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 2011 
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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 Specific 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 since 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 Not Domestically Processed or Used.......................53 

8. Identify Whether A Chemical Substance 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........................................................62 
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F. Definitions and Clarification Requests.............................................................63 

1. Changing the Reporting Standard for Processing 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-Related Definitions........................................................103 

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

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

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

3. General Comments on Upfront Substantiation 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, Future-Cycle Burden, and Methodology.............114

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

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

5. Modifications Specifically 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 .................................................................................................137 
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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 identify 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). Appendix A provides a complete list of the 

commenters and their associated ID number. 
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Acronyms 

ACC American Chemistry Council 

CA Chemical Abstracts 

CASRN Chemical Abstracts Service Registry Number 

CBI Confidential Business Information 

CDC Centers 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 and Health Administration 

NAICS North American Industrial 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 Restriction 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 Composition, or of Biological Origin 

XML Extensible Markup Language
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As part of the Inventory Update Reporting (IUR) Modifications final rule, EPA changed the 

identification of the regulation from IUR to Chemical Data Reporting (CDR). However, EPA is 

retaining the use of the IUR acronym throughout this document. The reader should recognize 

that where IUR is used to refer to the 40 CFR 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 reporting frequency, eliminating the 300,000 lb threshold for processing and 

use information, and required electronic reporting. Commenters stated that the changes would 

facilitate EPA’s ability to track chemical substances used and made in the United States, which 

would strengthen EPA’s ability to identify chemical 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 other 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 processing and use data for the entire U.S. Another 

commenter stated that no other ongoing data collection exists for estimating 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 EPA’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 mentioned that the Agency does not explain how 

the existing IUR fails to meet these goals or why an IUR expansion is needed to carry out its 

congressionally-mandated TSCA duties. Additionally, commenters 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 with chemical substances under its jurisdiction. 

As stated in the preamble of the proposed rule, 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 improperly completed, or identified invalid chemical 

identities, and/or inappropriately or incorrectly claimed certain data elements as CBI. 
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A large number of errors were created through the scanning process and required 

correction by hand, which was very labor intensive. 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 original 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 collection 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 claimed 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 claimed CBI on Form U, while the same or similar information was 

submitted voluntarily by the company without such 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. Correct designation of reported information as nonconfidential will facilitate 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 the 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 that the modifications to the rule will supply 

manufacturing and processing and use information 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 imported into the United States, how they are or may 

be used, and the types of exposures (occupational, consumer, environmental, etc.) potentially 

associated with the chemical substances. Many chemical substances are exempted from reporting 

under the IUR rule, which helps tailor IUR requirements 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 helps 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 rules in the HPV Challenge Program, which were 

implemented to generate health and environmental effects data on HPV chemical substances for 

risk assessment purposes. The IUR supported these test rules by providing production volume 

and exposure information needed to make the findings for these test rules. Without the IUR 

information, EPA might not have been able to make 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 substance 
8

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. EPA’s extensive use of the 2006 IUR data in the 

Agency’s Existing Chemicals Program is consistent with how EPA envisioned the data would be 

used when the 2003 Amendments were promulgated. EPA used the 2006 IUR data together with 

other available information in developing Action Plans on chemical substances beginning in 

2009, and noted the limitations inherent in those data. Any future program is expected to be 

similar in analytical approach regarding the use of screening-level 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, and 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 detail 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, including: (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 promulgation of the final rule, or (3) moving the 

submission period to 2012 and changing the principal 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 provide sufficient time for companies to 

comply with the amended reporting requirements and to finalize the proposed modifications, 

EPA promulgated a rule (Ref. 1) to suspend the 2011 IUR submission period. In the IUR 

Modifications final rule, EPA supersedes the suspension 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 the 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 develop their internal 

databases to collect the required information, on November 30, 2010 the Agency held an 

informational workshop and webinar to help companies develop a better understanding of the 

CDX registration process and the e-IURweb electronic reporting tool. A recording of the 
9

workshop and a summary of the questions and 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-release version of 

the tool. EPA also plans to conduct a training webinar shortly after the publication of this final 

rule to provide detailed instructions on the reporting requirements and on using the e-IURweb, to 

complete and submit Form U. Finally, to the extent 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 reporting 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 official in a different state to remotely certify the 

facility’s TRI submissions.

Comment A.2-2: One commenter suggested that EPA 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. Therefore, 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 further 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/existingchemicals/pubs/enhanchems.html), EPA’s comprehensive 

approach to enhancing the Agency’s current chemical management program includes requiring 

information needed to understand chemical substance risks and increasing transparency and 

public access to information about chemical substances (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 manufacturing, processing and use 

information. For example, the expansion of requiring processing and use information for all 

chemical substances in 2016 addresses the identified lack or insufficiency of such information 

for most chemical substances – including HPV chemical substances. EPA’s efforts to understand 
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and prioritize chemical substances based on risk, using the 2006 IUR data, were instrumental in 

shaping the changes to the IUR requirements. See Section A.3 of this document for more details 

on EPA’s use of the 2006 IUR data. 

In addition, requiring the use of electronic reporting 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 IUR is sufficient for its purposes. 

Between August 2007 and mid-2009, EPA developed screening-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 characterizations, EPA developed either a risk-based 

prioritization (RBP) or a hazard-based prioritization (HBP) for individual chemical substances or 

a group of chemical substances that were similar 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 understanding currently available to EPA. EPA’s experience using the 

IUR information to develop the prioritizations was that the 2006 IUR data were not sufficient to 

provide the exposure-related information needed. When EPA was developing RBPs for its HPV 

chemical substances, it needed both hazard and exposure screening-level information. Lacking 

sufficient exposure information, EPA found it necessary in many cases to make assumptions 

about exposure. Consequently, the resulting prioritization decision 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/existchem_hpv_prioritizations.INDEX_HTML) that further 

information on exposure was needed to confirm 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 developing these characterizations, EPA identified areas where the 

IUR data collection should be improved and enhanced. These improvements, which are reflected 

in the modifications to the reporting requirements in the final rule, will allow EPA to better 

prioritize chemical substances for further assessment as well as make appropriate risk 

management decisions for follow-up action on chemical substances that may pose potential risks 

to human health or the environment. 
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EPA is considering using other regulatory tools and authorities to collect more in-depth 

information, but believes the IUR (which is a TSCA section 8(a) rule) is the correct mechanism 

for the data collection required in this final rule. EPA also is considering ways to get public input 

on its use of the IUR data and its chemical substance prioritization process, 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 input 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 prioritization. In the past, EPA has used a variety of vehicles to 

obtain stakeholder input as it further developed both regulatory and voluntary programs. EPA 

will review the different options available to determine the best fit for specific issues, as those 

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

communicate its intentions to all 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 Canada completed in 2006. The DSL Categorization 

was a statutorily mandated risk-based prioritization 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 substances presenting human health hazards as well as 

the greatest potential for exposure to Canadians. Even though categorization was a legally 

mandated process with a deadline for consideration of all chemicals on the DSL, Health Canada 

felt that production volume alone was not a sufficient 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 decisions 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 identified 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 several 
12

fora, including in comments on the proposed rule, that it supports risk-based as opposed to 

hazard-based prioritization. A commenter also noted that industry strongly supports risk-based 

decisions and for that reason needs to provide robust production, processing 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 information on numerous additional chemical substances, 

not just those chemical substances that are 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 decision to phase out the 300,000 lb threshold is 

inconsistent with the Agency's previous reasoning, or with the cited conclusions of the GAO 

report. EPA acknowledges that its decision to phase out the reporting threshold incorporates 

additional information based on its experience collecting and analyzing 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 the 2003 IUR Amendments, the GAO concludes that 

"[t]he inventory could be more useful to EPA and other 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 obtained, 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 explained that it "still believes that information concerning lower 

production volume chemical substances is valuable, 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 future, EPA may find it necessary to collect 

information on chemicals at reporting thresholds below the thresholds proposed 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 was based on EPA's experience collecting and 

analyzing the 2006 IUR data. In 2003, EPA reasoned that the 300,000 lb reporting threshold 

would allow EPA to receive sufficient exposure and use data on HPV chemical substances while 

at the same time reducing reporting burden. However, based on the 2006 data, approximately 

23% of the reports submitted for known HPV chemical substances had reported production 

volumes below the 300,000 lb threshold and therefore, 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 the 
13

300,000 lb cutoff and therefore had minimal information 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 exposure was essential for making a real-world 

prioritization decision. In order to select the highest priority chemical substances based on risk, 

EPA must have sufficient hazard and exposure information; otherwise the 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 exposure and use information on lower production volume 

chemical substances so that chemical substances 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 Draft Instructions for 2011 Inventory 

Update Reporting as Proposed in the IUR Modifications Rule Guidance Document is confusing 

and inconclusive. Another suggested that EPA should ensure that detailed guidance is available 

as early as possible and the reporting tool is available for testing also well ahead of the deadline. 

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

 Response A.4: EPA has revised the guidance document to better explain the reporting 

requirements for various data elements and further 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 received, that companies were concerned about 

the time needed to develop their internal databases 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 document, 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 its decision to require electronic 

reporting of all IUR submissions. In general, commenters supported electronic 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 systems. 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 collecting and managing the 2006 IUR 

reports, has concluded that mandatory electronic reporting is a critical next step for collection of 

the 2012 data. Optional electronic reporting for 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 the 2012 IUR will eliminate many of the software 

compatibility and firewall setting issues that 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 identity 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-IURweb will substantially reduce error rates and 

burden; consequently, EPA does not believe it is necessary to have 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 comprehensive electronic reporting. EPA is continually 

looking for ways to improve CDX, to better address submitter and Agency needs. For example, 

EPA has developed an eTSCA registration for 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 reflect 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 document, there were many problems, errors, and 

delays associated with paper submissions of the 2006 IUR data, which make the continued use of 

paper reporting highly inefficient and therefore undesirable. In light of the substantial 

disadvantages associated with allowing paper submissions, 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 requirement until 2012, the Agency is confident that 

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

IUR rule in 2012. 

 

2. Training 
15

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 opportunities and guidance materials to 

facilitate electronic reporting, as well as product testing opportunities, to alleviate particular 

commenters’ concerns. For example, the Agency held an informational workshop and webinar 

on November 30, 2010. The workshop was designed to help companies develop a better 

understanding of the CDX registration process and the e-IURweb electronic reporting tool. EPA 

sent emails announcing the webinar to its established 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. Additionally, 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 modified Electronic Signature form, 

particularly the need for multiple notarized signatures, 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 electronic data to the EPA. Regarding the prior 

need for multiple notarized signatures, EPA has determined that requiring a notarized signature 

as part of the electronic 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 electronic signature agreement across all TSCA programs and is 
16

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 the submittal process that 

should be included in the final rule. 

Source: (0187-0090) 

Response B.3-2: Detailed instructions regarding support 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 document. To clarify, a support submitter will be a person designated by 

an authorized official to provide 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 authorized representative agent for the company. 

Support submitters are not allowed to sign the certification statement required for the initial IUR 

submission, but they may enter or modify data for 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 additional information (Ref. 9). 

Comment B.3-3: Commenters stated that there should 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 that 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, the 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 authorized 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 different 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 allowing foreign submitters to submit information to 

EPA through CDX. EPA provides instructions for foreign submitters in its guidance document 

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

4. Reporting Tool 

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

via an XML file to accommodate alternative data submission file formats. 

Source: (0187-0098) 

Response B.4-1: The continued deployment and enhancements 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 available 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 companies 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 reporting tool that allows an individual to upload a 

centralized report after 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 electronic signature agreement across all TSCA 

programs and is exploring the reuse of e-signatures issued under the e-PMN program as well as 

other EPA programs. Regarding notarized signatures, 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 concerned that securing confidential information 

would be an issue, and encouraged the Agency 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 expressed 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 and plans to conduct additional webinars to 

demonstrate the use of the reporting tool and the security layers built into the reporting tool to 

protect sensitive data. EPA is conscientious in securing the potentially confidential data and has 

updated previous systems to enhance data security. The 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-IURweb tool over the internet resides in an encrypted database. In 

addition this data cannot be accessed unless the IUR submitter has both their CDX two-factor 

authentication and the passphrase that was generated for the specific Form U. The passphrase 

cannot be reset by the system or by the help desk, 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 Program reporting software (e-PMN). Specifically, 

unlike the e-PMN downloadable solution, 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. Federal Information Processing Standards 

(FIPS) certified solution that encrypts a Form U before it is transmitted to EPA. FIPS has 

standards concerning acceptable encryption methods. For a solution to be FIPS certified, detailed 

documentation and source codes must be submitted to the National Institute of Standards and 

Testing’s (NIST’s) testing laboratories and receive validation. 

4. SSL. The encrypted Form U is then transmitted to EPA through a Secure Sockets 

Layer (SSL), a protocol that creates an encrypted connection between a browser and a Web 

server for the secure transmission of data over the Internet. The data is always 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 the 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 later reporting cycles. They noted that the new 

requirement is essential to effectively capture the substantial year-to–year fluctuation in 

production/import volumes that was missed in past IUR reporting cycles, thereby skewing the 

picture of how many and which chemical substances are actually in commerce at a given time 

and what levels of production or import. One commenter went further to say that the 

modification would eliminate gaps and uncertainties in the information collected under the 

current IUR that result from infrequent collections and reporting of data. Another said that this 

will keep manufacturers from disguising their actual output by producing certain specialty 
19

chemical substances only in years that are 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 the ability to obtain accurate 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 Agency and regulatory community can be justified, 

EPA should retain the mechanism whereby the need to report is based on consideration of a 

single reporting year. Some commenters stated that EPA had not shown special utility for the 

information generated. Another commenter believed that there is no significant incremental 

benefit to require reporting from companies that produce or import less than 25,000 lb of a 

reportable chemical substance for 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 threshold for several years, and then falling below 

the threshold during the IUR principal reporting year. EPA believes that using production 

volume reporting for all years since the last principal reporting year to determine reporting 

obligations would yield a much more accurate picture 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 determination method, EPA acknowledges that it had 

the statutory authority to implement the change for the 2012 reporting period. EPA’s decision to 

defer the change in the determination method to the 2016 reporting 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-year 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 past IUR reporting was not 

accurately characterizing the chemical production. As EPA noted in the proposed rule preamble, 

production volumes of chemical substances vacillating above and below reporting thresholds in 

different IUR reporting cycles resulted in a change 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 Butenedioic 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 production 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 had 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 volumes were above one million lb, making 
20

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 production volumes, neither SIDS 

datasets nor consistent exposure and use information were available for these chemical 

substances. Because of this lack of exposure-related information, these chemical substances were 

included in a cluster for which an HBP was developed instead of an RBP. One commenter also 

submitted an analysis of the degree of fluctuation 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 substances reported in 2006, including more than 200 

organic HPVs, were not reported in 2002. 

