receive a report for part, or any, of the volume manufactured or imported at this site.

6. Processing and Use-Related Definitions

a. Consumer Use and Commercial Use104 Comment F.6.a: Three commenters were in favor of the amended definition of

“consumer use” and “commercial use.”

Source: (0187-0244) (0187-0059) (0187-0100)

Response F.6.a: EPA agrees with the commenters supporting amending the terms

consumer use and commercial use to harmonize the definitions developed by the U.S. and

Canada.

b. Industrial Function

Comment F.6.b: One commenter indicated that such a term will add clar ity to industrial function and use reporting. In contrast, another commenter indicated that the definitions of "industrial," "commercial," "functi on," and "use," were unclear and referred to problems in reporting both product- and substance-level information.

Source: (0187-0100) (0187-0364)

Response F.6.b : EPA feels the terms industrial and commercial are adequately defined. To clarify, EPA defines industrial function as “the intended physical or chemical characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction pr oduct, or article; rep ackaged; or used.” Th is definition can be found in the “IUR Modifications Rule: Developmen t of Definitions for 40 CFR 711.3” (Ref. 40). EPA also notes that the terms “use”, “industria l use” “consumer use” and “commercial use” are have already been in use for IUR, and were previously defined in 40 CFR Part 710.43 (relocated in today’s final rule to 711.3).

G. Confidential Business Information

1. General CBI comments

Comment G.1-1: Commenters supported EPA’s commitment to provide meaningful information to the public and to reduce the number of unjustifiable claims. One commenter supported tightening the constraint on when a manufacturer may claim information as CBI, and noted that historically companies have been allo wed to claim CBI with little to no justification.

Other commenters stated that it is essential that transparency demands be balanced with the need to protect valuable proprietary information of great interest to competitors, without imposing

substantial burden. One commenter noted that it is important for EP A to recognize that competitive intelligence experts in an industry will employ any publicly disclosed info on chemical use and exposure to inform their mosaic picture of competitor operations.

Source: (0187-0100) (0187-0080) (0187- 0244) (0187-0086) (0187-0069) (0187-0071) (0187-0091) (0187-0065) (0187-0073)105 Response G.1-1: EPA agrees with these comments, and believes the proposed changes accomplish the balance between the transparency demands and the need to protect legitimate

confidential business information w ithout imposing unwarranted burden.

Comment G.1-2: Two commenters provided recommenda tions for data elements for

which CBI claims should not be allowed. One commenter recommended that EPA disallow CBI claims for specified data fields, such as site location. The commenter stated that information already reported under other laws or voluntary systems should be reportable under IUR without a provision for CBI claims, and that such a change would make the database more usable for the public. This commenter also recommended that EPA provide information cues when IUR data elements are likely to be public elsewhere (e.g., due to required reporting by other agencies or jurisdictions). Another comm enter recommended that EPA disallow CBI claims for the

children’s use data element. The commenter fails to see why such information should qualify for CBI protection.

Source: (0187-0069) (0187-0100)

Response G.1-2: EPA agrees that where specific info rmation is publicly available it is not eligible for confidential treatment. The Agency believes that bot h this point and the subsequent observation on providing cues as to where certain information may be listed publicly might be appropriate to highlight in a guidance document. Regard ing the suggestion to disallow CBI claims for particular data elements (i.e., si te identity and the children’s use data element), EPA does not conclude, at this time, that all su ch claims would be so similar as to justify prospectively disallowing them. The agency notes , however, that with respect to these data elements, the burden is on the submitter to provi de upfront substantiation of any CBI claims

asserted.

Comment G.1-3: One commenter provided an exam ple of a state program, the

Massachusetts Toxics Use Reducti on Act, under which only a small nu mber of facilities (i.e., 9 out of hundreds reporting in 2009) cl aimed trade secret status. The commenter cited this as an

illustration that detailed chemical information can be collected and made public without adverse effects on competitiveness. This commenter provi ded additional examples of publicly releasing data. The commenter noted that the Agency should use the smallest geographic area of aggregation that protects legi timate CBI for publicly releasing data, and that EPA should take advantage of the electronic collection of data to increase the sharing of the IUR data. The commenter noted that identifying what informati on is lacking would be useful to the public. Another commenter requested that the Agency ma ke public an analysis of the number and types of chemical substances whose identity has been claimed CBI, including an analysis of the information reported for those CBI chemical substances.

Source: (0187-0100) (0187-0349)

Response G.1-3: The Agency has a long history of cr eating and making available to the public information products derived from material s gathered from the various IUR collections.

The IUR website contains data bases of historical IUR da ta, including national production volume data for all IUR collections and specifi c company and chemical substance data for 1998,106 2002, and 2006 collections. In addition, a more complete database for the 2006 collection provides manufacturing, processing, and use data on a chemical substance basis. The document “2006 Inventory Update Reporting: Data Summary” (Ref. 41), whic h is available in the docket for the final rule, contains some analysis using a smaller geographic aggreg ation level of either EPA regions or states. EPA will be continuing th ese practices with regard to the upcoming IUR collection, and will consider analys es specific to those chemical substances with confidential

identities.

Comment G.1-4: One commenter noted that the increase in the production volume information, such as reporting for all years, is like ly to result in an increase in CBI claims for production volume. The commenter stated that k nowledge of production volume in one year out of four or five years was not sufficient informa tion for a competitor to gain a full understanding of a company’s business, but that this changes if production volume in every year is reported.

The commenter stated that this is also a conc ern for the volume of chemical substance used on site and the volume exported. Public knowledge of this information allows a competitor (or potential competitor) to have a complete pict ure of the chemical substance’s production and

markets.

Source: (0187-0068)

Response G.1-4: The Agency agrees that certain in formation requested, including site and chemical specific annual production volume in formation, might be considered confidential. For this reason the Agency has regulations in pla ce that allow for submitters to make CBI claims for production volume, and other data elements, including use.

2. Chemical Identity CBI Claims

Comment G.2-1: Commenters supported EPA’s continued limitation to the use of substantiated CBI claims for chemical identity to those chemical substances that are currently listed in the confidential portion of TSCA Inventory, noting that such a policy is consistent with Agency policy regarding the confidentiality of chemi cal identities from health and safety studies. A few commenters mistakenly thought the Agen cy was proposing to newly establish this

limitation. One commenter noted that confidentiality claims are hi ding a large portion of the IUR data, stating that more than 1,100 of the chem ical identities reported for the 2006 IUR were claimed confidential (and were not publicly re leased), and that since then the Agency has

released the names of 530 chemical substan ces for which the identity was not claimed confidential by at least one submitter. The commente r continued by stating that it is critical that

such CBI claims are substantiated.

Source: (0187-0059) (0187-0101) (0187- 0244) (0187-0080) (0187-0092) (0187-0349)

Response G.2-1: EPA notes that this limitation on th e use of substantiated CBI claims for chemical identity existed in the IUR before it was modified by this rule (Ref. 7, 68 FR at 905). Because the chemical identities listed on the public version of the TSCA Inventory are already publicly known, submitters cannot claim such chemical identities as CBI. Therefore, the Agency has in the past, and will continue to lim it chemical identity claims to only those chemical107 substances listed on the confidential po rtion of the Master Inventory File.

Comment G.2-2: Some commenters supported, and ot hers expressed concern with, the Agency’s proposal to make chemical identity information public without having to notify submitters when a company has asserted the ch emical identity to be CBI, even though the chemical substance is already present on the pub lic portion of the TSCA Inventory. Commenters stated that it seems inappropriate to release th e chemical identity information without at least informing the submitter of its plans to do so; one commenter suggested that, for the next IUR, the Agency communicate with th e submitter those cases where disclosure of the chemical identity is under considerat ion. This would provide the regulated community with the opportunity to gain experience with the new rule prior to more complete implementation in subsequent IUR reports. Commente rs are concerned that a repor ting error could result in public release of legitimate CBI.

Source: (0187-0059) (0187-0069) (0187- 0090) (0187-0056) (0187-0244) (0187-0092)

Response G.2-2: IUR regulations, which predate these modifications, have long provided that a submitter may make a CBI claim fo r chemical identity in the IUR only if the

chemical substance is listed on the confidential portion of the Ma ster Inventory File (Ref. 7, 68 FR at 905). For this reason, EPA disagrees that a phase -in period is required for the regulated community to further familiarize itself with the underlying limitation on CBI claims, 711.30(b), that is now also implemented as a part of 40 CFR 711.30(e). If the reported chemical substance

was not listed on the Master Invent ory File, then the claim is i nvalid and cannot be honored. The e-IURweb reporting tool disallows CBI claims for chemical s ubstances listed on the public TSCA Inventory. A submitter can claim the relationship between itself and a chemical substance as CBI by claiming company name as CBI.

3. General Comments on Upfront Substantiation of CBI Claims

Comment G.3-1: Commenters were concerned that a failure to substantiate a CBI claim could result in public rel ease of legitimate CBI. They suggested including a warning system in the reporting tool to allow submitters time to provide additional substantiation on CBI claims before the Agency determines the data is non-CBI and releases it as public information.

Source: (0187-0080) (0187-0244) (0187-0092) (0187-0090) (0187-0056)

Response G.3-1: There are three situations during which the Agency will release IUR

information claimed as CBI without further notice to the submitter. First is the circumstance that a CBI claim is made for the identity of a chemical substance already listed on the nonconfidential portion of the Master Inventory File. Any such CBI claims were invalid under the previous IUR regulations (applicable to the 2006 and earlier submission periods) and will remain

so in the final rule.

The second is the circumstance that a submi ssion lacks the certific ation required under 40 CFR 711.15(b)(1). 40 CFR 711.15(b)(1) requires a cer tification stating that the submitted information has been completed in compliance with the requirements of this part and that the108 confidentiality claims made on the Form U are true and correct. The certification must be signed and dated by the authorized official for the submitter company, and provide that person’s name, official title, and e-mail address. Consistent with this regulatory provision, the e-IURweb tool is designed to entirely block the submission of a Form U lacking an appropriate certification.

The third is the circumstance that a partic ular CBI claim is not accompanied by upfront substantiation required under 40 CFR 711.30(b),(c) ,or (d) (e.g., upfront substantiation of processing and use information). The e-IURweb re porting tool is designed to protect against a company not providing an upfront substantiation when required. When a CBI claim is made and substantiation is requir ed, the reporting tool will open th e substantiation question page. Should the submitter choose not to complete the substantiati on at that time, or to only partially complete it, the validation portion of the reporting tool wi ll again alert the submitter to the need for substantiation. The tool also includes warnings th at information with unsubstantiated CBI claims

will be released without furthe r notice to the submitter. EPA believes these reminders provide

sufficient notice to the submitter of the need to substantiate these claims.

Comment G.3-2: EPA has traditionally interpreted TSCA not to require the upfront substantiation of a CBI request. EPA’s upfront su bstantiation approach to CBI in the proposed rule is contrary to the agency’s historical interpretation of the stat ute. Creating barriers to protect American intellectual property was not the inte nt of Congress when cr afting TSCA, which is clear in the statutory language found in TSCA Section 14. In fact, Section 14 does not even address upfront substantiation for CBI claims.

Source: (0187-0352) (0187- 0101) (0187-0244) (0187-0092)

Response G.3-2: The commenter is incorrect. The Agency, since the inception of the IUR in the 1980s, has required th at persons asserting certain CBI claims substantiate these claims to explain the basis for any asserted confidential business information claim. For example, for the 2006 IUR reporting period, upfront substantiation was required when chemical identity or site was claimed as CBI. Upfront subs tantiations requirements ex isted even earlier for

CBI claims for chemical name in notices of commencement under the PMN program (see 40 CFR 720.102). The purpose behind a substantiation reque st is not to limit a CBI claim, but rather to ensure that such claims are well thought out by the potential submitter and consistent with the requirement of TSCA. As noted in the preamble to the propos ed rule, during its review of the processing and use information submitted for the 2006 IUR reporting period, EPA identified instances in which submitters claimed processing and use data as CBI, yet similar, if not identical, information was found in publicly av ailable sources, such as company websites, published Material Safety Data Sheets or information submitted to EPA and posted on the

HPVIS website. A decrease in the number of inappropriate CBI claims under the new substantiation requirement would improve EPA’s ab ility to make current plant site information available to other Federal agen cies and the public, because more information submitted under IUR could be released pub licly (Ref. 8, 75 FR at 49674).