In addition, in comments submitted to the Agency in response to other programs, industry 

representatives expressed concern that short reporting determination periods would drastically 

misrepresent the chemical substances that currently are in commerce. They stated they 

manufactured or imported some chemical substances only occasionally, and that these chemical 

substances would not be captured if the reporting covered 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 and 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 for some manufacturers, production 

volumes for a specific chemical substance does fluctuate 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 commerce, and might have provided an 

erroneous view of the exposure scenarios associated 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 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, and then falling below the threshold during the IUR 

principal reporting year. Consequently, previous IUR reporting has resulted in a change of 

approximately 30% in the composition of the chemical substances being reported from one 

submission period to the next. This high turnover of reported chemical substances from one 

submission period to the next indicates 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 substances with nationally aggregated production volumes of one 

million lb or more. As the HPV Challenge Program progressed, the Agency chose not to pursue 

certain chemical substances because new IUR reporting indicated that the nationally aggregated 

production volume had dropped below one million lb. However, based on the latest IUR, the 
21

production volume for some of the chemical substances the Agency was no longer pursuing had 

risen again to exceed one million lb. 

Comment C.1-3: Some commenters felt that companies were not given enough notice of 

this change and are unprepared to respond with their information collection processes 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 substance was manufactured (including 

imported) at a site in production volumes of 25,000 lb or greater. For example, for the 2016 

submission period, it would be necessary to examine the annual production volumes for the 

calendar years 2012 to 2015 for the site. If the production 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 substance, 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 requirement for determining need to 

report would create unnecessary obligations to monitor production volumes each year. They also 

thought that it would be very burdensome 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 representatives 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 reporting determination periods would drastically misrepresent the 

chemical substances that currently are in commerce. Industry representatives stated they 

manufactured or imported some chemical substances only occasionally, and that these chemical 

substances would not be captured if the reporting 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 agreed a longer timeframe to report chemical 

substances would capture those chemical substances 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 infrequently 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 into effect until the 2016 submission period. Furthermore, in many 

instances, production volumes for recent past years are tracked under standard business practices. 

For example, EPA believes it is standard business 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 Chemicals program are already required to maintain 

records of production volume for the first 3 years of production or import. They must be 

maintained for 5 years from the date of commencement of manufacture or import (See 40 CFR 

720.78). EPA expects that many companies would also 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 indicated that they archived these records. 

Should a submitter determine, after making the efforts required under the Agency’s 

known to or reasonably ascertainable standard, that no chemical substances were manufactured 

(including imported) above the applicable reporting 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 manufacturer 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 requirement 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 particular manufacturers’ prior lack of 

awareness respecting the IUR’s requirements is a basis to revise those requirements. At this time, 

EPA believes the appropriate response is to more prominently and clearly explain the reporting 

requirements relating to byproduct manufacturing. The Agency has provided such an explanation 

in the preamble to this rule and associated guidance. As noted above, the requirement (applicable 

to all manufacturers, including byproduct manufacturers) 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 reporting should only be required for those years where 

PV threshold was triggered. One commenter suggested that if there are specific chemical 

substances for which the principal year reporting threshold approach is inadequate, then the 

Agency should consider amending the requirement 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 reporting 
23

range of between 25,000 and 300,000 lb for which EPA should require a more limited amount of 

information. Manufacturers should only be required to report under the IUR rule if the 

production volume of a reportable chemical substance is above the threshold during the principal 

reporting year only. For those years during the reporting cycle when production volume did not 

exceed the established threshold, manufacturers should be allowed to indicate 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 essential to its understanding of 

exposure and use of chemical substances that EPA receive information based on a consistent set 

of reporting triggers. As noted above in Response C.1-2, the fluctuation of chemical substances 

above and below the previous 300,000 lb reporting threshold for processing and use information 

resulted in the Agency receiving an inconsistent set of exposure and use information for many 

HPV chemical substances. In order to obtain an accurate picture of chemical exposure, it is as 

important for EPA to learn that certain chemical 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 that the influx of inorganic chemical 

substances, coupled with the threshold change for 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 compile, review, and analyze the data submitted. 

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

Response C.2.a: In response to these and comments received during interagency review, 

EPA decided to phase in the eventual elimination of the 300,000 lb threshold as a separate 

reporting threshold. For the 2012 submission period, all submitters of non-excluded chemical 

substances are required to report processing and use information if they manufactured (including 

imported) 100,000 lb or more of a chemical substance 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 same 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 information 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 periods, EPA is better prepared now than it was 

for the 2006 IUR to compile, review, and analyze the anticipated increase of data. With the new 

e-IURweb electronic tool, large amounts of data will 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 (which necessitated phone calls and emails to submitters), and 

manual entry of data, which was time-consuming and resulted in many mistakes. Given the 

requirement for mandatory electronic submissions and the corresponding improvements to the eIURweb tool, the Agency is confident that the increase in IUR data submissions 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 concerned about the increased reporting 

burden, particularly for smaller companies, and the complexity of IUR Form U Part III. One 

commenter pointed out that EPA has not justified such additional reporting requirements and 

should assess those benefits to establish 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 impacts of this requirement to all 

submitters, including potential burden to small businesses, in the Economic Analysis (Ref. 15). 

EPA recognizes that reducing the reporting threshold for processing and 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 all future reporting cycles. 

EPA disagrees that the requirement may have a disproportionate effect on smaller 

companies (commenters suggested that smaller companies 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 (including imported) at a site is not necessarily dependent on the 

number of employees, which is the criteria by which a company is considered to be small. For 

example, a highly automated facility 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 small businesses affected by this final rule actually 

have average sales of more than $11 million, and because any potentially affected companies 

with sales of $0.81 million or less (the level at which the cost-to-sales ratio of the final rule 

would exceed 1%) would generally be exempt from 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 concerns 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 reduction and eventual elimination of 

the 300,000 lb threshold, importers may face an increase in burden to identify more component 

chemical substances contained within imported mixtures. EPA has addressed these concerns with 

modifications to the proposal that will reduce 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 involves reporting on the processing and use of imports occurring in 

2011) and the deferral of the threshold elimination 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 need only be as extensive as a reasonable person, 

similarly situated, might be expected to perform. 

EPA has several reasons to expect that importers 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, are 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 IUR (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 the 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 substances they import. EPA notes 

that one commenter described, in detail, its practice of accounting for component chemical 

substances in imported mixtures. The commenter stated that “[w]ith the advent of the 

[Registration, Evaluation, Authorization and Restriction 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 requirement in the Economic Analysis (Ref. 15). EPA 

recognizes that reducing the reporting threshold for processing and 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 all 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 undergoing testing by customers 

and are not established as full fledged products. 

Source: (0187-0068) 

Response C.2.b-3: Reporting is required for each chemical 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 circumstances, 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 ascertainable by the submitter in 

such circumstances, due to feedback recently received 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 evaluating 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 for all reported chemical substances. Others gave their support, but 

wanted the change to take effect after the next reporting cycle. Another commenter stated that 

this information is generally available, but difficult to collect and compile since it is spread 

through multiple functions, including sales, marketing, supply chain, and manufacturing and 

therefore proposed a tiered reporting time schedule. Other commenters had concerns about the 

value of the information that is reported in Part III. Another commenter felt that EPA should 

provide more specificity on its needs and explain why other, more 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 volume 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 processing and use, making it difficult for EPA to 

collect regular exposure information on many chemical 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 exposures 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 source of basic exposurerelated information for a subset of chemical substances listed on the TSCA Inventory. 

Furthermore, collection of this data is consistent with the Administrator’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 screening 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 more useful exposure-related information 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 subsequent reporting cycles (i.e., eliminating the 

separate, higher, threshold for production and use information) provides EPA with the exposurerelated information needed to continue efforts 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 chemical substances previously identified as 

HPVs were reported in amounts classifying them 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 Chlorobenzenes 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 high 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 Program. Screening chemical risks generally 

requires a combination of both hazard and exposure information. Because most MPV chemical 

substances were produced below the 300,000 lb reporting threshold, EPA did not have exposure 

information available from the 2006 IUR and therefore, developed hazard based prioritizations 

which were supported by a screening level hazard characterization and consideration of very 

limited exposure and use data. The lack of information on exposure and use was especially 

problematic in those instances where the screening level hazard characterization identified either 

a medium or high hazard. Basic hazard data is easier to find in existing 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 threshold for processing and use information in 

2016, EPA is trying to make the reporting requirements under the IUR more consistent with 

those of the TRI program. Under the TRI program, chemical substances of special concern listed 

at 40 CFR section 372.28 (e.g., mercury, lead), are required to be reported 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 the chemical substances on the TRI toxic 

chemical list may be different from those reported under the IUR, an analysis showed that over 

80 percent of the sites that reported under the 2006 IUR also reported under TRI in 2006. Given 

that there is substantial overlap in the companies that report and the information collected on 
28

activities and uses of chemical substances under both programs, EPA believes that companies are 

already accustomed to reporting on lower 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 screening 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 available from the Agency's website. See EPA’s 

archived Chemical Characterization Documents at 

http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML. 

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

the Chemical Action Plans. For some Action Plan chemical substances, the 2006 IUR was not a 

useful source of information. An example is the Action Plan for Dyes Derived from Benzidine 

and Its Congeners, where the chemical substances of concern are 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 been 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 reagents. The Action Plans 

are available on EPA’s web site at 

http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html. 

d. Lack of Data for Chemical Substances 

Comment C.2.d: Several commenters noted that the 2010 reporting year will be over by 

the time the rule is finalized, and companies would not have had the opportunity to establish 

systems for collecting the information for chemical 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 uncertainties 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 report this information to the extent that it is 

known or can be reasonably ascertained. Based on its experience with the New Chemicals 

Program, discussions with industry about voluntary risk management programs, and industry’s 

various self-regulation initiatives, the Agency believes that most submitters have at least some 
29

basic information about downstream uses, such as the information that is required by the IUR 

rule. 

EPA does not anticipate that the quality of the data collected 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 suspend the 2011 submission period to provide sufficient 

time for companies to comply with the updated IUR reporting requirements. This final rule was 

published in advance of the 2012 submission period, which is February 1, 2012 to June 30, 2012. 

For these reasons, companies should have had the opportunity to establish systems for collecting 

the information on their reportable chemical substances. Furthermore, many of the reporting 

elements are the same as in past IUR submission 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. The Agency believes that the data will be of sufficient 

reliability for use by the Agency and others for purposes 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 should be based on a chemical substance's use in 

children’s products, molecular structure, or demonstrated risk. Finally, one commenter 

recommended that the requirement only be imposed 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 needs 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 that numerous chemical substances previously 

identified as HPVs were reported in amounts classifying them 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. This led EPA to believe that the threshold was too high to provide sufficient exposurerelated information on these chemical substances. Additionally, some previously MPV chemical 

substances were reported in amounts that classified them as HPV chemical substances in 2006. 

The 2006 IUR data did not provide sufficient information 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 threshold, EPA did not have exposure information 

available from the 2006 IUR and therefore, developed hazard-based prioritizations which were 

supported by a screening level hazard characterization and consideration of very limited 

exposure and use data. When the screening level hazard characterization for a MPV chemical 

substance indicated that the hazard was low, the magnitude of exposure was generally less 
30

significant for the prioritization. However, when the screening level hazard characterization 

identified either a medium or high hazard, information on the magnitude and type of exposure 

would be essential for a realistic prioritization determination. Basic hazard data is easier to find 

in existing databases; however, specific exposure data is needed to make a priority determination 

risk-based. EPA believes that the lower threshold 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 entities 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 section, EPA has decided to take a phasedin approach to lowering the threshold for reporting processing and use information. EPA agrees 

with a phased-in 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. At the same time, EPA recognizes that submitters 

may not always have detailed information about how the chemical substance(s) they manufacture 

(including import) are used. However, many of the 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 report 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 threshold 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 threshold 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; however, EPA needs processing 

and use data for all chemical substances subject to IUR reporting. Therefore, for the 2016 

submission period and beyond, full reporting of exposure-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 that EPA should phase in the 

requirement for chemical substances manufactured 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 the 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 analyzing 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 reporting processing and use information, the industry 

sector is still inexperienced with Part III reporting and should be given an opportunity to report 

under the existing thresholds before EPA determines that the threshold creates 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 exemptions from reporting information for chemical 

substances manufactured between 25,000 lb and 300,000 lb or that the mining industry should 

receive additional exemptions from reporting processing and use information. Manufacturers of 

inorganic chemicals were notified that they would need to report 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 was subsequently suspended (Ref 1) and is 

superseded in this rule by the 2012 IUR submission 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 period. As discussed above, EPA is taking a 

phased-in approach to lowering the threshold for reporting processing 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 information if they manufactured 

(including imported) 100,000 lb or more of a chemical substance in 2011. Subsequent to the 

2012 submission period, the reporting threshold will be 25,000 lb. 

Inorganic chemical substances may pose hazards and/ or be produced in MPV or HPV 

quantities just as organic chemical substances are, and the manufacturers of inorganic chemical 

substances have been on notice since the 2003 IUR rule amendments that they would no longer 

be treated differently from organic chemical substances 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 for EPA to believe that this data need would 
32

be diminished for inorganic chemical substances. Commenters did not provide additional support 

for the assertion that the 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 the 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 familiar with the reporting requirements, and provides 

much needed processing and use information 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 produced using proprietary processes 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 threshold. TSCA CBI provisions are available and 

are not altered by production volume. 

3. Reduction of 25,000 lb Threshold for Specific 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 commenters suggested eliminating the threshold for 

other priority chemical substances identified on lists created by state, 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 present at any level in mixtures and more Form U 

submissions would be required. Some of these commenters felt that different thresholds for 

subsets of chemical substances added an unnecessary 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 information on chemical substances that are already 

being managed and regulated under TSCA. Some commenters, while generally supporting the 

concept of eliminating reporting thresholds for specific chemical substances subject to certain 

TSCA regulations, felt that many companies would not have sufficient time to prepare this 

information for the 2011 reporting cycle and they requested that implementation of this 

modification be delayed until a later reporting cycle. One commenter recommended that EPA 

convene an Advisory Panel to discuss the modification 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 IUR reporting for the specific regulated chemical 

substances. As a result, EPA is reducing 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 change to the IUR; it will not affect IUR 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 procedures to collect and report the 

required data for situations where the recordkeeping 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 burden associated with this 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 compliance with the rules. The new requirement 

will also contribute to the Administrator’s commitment to increase the availability of chemical 

information to the public.

EPA does not believe that it is necessary to convene an Advisory Panel for this issue. 

Companies are generally aware if they are manufacturing or processing chemical substances 

subject to proposed or promulgated TSCA rules, because many of them would have provided 

comments during a proposed rule comment period or may be keeping 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 requirement will be difficult to meet in 

practice, particularly for imports of mixtures. “The proposal would create a needle-in-a-haystack 

situation in which a company would need to examine all chemical substances and/or mixtures 

imported - regardless of the concentration of the chemical substance or volume of the import - to 

determine if any of the approximately 1,000 regulated chemical substances are present at any 

level.” Importers would have great 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 mixtures 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 other parties that the chemical substance it is importing is subject 

to any regulatory requirement. 

 Source: (0187-0050) (0187-0101) (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 imported products. Consequently, the reporting threshold 

will be 2,500 lb, instead of zero, and will be phased in to begin with 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 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 711.10, 40 CFR 720.30(g) and (h)). Furthermore, companies should be 

accustomed to reporting chemical-specific information to EPA because the Agency has always 

sought information on individual chemical substances 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 regulatory status of the chemical substances he 

or she is importing. If an importer does not know, or can’t reasonably 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 ingredient, and the importer does not otherwise know 

that the ingredient is present, EPA would generally agree that the importer does not know, and 

cannot reasonably ascertain that he or she is importing that ingredient. Therefore, no IUR report 

for that ingredient would be required. In addition, manufacturers and importers 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 ascertainable, but the chemical identity 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 supplier has decided to 

notify them that the chemical import contains a chemical substance regulated 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 into whether an imported chemical substance is 

subject to a TSCA restriction, thereby circumventing any risk protections 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 chemical substance is present in an imported 

mixture; he or she is not required to report the chemical substance under the IUR. However, 

importers of mixtures with constituents of proprietary 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 particular chemical substance 

above the relevant threshold, but does not know the chemical identity because the supplier is 

unwilling to share the chemical identity with the importer, it is sufficient for the importer to 
35

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 UVCB substances (chemical substances that 

are of Unknown or Variable composition, Complex 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 UVCB chemical substance. A mixture is any 

combination of chemicals that meets the statutory definition of “mixture” 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 individual identities and/or 

composition are not precisely or completely known. A UVCB combination of chemicals is 

subject to reporting under IUR and is considered a single chemical substance. Generally, the 

determination of whether a combination of chemicals 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 presented with this generality in mind. 

• If you imported a mixture, you will need to report the individual chemical components of 

the mixture to the extent that your total volume 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 chemical 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 exemptions. If a chemical reaction has not occurred, 

you have not manufactured any reportable chemical 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 also consider whether the combination of 

chemicals they have domestically manufactured 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 nomenclature guidance documents related to the 

mixture-UVCB determination titled: (1) Toxic Substances Control Act Inventory Representation 

For Chemical Substances Of Unknown Or Variable 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 EPA 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 “Chemical 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 “ Instructions for the 2012 TSCA Inventory Update 

Reporting (Ref. 9). This document, which has been 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 issued under section 5(e)or 

5(f) of TSCA; or relief that has been granted under a civil action under sections 5 or 7 of TSCA 

as of March 2011 (see 40 CFR 711.6, and 711.9 and TSCA § 8(a)(3)(A)(ii)). 

Comment C.3.c-2: One commenter noted that EPA should clarify that the reduction in 

reporting threshold for specific regulated chemical substances will not impact new chemical 

polymers and microorganisms that are subject to TSCA Section 5(e) consent 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 the 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 reporting under 40 CFR 711.6(a)(1) and (a)(2), respectively. 

However, that exemption is superseded by the introductory paragraph of 40 CFR 711.6 which 

indicates that a chemical substance described in 40 CFR 711.6(a)(1), (a)(2), (a)(4) or (b) is not 

exempted if that chemical substance is subject to a rule proposed or promulgated under TSCA 

section 4, 5(a)(2), 5(b)(4) or 6, an ECA, a TSCA section 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 Section 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 substances that are subject 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 could receive helpful information from IUR 

reporting. Those who opposed including chemical substances subject to proposed rules felt that 
37

the need for collecting such information 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 change to the IUR; it will 

not affect IUR submissions until the 2016 submission period. 

 The Agency disagrees with the commenter who argued that the change to the 25,000 lb 

reporting threshold (at 40 CFR 711.8(b), promulgated 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 circumstance 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 substance would be under review and because there might be an 

opportunity for a fuller IUR dataset would help inform that analysis and the development of risk 

management actions, EPA believes it is appropriate for the reduction of the 25,000 lb reporting 

threshold to be triggered at rule proposal. Furthermore, those chemical 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 reporting on these chemical substances during the 2016 reporting 

cycle if they are manufactured (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 indicated that it would be difficult to choose an appropriate level to 

decrease the reporting burden while including all chemical substances 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 chemical 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 at 
38

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 reporting 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 health 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 the regulated community should be sufficiently familiar with the 

2,500 lb threshold as it is similar to the threshold that is used under the EU’s REACH regulations 

to submit registration dossiers. Under REACH, a person who manufactures or imports a 

chemical substance in quantities of 1 tonne (metric tonne (mt) or if converted 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 would 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 which 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 with 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 Agency provide an up-to-date list of 

IUR reportable chemical substances, and those ineligible 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 or 
39

greater at a single site during the principal reporting year. Five chemical 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, microorganisms, certain forms of natural gas, 

naturally occurring substances, and water. Refer to 40 CFR 711.6(a) for precise definitions of 

these groups. Submitters should note that, with the exception of naturally occurring substances, 

these chemical substances become ineligible for the 40 CFR 711.6(a) exemption if they are the 

subject of any of the following (i.e., even though the chemical substance would otherwise 

exempt): 

• A rule proposed or promulgated under Sections 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 civil action under TSCA Sections 5 or 7; or 

• An enforceable consent agreement (ECA) under 40 CFR Part 790. 

EPA provides a list entitled “Chemical 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 “Instructions for the 2012 TSCA Inventory Update Reporting” (Ref. 9). Chemical substances 

are listed by CAS Registry Numbers (for non-confidential chemical substances) or by Accession 

Numbers (for confidential chemical substances). This document, which 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 information regarding the status of the 

petitions. The commenters maintain that these 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) were inorganic 

chemical substances (Ref. 22). Prior to the 2006 IUR, inorganic chemical substances were 

exempted, for the most part, from the IUR requirements. Because EPA had not collected 

information on these two chemical substances, the Agency did not have even basic 

manufacturing information and therefore denied the petitions, with the provision that it would 

revisit them once such information was collected. EPA has further considered these petitions, 

and the record of the response 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 manufactured 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 are 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 description 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 commenter also felt that the language in proposed 

40 CFR 711.6(a)(1)(iii) did not adequately capture the current polymer exemption rule 

requirement at 40 CFR 723.250(d)(3) that a polymer must not be reasonably anticipated to 

substantially degrade, decompose, or depolymerize after manufacture and use, even though it is 

not intended to do so. The commenter recommended that EPA modify the language at 40 CFR 

711.6(a)(1)(iii) to read: "This exclusion does not apply to a chemical substance which has been 

substantially hydrolyzed, depolymerized, or chemically modified to the extent that the final 

product is no longer polymeric 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 should 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 exemptions to the IUR. One specifically noted that 

the removal of this exemption would assist in addressing chemical substances of high concern 

for infants and children. 

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

Response D.4-1: EPA appreciates the support and agrees 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 for chemical substances subject to ECA is to 

gather data on chemical substances for which EPA has demonstrated heightened concern, just as 

EPA currently does with chemical substances subject 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 regulatory 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 reporting threshold (in case of a 

section 4 test rule) is to reduce the reporting threshold 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 should make available a current list 

of affected chemical substances if the proposed lowering of reporting 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 published at 40 CFR 799.5000 and 799.5025; new chemical 

substances are added to these lists whenever EPA and at least one other party 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 already 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 processing 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 indicates that EPA has a heightened interest in it 

and a greater need for current manufacturing, processing, use, and exposure data. EPA also 

disagrees with the comment that the circumstances leading EPA to enter into an ECA are 

significantly different than those that would lead EPA to promulgate 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 gather 
42

data that it needs to evaluate the risks posed by the chemical substance under consideration, since 

EPA does not have to publish formal risk or hazard-based findings, or accomplish other 

components of the often lengthy rulemaking process. The use of ECAs is not and was never 

intended to communicate a lower level of concern about a given chemical substance, as 

compared to chemical substances under section 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 substances 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 reporting purposes, and clarifying the meaning of 

"company name." Respecting the clarification, 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 organization. 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 identify 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 clearly identified in the rule, but disagrees that 

"domestic parent company name" is sufficiently specific. As noted in the proposed rule (Ref. 8), 

EPA believes that using an approach that is consistent with the TRI reporting requirements 

would be most clear both for reporters and users 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 States, that directly 

owns at least 50 percent of the 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 Reporting Forms and Instructions (Ref. 23). EPA 

provides further clarification regarding the correct domestic (U.S.) parent company name in the 

“Instructions for the 2012 Inventory 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. Commenters stated that allowing multiple technical 

contacts would afford maximum flexibility for companies to designate who can act as a technical 
43

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 located 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 the 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 multiple 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 EPA may have regarding the submission. EPA has 

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

submission or chemical substance and therefore may 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 standardize 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 would be difficult for an importer to 

require that another party complete a joint submission because foreign suppliers are not subject 

to the same Federal regulations as U.S. companies, 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 required the importer to ensure that 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 to 
44

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 circumstances in which the manufacture of a 

chemical substance is reportable under the IUR, yet the supplier of a reactant used in 

manufacturing that chemical substance would not have an independent legal obligation to report 

the chemical identity of the 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 respecting the identity of a chemical substance subject to reporting. 

The joint submission requirement 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 information to EPA, and explain how to provide a 

clear reference to the primary submission. Documentation of the request to the supplier must be 

submitted to EPA along with the rest 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 chemical identity of a chemical 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 submitter’s competitive 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, electronic 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, the joint submission requirement is 

no longer to ensure that foreign suppliers provide secondary submissions to EPA, but to properly 

ask that they do so. EPA will only accept electronic submissions from foreign suppliers using eIURweb and CDX. For the following reasons, EPA does not expect that the electronic reporting 

requirement will be an insurmountable obstacle 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 and report their proprietary chemical identity information without 

revealing any of the proprietary information to the importer. Furthermore, it should be noted that, 

as part of the electronic reporting process, submitters will be able to easily connect electronically 

from the IUR reporting tool directly to the Agency's SRS database in order to obtain CA Index 

Names and corresponding CASRNs, for all of their 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 electronically copied back to the IUR reporting tool. 
45

The use of the SRS to obtain the chemical identity information for all IUR reportable chemical 

substances will thus be a convenient way to meet 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 the reporting of chemical names for the IUR. 

As stated earlier in this document, EPA will 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, including foreign ones, to gain experience with 

the tool and provide comments as the Agency provides 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 recommended allowing IUPAC names as a substitute for 

CA Index Names for discrete chemical substances, 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 service 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 Names 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 directly related to positively identifying the listed 

TSCA Inventory chemical substance. Using a different nomenclature for the purposes of 

reporting for IUR could create confusion, both for Industry and for EPA. 

Additionally, there will generally be no need for submitters to use a fee-based service to 

obtain the CA Index Name and corresponding CASRN 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 Agency's SRS database in order 

to obtain CA Index Names and corresponding CASRNs, for all of their 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 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, suggesting that the Agency might be inundated with requests for 

Accession Numbers, and that for historical products, this may pose an extra burden for both 

industry and EPA. It was suggested that the Agency provide a cross-reference list of PMN 
46

numbers to Accession Numbers so that the information 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-reference 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 information for confidential chemical substances 

listed on the TSCA Inventory. In the SRS, a submitter 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 Inventory 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 chemical name corresponding to the confidential 

chemical substance intended to be reported.

There are certain circumstances where a submitter occasionally may not be sure of the 

particular PMN case number and Accession Number the Agency has assigned to one of its 

confidential chemical substances, such that the 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 chemical substances. This could also happen if a 

certain PMN represented a mixture of two or more confidential chemical substances, such that 

multiple Accession Numbers were assigned to the different 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 comprising that multi-component type of PMN. In 

such circumstances, a submitter should contact EPA well before initiating IUR reporting, to 

obtain the required Accession Numbers from the Agency. The Agency will respond to such 

inquiries in as timely a manner as possible. It is the responsibility of the submitter to contact the 

Agency for such information in sufficient time to allow for the Agency to respond. Detailed 

instructions on how to submit an Inventory Correspondence 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 collections and reporting of data. Another felt that the 

requirement would keep manufacturers from disguising their actual output by producing certain 

specialty chemical substances only in years that are not currently subject to IUR reporting. 
47

Finally, one commenter stated that because chemical volume information is already being 

collected, analyzed, and made public for investors, it should be utilized by EPA and made 

available to the public in a useful format to ensure the protection of the environment and human 

health. 