Comment G.3-3: Commenters were concerned that EPA would release data claimed as

CBI in cases in which EPA believes that a CBI cl aim is inadequately justified or may not be valid based on publicly available information, a nd stated that the Agency should contact the109 submitter and allow it time to provide additiona l substantiation before making a final decision on whether to accept the information as CBI or rel ease it to the public. Some commenters suggested the Agency should notify the submitter in the TSCA 14(c) prescribed timeframe after submission

if further substantiation is need ed to help prevent inadverten t disclosure to the public of legitimate CBI.

Source: (0187-0244) (0187-0092) (0187-0090) (0187-0056) (0187-0101)

Response G.3-3: As described in the response to co mment G.3-1, CBI cl aims made in the IUR context must comply with certain procedur al provisions in order to be recognized. These recognized CBI claims may only be declassified pursuant to sp ecific regulatory provisions. EPA has long established procedures fo r the protection of properly asse rted CBI claims and also the review of these claims. Regarding those instance s where a substantiation is required for a CBI

claim but EPA concluded that it wa s insufficient, the Agency has procedures in place in 40 CFR part 2, subpart B that provide for notification to the submitter prior to disclosure.

4. Upfront Substantiation for Processing and Use Information

Comment G.4-1: The Agency received comments both for and against the proposed upfront substantiation requirement when pro cessing and use information is claimed as

confidential. Commenters in s upport are in favor of reducing th e potential for abuse of CBI claims. Commenters opposing the proposed ch ange explained that processing and use information is often considered confidential by customers to protect their competitive positions

in the market. Commenters voiced concern that th e proposed change will impact their ability to remain competitive or will reduce innovation. Th ese commenters were concerned that the

manufacturers of the chemical substances woul d not correctly identify CBI associated with downstream uses, and that confidentiality agre ements between the chemical manufacturer and the downstream users would not provide suffici ent substantiation for the processing and use

information.

Source: (0187-0058) (0187-0092) (0187-0069)

Response G.4-1: The Agency appreciates the co mments in support of the upfront substantiation, and believes that the processing and use information in the publicly-released IUR reports is sufficiently agglomerated to addr ess the concerns. However, the Agency also recognizes that there are circumstances when the release of information about a particular use could harm the competitive position of the subm itter’s customer. Therefore, EPA has modified the substantiation question at proposed 40 CFR 711.30(d)(1)(ii) to include information about harm to the submitter’s competitive position “or to your customer’s competitive position.” EPA

also notes that under its confiden tiality regulations, the Agency normally solicits input from all affected businesses when making a final confidentiality determination respecting information

claimed as CBI.

Comment G.4-2: Commenters supported requiring upfr ont substantiation for processing

and use information. One commenter noted that requiring substantiation should help to reduce110 the number of spurious CBI claims. Another comme nter noted that their current processing and

use scenarios would not be much impacted by this requirement.

Source: (0187-0100) (0187-0059) (0187- 0071) (0187-0244) (0187-0292) (0187-0080)

Response G.4-2: The Agency appreciates the comme nts in support of the upfront

substantiation.

Comment G.4-3: Some commenters stated that providing written explanations for multiple scenarios would be burdensome. Another commenter argued, however, that requiring such explanations will help to limit CBI claims to information that in fact warrants protection as a legitimate trade secret. The comme nter asserted that the frequenc y with which site information was claimed as CBI dropped from 28% to 7% after EPA added an upfront substantiation requirement for that data element, and suggested that the drop represen ted an elimination of “excessive” trade secrecy claims.

Source: (0187-0079) (0187-0057) (0187- 0352) (0187-0292) (0187-0079) (0187-0073) (0187-0057) (0187-0352)

Response G.4-3: The Agency recognizes that there is a burden associated with providing written explanations. However, based on the si gnificant number of CBI claims for processing and use information in the last information collection, EPA believes that allowing submitters to assert CBI claims merely by checking a box encourag es submitters to assert such claims without sufficiently considering whether there is a basi s for the claim. While EPA believes that such claims are appropriate under cert ain circumstances, the Agency wants to ensure that all such claims are carefully considered and only informa tion that is truly confidential, the release of which would substantially injure the competitive position of the submitter, is claimed as CBI. A substantiation requirement for such claims helps ensure that this consideration takes place.

Comment G.4-4: One commenter stated that EPA s hould allow chemical processors and users to participate in the s ubstantiation of processing and us e information. The commenter was

concerned that the substantiation focused on th e competitive position of the manufacturer and did not take into account the downstream pr ocessors and users – the customers of the manufacturer. In particular, the commenter not ed that there are non-disclosure agreements between suppliers and customers committing both to maintain confidentiality; the manufacturer may not know the business rationale for its cu stomer. This commenter provided specific suggestions for a process to involve the downstr eam processors and users, including modifying the substantiation question to include harm to the competitive position of the processors and users; allowing for separate, c onfidential filings by downstream pr ocessors and users in support of substantiation; and afford ing the downstream processors and users the opportunity to supplement the substantiation record in the even t that a manufacturer’s CBI claim is denied.

Source: (0187-0086)

Response G.4-4: The entity required to file the IUR submission must assert and substantiate any CBI claims. This entity may cons ult with processors or downstream users of the111 chemical substances if it believes that such consultation may be beneficial in providing an explanation for the CBI claim. As noted in the response to G.4-1, EPA has modified the substantiation question at proposed 40 CFR 711.30( d)(1)(ii) to include information about harm to the submitter’s competitive position “or to your customer’s competitive position.” Further, under EPA confidentiality regulations the Agency normally solicits input from all affected

businesses.

Comment G.4-5: One commenter noted that “Percen t Production Volume” in Columns d. of both Part III A and B is most always c onfidential business information as it speaks to market share, and asked that EPA remove the need to substantiate this data element because it is clearly CBI in almost all cases.

Source: (0187-0364)

Response G.4-5 : EPA disagrees that percent producti on volume is clear ly CBI in most cases. For the 2006 IUR, percent production volume wa s claimed as confidential 35 percent of the time it was reported for commercial and consumer uses, and 41 percent of the time it was reported for industrial processi ng and use. Based on this expe rience, it is clear that many

submitters do not consider such information to be confidential.

5. Limitation on Confidentiality Claims for Data Elements Iden tified As “Not Known To or Reasonably Ascertainable”

Comment G.5: Commenters agreed with prohibiti ng CBI claims for processing and use information when it is designated as not "known to or reasonably ascertainable by" the submitter. The primary reason cited by supporters was that the proposed change will reduce the potential

for unwarranted CBI claims.

Source: (0187-0100) (0187-0059) (0187-0244) (0187-0073) (0187-0069)

Response G.5: EPA agrees with these commenters.

6. Reporting By Processors and Additional Data Elements

Comment G.6-1: A commenter stated that expandi ng the IUR to include reporting by processors would lead to unavoidable conflicts over CBI interests and manufacturer-processor relationships. “For example, if processors become subject to the IUR rule and a (chemical) manufacturer makes a CBI claim in its IUR repor t on a raw material it sells to its processor customers, those processors may or may not ad here to that claim in their own IUR reporting, particularly with changes in supplier relationships and corpor ate ownership that occur over

time.” The commenter has concerns that not only would this severely strain business relationships, but that it would likely place EPA in the middle of myriad legal challenges.

Source: (0187-0065)112 Response G.6-1: At this time, EPA is not requiring chemical processors to submit IUR Form Us. In the event that such a requirement is contemplated for the future, these comments

will be taken into consideration.

Comment G.6-2: A commenter stated that adding proce ssors to IUR reporting could also bring into question the prot ection of CBI and confidentia l chemical substances.

Source: (0187-0081)

Response G.6-2: EPA protects all data submitted to the EPA and does not release information that is properly claimed as confidenti al. At this time, EPA is not requiring chemical processors to file IUR submissions . In the event that such a requirement is contemplated for the future, these comments will be taken into consideration.

Comment G.6-3: A commenter stated that the numerous data elements under

consideration for addition to the IUR (listed in Table 5 of the pr oposed rule, Ref. 8) go to the heart of how a company manufact ures its chemical substances, and that the public release of these data would have serious consequences for the competitiveness of U.S. industry. Therefore, were EPA to require the reporting of these da ta, they will most likely be claimed CBI.

Source: (0187-0068)

Response G.6-3: EPA recognizes that some of the da ta elements may be viewed as potentially confidential business information and, fo r this reason, has identified procedures that

allow for such claims.

H. Administrative Comments

1. Change Reporting Frequency

Comment H.1: The Agency received comments regarding the proposed change to increase the IUR reporting frequency from ev ery 5 years to every 4 years. Commenters expressed support for the return to the reporting frequency of ever y 4 years, and stated that it would not increase burden on industry. However, other commenters opposed to moving to a four year reporting cycle felt that the change to the reporting frequency w ould be burdensome and costly to submitters. They also stated that EP A had not provided adequate justification for the change and that the five-year interval is appropriate to meet the Agency's data needs.

Source: (0187-0364) (0187-0351) (0187- 0099) (0187-0042) (0187-0244) (0187-0090) (0187-0065) (0187-0079) (0187-0078) (0187- 0056) (0187-0064) (0187-0092) (0187- 00810 (0187-0061) (0187-0098) (0187-0083) (0187-0101) (0187-0359) (0187-0192) (0187-0104) (0187-0304) (0187-0073)

Response H.1: In the 2003 IUR Amendments, EPA changed its reporting requirement from every 4 years to every 5 years to lessen the burden associated w ith complying with the amendments. However, EPA has decided to return to the reporting frequency of every 4 years, in113 order to better meet Agency needs. EPA has de termined that reporting every 5 years is too infrequent and does not provide enough data to sufficiently cover the Agency's and public's needs. As discussed in Unit III.D.1 of the propos ed rule, many chemical substances, even larger volume chemical substances, often experience wide fluctuations in manufacturing volume from year to year. This can result in the production volume of a chemical substance exceeding the threshold for several years, then falling belo w the threshold during th e IUR principal reporting year. A review of the previous reporting under the IUR indicates an approximately 30% change

in the chemical substances that are reported from one reporting pe riod to the next. Therefore, the 1–year snapshot of production volume does not pr ovide an accurate pict ure of the chemical substances in commerce, and may provide an erroneous view of the exposure scenarios associated with a particular chemical substance. In addition, EPA has been criticized for using outdated information, which will be remedied with more freque nt reporting. As such, EPA has determined that the value gained through obtaining more current and useful data is essential to fulfilling the Agency’s statutory obligations under TSCA, and outweighs the burden to

submitters.

2. Changes to the Regulatory Text

a. Move IUR Text to 40 CFR 711

Comment H.2.a: The Agency received one comme nt in favor of moving the IUR regulatory Text to 40 CFR part 711, because it enhances clarity of the regulations.

Source: (0187-0079)

Response H.2.a: EPA agrees with the submitter that moving the regulatory text for IUR requirements to its own CFR section will enhance the clarity of the regulations.

b. Delete Superfluous Text Regarding Production Volume

Comment H.2.b: The Agency received comments on the proposal to delete superfluous text associated with reporting production volumes, in particular th e +/- 10 percen t standard of precision. All commenters opposed changing th e current language. Several commenters indicated that reporting accurately to two significant figures is not equivalent to reporting to a precision of +/- 10%. One commenter indicated that, if reporting to two significant figures, at higher production volumes there would be a narrower allowable ra nge of variation.

Source: (0187-0244) (0187- 0364) (0187-0098) (0187-0092)

Response H.2.b: EPA is replacing “provided that th e reported figures ar e within +/-10% of the actual volume” currently found in 40 CF R 710.52(c)(3)(iv) with “This amount must be reported to two significant figur es of accuracy.” The deleted phr ase is superfluous because any number reported accurately to two significant figures is within 10% of the correct value. EPA recognizes some commenters’ concerns that this will result in a sliding precision scale between 1% and 10% that is solely based on the reported digits. However, EPA believes that reporting to two significant figures will maintain a balance between data needs for exposure screening and114 the industry burden associated w ith data collection. In the 2006 IUR data collection, nearly all manufacturers reported production volumes in gr eater precision (i.e., more significant figures) than is required for 2012 reporting. Based on year s of experience assessing chemical risks through programs such as the New Chemicals Progr am, the Agency believes requiring reporting to two or more significant figur es is appropriate to facilitate the Agency’s initial exposure screens of chemical substances, and to priori tize and make basic risk management decisions about those chemical substances of greatest co ncern. Those decisions then can prompt more detailed assessments as necessary.