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

the additional data and has not demonstrated the 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 reporting 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) (0187-0067) (0187-0101) 

Response E.4.a: EPA is making this change because of the mounting evidence that many 

chemical substances, even larger volume chemical 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 chemical substance manufacturing; to determine the 

effectiveness of various Agency and other programs; to estimate the magnitude of consumer, 

worker, and environmental exposures; and to determine the costs (and financial 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 would allow EPA to identify more consistently 

HPV chemical substances. Voluntary EPA programs such as Design for the Environment (DfE) 

and other pollution prevention programs would use the annual production volume data to 

identify trends and program performance. Relying on a single snapshot of annual production 

volume in each reporting cycle hampers EPA’s ability 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 companies 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 implementation of the reporting requirement until 

the next reporting cycle to allow companies sufficient time to prepare for the additional data 

collection effort. One commenter was concerned that the short period of time given by EPA to 

collect the information will result in significantly decreased data quality and reliability. Another 

commenter said that most companies archive data after 18-24 months. Some found it confusing 

that the threshold to determine the need to report in the 2015 cycle would change to include 
48

production data from previous years, 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) (0187-0092) (0187-0352) (0187-0058) 

 Response E.4.b. EPA acknowledges the possibility that certain information respecting 

past production volume, for the years between 2006 and 2009 might not have been known to or 

reasonably ascertainable to a submitter in 2011. EPA 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 reduce the extent to which submitters 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 the reporting of past production volumes as follows will both 

improve the quality of the information collected and reduce the burden of collecting it. 

 Based on the comments received, EPA is requiring 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 (domestically manufactured and imported volumes in 

pounds) of each reportable chemical substance at each site for each complete calendar year since 

the last principal reporting year are required to be reported. EPA believes its decision to require 

the reporting of 2010 production volumes in the 2012 submission period 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 simultaneous 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 compile the required information. 

c. Reporting Burden 

Comment E.4.c-1: Several commenters stated that the requirement is overly 

burdensome, especially for chemical importers and manufacturers who (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 information would be of little value to the Agency. 

On the other hand, one commenter stated that the 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, commenters 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 misunderstanding of the reporting requirements 

with respect to byproducts. As described elsewhere in this Unit, accounting for the manufacture 

of a byproduct does not necessarily entail accounting 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 additional recordkeeping procedures into 

practice. For additional discussion of the reporting 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 confidential 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 approximately $68,000 in the first reporting year and 

$175,000 in subsequent reporting cycles 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 manufacture (including import) from becoming publicly 

available. 

d. Retroactive Reporting 

Comment E.4.d: Several commenters expressed concerns asserting that EPA 

retroactively is requiring historical data and that the requirement 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 historical data for the many byproducts that 

companies produce and send for recycling, primarily because manufacturers did not know they 

needed to have such data gathering 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’ suggestion that reporting information 

on past production constitutes an imposition of retroactive reporting requirements. This is 

because the final rule does not establish a new legal requirement to have taken some particular 

recordkeeping action in the past. Instead, it holds 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 that 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 are more valuable to the Agency. Examples of 

criteria include chemical substances with a history of fluctuations in chemical manufacture and 

import practices or chemical substances 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 reporting production volume in ranges or estimates 

would provide data of comparable value. Though EPA requires some of the IUR information to 

be reported in specified ranges, EPA sees little 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 all 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 reasonably ascertainable to the submitter. 

EPA disagrees with the suggestion 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 industries 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 provide a definitive list of chemical 

substances with a “known history of fluctuations.” 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 confining that list to 
51

substances with a “history” of fluctuations would not capture the industry variability that EPA is 

seeking. 

It is important to note that EPA is interested in use and other exposure-related data on all 

chemical substances that are not exempted from IUR reporting, and manufacturing exposurerelated data on partially exempted chemical substances. Especially since there is a multi-year gap 

between IUR submission periods, the mere fact that 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, EPA would potentially need to wait several years 

before obtaining the basic exposure information necessary to determine whether a hazardous 

chemical substance may present an unreasonable risk (since the collection of screening-level 

exposure information would not be triggered until hazard data had been assessed). In summary, 

after considering the suggestions, 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 EPA clarify how the responsibility 

will be assigned for reporting chemical substance manufacture and import activities for entities 

that will be acquired or divested. One commenter noted that the current owner of a newly 

acquired facility may not have access to manufacture/import volume information for years before 

they acquired the facility. Another commenter indicated that exemptions should be provided for 

any company engaged in an acquisition or divestiture during the years since 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 the event of a change in ownership (Ref. 9). 

Reporting should be based on ownership of the manufacturing entity, as of the date that the 

report is submitted. EPA acknowledges, in any event, that there will be submitters for whom 

certain information is not known or reasonably ascertainable because of a change in ownership.

If information is not known or reasonably ascertainable, it need not be reported under the IUR. 

EPA is not persuaded that there is a justification to further relax the reporting standard (i.e., 

exempt companies from reporting information that 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 are included in imported product mixtures. One 

commenter stated that the formulations of these 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 year’s total material import record can yield an 

accurate aggregate record of each imported chemical substance. Other commenters said that 

since the same chemical substance can be present in multiple products, all products will need to 
52

be assessed and the volumes totaled to determine if the reporting threshold has been met. 

Another commenter said that many imports are multi-component mixtures and determining 

whether any single chemical substance has been imported at a volume above the threshold for 

reporting requires that every import must be broken down into its component chemical 

substances, the volume of each chemical substance 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 difficult, in certain circumstances, for 

importers to determine the processing and use information for component chemical substances in 

imported products. EPA also notes that the IUR rule does not require importers to report 

information that is not known or reasonably ascertainable to them. However, EPA believes that 

importers are likely already accustomed to reporting chemical-specific information to EPA, 

because the Agency has always sought information on individual chemical substances under the 

IUR and other TSCA regulations. EPA believes that instances where this information is not 

known or reasonably ascertainable will decline substantially for reporting periods subsequent to 

2012 as additional recordkeeping procedures are established. EPA also notes various features of 

the IUR (including features that were modified or clarified based on comment from importers) 

that mitigate importers’ burden to report product 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 stated, it was more informative for screeninglevel risk assessment. Five commenters expressed confusion about the requirements of reporting 

this data element. Specific concerns included a concern about duplicative reporting for this data 

element and the industrial processing and use information for chemical substances used on-site; 

whether this applied to chemical substances used in synthesis or also 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 who felt that reporting volumes of 

chemical substance used at a site will increase 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-site 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 reported under the IUR. Exposure-related data in 
53

PMNs include estimates of production volume, categories of use, percent production volume in 

the categories of use, maximum numbers of workers exposed, and concentrations and physical 

forms of the chemical substance. EPA uses these exposure-related data to generate screeninglevel risk assessments for regulatory decision making under TSCA section 5. The reporting 

obligation and the phrase “site use” applies to all nonexempt chemical substances produced for 

commercial purposes that are on the TSCA inventory. 

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

detailed and clearer information than did the 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 chemical 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 report 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 and 25,000 lb for the volume used on-site. If a 

site imported 30,000 lb and used it at the import 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 chemical substance on-site during a particular time 

period, but rather the amount of a chemical substance that is manufactured (including imported) 

and used at the same site. 

Commenters also asked for clarification regarding the activities considered to be “used at 

the reporting site.” For a domestically manufactured chemical substance, 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 manufactured, temporarily stored, and then packaged for 

shipment off of the site, that volume would not be considered “used at the reporting site.” For an 

imported chemical substance, any use at the importing site, including for repackaging, would be 

considered “used at the reporting site.” 

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

manufactured and used on site will result in duplicative reporting. Even with the previous sitelimited check box, submitters provided information about the use of a chemical substance in both 

the manufacturing and industrial processing and use sections of the IUR Form U. The 

information reported under the manufacturing section identifies that this chemical substance is 

processed or used at that particular site and identifies the number of workers associated with the 

manufacture of that chemical substance. In the same report, the information reported under the 

industrial processing and use section provides more details about how the chemical substance is 

processed or use. In the event that a chemical substance has a use identified by the same 
54

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 requirement stated that these 

additional data will improve the Agency's ability to estimate the portion of the production 

volume that is relevant with respect to associated processing and use information. Those opposed 

questioned the need and utility for this information 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 will 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 chemical 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 warehouse, a processing or use site, or a customer’s site. Therefore, 

identifying whether the chemical substance is physically at the reporting site provides more 

accurate information about who might be potentially 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 deferred 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 regarding 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 utility 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 reporting 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 significantly 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 substance that is directly exported. If the chemical 

substance is processed in any way (e.g., combined with other substances 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 processing to form a mixture or the transfer to a distributor under 

the processing and use portion of the IUR reporting form. “Directly Exported” and 

“Domestically Processed or Used” are mutually exclusive designations; only one designation 

applies to any particular portion of the production volume. 

EPA’s proposal to make the production volume 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 that it is necessary or desirable 

to delay implementation of this reporting requirement 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 consider 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” should be considered a use of a 

chemical substance. Under the IUR rule, industrial use is defined as “use at a site at which one or 

more chemical substances or mixtures are manufactured (including imported) or processed.” 

Information reported in Part III of IUR Form U pertains 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 understand the distribution of the total volume of the chemical substance 

in commerce. 

Comment E.7-3: One commenter stated that they manufacture chemical substances that 

are formulated into consumer products prior to distribution across North America (including US, 

Canada, and Mexico). The commenter believes the IUR proposal is unclear as to whether a 

manufactured chemical substance that undergoes 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 substance is processed in any way (e.g., combined with other chemical 

substances to form a mixture), the chemical substance 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, the manufacturer would instead report either the 

processing to form a mixture or the transfer to a distributor under the processing and use portion 

of the IUR reporting form. In other words, a chemical substance that is directly exported is not 

domestically processed or used, and therefore such volumes should be reported either as directly 

exported or as processed or used (not both). 

8. Identify Whether A Chemical Substance 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 substance was or is expected to be recycled, 

including remanufactured, reprocessed, 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 other 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 recycle 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 would 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 reworked, intending to capture a broad array of 

similar, and perhaps synonymous, activities by which a chemical 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 recycling 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 occurring, and could be used to recognize companies, industries, and sectors 

that are using “green” practices. This information would also help to identify sectors where 

recycling is not occurring, providing useful data to measure the effectiveness of various EPA 

programs, such as the Resource Conservation Challenge (RCC) Program, and informing other 
57

Agency efforts to encourage practices that reduce waste. EPA disagrees that a precise definition 

of “recycle” is needed to make this data element useful for the 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 substance that they manufactured, 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 processes, 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 interpreted 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 that revealing whether a chemical 

substance they manufactured was recycled would reveal sensitive intellectual 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 element would be extremely 

inefficient and needlessly time-consuming for both 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 comments 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, route, and duration of exposure to chemical substances during 

manufacture, processing, and use of the chemical substances. This type of information is 

necessary for state pollution prevention technical assistance programs to help evaluate pollution 

prevention opportunities and reduced worker exposures. 

Other commenters said it would require additional effort by the regulated community to 

assign the new codes, and a clear explanation of the changes with the reporting instructions, e.g., 

a “read across” of old and new codes. Assigning new codes would also 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 function categories (IFCs), and industrial sector 

(IS) categories. In selecting the proper IFC, submitters must determine for each reportable 

chemical substance which IFC best represents the 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 United States and Canada for IUR reporting. EPA 

agrees with commenters who felt that harmonization of the categories for reporting the industrial 

functions of chemical substances would facilitate the exchange of information between EPA and 

Canadian agencies In addition, the harmonized categories would facilitate consistent reporting of 

chemical substance use information by industry in the United States and Canada. 

EPA agrees with the commenters that a table indicating the relationship between the 2006 

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

code. The “Instructions for the 2012 TSCA Inventory 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 concern for including the “U999 Other” IFC code. 

EPA will require submitters to choose from among 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 burdensome than for the other IFC codes, but expects 

any increase to be minor. The descriptive information is essential to enable users of the data to 
59

estimate potential exposures associated with the overall processing or use of the chemical 

substance, of which the function is an important 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 desire is to limit the number of scenarios 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 IFC codes in the future, including 

those applicable to inorganic chemical substances. 

Comment E.10.a-2: One commenter cited unclear definitions of "industrial," 

"commercial," "function," and "use," and referred 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 intended physical or chemical 

characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated 

into a formulation, mixture, reaction product, or article; 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 collaboratively 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 chemical 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 reporting entities and on the Agency. 

Source: (0187-0074) 

Response E.10.a-3: EPA disagrees with the suggestion 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 functions. 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 substances 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 digit NAICS code with a new code 

to describe the industrial setting. Commenters in favor of IS codes noted that using harmonized 
60

codes will provide the Agency with a better understanding of how chemical substances are used 

in downstream products and would help facilitate 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 that harmonizing codes was essential to eliminating 

the extensive non-reporting or use of an unspecified "other" designation in the last IUR reporting 

cycle. One commenter suggested that EPA harmonize 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 classification system with which industry and regulators are most familiar, 

and in some cases, the IS codes are less descriptive than the NAICS codes. Others felt that 

replacement of NAICS codes with IS codes is occurring 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 chemical 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 that 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 providing 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 known NAICS codes. The “Instructions for the 2012 

TSCA Inventory Update Reporting (Ref. 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 new 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. The sectors were adapted from the 

EU’s ‘‘Guidance on information requirements and chemical safety assessment.’’ EPA evaluated 

reporting under the 2006 IUR and EU’s use code descriptions 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 the technical support 

document discussing the replacement of the NAICS Codes (Ref. 24). In developing the IS 

codes, EPA considered the level of detail required 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 scenarios that could be 

reported. Although not all of the NAICS codes are applicable to chemical substance 

manufacturing and processing, the 2006 IUR database has over 2,300 unique combinations of 

P/U, NAICS, and IFC. Many of the NAICS codes reported are from similar industries that would 

have similar exposure scenarios. 
61

 EPA agrees that the new IS codes are less descriptive 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 data for screening-level purposes. The large number of unique 

combinations increases the difficulty and time required to sort and classify chemical substances 

since EPA would either need to develop exposure 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. Additionally, the IS codes will more closely align 

to the EU Sector of Use codes which will allow EPA 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 correspond 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 disagrees that a partial exemption from IUR is 

needed for chemical substances that are regulated by the FDA. TSCA already excludes from the 

definition of "chemical substance" those chemical substances that are, inter alia, regulated under 

the Federal Food Drug and Cosmetics Act. Chemical substances that are food, food additives, 

drugs, or cosmetics covered by that 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 chemical substance's production volume is made for 

uses other than those that are excluded from the definition of "chemical substance," that portion 

is covered by TSCA and, unless otherwise exempted, 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 harmonized codes will (1) provide the Agency with a 

better understanding of how chemical substances are used in downstream products and would 

help facilitate consistent reporting of chemical use information in the U.S. and Canada and (2) is 

essential to eliminating the extensive non-reporting or use of an unspecified "other" designation 

in the last IUR reporting cycle. Some commenters stated that providing a description for the 

product category “Other” will be challenging in practice and may not provide useful information, 

end-use type applications, and all employees 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 commercial 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 partners of ACC who have 

committed to the Responsible Care initiative, have 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 initiative, 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 the 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 control their customers’ sites. The Agency believes 

that most submitters know (or can reasonably ascertain) 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 Canadian 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 rule were required to report the industrial and 

consumer/commercial product categories in which their chemical substances 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 descriptive information in the “Instructions for the 2012 

TSCA Inventory Update Reporting” (Ref. 9). 

EPA recognizes that the requirement to report a description when the submitter selects 

the product code “Other” may be more burdensome than for the other product codes, but expects 

any increase to be minor. The descriptive information is essential to enable users of the data to 

estimate potential exposures associated 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 regarding the need to designate 

whether the indicated product category is consumer use, commercial use, or both. A commenter 

in favor stated that the proposed modifications would increase the utility and specificity of the 

reporting information, reduce confusion, and increase ease of reporting, while also facilitating 

harmonization of reported information across North America. Those opposed said that (1) 
63

providing a description for the product 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 supply 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 chemical 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. However, 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 customers’ sites, and can report this information based on what is known 

to or reasonably ascertainable by the submitter. 

EPA also recognizes the concern for including the “C909 Other” commercial and 

consumer use category. 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 Canadian agencies and the reporting of 

chemical substance use information by industry 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 scenarios 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 information, 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 sharing such data with suppliers could divulge elements of trade 

secrecy, proprietary technology, or sensitive business information related to product uses, 

markets, market size, or processing technology. It was suggested that the Agency rely on worker 

statistics from the Bureau of Labor Statistics as it conducts risk assessments, or gather additional 

data under a separate TSCA Section 8(a) rule. 

Source: (0187-0091) 
64

Response E.11.c: EPA is requiring this information to better assess the size of the 

commercial population in screening risk assessments. In the past, the Agency has used the 

Bureau of Labor Statistics for general workers statistics to conduct chemical-specific risk 

assessments; however, these worker statistics, which are industry-specific, overestimate the 

exposures associated with a chemical substance because a chemical substance is likely to be used 

by only a portion of the industry. Identifying chemical-specific worker populations for 

downstream activities will fill this gap for the Agency. The knowledge of a chemical substance’s 

uses in industry and the respective commercial population 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 manufacturer generally has a certain awareness of the 

downstream uses of chemical substances it manufactures and sells, even if it does not control its 

customers’ sites. Based on its experience with 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 industrial 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 her 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 screening-level risk assessments and prioritization. 

EPA recognizes the industry’s concern in reporting 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 number of commercial workers may designate the 

information as confidential. However, EPA does 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 Clarification Requests

1. Changing the Reporting Standard for Processing 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 Instructions) of the scope of pre-reporting inquiry that would be 

required under the “known to or reasonably ascertainable by” reporting standard. Specifically, 

the commenters requested further clarification of how this reporting 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 expressed some confusion about how this standard 

would differ from the “readily obtainable standard,” previously applicable to such reporting, and 
65

whether the change of standard indicates that “extensive file searches and customer surveys” 

would now be expected of submitters. Other commenters from the chemical industry expressed 

their understanding that the change in reporting standard only altered the level 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 does 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 employees 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), without confining its inquiry solely to what is 

known to managerial and supervisory employees, but would also be expected to review other 

information which the manufacturer (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 requires that submitters conduct a reasonable inquiry 

within the full scope of their organization (not just the information known to managerial or 

supervisory employees). The inquiry would be as extensive as a reasonable person, similarly 

situated, might be expected to perform within 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 after a reasonable inquiry within the organization. The standard 

does not necessarily require that the manufacturer conduct an exhaustive survey of all 

employees. 

EPA agrees that further clarification would be useful regarding what is “reasonably 

ascertainable” to submitters about processing and use information because this component of the 

reporting standard potentially may require submitters to obtain information 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 industry commenters (e.g., the expense and burden 

of surveying customers, and uncertainty as to the extent to which customers will respond to such 

surveys), EPA agrees that if particular information cannot be derived or reasonably estimated 

without conducting further customer surveys (i.e., without sending a comprehensive set of 
66

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 reasonable 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” standard may entail inquiries 

outside the organization to fill gaps in the submitter’s knowledge. Further examples of actions 

that would meet the “known to or reasonably ascertainable by” reporting standard are provided 

in Response F.1-2. 

Comment F.1-2: A few commenters requested that EPA 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 the 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, EPA does not anticipate that the IUR 

will require manufacturers to survey customers. If particular information cannot be derived or 

reasonably estimated from the information available to the company without conducting further 

customer surveys, it would not be “reasonably ascertainable” 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” information includes, but is not limited to, 

information that may be possessed by employees or other agents of the company reporting under 

the IUR rule, including persons involved in the research, development, manufacturing or 

marketing of a chemical substance and includes knowledge gained through discussions, 

symposia, and technical publications. The standard 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, such 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 application of the “known 

to or reasonably ascertainable standard,” in the specific context 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 analysis of a submitter’s particular circumstances: 

Company XYZ discovers that it has no knowledge of how a particular reportable 

chemical substance (Substance #1) is processed or used by its customers. Company XYZ 

usually maintains marketing data documenting customers’ use of its chemicals, in line with the 
67

reasonable business practices typical of comparable manufacturers, but it irrevocably lost these 

data for Substance #1 due to an inadvertent computer malfunction. Company XYZ has many 

customers, but it expects that it could substantially reconstruct this missing information by 

briefly contacting its largest customer 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. 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 XYZ has never maintained information 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 information 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 information contained in the web site. Company XYZ 

has likely fulfilled its duties under the reporting 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). Comparable manufacturers typically only maintain 

such data on an annual basis, 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 could substantially reconstruct the missing summer 

marketing data by contacting its largest customer and asking the customer what it used or 

processed Substance #3 for in the past summer. Nevertheless, instead of attempting to 

reconstruct the summer data in this manner, Company ABC reports on the basis of the 

processing and use data that it already knows (regarding the winter, spring, and 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 standard 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 information 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 information 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 how Substance #4 is processed and used, but that 

customer is unwilling to supply this information. 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 use information outside of the submitter’s direct 
68

control. Other commenters objected to the standard’s reference to what a reasonable person 

similarly situated “might” be expected to possess, 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 excessively vague. The standard is set forth in EPA’s statutory authority 

to collect information under Section 8(a) of TSCA, and EPA’s definition is consistent with 

Congressional intent to establish an objective standard: “The conferees intend that the 

‘reasonably ascertainable’ standard be an objective rather than a subjective one. Thus, the 

manufacturer or processor must provide information of which a reasonable person similarly 

situated might be expected to have knowledge” (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 appropriate to define the standard consistently for all persons 

reporting under Section 8(a) of TSCA, and that the existing definition appropriately reflects 

Congressional intent. Finally, EPA does not think 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 aspects of the information collection other than 

processing and use information. 

Comment F.1-4: A number of persons questioned EPA’s rationale to propose changing 

the reporting standard for processing 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. Others suggested that confusion about the scope of 

reporting obligations, but not the “readily obtainable” standard itself, was responsible for the low 

levels of processing and use information provided 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) (0187-0067) (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 the industrial processing and use of the chemical 

substances they manufactured or imported and only 3% contained complete information on 

processing and use of their chemical substances. Although the information collected was very 

useful, EPA believes more complete information is needed to support regulatory decisions and 

the decisions would be fairer to the regulated community if the completeness of the information 

were improved. 

The standard set forth in Section 8(a) of TSCA, which authorizes the IUR data collection, 

is that EPA may require information to be provided to the extent that it is known to or reasonably 
69

ascertainable by the person reporting the IUR data. Although the lesser standard of “readily 

obtainable” applies to the collection 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 effective in obtaining information needed to assess 

new chemical substances. The effectiveness of this standard in the new chemical substances 

context derives not from the circumstances in which 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 “management and supervisory employees of the 

submitter” (Ref. 7, 68 FR at 879). None of the purported distinctions between IUR and PMN 

reporting cited by the commenters led EPA to conclude 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 different 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 confronting those challenges. Finally, EPA does not 

have a basis to assume, as one commenter suggested, that existing chemical substances are of 

inherently lesser concern than new chemical substances—many thousands of chemical 

substances were included in the initial compilation of the TSCA Inventory, which did not include 

a review process similar to the PMN review process. Consequently, EPA may know much less 

about these “grandfathered” chemical substances than it does about chemical substances that 

have since been added to the TSCA Inventory 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 obligations for the 2006 IUR were clearly defined by 

regulation at 40 CFR 710.43 and further explained in the 2006 IUR 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 Instructions. Few, if any, persons reporting IUR 

information in 2006 had any difficulty in distinguishing the 300,000 lb threshold which required 

reporting of industrial processing and use information, or that imported chemical substances 

were to be included in manufactured volumes. Rather, it appeared to EPA that the 

incompleteness in the reported data arose from application of the lesser 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 those representing chemical substance 

processors and distributors, expressed concern that moving from a “readily obtainable” (RO) to a 

“known or reasonably ascertainable” (KRA) standard would have an adverse effect on the 

quality of data reported under the IUR. These persons were concerned that under the new 

standard, manufacturers will begin reporting unreliable processing and use information based on 
70

“best guesses,” whereas the manufacturers previously would have simply stated that the 

information was “not readily obtainable” (NRO). In contrast, commenters representing 

environmental and pollution prevention interests 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 collected 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 reporting standard from RO to KRA 

will improve the completeness of the information reported. As noted in the proposal for 

modification of this regulation (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. Under the KRA standard, it is expected that the 

person responsible for the IUR submission will collect or direct the 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 estimates of data, are unavailable after a 

reasonable inquiry. Neither, as a general matter, does the standard require 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 estimates 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 reporting standard is provided in the “Instructions 

for the 2012 TSCA Inventory Update Reporting” (Ref. 9). Because the IUR now requires a more 

thorough search for processing and use information, 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 further characterization of the burden 

and expected benefits of switching from the “readily obtainable” to the “known or reasonably 

ascertainable” standard was needed. Commenters noted that while KRA is not itself a novel 

reporting standard for the IUR, the RO standard for the processing and use information was 

introduced at the same time as the underlying obligation to report processing use information 

under the IUR. Thus, they suggest that the additional burden of reporting processing and use 

information under the KRA standard has not yet been adequately evaluated. The commenters 

also expressed their expectation that manufacturers’ efforts to embark 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) (0187-0101) (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 Economic 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 standard requires an economic analysis of the 

expected burdens and benefits of manufacturers surveying their customers. While manufacturers 

may be required to report processing and use data based on customer surveys they have already 

performed, EPA does not anticipate that the IUR will trigger any obligation to conduct such 

surveys. See Response F.1-1. EPA need not incorporate 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 information, the change in reporting 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 standard, 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 reporting 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 also encompasses information that is not 

known, but is nevertheless reasonably ascertainable. 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 what a reasonable person similarly situated might be expected to 

possess, control, or know, it already addresses context-specific considerations, such as the 

amount of time available to the submitter for preparatory inquiry. Because the standard already 

addresses context-specific timing considerations, EPA does not believe those same timing 

considerations can be considered as grounds for delaying implementation of the standard. 
72

Comment F.1-8: Several commenters expressed concern that additional material 

reportable under the KRA standard, 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 asserting 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 are 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 based on harm to a customer's competitive position. 

Furthermore, EPA has modified the substantiation question at 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.” If a submitter believes that particular processing and use information is 

not publicly known from any source 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 and use information for inorganic chemical 

substances. The commenter noted that EPA’s factual basis for changing reporting standards was 

based on the level of processing and use information provided in the 2006 IUR for organic 

chemical substances (inorganic chemical substances were exempted from reporting obligations 

for processing and use information in that year). 

Source: (0187-0354) 

Response F.1-9: EPA acknowledges that previous years’ 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 “readily obtainable” standard, would be any more complete than 

past IUR reporting of organic chemical substances under that standard. Furthermore, the impact 

of the basic structural framework of the RO standard (e.g., limitation of reporting to what is 

already known, limitation of inquiry to managerial and supervisory employees) is likely to be 

independent of the particular type of chemical substance being 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 electronically via e-IURweb and CDX. 

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

Response F.2-1: EPA understands the concerns regarding the reporting of proprietary 

chemical substances requiring joint submissions with foreign suppliers. The reporting tool was 
73

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 inadvertently being made 

viewable to any unauthorized personnel. Additional details on submitting a joint report is 

provided in the “Instructions for the 2012 TSCA Inventory Update Reporting” (Ref. 9). 

Comment F.2-2: One commenter stated that they have no contractual means to require 

foreign suppliers of already purchased 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 required the importer to ensure that 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 circumstances in which the manufacture of a 

chemical substance is reportable under the IUR, yet the supplier of a reactant used in 

manufacturing that chemical substance would not have an independent legal obligation to report 

the chemical identity of the 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 respecting the identity of a chemical substance subject to reporting. 

The joint submission requirement 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 information to EPA, and explain how to provide a 

clear reference to the primary submission. Documentation of the request to the supplier must be 

submitted to EPA along with the rest 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 the submitter. In the event that a manufacturer 

(including importer) actually knows the chemical identity of a chemical 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 submitter’s competitive position “or to your supplier’s 

competitive position.” 

3. Clarifications to Byproduct Reporting 

a. General Comments on Byproducts 
74

Comment F.3.a-1: One commenter stated that EPA has wrongly interpreted the act of 

finding a useful purpose for what would otherwise be a waste product, otherwise known as 

recycling, as somehow changing and transforming 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 purposes depends on the circumstances by which it came into 

being. See 40 CFR 704.3. The particular commercial purposes to which a byproduct may be put 

after it comes into being (e.g., recycling) are irrelevant to whether 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 exercise 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 with concluding that a chemical 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 during the manufacture, processing, use, 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 substance or mixture. Such byproducts and impurities 

may, or may not, in themselves have commercial 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 commercial 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 activities for which reporting is not required. Some 

recycling activities may affect the byproduct manufacturer’s eligibility for the reporting 

exemption at 40 CFR 711.10(c). 

Comment F.3.a-2: Another commenter cited inequity with imported byproducts 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 (like any other manufacturers of metal scrap) may 
75

potentially avail themselves of byproduct reporting 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 believes the distinction between importers’ and 

recyclers’ reporting responsibilities is clear. 