I. Economic Analysis

1. Identification of Affected Entities

Comment I.1: According to one commenter, the Economic Analysis does not identify all affected entities, and EPA has inaccurately assu med that the proposed rule will impact only

chemical manufacturers. The commenter noted th at a wide range of industries manufacture byproducts, and in order to accurately estimate the burden of the proposed rule, EPA must identify all affected industries and facilities. Th e commenter further stated that byproducts sent for recycling are chemical substances that are newly reportable under the IUR rule and the Economic Analysis (Ref. 15) fails to identify these manufactures.

Source: (0187-0103)

Response I.1: The Economic Analysis (Ref. 15) assumes that all companies manufacturing or importing chemical substance s annually in amounts of 25,000 lb or greater that are listed on the TSCA Inventory will report unde r this rule. Chemical users and processors who may manufacture a byproduct chemical substance fo r a commercial purpose, e.g., utilities, paper manufacturers, primary metal manufacturers, an d semiconductor and other electronic component manufacturers (NAICS codes 22, 322, 331, and 3344), are considered to be chemical manufacturers for the purposes of the IUR rule . Sites that manufactured a byproduct in a volume above the 25,000 lb threshold during the 2006 reporti ng cycle were required to report under IUR,

and therefore are included in the 2006 baseline estimates.

The commenter suggested that byproducts sent for recycling are chemical substances that are newly reportable under the amended IUR rule . While the amended rule will now require a submitter to identify whether a chemical substance is to be recycled, remanufactured, reprocessed, or reused, byproducts have always been subject to the IUR (unless exempted). Indicating a manufactured chemical substance, such as a byproduct, is to be recycled, remanufactured, reprocessed, or reused does not affect the reporting requirements associated with any chemical substance manufactured fr om the byproduct. Therefore, byproducts are not newly subject to the IUR and are not treated as such in the Economic Analysis (Ref. 15). The

commenter did not offer an alternative method to identify any addi tional manufacturers.

2. Overall Burden, Underlying Data, Future-Cycle Burden, and Methodology115 a. Total Industry Compliance Determination Burden and Cost of all Amendments

Comment I.2.a-1: Several commenters believe that EPA has significantly underestimated the effort required to collect, organize, verify and report the proposed IUR data, and that EPA’s analysis does not capture all of the “upfront” deta ils that go into reporting. Some

commenters asserted that the re porting burden of the proposed rule will be between two and six times greater than the burd en for reporting in 2006

. One commenter stated that the average cost increase per site to comply with all of the new requirement s would be $100,000 during the first reporting cycle and $40,000 during each additional reporting cycle.

Source: (0187-0053) (0187-0065) (0187- 0083) (0187-0096) (0187-0098) (0187-0102) (0187-0244) (0187-0352) (0187-0364)

Response I.2.a-1: EPA disagrees that the EA undere stimates the reporting costs and burdens of the IUR amendments as asserted by the commenters and stands by its estimates. As described in the final rule preamble and responses to comments in this document, in some cases (most notably for byproduct chemical substances ) the commenter clearly misunderstood the reporting requirements (see Unit F of this documen t for further discussion) which leads to a misinterpretation of the burden and costs of the proposed rule.

EPA does not believe that it has underestimated the effort to collect, organize, verify, and report IUR data. EPA expects that it is standard business practice to tr ack and appropriately maintain (including organization and verifica tion) records of production volumes and other

information for all chemical substances manufact ured at a given site. As such, EPA does not

believe these costs are attributable to the proposed rule. EPA notes that if particular information on processing and use is not known or reasonably ascertainable to the submitter, it need not be reported under the IUR.

It is important to note that the Agency has used the best available data to estimate the

burden associated with the modifications to the IUR rule. The burden estimates presented in the economic analysis are reasonable estimates for the average IUR submitter and some sites may have a higher or lower burden. As such, commen ters should be aware that their particular circumstance may not be average and, therefore, the estimate may not accurately reflect their own, individual, circumstances. The commenters did not provide any analytical basis to substantiate a claim that the burden for reporti ng in 2012 will be, on averag e, greater than that estimated in the Agency’s analysis.

Comment I.2.a-2: According to one commenter, provisi ons requiring reporting of more data for many chemical substances, replacing NAICS codes with European Industrial Sector codes, and requiring upfront substantiation for CBI claims for Part III information contribute to the increased effort required. Another commenter noted that data from prior years will need to be extricated from records as collection systems had not been established, and personnel will need

to be trained

Source: (0187-0053) (0187-244)116 Response I.2.a-2: EPA agrees that many of the ame nded rule requirements, including provisions requiring reporting of more data for many chemical substances, replacing NAICS codes with Industrial Sector codes, and requiring upfront substantiation for CBI claims for Part III information, will cause an increase in burden a nd cost. As the one commenter noted, some of that increase could be due to developing new collection systems or training personnel. These circumstances are captured in the EA.

Comment I.2.a-3: One commenter stated that critical estimations in the EA were based on assumptions and past data instead of current information, which would have led to a more accurate analysis. The commenter also noted that throughout the EA is an admission of possible underestimation of the burden and the cost, as well as statements regarding the limitations of the study.

Source: (0187-0098) (0187-0364)

Response I.2.a-3 : The commenter is correct that the EA documents the limitations of the analysis, including noting places for which the burd en and/or cost may be either underestimated or overestimated. Such statements regarding limita tions of the study serve to make the analysis more transparent and are standa rd practice. In response to th e comment that the EA uses assumptions and past data instead of current in formation, EPA has used the most recent data available for the analysis (in many cases, data from the 2006 IUR). EPA also has made every effort to ensure that the assumptions the Agen cy used in the EA are as realistic and as representative of actual situations as possible.

Comment I.2.a-4: One commenter stated that the EA has not addressed the effects of company downsizing, growth, mergers and acquisitions.

Source: (0187-0098)

Response I.2.a-4 : EPA agrees with the commenter that the EA does not address the impacts of individual company events such as those mentioned by the commenter. This is because EPA does not have the ability to take into account the effects of individual company circumstances concerning downsizing, growt h, mergers and acquisitions, on estimates of reporting burden and cost.

b. Future-Cycle Burdens

Comment I.2.b: One commenter believes that EPA underestimated the burden reductions associated with reporting in future re porting cycles and stated that a sliding scale should be used to estimate how efficiencies gained from the first reporting cycle affect future reporting cycles. The commenter also believes that EPA has failed to include efficiencies gained from more frequent collection and reporting of information that rela tes to factors such as reduced staff turnover and retention of rule familiarity, and information transferable from one collection or reporting period to the next117 Source: (0187-0069)

Response I.2.b: As explained in the Economic Analys is, the burden reduction estimates of 20 and 80 percent are taken from the 2002 EA es timates for a four-year reporting cycle. These estimates are based on industry information. The co mment stated that slid ing scale efficiencies would be gained from annual reporting, under which companies would experience less staff turnover and loss of company memory because of the reduced time between reporting cycles. However, EPA is not requiring annu al reporting in this final rule . EPA expects little efficiency gains after the second reporting cycle, as most industry lear ning will occur during the first reporting cycle. The 20 and 80 percent figures do , however, account for the retention of rule familiarity and information that is transfer able from one reporting cycle to the next.

c. EA Methodology: Compliance Determination Costs Estimated on a Per-Report Basis

Comment I.2.c: Several commenters asse rted that EPA has underestimated the burden associated with IUR compliance determination by estimating the burden on a per-report basis. According to the comments, this methodology does not capture the burden associated with tracking, screening, and keeping records for chemical substances that ultimately are not required to be reported to IUR because they are below the reporting threshold.

Source: (0187-0065) (0187-0083) (0187- 0085) (0187-0244) (0187-0352) (0187-0367)

Response I.2.c: Compliance determination occurs on a per-site basis and is based on a manufacturer (including importer) determining that it manufactures at least one chemical

substance at or above the threshold, thus necessitati ng that the site complete and submit a Form U. The EA assumes all sites that report unde r the IUR incur the sa me average cost for compliance determination regardless of the num ber of chemical substances reported. EPA expects that it is standard company practice to track and maintain records of production volumes for all chemical substances manufactured at a gi ven site. Therefore, EPA expects that the burden associated with compliance determination should not be substantial. The commenters appear to have interpreted EPA’s compliance determinatio n burden as including the burden of actually reporting for the chemical substances subj ect to the IUR, which is not the case.

In Section 4.2.2 of the EA, EPA estimates a baseline 2.5 hour burden, per site, for compliance determination. This burden is from the 2002 Economic Analysis for the Amended Inventory Update Rule, Final Report (Ref. 42), and accounts for the time for the submitter to determine whether the site is required to s ubmit a Form U. If a person at any single site

manufacturers at least one chem ical substance subject to the rule at or above the 25,000 lb threshold, then that person must submit a Form U for that site. The burden estimate is not intended to cover the cost of reporting the pr oduction volume for each chemical substance manufactured at a given site. The burden for that activity is accounted fo r elsewhere in the EA. EPA expects the effort required for compliance determination to be small for the majority of sites and its estimate to be accurate for the average site.

Finally, EPA notes that the IUR does not require submitters to retain documentation showing that particular chemical substances did not need to be in cluded in a given year’s report.118 In addition, once a submitter has made a comp liance determination th at it has reporting obligations under the IUR, it can rely on pr oduction volume information already reasonably available, in the ordinary course of business, to determine that particular chemical substances do not need to be reported under the IUR. For th is reason, EPA believes it is unreasonable to attribute to the rule the costs of tracking, screening, and keeping records of the various production volumes of chemical substances that ultim ately are not required to be reported to IUR because they are below the reporting threshold.

d. EA Methodology: Amortization Period

Comment I.2.d: One commenter questioned EPA’s use of a 25-year amortization period, as opposed to a 10-year amortization period.

Source: (0187-0244)

Response I.2.d: A 25-year amortization period was used in Section 4.6 of the EA (which describes the annualized industry co st estimate of all modifications combined) to better illustrate the comparison between the baseline and post-amen dment costs. That is, under a 25-year period, both the four-year (amended) repo rting cycles and five-year (bas eline) reporting cycle would end in the same year. The analysis would therefore capture an entire repo rting cycle and not stop mid-cycle in the comparison. The economic analys es prepared for IUR rule amendments in 2002 and 2006 used a 20-year period, which suggests th at there is no strong precedent for using a 10- year period in recent IUR economic analyses.

e. Underlying Assumptions and Data: Baseline Costs

Comment I.2.e-1: One commenter questioned whether EPA’s estimate included inorganic chemical substances.

Source: (0187-0244)

Response I.2.e-1: The 2006 data do include reports fo r inorganic chemical substances, because while inorganic chemical manufacturer s were exempt from submitting downstream processing and use information in the 2006 reporting cycle, they were requi red to submit Parts I and II of Form U, and therefore are include d in the baseline nu mber of reports.

Comment I.2.e-2: One commenter questioned whether EPA has adjusted the baseline estimates to account for new manufacturing faciliti es that never reported previously under the IUR rule, the elimination the 300,00 0 lb threshold for processing and use data, and the change in the method of determining th e eligibility to report.

Source: (0187-0103)

Response I.2.e-2: The 2006 IUR submission data pr ovide the best estimate of the number of reports that would be su bmitted under the baseline scenario. The baseline scenario in the EA assumes no changes have been made to the 2006 reporting requirements and is used as a119 basis for calculating the incrementa l cost of the modifications rule. Therefore, in the baseline, the number of reports should not be adjusted to account for any modifications. The EA does estimate

the additional number of Part IIIs that will be submitted as a result of the rule amendments, including the eliminatio n of the 300,000 lb threshold for proce ssing and use data reporting (see Section 4.4.4), as well as the additional number of reports submitted as a result of the change in the method of determining the eligibility to report (see Section 4.4.3). In addition, the Economic Analysis accounts for rule familiarization cost s for any new companies submitting data (see Section 4.2.2).

f. Underlying Assumptions and Data: Us e of 2002 Industry Burden Survey

Comment I.2.f: Commenters question EPA’s relian ce on burden estimates from an industry survey conducted in 1996 for the 2002 Ec onomic Analysis. One commenter noted that these results do not reflect the 2010 economy, job market, or industry perspective and do not include the burden for additional process and use information data elements. Another commenter implied that if EPA had contacted industry again prior to this rulemaki ng, then EPA’s analysis would have been more accurate. Additionally, one commenter noted that since this survey was conducted, there have been great advances in com puter recordkeeping and vast consolidation of many oil and petroleum companies. According to the commenter, electronic recordkeeping and transfer have lead to increases in productiv ity, making the 1996 estimates overestimates. The

commenter also asserted that if industry consolidation has increas ed the number of big and small companies and reduced the number of medium comp anies, then using data from 1996 would lead EPA to overestimate costs because data from the 1996 survey show medium companies had the highest per-unit costs.