Comment F.3.a-3: Regarding the general public’s risk of exposure to byproducts, one 

commenter from the metals industry indicated that, when byproducts are to be further processed 

for recovery of chemical components, such byproducts are essentially non-isolated intermediates, 

with a very limited potential for 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. Another commenter stated that reporting 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 byproducts, 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 typically shipped to other sites engaged in the 

production of those other metals, and where the other sites may extract the metal in a manner that 

changes its chemical form somewhat. The commenter 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 the 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 exemption 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 intermediates. 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 manufactured. Byproducts, like many other chemical 

substances, often are accumulated, leave their manufacturing or processing equipment, and are 

shipped off the manufacturing site. In the rare situation when a byproduct is an actual nonisolated intermediate, the reporting requirements associated with non-isolated intermediates 

would apply. 

Byproducts that are shipped from the manufacturing site to a processing site such as a 

recycler would have similar exposure scenarios to any other chemical substance that is in a 

similar physical form and shipped from a manufacturing 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, processing, or use of such chemical substances. 

Comment F.3.a-4: One commenter noted that, at the outset of the Draft Q&A Document 

(Ref. 26), EPA indicates that the document “does not establish any legal obligations beyond 

those that already exist pursuant to TSCA and its implementing regulations.” This commenter 
76

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 providing an opportunity to comment on the guidance 

document in parallel to a rulemaking proceeding on a separate binding regulation. 

Source: (0187-0354) 

Response F.3.a-4: Consistent with the disclaimer language quoted, the purpose of the 

Agency’s guidance documents is to articulate EPA’s interpretation of the applicable regulations 

and to assist industry in understanding the scope of potential reporting obligations under the IUR 

rule.

b. Concern that New Byproduct Reporting Requirements are Being Added

Comment F.3.b-1: In general, some commenters asserted that EPA’s explanation of the 

IUR’s byproduct-related reporting requirements reflect new requirements, inconsistent with 

current byproduct exemptions. To one commenter, the Agency is attempting to make a 

significant change without invoking appropriate rulemaking procedures, which the commenter 

states is fundamentally unfair to the regulated community and does a disservice to the broader 

objectives of EPA concerning recycling. Commenters indicated that the guidance document 

offers interpretations that are confusing, using new principles that have no basis in the history of 

TSCA IUR regulations and that this restrictive interpretation of the exemption as it applied to 

recycled chemical substances did not exist prior to 2006 IUR. 

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

Response F.3.b-1: EPA is clarifying, not enlarging, the reporting requirements for 

byproducts, which have been in place for decades. The definitions of “Byproduct” and 

“Manufacture for commercial purposes” (referencing byproducts) at 40 CFR 704.3 have been in 

place since 1983 (Ref. 27) and have been applicable to the IUR since the IUR’s inception in 

1986. See 51 FR at 21447 (incorporating definitions from 40 CFR 704.3) (Ref. 28). The 

reporting exemptions for byproducts at 40 CFR 720.30(g) and (h)) (cross referenced 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 portion of the revised definition (providing that manufacture 

includes “the extraction, for commercial purposes, of a component chemical substance from a 

previously existing chemical substance or complex combination of chemical substances”) is 

consolidated from materially identical language found 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 exemption for the manufacture of byproducts is only potentially 

applicable to the manufacture of the byproduct and would in no case apply to the manufacture of 

component chemical substances extracted 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 and the chemical substance extracted from the 

byproduct are distinct chemical substances, neither the manufacture of the byproduct nor the 

manufacture of the extracted chemical substance 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 past guidance issued in connection with the IUR 

and TSCA New Chemicals Program. For example: In a 2002 response to public comments on a 

previous proposed amendment to the TSCA Inventory Update Rule (Ref. 7), EPA explained that 

“distillation, extraction, refining, 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 aluminum from aluminum dross 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 (Ref. 32). In 2008, EPA provided similar guidance 

by letter to IPC, another trade group (Ref. 33). 

Due to the 2003 expansion of the IUR reporting requirements to inorganic chemical 

substances, many companies have recently become aware of their status as chemical 

manufacturers when they recycle their waste materials. 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 may 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 returns a waste to commerce. However, many recycling activities fit 

the TSCA and IUR rule definition of manufacture, and are likely to be considered “manufacture 

for a commercial purpose.” EPA has finalized the draft IUR guidance documents that were 

published with the proposed rule. These documents 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 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 F.3.b-2: As a result of questions received during the 2006 IUR submission 

period, EPA identified the need for specific guidance regarding byproduct chemical substances. 

As described in the preamble to the proposed rule, EPA drafted such guidance and will make it 

available for the 2012 IUR. In addition, EPA has met with various industry representatives and 

associated groups to help ensure that those potentially subject to the IUR are educated as to the 

requirements of the rule. 
78

Although the need to report for 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 may be byproduct manufacturers that 

remain unsure of their reporting obligations under the IUR. In particular, the Agency recognizes 

that this may be an issue for those byproduct manufacturers who recycle byproducts by sending 

them off-site to a recycler. The Agency is committed to helping byproduct manufacturers report 

according to the IUR requirements and views the 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 training specific to byproduct reporting and to make 

available Agency personnel to answer questions on an individual basis. 

EPA also intends to continue to work with 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 products. 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 intent 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 Congressional intent regarding the interpretation of manufacture “for 

commercial purposes,” in TSCA section 5(i). The legislative history provides that this term is not 

restricted to only chemical substances manufactured or process “for sale.” The 1976 House 

Committee Report states that “By the use of the term ‘for commercial purposes’ the Committee 

does not intend to restrict coverage to chemical substances manufactured or processed ‘for sale’. 

Any commercial purpose, such as use as a chemical intermediate in a manufacturing process, is 

sufficient to bring the manufacturing 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 regulations at 40 CFR 704.3 

reflect the Agency’s longstanding view that byproducts, because they are part of the manufacture 

of another chemical product for a commercial purpose, are themselves manufactured for 

commercial purpose, irrespective of their inherent commercial value. 

c. Identity of Byproduct Chemical Substances 

Comment F.3.c: Commenters expressed concern with the need to definitively identify 

their byproduct chemical substances, especially those that are a potentially fluctuating mixture of 

chemical substances or for which the byproduct manufacturer may not know the exact 

composition of the byproduct produced. A commenter stated that it would need to initial 
79

thousands of requests for new CASRNs, noting that 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 specific or detailed information on 

the individual components of the by-product mixture, much less the volumes of each 

component.” One commenter noted that the amount of resources and time to identify, 

characterize, and report these byproduct streams can, in some instances, outweigh the economic 

benefit to recycle or reclaim the chemical substances. 

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

Response F.3.c: The comments reflect a misperception that 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 chemical 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 composition of chemical substances. In this way, 

the chemical identity of a byproduct may represent 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 description itself indicates that the proper identification of such a 

reaction product is as a UVCB chemical substance (Ref. 19). As stated in EPA’s on-line 

guidance, “Each combination of chemical substances resulting from a reaction is considered by 

the Agency to be either (1) a mixture, composed 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 collectively 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 from a chemical reaction is considered a mixture 

provided that all of the component product chemical substances are unambiguously identified 

and are represented as forming each time the reaction is run.” 

Approximately one third of the chemical substances included on the TSCA Inventory are 

UVCB chemical substances. UVCB chemical substances in some cases include a TSCA 

Inventory definition to further describe the chemical substance. Here are some examples of 

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

Dust, iron-ore, sinter 

CASRN 69012-53-9 

Definition: Dust generated during the making, breaking and handling of sinter which is 

recovered through the use of pollution 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 reported 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 would 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 stewardship of potential chemical substance risks, EPA 

believes that chemical substance manufacturers, processors, and users should know and 

understand the identities of chemical substances they handle.

d. Determining When a Byproduct Is Manufactured 

Comment F.3.d-1: Commenters stated that clarification 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, regardless of the method of 

purification. Commenters referenced 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 purification of a chemical mixture, without any chemical synthesis 

and (b) amend the definition of “manufacture” to add language concerning extraction of a 

previously existing substance. Considering TSCA 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 distillation of a reaction solvent for reuse in a given process. If such 

a solvent does not undergo any chemical change, but only becomes 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 any change in its chemical identity. Such an 

expansion in the scope of the definition of “manufacture” would constitute a very substantial 

change in reporting requirements 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 dissociate in solution to form metal ions, the 

removal of this ion (which is in reality a component of the byproduct) is not recognized as valid 

“extraction” activity under the exemption. This commenter indicated that such an interpretation 
81

represents the Agency’s attempt to narrow the scope of the commercial byproduct exemption to 

the greatest degree possible. 

Another commenter noted that providing information on byproducts produced in some 

sectors would be essentially impossible, providing these examples: "when metals are reclaimed 

from secondary materials of mining and manufacturing 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 considered 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 Sections 5 and 8(a) clarify the 

statutory definition of “manufacture” by defining “manufacturer” to include persons who extract 

a chemical substance from another chemical substance or mixture of chemical substances. 

“Manufacturer” means a person who imports, produces, or manufactures a chemical substance. 

A person who extracts a component chemical substance 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 regarding the differences between purification and 

extraction appears to concern whether extraction or purification involves a change in chemical 

identity; the potential for a change in chemical identity is closely linked with the proper 

identification of the manufactured chemical substance, as described in the previous comment 

response. As described in response F.3.c, byproducts are typically identified for TSCA reporting 

and Inventory purposes as complex chemical substances or process streams having chemical 

names that best describe the typically indefinite compositions of the byproducts in somewhat 

generic single substance names (i.e., UVCB names). The extraction of component chemical 

substances from certain complex byproduct mixtures or process streams, such as UVCB 

chemical substances, is not considered purification, 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 solvent A, finished product, unreacted reactants, 

individual byproduct chemical substances, and other 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 case, 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 extraction 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 extracted solvent A is nevertheless reportable for 

purposes of IUR. 
82

As another example, tall oil is a byproduct from the pulping of pine trees representing a 

complex combination which is composed of numerous 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 composition of the tall oil 

could be influenced by the climate and local terrain. This byproduct, tall oil, is used as the 

feedstock for fractional distillation, 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 chemical 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% purity and it is correctly 

identified as that discrete chemical substance (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 recyclable 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 processes, 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 manufactured in the course of machining the metal 

articles. There is the potential need for IUR reporting of aluminum if someone, for example, was 

to melt down the chips into another 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 the 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 likely activity, if the aluminum chips were to be 

used directly as a chemical feedstock for manufacturing 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 Reporting 
83

Comment F.3.e-1: Commenters also argued that there would be duplicative reporting by 

the byproduct manufacturer and the recycler/processor who extracted a component chemical 

substance from the byproduct mixture. 

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

Response F.3.e-1: EPA does not agree that such reporting 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 they chemically manufacture from the byproduct. 

Generally, reporting will fall into one of following 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 substance manufactured from the UVCB byproduct is 

distinct from any chemical substance present in the 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 duplication of reporting between 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 users should know and understand the identities of 

chemical substances they handle. 

Comment F.3.e-2: Some commenters stated that double 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 commenters stated that many 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 substance (i.e., that if Nickel (II) hydroxide 

(Ni(OH)2) is present in a byproduct mixture, then the elemental chemical substance Nickel (Ni) 

should be considered the component chemical substance). 

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

Response F.3.e-2: EPA disagrees that reporting both the byproduct chemical substance 

and the extracted elemental metal are duplicative. Although the commenter stated that many 

byproduct mixtures in the metals industry are processed to recover “the metal values,” which is 

somewhat of a generic term, the IUR requires reporting 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 metal 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 is 
84

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 component 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 pertaining to manufacture of a 

chemical substance need only be reported to the extent that the information is known to or 

reasonably ascertainable by the submitter. 

A second example of a metal-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 substance 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 exempted from reporting (but the copper sulfate is 

subject to reporting). On the other 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, copper-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 should not be reported as copper sulfate (or as copper) and sulfuric 

acid). 

Comment F.3.e-3: Commenters stated that raw materials that are recovered from 

byproduct streams for reuse in the same chemical 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 and reused in a process may be counted multiple times, especially 

when they have already been accounted for by the 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 solvent 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 the amount of resources and time to identify, 

characterize, and report these streams may outweigh the economic benefit to recycle or reclaim 

the chemical substances. The commenter was concerned that the Agency’s efforts to provide 

increased transparency to the public may unfairly and inappropriately stigmatizes a manufacturer 

by making it appear to be a manufacturer of large volumes of chemical substances, when it is 

actually using good environmental and economic practices associated with the reuse of raw 

materials. The commenter also noted that this can unnecessarily cause that manufacturer to the 
85

subject to HPV testing as well as section 4 test rules and section 8(a)PAIR reporting, potentially 

resulting in the manufacturer being subject to these additional 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 repetitive counting of chemical substances regenerated from a 

byproduct in cyclical manufacturing process. Cyclical or looping processes either extract or 

manufacture chemical substances from other chemical substances during each cycle, thereby 

introducing the desired recovered chemical substances back into commerce during each cycle or 

loop. The situation where a chemical substance is separated from a complex, unknown and 

variable composition substance (a.k.a., a UVCB chemical substance) – even if that separated 

chemical substance is one of the raw materials to the manufacturing process – is manufacturing 

and, because it is used as a feedstock, is manufactured 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 chemical substance (i.e., the raw 

material that is separated from the chemical substance) is considered to be manufactured and 

therefore potentially reportable. 

For example, EPA has been presented with the following scenario: An excess of reactant 

A is mixed with reactant B, to form a mixture of product C and excess reactant A. The unreacted 

A and product C (along with possibly some byproducts) are separated in a distillation column, 

with reactant A being returned to the process. 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 substance is not isolated, and therefore can be 

considered a non-isolated intermediate. A distillation column is used to separate (or extract) the 

unreacted A from the manufactured chemical substance. The resulting reactant A is used for 

commercial purposes (as a feedstock), and therefore is subject to IUR reporting (assuming other 

requirements, such as production volume, are met). Product C is also manufactured (and subject 

to reporting). Note that the UVCB chemical substance resulting from the reactor may need to be 

reported if it is stored, thereby negating its non-isolated intermediate status. 