Source: (0187-0069) (0187-0244) (0187-0098)

Response I.2.f: The survey conducted for the 2002 IUR Economic Analysis (Ref. 42) is

the best available data source EPA has for data on the industry burden asso ciated with IUR data collection and reporting. While changes in the industry over th e past 14 years have both increased and decreased the burden of reporting fo r some sites, estimates used in the EA are meant to represent an average site burden, mean ing that some sites may have a higher or lower burden. For example, EPA’s average estimates are in tended to cover companies of varying sizes. While the Agency agrees that improvements in el ectronic recordkeeping a nd transfer have lead to increases in productivity, EPA has chosen to us e more conservative estimates, rather than attempt to adjust the baseline burden estimat es to account for advances in technology. In analyzing the impacts of each rule amendment, EPA did make adjustments to the burdens estimated through survey results, as appropriate.

g. Agency Burden and Cost Estimates

Comment I.2.g: One commenter believes that the annual production vo lume, volume of chemical substances used on-site, and volume expor ted data could and likel y will be claimed as CBI; more information claimed as CBI could greatly increase the EPA burden.

Source: (0187-0068)120 Response I.2.g: While more CBI claims may incr ease EPA’s burden sl ightly, the EA estimates the amendments will save EPA appr oximately $180,000 in the first reporting year

attributable to efficiencies from electronic reporting, which outweigh estimated increases in Agency burdens created by other new provisions. In addition, EPA curre ntly only publicly reports national production volume in ranges for each chemical substance and does not provide production volumes by site to the public. Theref ore, any additional CBI claims on production volumes are unlikely to create any significant burden beyond what is estimated in the EA. Furthermore, the commenter does not provide any basis for the assumption that EPA’s burden could increase substantially as a result of increases in CBI claims for the new reporting requirement in the final rule.

h. Benefits of the Modifications

Comment I.2.h-1: One commenter stated that EPA did not estimate the monetary value of the benefits of the proposed rule. A commenter asserted that by failing to quantify the benefits of the proposed rule, the Economic Analysis plac es too great an emphasis on the cost to the industry and not enough emphasis on the benefits to society. In addition, the Economic Analysis fails to create a tangible link between the proposed modifications and the tangible health benefits of the rule. The commenter stated that industry al so stands to benefit from effective government policies and programs that provide the public and market with greater confidence in the safety of chemical substances, such as the European Union’s REACH program.

Source: (0187-0069)

Response I.2.h-1: EPA is required under Executive Or der 12866 to describe the benefits associated with its rulemakings, and makes every reasonable effort to quantify these benefits. In this case however, the benefits of the amendments to the IUR information collection were not possible to quantify directly. Quantification of th e benefits of the proposed rule would require more specific information about each user’s use pa tterns and preferences, and the changes in the use patterns and preferences wh ich would result from the additi onal information made available under the proposed rule. These data are not readily available, and collecting such data would be cost-prohibitive. Any direct cost-t o-benefit ratio, therefore, is al so impossible to calculate. EPA agrees with the comment that industry also sta nds to benefit from effective government policies and programs that provide the public and market with greater confiden ce in the safety of

chemical substances. As noted in the Economic Analysis, EPA generally expects that the rule will benefit society by filling information gaps a nd contributing to better assessments of potential chemical risks and risk management decisions. Other Federal and stat e agencies will also be able to make use of the data in their programs to ma nage chemical risks. Predicting and describing the tangible health benefits of the rule is difficult because EPA does not prescribe how data collected

under this information rule must be used.

Comment I.2.h-2: One commenter stated that EPA has not demonstrated that the

benefits of the data that will result from the ru le amendments will be of value proportional to the effort that will be necessary to provide the information.121 Source: (0187-0087)

Response I.2.h-2: The benefits chapter of the Ec onomic Analysis describes several chemical risk-screening and management programs th at have used IUR data in the past and are expected to continue to do so. See also th e response to comment at section I.2.h-1.

3. Burden and Cost by Specific Data Element

a. Method for Determining Whether a Manuf acturer is Subject to IUR Reporting Requirements

Comment I.3.a: One commenter suggested that the industry burden from instituting the new method for determining whether a manufacturer is subject to IUR reporting requirements (“triggering approach”) in the upcoming reportin g cycle, rather than wait until the following cycle, should be relatively small. The commen ter also noted that EPA has not provided an indication of how many comp anies would be affected.

Source: (0187-0069)

Response I.3.a: The commenter is correct in sta ting that EPA did not indicate the number of companies that woul d be affected if EPA implemen ted the new “triggering approach” in the upcoming cycle (now 2012), rather than wait until the following cycle. This was not discussed because EPA did not propose such an approach. Because data on the production volume of chemical substances reportable unde r the IUR rule during non-principal reporting years currently is not available to EPA, the pe rcentage increase in these numbers, during any cycle, is unknown. For the purposes of the EA, the Agency used its best professional judgment to estimate that the amendment will increase the number of submitters and reports in future reporting cycles by approximately five percent.

b. Replacement of the 300,000 lb Thres hold for Processing and Use Reporting

Comment I.3.b-1: A few commenters asserted that EPA has underestimated the burden associated with the proposed elimination of the 300,000 lb threshold for reporting downstream processing and use information.

Sources: (0187-0098) (108-0079) (0817-354)

Response I.3.b-1: In Section 4.4.3 of the Economic Analysis, EPA estimates a $33 million increase in cost to the industry as a resu lt of the proposed modification to eliminate the 300,000 lb threshold for processing and use inform ation. EPA based this estimate on the best data available, including the 2002 industry burde n survey results. While it is true that the incremental burden reporting may increase greatly for sites that previously reported only for chemical substances they manufactured in volumes below the 300,000 lb. threshold in 2006, there are also likely to be other sites with a minimal increase in burden, because they reported mostly on chemical substances they manu factured above the 300,000 lb threshold in 2006.122 Comment I.3.b-2: One commenter stated that lowe ring the 300,000 lb threshold would triple the burden associated with reporting downstream proce ssing and use information. Other

commenters believed the burden associated w ith reporting this information will double or quadruple. One commenter recommended that EPA recalculate the burden associated with the proposed modification.

Sources: (0187-0067) (0187- 0079) (0187-0098) (0187-0354)

Response I.3.b-2 : The commenters have not substant iated or explained why the burden would double, triple, or quadruple over 2006 burden estimate for the average IUR reporter as a result of the elimination of the 300,000 lb thre shold. The commenter who suggested that EPA

recalculate the burden associated with this modi fication did not offer any alternative approaches or any demonstrably better burden estimates.

Comment I.3.b-3: One commenter stated that EPA has grossly underestimated the burden associated with the proposed modifi cation because the rule will now include manufacturing sectors that recycl e their byproducts and that were never subject to the IUR rule in the past

Sources: (0187-0103)

Response I.3.b-3: Manufacturers of byproducts used fo r commercial purposes are treated by IUR as chemical manufacturers, and are not newl y subject to IUR. EPA notes that the Agency is not changing a legal regime; it is only interp reting and clarifying an existing rule, which does not necessitate that EPA redo the Economic Analysis.

c. Reporting Production Volume for Each of the Years since Last Principal Reporting

Year

Comment I.3.c: Several commenters claimed EPA has underestimated the burden associated with the reporting of production volumes fo r all prior years in the reporting cycle. Many commenters stated that EPA has not acc ounted for the difficulty and expense of recalibrating current tracking systems, which sites have programmed to meet the 2006 IUR requirements, to retroactively gath er data, or the costs that compan ies may incur if they have to review data by hand. One commenter stated that EPA has underestimated the burden associated with reporting past import volumes. This comme nter claimed that the proposed amendment would quadruple the number of impo rted chemical substances that would have to be processed and assessed for IUR reporting.

Source: (0187-0062) (0187-0081) (0187- 0083) (0187-0084) (0187-0091) (0187-0092) (0187-0096) (0187-0098) (0187-0102) (0187-244)

Response I.3.c: While EPA recognizes that submitters were not previously required to report data on several years of past activities, the Agency believ es that production volumes for recent past years are generally tracked under stan dard business practices, and in many instances is required under other TSCA ru les, so most sites should be ab le to gather this information123 without a substantial effort. In many instances , production volumes for recent past years are tracked under standard business practices. For ex ample, EPA believes it is standard business practice for a company to furnish records of rece nt operations in the case of a proposed sale or merger, and that companies therefore typically retain such records so as to be prepared for such

eventualities. EPA also notes th at in the case that prior years’ production volume information is not known to or reasonably ascertainable by the submitter (EPA expects that such cases would be extremely rare), those data would not be subject to reporting under the IUR and therefore would not trigger an obligation to report. Furthermore, persons who have submitted a PMN to the Agency’s New Chemicals program are require d to maintain records of production volume for the first three years of production or import, incl uding but not limited to the names, addresses of any person to whom the chemical substance is di stributed (information in cludes any distributed). They must be maintained for five years from the date of commencement of manufacture or import (See 720.78). EPA expects that many companie s would also track production volumes for planning, marketing, and sales projection purposes . Several TSCA regulati ons, such as 5(a)(2) SNURs and 5(e) orders also re quire that production volume record s be kept for five years for certain chemical substances, and several commenters indicated that they ar chived these records.

d. Reporting Production Volume Exported

Comment I.3.d: Commenters claimed that the Econo mic Analysis has underestimated the burden associated with reporting the volume of a chemical substance exported, and that the rule amendments will require the redesign of internal company tracking systems.

Source: (0187-0080) (0187-0090) (0187-0092)

Response I.3.d: EPA disagrees that the Economic Anal ysis underestimated the burden of reporting total volumes exported, and believes some commenters misunderstood the reporting requirement. As described elsewhere in this do cument and in the preamble, EPA is requiring only the volume of the chemical substance dire ctly exported. Any volume that is processed or otherwise used domestically is not directly exporte d and therefore is not in cluded in the directly exported volume. Export volume is data a compa ny is likely tracking and maintaining for their records as part of standard bus iness practices. Commenters do not offer any alternative methods

to estimate the burden.

e. Revised Consumer and Commercial Product Categories

Comment I.3.e-1: A commenter requests that EPA rec ognize that new revisions to the consumer and use codes will increase the report ing burden, as companies will need to re-map previous use and exposure information to the new use reporting codes.

Source: (0187-0244)

Response I.3.e-1: The Economic Analysis currently estimates an increased industry burden resulting from familiarization with the revised consumer and commercial product categories. Commenters do not pr ovide any specific suggestions on how EPA's estimates should be further revised or improved.124 Comment I.3.e-2: One commenter noted that replaci ng NAICS codes with Industrial Sector codes will have little impact on the burden.

Source: (0187-0101)

Response I.3.e-2: As discussed in the proposed rule, one of the primary purposes of the IUR data collection is to group toge ther similar data for priority setting exercises and activities. Respondents to the 2006 IUR submitted 342 unique 5–digit NAICS codes, which made it difficult for EPA to group chemical substances ba sed on industrial processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of processing or use code, NAICS code, and industrial function category, in all. This larg e number of unique comb inations increases the difficulty and time required by EPA to sort and cla ssify chemical substances because EPA either would need to develop exposure scenarios fo r each unique combination, or determine which three–code combinations have similar exposure scenarios and can be grouped. The use of the sectors would reduce the number of unique combin ations, thereby increasi ng the usability of the data, and also reducing the IUR reporting burden. The rationale for selecting the sectors and the link between the sectors and the NAICS system is further described in “Inventory Update Reporting (IUR) Technical Support Document—R eplacement of 5–digit NAICS Codes with

Industrial Sector Codes” (Ref. 24).

f. Number of Commercial Workers Exposed

Comment I.3.f-1: Commenters stated that the Economic Analysis has underestimated the burden associated with reporting the number of commercial workers exposed; obtaining this information would be extremely burdensome and lik ely not even possible, given the number of downstream users of chemical products.