 EPA also disagrees with the commenter that this is not a true reflection of the amount of 

these chemical substances in commerce because the Agency believes that the company is 

manufacturing the subject chemical substance and notes that potential exposures 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 environmental and economic practices. Making use of the 

recycling checkbox data element on its IUR submission will enable the public also to identify 

such practices. 

Comment F.3.e-4: Commenters stated that raw materials that are regenerated from 

byproduct streams (i.e., by chemical reaction or other means) for reuse in the same chemical 

process should not be reported as manufactured chemical substances. Commenters provided 

examples of the pulping cycle used by many paper manufacturers and the regeneration of metal 

acetate catalyst. One commenter suggested that, instead of reporting the volumes manufactured 
86

in these “looping” manufacturing operations where a byproduct is produced and used onsite to 

regenerate chemical substances in a loop or cycling process, the annual net volume of reportable 

chemical substance(s) in the cycling process should be reported. The commenter further 

recommends that the net volume of a regenerated 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 change 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 counting of chemical substances regenerated from a 

byproduct in a loop or cycling process. Cyclical or looping processes either extract or 

manufacture chemical substances from other chemical substances during each cycle, thereby 

introducing the desired recovered chemical substances back into commerce during each cycle or 

loop. Each manufacturing cycle results in potential exposures to the extracted and reused 

chemical substances. 

EPA disagrees with the commenter’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 chemical 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 use and recycling possibilities associated with 

these streams are not necessarily known at the time the material is generated, and therefore the 

manufacturer may not have reported the chemical substance under the TSCA section 5 PMN 

regulations. Therefore, if a recycling option becomes available 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 commerce a byproduct chemical substance that is not 

listed on the TSCA Inventory because it has traditionally 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 should 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 concerns that the requirement for IUR 

reporting of byproducts that are sent for recycling would have the unintended consequence of 

discouraging recycling and sustainability efforts. For example, if a manufacturer sends a 

byproduct to a landfill, as opposed to sending it for recycling, the 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 reused. 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 that the Draft Q&A Document (Ref. 26) sends a 

message that recycling is for other “educational” programs of the Agency and that the TSCA 

program does not acknowledge that the reporting burdens of TSCA do discourage recycling of 

waste streams, just as they did in 1977 when the commercial byproduct exemption was first 

established. Commenter stated that EPA should exempt 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 recycle reflects certain misunderstandings of the IUR requirements. 

The Agency expects that revised byproduct guidance 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. EPA 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 limitations 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 these 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 industry 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 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. 

g. The Relationship between IUR and Other EPA Regulations 

Comment F.3.g-1: Citing the original TSCA Inventory 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 chemical 
88

management that would encourage recycling activity. This commenter also noted that RCRA, 

not TSCA, is the lead Agency program addressing 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 regulatory action on commercial 

byproducts in later stages of the TSCA Inventory regulations. In 1983, however, it did 

incorporate the commercial byproduct exemption language from the Inventory Reporting 

Regulations into the new chemical review regulations at 40 CFR § 720.30(g). In addition, this 

commenter requested that EPA initiate a cross-program 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 designed for separate purposes, EPA does not believe 

that it is necessary to conduct a program review of the appropriate roles of TSCA and RCRA 

regarding recycled materials. Rather, EPA believes that a better understanding of the goals and 

requirements of the various programs should help the reader determine reporting 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 understand the universe of chemical substances in 

commerce in the United States. (Section 5 also provides 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 information 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 trigger 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 concerned with the generation, transportation, 

treatment, storage, and disposal of hazardous wastes and the management of non-hazardous solid 

wastes. RCRA is also focused on waste minimization, phasing out land disposal of hazardous 

waste, corrective action for releases, and recycling. EPA notes that while RCRA or other statutes 

may exempt a certain chemical substance from 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 relieve the manufacturer of that chemical 

substance from some RCRA requirements, but may 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 for reporting under RCRA and the TSCA IUR are 

different, and therefore the required data sets are different. While the data sets are not 

duplicative, EPA recognizes that there may be limited circumstances where particular elements 
89

of the data sets overlap. EPA strives to reduce such overlap, while ensuring that it is 

administratively feasible to collect and collate the data that are 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 important 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 are governed by section 313 of EPCRA, section 

6607 of the Pollution Prevention Act (PPA), and the regulations at 40 CFR part 372. TRI’s 

program goal is to provide communities with information about toxic chemical releases and 

waste management, and the TRI reporting requirements are designed to address that goal. 

Because the IUR program goals differ, the specific information collected under each program is 

not the same. Where a person must report for both 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 collections 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 program 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 IUR reporting guidance (Ref. 9). For purposes of IUR and PMN, the 

term byproduct could refer to a chemical substance that, 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 without a separate commercial intent 

during the manufacture, processing, use, or disposal of another 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 used 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 liquid waste generated from a municipal, 

commercial, or industrial wastewater treatment plant, water supply treatment plant, or air 

pollution control facility exclusive of the treated 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 produced by the production process. Examples are 

process residues such as slags or distillation column bottoms. The term does not include a 
90

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 instance, 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 specifically 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 recovery of lead values from spent batteries and regeneration 

of spent solvents. In addition, for purposes 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 chapter, 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 use as an intermediate) in an industrial 

process to make a product (for example, distillation bottoms from one process 

used as feedstock in another process). However, a material will not satisfy this 

condition if distinct components of the material are recovered as separate end 

products (as when metals are recovered from metal-containing secondary 

materials); or 

(ii) Employed in a particular function or application as an effective substitute for a 

commercial product (for example, spent pickle liquor used as phosphorous 

precipitant and sludge conditioner in wastewater treatment). (40 CFR 261.1) 

A recent RCRA publication states that “certain 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 principle is that recycling of these materials 

often closely resembles industrial manufacturing rather than waste management” (Ref. 37). 

Effectively, these materials, provided some rather stringent conditions are met, are not subject to 
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RCRA’s hazardous waste management requirements. However, some of the same facts and 

conditions that would qualify a recycling activity for an exemption from RCRA hazardous waste 

management requirements may trigger TSCA reporting requirements, due to the fact that the 

activity meets the TSCA definition of manufacturing a chemical substance for a commercial 

purpose. 

See the IUR reporting guidance for additional information regarding reporting 

requirements for byproducts. In addition to an extension of the discussion in this comment 

response, current and potential differences between RCRA and TSCA regarding some specific 

situations, such as those identified in the paragraph describing when a material is reclaimed 

(specifically associated with metals 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 transport and recycling facilities regulated under 

RCRA, TRI, and other federal and state laws and regulations. One 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 requiring 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 comprising the TRI list that are either manufactured, processed, or 

otherwise used in quantities exceeding certain thresholds. The IUR program is concerned with 

developing data related to the manufacture, processing 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 reporting is not an adequate substitute for 

IUR byproducts reporting is that the universe of chemical substances 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 those required under the IUR, 

because the two programs are designed to serve different purposes. For example, TRI entries 

may, in certain circumstances, aggregate quantities of several chemical substances that fall 

within a broad category of chemical substances; this information would not achieve the IUR’s 

purpose of gathering information on the specific chemical substances on the TSCA Inventory. 

Such aggregate reporting is particularly 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 information 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 the 
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differences in the information reported respecting each chemical substance the Agency does not 

agree that concurrent reporting under TRI warrants the elimination of byproducts reporting under 

IUR. 

Regarding the relationship between RCRA and IUR obligations, please see above 

Response F.3.g-1. Regarding “other federal and state laws and regulations,” EPA is not aware of 

any other comprehensive source of the information that Congress has mandated that EPA collect 

and keep current, respective the TSCA Inventory. If we receive information concerning specific 

alternatives to collecting this information through IUR, we will consider 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 Asarco’s Amarillo Copper Refinery, in Amarillo, 

TX. Note that any specific discussion within this 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 chemical substances and 

eight compound categories. Each of the four chemical substances reported under IUR could fit 

within a compound category reported under TRI (note that this 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 category (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 reported 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; TRI 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 weight of the copper compound. The 

maximum amount of copper in the copper compounds onsite was substantial, 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 specific 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 byproduct and/or impurity. A small portion (94 lb 

(copper weight only)) was transferred offsite for land treatment, and another small portion (803 

lb (copper weight only)) was sent offsite for metals recovery. There is no indication of the total 

amount produced or imported. As an inorganic chemical 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, including 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 manufacturing workers was reported for the 2006 IUR, and will 

also be reported industrial processing 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 requiring 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 regarding a company’s RCRA and TRI reporting 

obligations. As described in response F.3-g-1, substantial differences exist between the reporting 

requirements. As stated in that response, there are circumstances under which a chemical 

substance is reported for both 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 noted 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 whether these secondary 

components will simply be disposed of (in which case, 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 whether its use would be covered by the byproduct exemption under 
94

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, question 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 byproduct is reportable unless the extracted chemical 

substances are component chemical substances of the byproduct. The byproduct manufacturer 

needs to determine its IUR reporting obligations based on whether the recycler is extracting a 

component chemical substance or reacting a chemical substance in the byproduct to extract a 

different chemical substance (e.g., an elemental metal), to the extent such information is known 

to or reasonably ascertainable 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 extracting an elemental metal from a metal compound or complex 

that exists as a component chemical substance in the byproduct. A commenter stated that the 

regulatory language does not necessarily 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 720.30(g)(3) when used to extract component 

chemical substances from it for commercial purposes. Note that a component chemical substance 

that is extracted or separated from a byproduct must be a chemical substance that is actually 

present in the byproduct. Any method 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 “manufacture 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 considered to be manufactured. 

 It should be noted a byproduct is typically identified for TSCA reporting and Inventory 

purposes as complex chemical substances or process streams having a single chemical name that 

best describes the typically indefinite compositions 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 purification 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, although 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 byproducts, the reporting should be provided 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 regulation clearly states that excluding byproducts 
95

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 therefore, the reporting requirements should be the 

responsibility of the recycler. Furthermore, recyclers will have data on the processing and use of 

the component chemical substances that are extracted, since they would be selling the final 

chemical product. Recyclers should be required to report on the 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 substances that are different from the byproduct should 

require the reporting of the different chemical substances by the recycler. In this case, the 

recycler is considered to be a manufacturer of the different chemical substances, regardless of the 

production method used (e.g., extraction or chemical reaction). Furthermore, the byproduct 

manufacturer is responsible for reporting the manufactured 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 the Draft Q&A Document (Ref. 26), 

EPA does not clearly state that byproducts sent for recycling are subject to the IUR rule and that 

the definition of an IUR reportable chemical substance does not include byproducts sent for 

recycling. The commenter states that the definition in the guidance document 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 Inventory, and is not exempted by 40 CFR 711.6 in 

TSCA,” and that electronics manufacturers do not consider the byproducts 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 statement. The guidance document, titled 

“Q&A Document: Recycling and the 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 activities. 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 byproduct 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 Byproduct-Related Exemptions 

Comment F.3.i-1: One commenter urges EPA to exclude 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 circumstances 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 eligible for the byproduct 
96

exemption based on 40 CFR 711.10 (activities for which reporting is not required), are not of 

current interest to EPA. There is no reason for EPA to believe that exposures or hazards of 

byproduct chemical substances are generally lower than for chemical substances that are the 

target of the manufacturing activity. The fact that some companies 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 not an appropriate basis to grant a reporting 

exemption. EPA cannot meet its mandate to protect 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 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.i-2: One commenter requested a generic or general partial exemption from 

IUR reporting for the byproduct “recycled spent metal 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 interest” 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 asked 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 exemptions 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 reviewed based on the “totality of information 

available” to screen the risks of a particular chemical substance. EPA is not substantively 

responding to it in this response to comment. EPA 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 prior to the start of the reporting year. For the 2012 IUR, the reporting year 

is 2011 and therefore the request needed to have been made by January 1, 2010. Because this 

petition was submitted too late for consideration 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 scrap recycling industry 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 facilities would provide little, if any, additional 

useful information to EPA because the processing of scrap metals and the downstream use of 

specification-grade scrap metal commodities are 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 “strongly suggests that bulk elemental solid metals 

do not pose a hazard.” 

 To address the above concerns, the commenter 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 requirements 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 substances imported as part of an “article.” 

Source: (0187-0351) 

Response F.3.i-3: Regarding the commenter’s general desire for an exemption for bulk 

scrap elemental metals, EPA has provided a process 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 substance. In addition to providing 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. Therefore, EPA recommends that the commenter review the 

requirements for such a request and prepare a petition 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 microns) represents a conclusion that bulk elemental 

solid metals never pose a chemical hazard. The 100 micron cutoff is not based on a general 

hazard determination, but rather it represents the particle size below which notification of the 

release of a reportable quantity is required under the regulation under EPCRA or CERCLA. The 

cutoff size was deliberately set ten times larger than the maximum size considered by EPA to be 

respirable dust to ensure that releases containing small particles of metals would result in 

notification. The primary purpose of emergency notification is to ensure 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 environment (Ref. 39, 50 FR at 13461). The exemption at 40 
98

CFR 302.4 addresses exposure to substances in respirable dust under accidental release 

conditions. It does not cover all potential routes of exposure to a chemical substance under 

occupational and general population exposure conditions that are the subject of IUR reporting. 

Additionally, as noted in previous responses, the purpose of IUR reporting is to update the TSCA 

Inventory which includes chemical substances currently 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 applicable 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 “to import into the customs territory of the United 

States.” The commenter did not articulate an adequate rationale to justify differentiating certain 

importers from other manufacturers, simply because 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 composition 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 Inventory. Such an action 

would potentially convert a “new chemical substance” 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 exemption at 710.50(b) (finalized as 40 CFR 711.10(b)), 

EPA does not agree, based on the information supplied in the comment, that bulk scrap metal 

qualifies as an article. For purposes of the IUR, the term “article” 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 end use of scrap metal is metallurgical 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 definition of article to encompass 

scrap metal. The definition of “article” is long-standing and the modifications requested by the 

commenter (essentially to abandon the traditional 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 that the definition of manufacture 

included in the proposed rule was inconsistent with 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 existing definitions into a single “manufacture” definition to reduce 

confusion. EPA also added a very short clarifying definition that “a manufacturer is a person 

who manufactures a chemical substance,” 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 “manufacture” is consistent with established 

regulatory and statutory definitions, and is sufficiently flexible to accommodate the actual 

allocation of knowledge between toll manufacturers and contracting companies. EPA has 

separately addressed the comments received relating to the extraction of component chemical 

substances. (See the discussion on reporting byproducts 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. Manufacture includes the 

extraction, for commercial purposes, of a component chemical substance from a previously 

existing chemical substance or complex combination 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 the 2006 IUR reporting period is in 40 CFR 704.3: 

“Manufacturer means a person who imports, produces, or manufactures a chemical substance. A 

person who extracts a component chemical substance from a previously existing chemical 

substance or a complex combination of substances is a manufacturer of that component chemical 

substance.” The two similar definitions of “manufacture” in effect for the 2006 IUR reporting 

period were found in 40 CFR 710.3 (“to manufacture, produce, or import for commercial 

purposes,” and 40 CFR 704.3 (“to manufacture for commercial purposes”). The Part 711 

definition of “manufacture” is also consistent with the established 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 definition of manufacture: “Manufacture means to 

manufacture for commercial purposes,” and a definition of “manufacture for commercial 

purposes” that makes clear that byproducts produced during manufacturer 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 “manufacture” at Section 3: “’manufacture’ means to import in the 

customs territory of the United States, produce, or manufacture,” and Section 8: (“For purposes 

of this section, the term “manufacture” . . . mean[s] manufacture . . . for commercial purposes.”) 