Source: (0187-0080) (0187-0091)

Response I.3.f-1 : EPA developed its burden estimat es of 21.4 hours per report for reporting the number of commercial workers reasonably likely to be exposed using the best data available. Commenters did not provide an alte rnative estimate. EPA reminds commenters that they are required to report only data accordi ng to the known to or reasonably ascertainable standard. EPA does not expect this standard to entail conducting a new survey of downstream

customers to obtain the data. A dditionally, the standard does no t necessarily require that the

manufacturer conduct an exhaustive survey of all employees.

Comment I.3.f-2: A commenter noted that the cost of collecting information about downstream customers will be a primary cost driver of the rule

Source: (0187-0354)

Response I.3.f-2: EPA disagrees that this provision w ill be a primary cost driver of the rule. EPA is confident that many submitters will be able to report data for this element, but submitters have the option to report that the data are “not known to or reasonably ascertainable”125 by them if applicable. As discussed in response I.3.f-1, EPA does not e xpect IUR reporters to conduct a survey of their customers to comply with the IUR requirements.

g. Upfront Substantiation for Proces sing and Use Information CBI Claims

Comment I.3.g: Commenters stated that the requireme nt for an upfront substantiation for processing and use information, combined with the replacement of th e “readily obtainable” standard with the “known to or reasonably as certainable by” standar d, would substantially increase reporting burden.

Source: (0187-0079) (0187-0083)

Response I.3.g: The estimates for burden for upfront substantiation for processing and

use in EPA’s EA include the burden increase from the “known to or reasonably ascertainable by” standard. EPA surveyed industry in 1996 to dete rmine the IUR burden associated with a similar upfront CBI substantiation requirement. At the time of the 1996 survey, EPA required a higher reporting standard of “reasonably ascertainable” information and the survey results are therefore based upon that standard. Commenters above stat ed that the upfront substantiation requirement will “substantially increase” the reporting burden only when combined with the new ‘‘known to or reasonably ascertainable by” standard. Howeve r, because estimates of upfront substantiation in the Economic Analysis are based on resu lts reported in the 1996 survey, the Economic Analysis does include the burden associated with the “known to or reasonably ascertainable by”

standard in its estimates of upfront substantiation.

4. Requiring Electronic Submissions

Comment I.4-1: Commenters suggested that EP A has underestimated the burden associated with mandatory electronic reporti ng and CDX registration costs and electronic signature costs have no t been accounted for in the Economic Analysis. The commenters estimate that, on a per company basis, the programming costs alone will be between $100,000 and $200,000, in addition to the burden associated wi th learning the new reporting system, making adjustments to internal collection and reporti ng systems, and collecti ng and centralizing the information for reporting.

Source: (0187-0065) (0187-0083) (0187-0101) (0187-0102) (0187-0244)

Response I.4-1: EPA disagrees that the burden asso ciated with mandatory electronic

submissions has been underestimated. The Economic Analysis currently accounts for labor costs related to CDX registration and electronic signatures. Electronic reporting will involve data entry into EPA’s e-IURweb, a tool developed by EPA; the Agency expects that no special programming costs will be incurred by submitters. The cost estimate of $100,000 to $200,000 provided by three commenters is not e xplained or otherwis e substantiated.

Comment I.4-2: One commenter implied that it is not th e cost of entering data into the eIURweb tool that is important, but rather, the cost of assembling the information that is likely to be the primary cost th at companies will face.126 Source: (0187-0354)

Response I.4-2: EPA notes that while Section 4.4.27 of the Economic Analysis addresses the specific costs associated w ith submitting IUR report informati on electronically (e.g., entering data into the web-based form instead of on paper) , much of the rest of Chapter 4 examines the incremental costs to gather and assemble info rmation that is newly required under the rule

amendments.

5. Modifications Specifically Affecting Importers

Comment I.5-1: Commenters asserted that the Economic Analysis significantly

underestimated the burden a ssociated with reporting chem ical production volumes from imported chemical mixtures. Commenters expressed particular concern about sites importing mixtures; these sites would presum ably be required to determine the chemical substances in the mixture that are subject to IUR reporting, calcula te the volume of each IUR chemical substance in each imported mixture and aggregate the total volume by IUR chemical substance to determine whether they met the IUR reporting thres hold. The site would then have to attempt to determine the use and exposure information based on the use(s) of the imported mixture. In addition, many companies’ internal systems were not originally developed to annually track the volume of imported chemical substances as part of imported formulated products. The

commenters stated that track ing this information annually would require significant reorganization and expansion of internal systems.

Source: (0187-0080) (0187- 0083) (0187-0092) (0187-0244)

Response I.5-1: Commenters have not provided an alternative burden estimate for reporting imported production volumes; therefor e the estimate of 1.51 hours per report for an average company is the best burden estimate ava ilable to EPA. As desc ribed in Section 4.2.2 of the Economic Analysis, EPA calculated the es timate of 1.51 hours based on industry data provided for the 2002 EA survey.

The IUR rule amendments specify that IU R reporting is required of entities that manufacture (i.e. produce or im port) 25,000 lb or more of an IU R-reportable chemical substance at a single site in a year. The requirement th at IUR reporting be done by a particular entity,

whether a domestic manufacturer or an importer, does not depend on that entity’s use or release of a chemical substance. EPA appreciates the di fficulty that sometimes may be associated with requesting ingredient information from foreign ma nufacturers, and notes that U.S. importers are required only to report such information as it is known to or reasonabl y ascertainable by the importer.

6. Modifying Reporting Frequency

Comment I.6-1: Several commenters stated that EPA has not provided a justification for reverting to a four-year reporti ng cycle and imposing an increa sed burden on industry, and that

EPA has underestimated the burden that more frequent reporting places on the industry.127 Source: (0187-0064) (0187-0088) (0187- 0103) (0187-0187) (0187-0354) (0187-0355) (0187-0359)

Response I.6-1: As one commenter stated, less fre quent reporting does reduce burden over time, and in the past EPA did conclude that reducing the frequency of reporting would still satisfy its information needs. However, contra ry to its expectation, EPA has found now that reporting every five years does not provide data sufficiently current to meet Agency and public needs. The Agency has been criticized for us ing outdated information. EPA, therefore, is returning to the previous freque ncy of a four-year reporting cycle. With more frequent reporting, companies would be able to establish standard systems and practices to collect the required information. See Unit III.D.1 of the proposed ru le and response H.1 for further explanation.

EPA’s Economic Analysis includes an estimat e of the industry burden for the increased reporting frequency. The estimate includes an eval uation of the burden over a 25-year period in order to capture the long-term increase in bur den due to increased reporting frequency. The commenters have not provided any additional info rmation to support their claim that EPA has

underestimated the burden of more frequent reporting. Se e section 4.4.31 of the Economic Analysis for additional details.

Comment I.6-2: While EPA’s Economic Analysis estimates a per-cycle burden reduction of approximately 20 percent generated by more frequent reporting due to efficiency gains, commenters stated that EPA does not acknowledge that th is per-cycle reduction does not make up for the increased costs generate d by more frequent reporting over time

Source: (0187-0088) (0187-0354) and 0187-0359)

Response I.6-2: EPA does acknowledge that more fre quent reporting results in higher costs over several reporti ng cycles. EPA calculates the incremen tal cost to industry associated with increasing the reporting frequency from ever y five years to every four years, which is estimated to be $82.82 million over 25 years. In this analysis, EPA has accounted for both the

burden reductions associated with more fr equent reporting (a 20 or 80 percent reduction depending on the data element) which are incorpor ated after the first reporting cycle, and the increased cost to industry over ti me of more frequent reporting, as costs are calculated over a 25- year period.

7. Byproduct Reporting

Comment I.7: A commenter asserted that EPA’s bur den estimate of 1.5 hours to provide the production volume for byproduct is a significant underestimate. The commenter claimed that many byproduct manufacturers are first-time IUR s ubmitters and have not been gathering this data. In addition, the commenter e xplains that calculating the volum e of a given chemical in each byproduct is not a straightforwar d process; for example, electronics manufacturers must determine the production volume of each compon ent chemical substance in all the byproducts recycled in a single year. Therefore, according to the commenter, EPA’s estimate of the total128 burden for providing production volumes is not even close to being approp riate for all affected

industries and must be recalculated.

In addition, the commenter stated that if EPA maintains that byproducts sent for recycling

are manufactured chemical substances re portable under the IUR rule, many byproducts generators would be reporting fo r the first time. Electronics manufacturers have not been tracking or collecting data on production volumes of byproducts they manufacture, and have never considered the bypr oducts they generate to be chemical substances.

Source: (0187-0103)

Response I.7: As described in the comment re sponse associated with byproduct reporting, this commenter appears to have mi sunderstood how to properly name and report byproduct chemical substances. As with other aspects of the economic analysis, the burden associated with reporting represents averag e burdens and may not ma tch an individual’s experience. In addition, EPA’s burden estima te (see Section 4.4.12 of the EA) of 1.51 hours burden estimate for is based on industry data from a 2002 survey. Because byproduct manufacturers have been subject to the IUR pr eviously, EPA does not believe that the burden

estimate of 1.51 hours is an underestimate for an av erage site. See comment response F.3.a-1 for further discussion regarding properly id entifying byproduct chemical substances.

8. Other Regulatory Options

a

. Requiring Submitters to Submit Full Data Annually

Comment I.8.a: One commenter felt that EPA failed to assess the considerable benefits that would result from the reporting of annual da ta. The commenter noted that there are clear efficiencies to be gained from annual reporti ng and annual reporting w ould prevent the loss of learning and have less staff turnover. By failing to present the benefits of this regulatory option, EPA is implying this option is impractical.

Source: (0187-0069)

Response I.8.a: EPA agrees with the commenter that there are efficiencies to be gained from annual reporting, or reporting that is more fr equent than every four years. However, the Agency must balance the costs of an option with the benefits, and has concluded that reverting to the previous schedule of repor ting every four years is th e most reasonable option.

b. Comments on Changing the Threshold for Reporting to 10,000 lb

Comment I.8.b: EPA failed to assess the considerab le benefits that would result from lowering the threshold to 10,000 lb, and places too much emphasis on the cost of the regulatory option. By using outdated data from the year 2000, EPA failed to account for changes in

structure and consolidation in the regulatory community. The co mmenter doubts that such data may be used to accurately estimate the number of sites that may be affected.129 Source: (0187-0069)

Response I.8.b: In the Economic Analysis, EPA used the best data it had available to analyze the costs and benefits of the rule. While it agrees with the commenter that more recent

data on the structure of the chemical industr y would be helpful, EPA believes that the methodology it used to estimate the number of additional sites reporting provides sufficiently accurate data for the Economic Analysis. EPA agrees that additional benefits would accrue to the public from data on additional chem ical substances that would be reporting if EPA were to lower the reporting threshold to 10,000 lb. However, agai n, the Agency must balance the costs of an option with the benefits, and has determined th at maintaining the 25,000 lb threshold for most chemical substances is the most reasonable option.

J. Statutory and Executive Order Reviews

1. Paperwork Reduction Act

Comment J.1: The Agency received one comment in opposition that stated that the proposed change requires duplica tive reporting and is, therefore, in violation of the Paperwork Reduction Act. The duplicative repo rting cited is: (1) the requirem ent of manufactu rers to report worker exposure data that is already currently collected by OSHA; and (2) duplicate reporting of byproducts by the recycler and the manufacturer of the byproduct.

Source: (0187-0103)

Response J.1: EPA disagrees that reporting under th e IUR is duplicativ e, and therefore in violation of the PRA. With respect to the fi rst issue raised by the commenter, EPA disagrees that worker exposure data collect ed under the IUR rule is duplic ative of OSHA’s or any other agency’s reporting requirements. The commenter did not identify what specific OSHA data collection requirement to which they were referring, but EPA is aware that OSHA collects and compiles the results of worker exposure samp ling it undertakes as part of its compliance monitoring program. OSHA and EPA are collecting di fferent types of worker exposure data, and

what OSHA collects for its needs does not meet EPA’s needs. OSHA’s database includes samples OSHA has taken of airborne contaminants , taken at various workplaces in many sectors (not just chemical manufacturi ng and processing), and includes results of personal (sampling device was being wore by a pers on) and area (sampling device at a fixed location) samples. OSHA’s data collection is primarily concerned with enforcing workplace safety requirements,

such as the PELs that have been set for some chemical substances. The IUR rule collects broader, but less specific exposure data-- the number of workers at every chemical manufacturing site for all chemical substances on the TSCA Inventory that are manufactured at that site in greater than threshold quantities. The IUR rule also collects data on the number of workers involved in downstream processing of that chemical substance. Neither OSHA nor any other agency collects and/or makes available this type of broad chemical worker exposure data.

With respect to the second issue raised by the commenter, EPA disagrees that reporting of byproducts will lead to duplic ative reporting by the manufactur er and the recycler of the byproduct. As discussed in the Q&A Docu ment (Ref. 26), under 40 CFR 720.30(g)(3) the130 manufacture of a byproduct is not reportable if the only subsequent commercial use of the byproduct is the extraction of component chemical substances. In that instance, the recycler who extracts the component chemical substances re ports the component chemical substances under the IUR, and the manufacturer of the byproduct does not. Thus, ther e is no duplicative reporting.

Also, as noted in the Q&A Document (Ref . 26), if the recycling process involves breaking chemical bonds or forming new chemic al bonds to convert a component chemical substance in the byproduct into a different chemical substance (w hich is then extracted), then the recycling process does not count as extracting a component chemical substance of the byproduct. 40 CFR 720.30(g)(3) would not apply. Under thes e circumstances, the manufacturer of the byproduct reports the byproduct, and the recycler reports the different chemical substance extracted from the byproduct. As in the scenario described in the para graph above, there is no duplicative reporting. The reporting by the manuf acturer of the byproduct and the reporting by the recycler of the byproduct are not duplicative because they re late to different chemical

substances.

2. Environmental Justice

Comment J.2: One commenter asserted that the requi rement to report under the IUR rule could discourage recycling, and that EPA had failed to anal yze the environmental justice implications of the IUR rule (such as is re quired under EO 12898, Federal Actions to Address Environmental Justice in Minority Popul ations and Low-Inco me Populations).

Source: (0187-0103)

Response J.2: EPA disagrees that such an analysis is required for this rule, and with the premise that the IUR rule requirements discoura ge recycling generally. While as an Agency, EPA encourages recycling, the IUR rule is not intended or likely to influence chemical manufacturing industry waste management practic es. EPA believes that many factors play into whether a company chooses to recycle, includi ng the value of the rec overed materials, the expense of disposal, desire to maintain or bu ild a “green” reputation, technical limitations or flexibility, state and local require ments or incentives, and the incen tives offered or requirements imposed by other federal laws. EPA has no eviden ce to suggest that IUR reporting requirements generally discourage chemical ma nufacturers from recycling, let al one evidence that alternative waste disposal methods would have a dispropo rtionate adverse impact on low-income or minority populations.

In fact, the information collected under the IU R rule is intended to enhance EPA’s ability to identify at-risk populati ons and areas. As explained in th e preamble to the proposed rule, EPA

believes that the information collected under this rule will assist EPA and others in determining the potential hazards and risks a ssociated with the chemical substances covered by the rule, enabling the Agency to target educational, regulatory, or enforcement activities towards industries or chemical substances that pose th e greatest risks and/or to target programs for geographic areas that are at the highest risk. Thus , the information to be gathered under the rule will help EPA make decisions that will benefi t potentially at-risk communities, including lowincome and minority communities, and especially vulnerable populations, such as children. The131 rule is directed at manufacturer s (including importers) of chemical substances. All consumers of these chemical products and all workers who come into contact with these chemical substances could benefit if data regarding the chemical substances’ health and environmental effects were developed.

K. Other Regulatory Options

1. Additional Exposure-Related Data

EPA solicited comments concerning the best method for collecting additional exposurerelated data, similar to those collected under TSCA section 5 (New Chemicals Program), to enhance the Agency’s capabil ities in conducting screening le vel exposure assessments of chemical substances reported to the IUR. EPA also solicited suggestions for any supplemental

data elements that could be used for th e improvement of our assessment tools and methodologies.

a. General Comment

Comment K.1.a: One commenter stated that the bul k of the information relates to environmental releases and human exposure. The commenter said that in the case of metals produced by them and other mining companies, other federal regulatory programs require the

submission of similar information or addre ss many potential exposure scenarios (e.g., TRI release reporting and emissi on reporting under various permits , MSHA and OSHA workplace safety requirements).

Source: (0187-0104)

Response K.1.b: While it may seem that some fede ral regulatory programs require the
submission of similar information, actually each federal regulatory program has different goals
which result in different types of informa tion being reported and the programs are not
duplicative. EPA discusses the re lationship of IUR to other EPA programs, such as RCRA and
TRI in Responses F.3.g-1 and F.3.g-2. A further comparison of the IUR and TRI reporting
programs is provided here. The TRI does not require submitters to report the quantity of
chemical substances manufactured at a particular site. While one of the po ssible triggers of TRI
reporting obligations is manufactur ing above a specified level, the TRI does not require that the
production volume be reported. TRI data also refl ect chemical management procedures. Data are

collected on sources of release, disposal and waste management of TRI chemicals. The purpose
of the IUR is to collect a broader range of in formation on the manufact uring, processing, and use

of chemical substances manufact ured for commercial purposes in the United States--its scope is

not limited to release information. Furthermore, the threshold for IUR reporting is defined by
what EPA may "reasonably requir e," under TSCA 8(a), not by a fi xed statutory threshold as in

TRI. The IUR collects data, such as the amount of a chemical manufactured or imported, and the
number of workers at that site, so that poten tial for worker exposure may be determined.
Additionally, information characterizing the subs equent processing and use of the chemical132 production volume is reported under the IUR. This information, which is not captured by the
TRI, allows EPA to estimate potential exposures to commercial workers, consumers, and the
general population.

b. Manufacturing Process

Comment K.1.b: The Agency received one comme nt regarding the collection of information related to the manufacturing opera tions involving a chemical substance. The commenter opposed the use of the IUR to collect the detailed information because maintaining the confidentiality of this type of information is vital to the industry and supplier/manufacturer relationships may be damaged by having to repo rt this type of information. The letter recommended instead that targeted information be collected on an as-needed basis for a riskbased process, either through the IU R or through some other method.

Source: (0187-0058)

Response K.1.b: There were three approaches under consideration (i.e., integrating the data elements into the IUR rule, promulgating a new reporting mechanism under TSCA section 8 (a), or using TSCA section 11 (c) subpoena auth ority) for collecting add itional exposure-related data. EPA's intent is to develop the best met hod in which to collect this information. EPA has committed significant resources to strengtheni ng its CBI management procedures and is continually exploring ways to be tter protect information claimed as confidential. The Agency has

no reason to believe that the collection of this ad ditional information would impair its ability to appropriately protect material claimed as CBI. EPA will consider this comment as it further

evaluates data elements for future IUR revisions.

c. Worker Exposures

Comment K.1.c: One commenter supported the coll ection of information on worker exposures because it would help track worker ch emical exposures in the U.S. The commenter

stated that no other data collection exists fo r estimating the number of workers exposed to

chemical substances in the U.S. The commenter also suggested that EPA include the data element “Personal protective equipment and engineer ing controls used by workers” to Table 5 in Unit V of the proposed rule.

Source: (0187-0042)

Response K.1.c: EPA agrees that the collection of th is data would assi st the Agency in developing screening level estimates of chemical exposures to potential ly exposed populations, such as workers. Using the 2006 data, EPA was unable to develop estimates of worker exposure, because they were reported in ranges. Enhanced data elements on worker activities and the duration and frequency of worker exposure, for example, would provide information that could be combined with existing methods and approach es to estimate worker exposure to chemical

substances. EPA will continue to consider the commenter’s suggestions as it further evaluates

data elements for future IUR revisions.133 2. Using TSCA Section 8(a) to Collect Exposure Data

Comment K.2: The Agency received one comment regarding the use of TSCA section 8(a) as a reporting mechanism to collect expos ure data, and this comment was opposed to the proposed change. The letter stated that the intent of section 8(a) is only to ke ep the list of chemical substances in commerce current, and th at Congress did not intend for updates to the TSCA Inventory to be used to collect detail ed use and exposure information. The commenter suggests that EPA should use TSCA section 8(a) in the form of a PAIR to obtain the detailed use and exposure information it seeks, not the IUR.

Source: (0187-0101)

Response K.2: The IUR rule is a TSCA section 8(a) rule and EPA believes this section of TSCA affords ample statutory authority to collect exposure-related data. See Unit II.B. of the preamble to the proposed rule. Despite the use of th e word "Inventory" in the title, it does not actually operate to update what chemical subs tances are included on the TSCA Inventory. Instead, it provides periodically updated informati on about chemical substances that are on the Inventory, and that are current ly in commerce and being prod uced above certain specified thresholds. In contrast, the PAIR rule is a one-tim e collection of a different set of data on a much smaller set of chemical substances, which may ha ve been produced at volumes much lower than would trigger IUR reporting obligations, and are often those chemical substances that the Agency or the ITC have identified as under consideration for a test rule.

3. Collecting Exposure Data from Processors

a. Separate Data Collection Process

Comment K.3.a: Some commenters were in favor of EPA collecting exposure-related data from processors. One commenter stated that processors have much more accurate knowledge about the chemical substances they process, and will be much more comfortable reporting this information directly to EPA than they are reporting it to businesses who may also be their competitors. Others argued that in formation should be collected from processors separately from the IUR, under different timelin es from those of the IUR, and specific to chemical substance manufacturers or importers.

Source: (0187-0069) (0187-0100) (0187- 0067) (0187-0244) (0187-0364) (0187-0091) (0187-0081)

Response K.3.a: EPA agrees with commenters who be lieve that processors may be more familiar with the processing and use of chemical substances than manufactures (including importers). Collecting information from proce ssors, manufacturers, and importers will provide the Agency with more complete and accurate ex posure-related data about chemical substances.

EPA will continue to consider thes e comments for future rulemakings.

b. Reporting Burden134 Comment K.3.b-1: Commenters contended that adding processors to the IUR reporting cycle would make the IUR even more complicat ed and cumbersome. One commenter indicated that before this decision is made, the Agency s hould carefully address the costs and benefits and ensure that they have a clear benefit in mind.

Source: (0187-0244) (0187-0062) (0187- 0091) (0187-0351) (0187-0081) (0187-0065) (0187- 0075)

Response K.3.b-1: The costs and benefits were consid ered as part of the proposed rule, and can be found in Appendix H. of the Economic Analysis (Ref. 15). The Agency estimated the cost to processors by using the TRI as a pr oxy for IUR reporting. The TRI collects chemical

release information from of manufacturers and processors, and by comparing the number of processors who submit information to the TRI program, the Agency was able to estimate the number of processors who may report informa tion to the IUR. In estimating the cost to processors, the EPA multiplied the per report cost of $5,673 in the first reporting cycle, and $4,539 during future reporting cycles, by the to tal number of reports EPA expects to be submitted. As indicated by EPA’s analysis, EPA estimated the cost to processors would be $523 million in the first reporting cycle and $418 million for future reporting cycles based on an estimated 141,220 reports that could be submitted by processors. The Agency has considered all comments, etc., and has decided not to add this requirement to the IUR rule at this time.

Comment K.3.b-2: Some commenters t hought EPA may not even be equipped or prepared to assess and evaluate the increase in data from processors.

Source: (0187-0244) (0187-0059) (0187-0062)

Response K.3.b-2: At this time, EPA is not requiring chemical processors to submit IUR

Form Us for those chemical substances. In the ev ent that such a requirement is contemplated for the future, these comments will be taken into consideration.

c. Data Quality

Comment K.3.c: Commenters stated that informa tion from processors would not be useful to the Agency. However, some comme nters noted that in order to gain a full understanding of the flow of chemical substa nces through the economy, public health, and the environment, it is essential to collect informa tion from downstream processors. This information would ensure robust processing and use informa tion, especially considering that manufacturers and importers frequently have only limited access to such information.

Source: (0187-0065) (0187-0086) (0187-0100) (0187-0069) (0187-0067)

Response K.3.c: EPA believes that processors may be more familiar with the processing

and use of the chemical substances than manu facturers and may be able to provide more complete and accurate exposure-related data. EPA will continue to consider these comments for future rulemakings.135 d. Reporting Exposure-related Data

Comment K.3.d: Two commenters were in favor of processors reporting the exposurerelated information listed in table 5 of Unit V of the proposed rule. Specifically, commenters believe the Agency should collect the consumer and commercial information from formulated product companies, with some stipulation.

Source: (0187-0080) (0187-0092)

Response K.3.d: Currently, only manufacturers (includi ng importers) are responsible for providing information required by th e IUR rule. Section 8(a) of TS CA enables the Agency also to collect information from processors. In ag reement with the commenter, EPA believes that processors may be more familiar with the proces sing and use of the chemical substances than manufacturers (including importers ), and therefore may be able to provide more complete and accurate exposure-related data. EPA will consider these comments as it further evaluates data

elements for future IUR revisions.

4. Change Reporting Threshold to 10,000 lb.

Comment K.4.a.: Some commented that this change would greatly increase the burden for the chemical industry, especially small busine sses. Some stated that the current threshold is the same as the manufacturing threshold under the TRI program, and should therefore stay consistent. Others noted that the Agency shoul d first determine how it would use all of this information without becoming overwhelmed with the increase. Those in favor not only support lowering the threshold to 10,000 lb, they even sugge st that EPA consider lowering the threshold further, to 1 metric tonne. These commenters noted that the lower the threshold, the more complete the information on chemical production and use is for federal agencies, states and other

stakeholders to use.

Source: (0187-0042) (0187-0064) (0187- 0091) (0187-0069) (0187-0075) (0187-0078) (0187-0083) (0187-0089) (0187-0091) (0187- 0095) (0187-0099) (0187-0100) (0187- 0101) (0187-0104) (0187-0244) (0187- 0340) (0187-0349) (0187-0351) (0187-0355) (0187-0364) (0187-0369)

Response K.4.a.: Although EPA asked for comment on reducing the reporting threshold from 25,000 lb back to the earlie r 10,000 lb limit, as noted in th e proposal, EPA is not including this change in the final rule. As EPA noted when it raised the general re porting threshold from 10,000 to 25,000 lb in 2003, EPA may lower the threshold if additional information on lower volume chemical substances is needed in the future. EPA will explore any further changes to the reporting threshold in future rulemakings.

Comment K.4.b: One commenter stated that EPA raised the threshold from 10,000 lb to 25,000 lb as part of the IUR Amendments in 2003. Th e commenter said that the stated purpose in the 2003 IUR amendments was to align the IU R reporting threshold with the threshold established for the TRI and the Low Volume Exemption (LVE) threshold under EPA's New136 Chemicals program. The rationale behind the change was that under TRI, EPA found that releases of 25,000 lb would not present an unreasonable risk, except in rare cases.

Source: (0187-0101)

Response K.4.b: EPA disagrees with the commenter’s broad characterization that “under TRI, EPA found that releases of 25,000 lb would not present an unreasonable risk, except in rare cases.” The TRI chemical activity thresholds fo r TRI-listed chemicals were first established by section 313(f) of EPCRA and not by EPA pursuan t to a specific rationale. These statutory thresholds are 25,000 lb for manufacturing a t oxic chemical, 25,000 lb for processing a toxic chemical, and 10,000 lb for use of a toxic chemical . Lower thresholds for chemicals of special concern, such as mercury and lead, have been established by the Agency through rulemakings years after the statute was enacted. While EPA did indicate in th e 2003 IUR amendments that the 25,000 lb threshold for IUR reporting woul d be similar to the TRI and LVE reporting thresholds, EPA made it clear that the change in reporting threshold was not a risk-based determination by stating the following:

“EPA is raising the basic IUR reporting thre shold in order to reduce the number of reports filed, thus reducing th e overall industry burden associ ated with this regulation. The new reporting threshold doe s not represent a finding of low exposure or low risk.” (Ref. 7, 68 FR at 856).

5. Further Increase Reporting Frequency

Comment K.5: The Agency requested comment on whether the reporting frequency should be increased to every th ree years, biennially, or annua lly. Some commenters were in favor of more frequent reporting and stated that the proposed ch ange would improve the quality of data on the manufacturing and use of chemi cal substances in commerce and capture year-toyear fluctuation in producti on and import volume. Three commenters thought IUR data should be reported at least annually. Other commenters felt the Agen cy did not provide adequate justification for increasing reporting frequency and that companies are unlikely to have many changes on a year-to-year basis. These commente rs also stated that increasing the reporting frequency would increase the burden for submitters . One commenter argued that their facilities already expend significant resources annually on TRI reporting, and adding annual IUR reporting would significantly increase those burdens. Another commenter said they did not know what type of “tie-in” the Agency believes can be made between TR I and IUR. It stated that the TRI report is a completely different report. That is, TRI involves a very fi nite list of chemical substances, encompasses releases from domestic production process and affects only domestic production facilities. The IUR report includes imports as well as domestics, has no defined set of chemical substances and extends far past the pr oduction facilities down the entire value chain. The commenter said they needed additional in formation from EPA on where they envision any parallel processes between these two reports.

Source: (0187-0035) ( 0187-0047) (0187-0069) (0187-0349) (0187-0100) (0187-0360) (0187-0104) (0187-0340) (0187-0060) (0187-0364) (0187-0244)137 Response K.5: EPA acknowledges these comments and wi ll continue to consider them as it explores any further changes to the reporti ng frequency in future rulemakings. The current

TRI toxic chemical list contains over 600 listed chemicals. The list of TRI chemicals can be found at 40 CFR section 372.65. While TRI reporti ng is restricted to domestic facilities, quantities of toxic chemicals imported by covered facilities are subject to TRI reporting. In fact, the statutory definition of “m anufacturing” for TRI reporting purposes specifically includes importation of a chemical.

6. Utility of Data

Comment K.6: EPA requested comment on the draft economic analysis to evaluate whether the proposed collection of information wa s necessary for the proper performance of the functions of the Agency, including whether th e information will have practical utility. One

commenter was concerned that information generated under the IUR program may be misinterpreted, as commonly happens with TRI data from the mining industry. The commenter stated that, like the TRI program, the IUR repor ting rule requires its company to report its “manufacturing” of many natu rally occurring minerals, even though most mining and mineral processing consists of merely removing and conc entrating naturally occurring substances. The commenter indicated that it supported more limited and focused IUR reporting for the mining industry because of the activities wi th naturally occurring minerals.

Source: (0187-0104)

Response K.6: EPA disagrees with the commenter that mining data is misinterpreted by either the TRI program or the IUR program. W ith respect to the mining industry, EPA provided detailed responses to comments about IUR cove rage of the mining industry as part of its discussion of phasing in IUR reporting for all in organic chemicals in the 2006 IUR rule. As EPA noted in the 2003 Response to Comments documen t, although naturally occurring minerals are excluded from IUR reporting, many mined mineral ar e listed on the TSCA Inventory because at least some of the time they are produced by “non-n atural” means. EPA also noted that while the hazard potential for metals is relatively well established, EPA needs exposure information to screen these chemicals for potentia l risk. Risk is composed of bot h hazard and exposure. Metals such as zinc and copper which appear in tr ace amounts in dietary supplements are a classic example of the effect of exposure, as these metals may be toxic in amounts higher than the FDA’s Recommended Daily Allowance. For further di scussion of this issue, please refer to the earlier 2003 Response to Commen ts document (Ref. 43).

L. Other Comments

Comment L.1: EPA received several comments and recommendations regarding IUR’s data collection that were beyond the scope of the proposal. A commenter suggested that EPA

include collection of R&D chemical substances to capture information on emerging chemical

substances. One commenter recommended that the Agency collect more information related to commerce, similar to the New Chemicals program, and require industry to identify ports of entry for imported chemical substances. Thus, info rmation on commerce combined with TRI data could capture a more coherent picture of the flow of chemical substances through the economy. Other commenters encouraged EPA to work with other agencies such as CDC to link the data138 collected under IUR and other chemical monito ring efforts with those aimed at identifying chemical exposures and disease in the U.S. population. There should also be greater collaboration between EPA programs for inform ation collected on wate r supplies to reduce

contamination.

Source: (0187-0100) (0187- 0349) (0187-097) (0187-0095)

Response L.1: EPA appreciates the additional re commendations for improving the IUR data collection process. The Agency continually strives to coordinate data collection activities with other agencies and other EPA programs to ach ieve a more complete approach to human and

environmental risk assessment. EPA’s ultimate goal is to align reporting objectives between agencies and programs to develop a comprehensiv e data set that can be relied on for future Agency work. EPA will consider these comments in future rulemaking.

Comment L.2: One commenter noted that the propos al did not make any mention or provide provisions specific to an important, critical emerging class of chemical substances subject to TSCA, nanomaterials. Another comme nter stated that engineered nanomaterials should meet the same IUR reporting requirement s, as other chemical substances, with no exemptions.

Source: (0187-0069) (0187-0349)

Response L.2: As part of the Agency's efforts to ensure a more comprehensive understanding of nanoscale materials that are already in commerce, EPA is developing a proposed rule under TSCA section 8(a) to requi re the submission of additional information on

nanoscale materials.

Comment L.3: One commenter stated that the IUR re ports should be pub licly accessible

within two months.

Source: (0187-0349)

Response L.3: EPA recognizes the need to make the da ta publicly availa ble as quickly as possible, and will strive to do so. The requi rement to report electronically and the many improvements to the reporting tool and to the reporting requirements in general address the

issues identified as the main contributors to the delayed publicati on of the 2006 IUR data. However, EPA also recognizes the need to ensure that CBI claims are protected, and will take the time needed to ensure that the public data release protects submitters’ confidential data.

Comment L.4: One commenter requested that EPA clarify the difference between TSCA and FDA-regulated activities in industrial codes.

Source: (0187-0244)

Response L.4: In regards to the newly developed lis t of industrial sector codes, EPA acknowledges that there may be some FDA-regul ated activities included and acknowledges that139 FDA-regulated chemicals are not reportable under IUR; however, in developing the IS codes and NAICS codes crosswalk, included in the “Ins tructions for the 2012 TSCA Inventory Update Reporting” (Ref. 9), EPA wanted to be complete in assigning IS codes to the span of available NAICS codes so that the need for “Other” repor ting is minimized. EPA will use the 2012 data to further evaluate the need for adding or rem oving IS codes as well as industrial function categories.140 References

A docket was established for the final IUR M odifications rule under docket ID number EPA– HQ–OPPT–2009–0187. The following is a listing of the documents that are specifically

referenced in this document and are included in the docket.

1. EPA. TSCA Inventory Reporti ng Modifications; Submission Pe riod Suspension; Final rule. Federal Register (76 FR 27271, May 11, 2011) (FRL–8874–2).

2. Environmental Defense Fund, Letter to Dock et # EPA-HQ-OPPT-2009- 0187 (on behalf of 32 organizations), from Richar d Denison, PhD, October 12, 2010.

3. EPA. OPPT. Enhancing EPA’s Chemical Ma nagement Program. Available on-line at: http://www.epa.gov/oppt/existingc hemicals/pubs/enhanchems.html.

4. Health Canada. Proposal for Priority Setti ng for Existing Substances on the Domestic

Substances List under the Canadian Environm ental Protection Act, 1999. Greatest Potential for Human Exposure, Canada, 2003.

5. U.S. General Accounting Office, Toxic Subs tances: EPA should Focus Its Chemical Use Inventory on Suspected Harmful Substances (1995) (GAO Report).

6. EPA. TSCA Inventory Update Ru le Amendments; Proposed Rule. Federal Register (64 FR 46786, August 26, 1999) (FRL-6097-4).

7. EPA. TSCA Inventory Update Rule Amendments; Final rule. Federal Register (68 FR 848, January 7, 2003) (FRL–6767–4).

8. EPA. TSCA Inventory Update Repor ting Modifications; Proposed Rule. Federal Register (75 FR 49656, August 13, 2010) (FRL-8833-5).

9. EPA. Instructions for the 2012 TSCA Inventory Update Reporting, July 2011.

10. EPA. OPPT. Screening-Level Hazard Character ization and Prioritizat ion Document. March

2009. Available on-line at: http://www.epa.gov/chemrtk/hpvis/rbp/Butene dioic%20Acid%20Dialkyl%20Esters_HBP_Ma rch%202009.pdf

.

11. Portland Cement Association, Letter to Docket ID No. EPA-HQ-OPPT-2009-0187 from Tyrone P. Wilson, October 12, 2010.

12. American Petroleum Institute, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785 from Howard J. Feldman, December 8, 2008.

13. Proctor & Gamble, letter to Docket ID No. EPA-HQ-OPPT-2008-0785, from Julie Froelicher, January 23, 2009.141 14. Synthetic Organic Chemical Manufacturers Asso ciation, Comments submitted to Docket ID No. EPA-HQ-OPPT-2008-0785 from Daniel Newton, January 23, 2009.

15. EPA. OPPT. Economics, Exposure and Technol ogy Division (EETD). Economic Analysis for the Proposed Inventory Update Reporti ng (IUR) Modifications Rule, July 20, 2010.

16. NOVA Chemicals Corporations, Letter to Docket ID N o. EPA-HQ-OPPT-2009-0187 from Linda J. Santry, PhD., October 7, 2010.

17. EPA. OPPT. Initial Risk-Based Prioritizati on of High Production Volume (HPV) Chemicals. April 2009. Available on-line at: http://www.epa.gov/chemrtk/hpvis/rbp/Ca tegory_Chlorobenzenes_Web_April%202009.pdf

.

18. EPA. TSCA Inventory Update Re porting Modifications; Final Rule. Federal Register (August 16, 2011).

19. EPA. OPPT. Toxic Substances Control Ac t Inventory Representation for Chemical Substances of Unknown or Variable Compositio n, complex reaction products and biological

materials: UVCB substances. Available on-line at: http://www.epa.gov/oppt/newchems/pubs/uvcb.txt

.

20. EPA

. Toxic Substances Control Act Inventory Repr esentation for Combinations of Two or More Substances: Complex Reacti on Products. Available on-line at: http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt

.

21. European Commission. Registratio n, Evaluation, Authorization and Restriction of Chemicals (REACH). Regulation (EC) No. 1907/2006 of the European Parliament and of the Council. 2006. Off J Eur Commun. L396/17:1-849. Europ ean Commission. REACH, 2011. Available

on-line at: http://ec.europa.eu/en vironment/chemicals/r each/reach_intro.htm

.

22. Letter from Charles M. Auer, EPA, to Robert Strieter, The Aluminum Association, August 3, 2006 response on AL petitions, August 3, 2006.

23. EPA. 2009 Toxic Chemical Release Invent ory Reporting Forms and Instructions. Available

on-line at: http://www.epa.gov/tri/repor t/rfi/ry2009rfi121709.pdf.

24. EPA. OPPT. EETD. Inventory Update Repor ting (IUR) Technical Support Document Replacement of 5-digit NAICS Codes with Indu strial Sector (IS) Codes. October 2009.

25. H.R. Rep. No. 94-1679, 94th Cong., 2d Sess. (1976), reprinted in, Environmental and Natural Resources Policy Division of the Library of Congress, 94th Cong. 2d Sess., A Legislative History of the Toxic Substances Control Ac t, (Com. Print 1976) ("Leg. Hist.") at 667-721.

26. EPA. OPPT. Draft Q&A Document: Recycli ng and the TSCA Inventory of Chemical

Substances Premanufacture Notification and I nventory Update Reporting Requirements, July

2010.142 27. EPA. Recordkeeping and Reporting Requi rements. Final rule/ Redesignation. Federal Register (48 FR 23420, May 25, 1983) (FRL-2370-70).

28. EPA. Partial Updating of TSCA Inventory Database; Production and Site Reports. Final

Rule. Federal Register (51 FR 21438, June 12, 1986) (FRL-2973-3).

29. EPA. Premanufacture Notification. Preman ufacture Notice Requirements and Review

Procedures. Final Rule and notice form. Federal Register (48 FR 21722, May 13, 1983) (FRL 2998-5).

30. EPA. Comprehensive Assessment Information Rule. Final Rule. Federal Register (53 FR 51698, December 12, 1988) (FRL-3368-1).

31. Prenotice Communication Letter from Ma ry E. Cushmac, EPA, July 29, 1991.

32. Letter from Susan Sharkey, EPA, to Robert P. Strieter, The Aluminum Association, October 24, 2006.

33. Letter from Charles M. Auer, EPA, to Fern Abrams, IPC, August 27, 2008.

34. H.R. Rep. No. 94-1341, 94th Cong., 2d Sess. (1976), reprinted in, Environmental and Natural Resources Policy Division of the Library of Congress, 94th Cong. 2d Sess., A Legislative History of the Toxic Substances Control Ac t, (Com. Print 1976) ("Leg. Hist.") at 407-517.

35. EPA. General provisions and Inventory repor ting requirements; Proposed rule; supplemental notice; public meeting. Federal Register (42 FR 39182, August 02, 1977) (FRL 764-1).

36. EPA. OPPT. New Chemicals Program. Available on-line at: http://www.epa.gov/opptintr/newchems/index.htm.

37. EPA

. Revisions to the Definition of Solid Waste Final Rule Compilations: The Legitimate Recycling Standard. Version 1. EPA530- R-10-007, June 2010. Available on-line at: ( http://www.epa.gov/waste/hazard/ dsw/downloads/legit-recycling.pdf.

38. Letter from Robert Lee, EPA, EPA le tter to Fern Abrams, IPC, Nov. 30, 2007.

39. EPA. Notification Requirements; Reportable Quantity Adjustments; Final Rule. Federal Register (50 FR 13456, April 04, 19 85) (FRL-2665-6(b)).

40. EPA. OPPT. IUR Modifications Rule: Devel opment of Definitions for 40 CFR 711.3, July 8,

2010.

41. EPA. OPPT. 2006 Inventory Update Repor ting: Data Summary. EPA Report No.

740S08001. December 2008. Also available on-line at: www.epa.gov/iur/tools/data/index.html

.143 42. EPA. OPPT. EETD. 2002 Economic Analysis for the Amended Inventory Update Rule, Final
Report.

43. EPA. OPPT. Summary of EPA’s Responses to the Public Comments Submitted for the
Proposed TSCA Inventory Update Rule Am endments (64 FR 46772), November 20, 2002.144 

## Appendix A: Commenter Referen ce List by FDMSID Number

FDMSID Company/Organization

0187-0042 NIOSH 0187-0050 General Electric Company 0187-0051 NOVA Chemicals Corporation
0187-0055 Sunoco, Inc. 0187-0056 Georgia Mining Association

0187-0057 Pine Chemicals Association 0187-0058 Semiconductor Industry Association 0187-0059 Hewlett-Packard Company 0187-0060 Eastman Kodak Company 0187-0061 Xcel Energy Services, Inc. 0187-0062 EHS Strategies, Inc. 0187-0063 LANXESS Corporation 0187-0064 Indianapolis Power & Light 0187-0065 American Coatings Association
0187-0066 Alcoa, Inc. 0187-0067 Society of Chemical Manufacturers & Affiliates
0187-0068 PPM Consultants, Inc.

0187-0069 Environmental Defense Fund

0187-0071 American Associ ation for Justice 0187-0072 OXEA Corporation

0187-0073 North American Metals Council

0187-0074 Aluminum Association
0187-0075 Dominion Resource Services, Inc. 0187-0078 Dow Chemical Company

0187-0079 American Petroleum Institute 0187-0080 American Cleaning Institute 0187-0081 Society of the Plas tics Industry, Inc.

0187-0083 National Association of Chemical Distributors

0187-0084 National Association of Manufacturers

0187-0085 AkzoNobel

0187-0086 Chemical Users Coalition
0187-0087 Chlorine Institute, Inc.

0187-0088 Fertilizer Institute 0187-0089 Utility Solid Waste Activities Group
0187-0090 CARBO Ceramics, Inc. 0187-0091 Fragrance Materials Associ ation of the United States 0187-0092 Procter & Gamble Company 0187-0093 Eastman Kodak Company

0187-0094 Western Business Roundtable 0187-0095 Association of Metropolitan Water Agencies

0187-0096 Corn Refiners Association145 FDMSID Company/Organization

0187-0097 American Water Works Association 0187-0098 E.I. DuPont de Nemours and Company
0187-0099 Koch Industries, Inc.

0187-0100 National Pollution Prevention Roundtable

0187-0101 National Petrochemical & Refiners Association

0187-0102 U.S. Chamber of Commerce

0187-0103 IPC

0187-0104 ASARCO 0187-0244 American Chemistry Council

0187-0292 American Coke and Coal Chemicals Institute 0187-0340 Battery Council International 0187-0349 Environmental Working Group 0187-0351 Institute of Scrap Recy cling Industries, Inc.

0187-0352 Rubber Manufacturers Association 0187-0353 Clariant Corporation 0187-0354 National Mining Association 0187-0355 Brush Engineered Materials Inc. 0187-0357 US Congress

0187-0358 3M

0187-0359 Portland Cement Association 0187-0360 American Forest & Paper Association

0187-0362 American Sustainable Business Council

0187-0363 Environmental Health Fund 0187-0364 BASF Corporation

0187-0369 Arkema146 

## Appendix B: Commenter Refe rence List by Company

FDMS ID Company/Organization

0187-0358 3M

0187-0085 AkzoNobel
0187-0066 Alcoa, Inc.

0187-0074 Aluminum Association

0187-0071 American Associ ation for Justice 0187-0244 American Chemistry Council 0187-0080 American Cleaning Institute 0187-0065 American Coatings Association

0187-0292 American Coke and Coal Chemicals Institute 0187-0360 American Forest & Paper Association

0187-0079 American Petroleum Institute

0187-0362 American Sustainable Business Council

0187-0097 American Water Works Association

0187-0369 Arkema

0187-0104 ASARCO LLC 0187-0095 Association of Metropolitan Water Agencies 0187-0364 BASF Corporation 0187-0340 Battery Council International 0187-0355 Brush Engineered Materials, Inc.
0187-0090 CARBO Ceramics, Inc.

0187-0086 Chemical Users Coalition
0187-0087 Chlorine Institute, Inc. 0187-0353 Clariant Corporation

0187-0096 Corn Refiners Association
0187-0075 Dominion Resource Services, Inc. 0187-0076 Dow Chemical Company 0187-0098 E.I. DuPont de Nemours and Company 0187-0060 Eastman Kodak Company 0187-0093 Eastman Kodak Company 0187-0062 EHS Strategies, Inc.

0187-0069 Environmental Defense Fund

0187-0363 Environmental Health Fund 0187-0349 Environmental Working Group

0187-0088 Fertilizer Institute 0187-0091 Fragrance Materials Associ ation of the United States 0187-0050 General Electric Company 0187-0056 Georgia Mining Association 0187-0059 Hewlett-Packard company 0187-0064 Indianapolis Power & Light 0187-0351 Institute of Scrap Recy cling Industries, Inc.147 FDMS ID Company/Organization

0187-0103 IPC
0187-0099 Koch Industries, Inc. 0187-0063 LANXESS Corporation

0187-0083 National Association of Chemical Distributors

0187-0084 National Association of Manufacturers 0187-0354 National Mining Association (NMA)

0187-0101 National Petrochemical & Refiners Association

0187-0100 National Pollution Prevention Roundtable 0187-0042 National Institute for Occupational Safety and Health

0187-0073 North American Metals Council 0187-0051 NOVA Chemicals Corporation 0187-0072 OXEA Corporation

0187-0057 Pine Chemicals Association

0187-0359 Portland Cement Association
0187-0068 PPM Consultants, Inc. 0187-0092 Procter & Gamble Company

0187-0352 Rubber Manufacturers Association 0187-0058 Semiconductor Industry Association 0187-0067 Society of Chemical Manufacturers & Affiliates 0187-0081 Society of the Pl astics Industry, Inc.
0187-0055 Sunoco, Inc.

0187-0102 U.S. Chamber of Commerce 0187-0357 US Congress 0187-0089 Utility Solid Waste Activities Group

0187-0094 Western Business Roundtable 0187-0061 Xcel Energy Services, Inc.