Finally, EPA disagrees with one commenter’s suggestion that a new definition of “produce” is 

necessary to clarify that production involves a chemical substance that is “chemically different” 

from the chemical substance in the starting materials. “Chemically different” is itself an 

undefined term, so it would not bring additional clarity to a new definition of “produce.” 

Furthermore, the difference between one chemical substance and another (and hence, the 

question of whether a chemical substance is being 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 “manufacturer” in Part 720, of the conditions under 
100

which a contract manufacturer would be considered to “manufacture,” and therefore be 

responsible for IUR reporting. Persons contracting with a toll manufacturer and toll 

manufacturers are now considered to be co-manufacturers of what is produced at the toll 

manufacturer’s site. Consistent with 40 CFR 711.22(c), such parties should coordinate amongst 

themselves to submit a single report, rather than duplicative individual reports, respecting what 

they have co-manufactured. The joint submission mechanism, under 40 CFR 711.15(b)(3)(i), is 

not available to co-manufacturers. The joint 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 question) 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” rather 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) and those at 40 CFR 711.15(b)(3)(i). 

EPA also notes that it made minor changes to the definition of “manufacture” 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 clear that the conditions 

in paragraph (1), and the conditions in paragraph (2) (up to the comma), must both be satisfied 

before a chemical substance will be considered “jointly manufactured” by the producing 

manufacturer (i.e., the toll manufacturer) and the person contracting for such production (i.e., the 

contracting company). 

Comment F.4-2: One commenter pointed out that the 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 manufacture encompasses both the import of a chemical 

substance and the domestic production 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-interpretation that there is a third 

type of manufacturing (other than import and domestic production) that is outside the scope of 

the IUR. 

Comment F.4-3: Another commenter suggested that a separate 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 production involves a chemical substance that is 

“chemically different” from the chemical substance in the starting materials. “Chemically 

different” is itself an undefined term, so it would not bring additional clarity to a new definition 

of “produce.” Furthermore, the difference between one chemical substance and another (and 

hence, the question of whether a chemical substance is being produced) already has a basis in the 
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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 manufacturer situations, one commenter 

supported the assignment of responsibility as proposed while others suggested that the toll 

manufacturer should be primarily or solely responsible for IUR reporting, or expressed concern 

that the rule would compel contracting companies to submit information on behalf of toll 

manufacturers. Some also indicated that the contracting company should be responsible, or that 

reporting responsibility in toll situations 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 diversity of contractual arrangements may exist, and 

notes that there was nothing in the proposed rule to prevent toll and contracting manufacturers 

from sharing information and agreeing between themselves that one or the other will undertake 

all or a portion of the work associated with IUR reporting for a given chemical substance, though 

comments indicated that there was some confusion caused by EPA’s assignment of “primary” 

responsibility for reporting to the contracting manufacturer (see 40 CFR 711.22(c)). EPA expects 

that in most instances, a person that contracts with a toll manufacturer 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 substance, and on commercial and consumer uses of 

products containing the chemical substance. Similarly, EPA expects that the toll manufacturer 

will generally be in a better position to report 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,” and based on EPA’s expectations of the relative 

knowledge of the contracting company, EPA initially indicated, in proposed section 711.22(c), 

that the contracting company would be “primarily 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 either 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 specify 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-manufactured, as specified in the proposed rule. 

5. Definition of Site 

Comment F.5-1: Several commenters asserted that 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) 

 
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Response F.5-1: EPA disagrees with this assertion. In the proposed rule, EPA added 

explanations to accommodate manufacturing under contract and for portable manufacturing 

units, and clarified that an importer’s site must be a US address. The definition of site used in the 

past, at 40 CFR 710.3, was not otherwise significantly 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 retained, 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 located 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 person 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 define ”site.” Furthermore, “site” for the purposes 

of the IUR rule was previously and very similarly defined in the CFR, at 40 CFR 710.3. 

Comment F.5-3: One commenter expressed concern that persons engaged in portable 

manufacturing might not be aware 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 company, they thought submitters in other industries 

could be adversely impacted by the changes, especially 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 possible may be beneficial. Several outreach efforts have already been 

undertaken and will be expanded in the near future. 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 collection. This indicates that at least some of 

the affected community is already aware of IUR rule reporting requirements. 

Comment F.5-4: One commenter noted that its headquarters location (physically 

separated from its manufacturing site) controls import transactions, and therefore completes the 

IUR report for its imports. The commenter noted other circumstances in which headquarters and 

manufacturing operations are located at the same site, yet maintain separate D&B numbers. The 
103

commenter suggested that for the sake of consistency, the IUR definition of "site" should be 

revised so that when a company 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 definition 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 structure and manage their property. However, the 

commenter did not clearly explain the potential inconsistency or concern that would require 

further modifying the proposed definition of "site," and EPA disagrees that a change along the 

lines the commenter sought is warranted. For purposes of the IUR, EPA believes that it is 

preferable to aggregate all manufacturing (including import) activities that a particular 

manufacturer conducts at a single site, even if the manufacturer operates several facilities with 

different D&B numbers at the same 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. Because importing could be considered to occur at any of several 

physical locations (e.g., at the border, or at any of perhaps several locations within the importer’s 

organization), EPA has specified, for clarity and consistency, how to determine the site for 

imported chemical substances. The change suggested by the commenter would cause companies 

with one D&B number for all facilities at one physical property to be treated differently from 

companies with more than one D&B number for different 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 the 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. Further, 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 (including 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 imported at the same contiguous 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 property 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 triggered 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 Use 
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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 clarity to industrial 

function and use reporting. In contrast, another commenter indicated that the definitions of 

"industrial," "commercial," "function," 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 product, or article; repackaged; or used.” This definition can be 

found in the “IUR Modifications Rule: Development of Definitions for 40 CFR 711.3” (Ref. 40). 

EPA also notes that the terms “use”, “industrial 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 allowed 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 EPA 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 without imposing unwarranted burden. 

Comment G.1-2: Two commenters provided recommendations 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 commenter 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 information is publicly available it is 

not eligible for confidential treatment. The Agency believes that both 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. Regarding the suggestion to disallow 

CBI claims for particular data elements (i.e., site identity and the children’s use data element), 

EPA does not conclude, at this time, that all such 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 provide upfront substantiation of any CBI claims 

asserted. 

 Comment G.1-3: One commenter provided an example of a state program, the 

Massachusetts Toxics Use Reduction Act, under which only a small number of facilities (i.e., 9 

out of hundreds reporting in 2009) claimed 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 provided additional examples of publicly releasing 

data. The commenter noted that the Agency should use the smallest geographic area of 

aggregation that protects legitimate 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 information is lacking would be useful to the public. 

Another commenter requested that the Agency make 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 creating and making available to the 

public information products derived from materials gathered from the various IUR collections. 

The IUR website contains databases of historical IUR data, including national production 

volume data for all IUR collections and specific 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), which is available in the docket 

for the final rule, contains some analysis using a smaller geographic aggregation level of either 

EPA regions or states. EPA will be continuing these practices with regard to the upcoming IUR 

collection, and will consider analyses 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 likely to result in an increase in CBI claims for 

production volume. The commenter stated that knowledge of production volume in one year out 

of four or five years was not sufficient information 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 concern 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 picture of the chemical substance’s production and 

markets. 

Source: (0187-0068) 

Response G.1-4: The Agency agrees that certain information requested, including site 

and chemical specific annual production volume information, might be considered confidential. 

For this reason the Agency has regulations in place 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 chemical identities from health and safety studies. 

A few commenters mistakenly thought the Agency was proposing to newly establish this 

limitation. One commenter noted that confidentiality claims are hiding a large portion of the IUR 

data, stating that more than 1,100 of the chemical identities reported for the 2006 IUR were 

claimed confidential (and were not publicly released), and that since then the Agency has 

released the names of 530 chemical substances for which the identity was not claimed 

confidential by at least one submitter. The commenter 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 the 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 limit chemical identity claims to only those chemical 
107

substances listed on the confidential portion of the Master Inventory File. 

Comment G.2-2: Some commenters supported, and others expressed concern with, the 

Agency’s proposal to make chemical identity information public without having to notify 

submitters when a company has asserted the chemical identity to be CBI, even though the 

chemical substance is already present on the public portion of the TSCA Inventory. Commenters 

stated that it seems inappropriate to release the 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 the submitter those cases where disclosure of the chemical 

identity is under consideration. 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. Commenters are concerned that a reporting 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 for chemical identity in the IUR only if the 

chemical substance is listed on the confidential portion of the Master 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 Inventory File, then the claim is invalid and cannot be honored. The 

e-IURweb reporting tool disallows CBI claims for chemical substances 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 release 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 submission lacks the certification required under 40 

CFR 711.15(b)(1). 40 CFR 711.15(b)(1) requires a certification stating that the submitted 

information has been completed in compliance with the requirements of this part and that the 
108

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 particular 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 reporting tool is designed to protect against a 

company not providing an upfront substantiation when required. When a CBI claim is made and 

substantiation is required, the reporting tool will open the substantiation question page. Should 

the submitter choose not to complete the substantiation at that time, or to only partially complete 

it, the validation portion of the reporting tool will again alert the submitter to the need for 

substantiation. The tool also includes warnings that information with unsubstantiated CBI claims 

will be released without further 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 substantiation approach to CBI in the proposed 

rule is contrary to the agency’s historical interpretation of the statute. Creating barriers to protect 

American intellectual property was not the intent of Congress when crafting 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 that 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 substantiations requirements existed 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 request 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 proposed 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 available 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 ability to make current plant site information 

available to other Federal agencies and the public, because more information submitted under 

IUR could be released publicly (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 claim is inadequately justified or may not be 

valid based on publicly available information, and stated that the Agency should contact the 
109

submitter and allow it time to provide additional substantiation before making a final decision on 

whether to accept the information as CBI or release 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 needed to help prevent inadvertent 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 comment G.3-1, CBI claims made in 

the IUR context must comply with certain procedural provisions in order to be recognized. These 

recognized CBI claims may only be declassified pursuant to specific regulatory provisions. EPA 

has long established procedures for the protection of properly asserted CBI claims and also the 

review of these claims. Regarding those instances where a substantiation is required for a CBI 

claim but EPA concluded that it was 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 processing and use information is claimed as 

confidential. Commenters in support are in favor of reducing the potential for abuse of CBI 

claims. Commenters opposing the proposed change explained that processing and use 

information is often considered confidential by customers to protect their competitive positions 

in the market. Commenters voiced concern that the proposed change will impact their ability to 

remain competitive or will reduce innovation. These commenters were concerned that the 

manufacturers of the chemical substances would not correctly identify CBI associated with 

downstream uses, and that confidentiality agreements between the chemical manufacturer and 

the downstream users would not provide sufficient substantiation for the processing and use 

information. 

Source: (0187-0058) (0187-0092) (0187-0069) 

Response G.4-1: The Agency appreciates the comments in support of the upfront 

substantiation, and believes that the processing and use information in the publicly-released IUR 

reports is sufficiently agglomerated to address 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 submitter’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 confidentiality 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 upfront substantiation for processing 

and use information. One commenter noted that requiring substantiation should help to reduce 
110

the number of spurious CBI claims. Another commenter 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 comments 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 commenter asserted that the frequency 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 represented 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 significant 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 encourages submitters to assert such claims without 

sufficiently considering whether there is a basis for the claim. While EPA believes that such 

claims are appropriate under certain circumstances, the Agency wants to ensure that all such 

claims are carefully considered and only information 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 should allow chemical processors and 

users to participate in the substantiation of processing and use information. The commenter was 

concerned that the substantiation focused on the competitive position of the manufacturer and 

did not take into account the downstream processors and users – the customers of the 

manufacturer. In particular, the commenter noted 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 customer. This commenter provided specific 

suggestions for a process to involve the downstream processors and users, including modifying 

the substantiation question to include harm to the competitive position of the processors and 

users; allowing for separate, confidential filings by downstream processors and users in support 

of substantiation; and affording the downstream processors and users the opportunity to 

supplement the substantiation record in the event 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 consult with processors or downstream users of the 
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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 “Percent Production Volume” in Columns 

d. of both Part III A and B is most always confidential 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 production volume is clearly CBI in most 

cases. For the 2006 IUR, percent production volume was 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 processing and use. Based on this experience, it is clear that many 

submitters do not consider such information to be confidential.

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

Reasonably Ascertainable” 

Comment G.5: Commenters agreed with prohibiting 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 expanding 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 report on a raw material it sells to its processor 

customers, those processors may or may not adhere to that claim in their own IUR reporting, 

particularly with changes in supplier relationships and corporate 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) 
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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 processors to IUR reporting could also 

bring into question the protection of CBI and confidential 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 confidential. 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 proposed rule, Ref. 8) go to the 

heart of how a company manufactures 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 data, they will most likely be claimed CBI. 

Source: (0187-0068) 

Response G.6-3: EPA recognizes that some of the data elements may be viewed as 

potentially confidential business information and, for 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 every 5 years to every 4 years. Commenters 

expressed support for the return to the reporting frequency of every 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 would be burdensome and 

costly to submitters. They also stated that EPA 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 with complying with the 

amendments. However, EPA has decided to return to the reporting frequency of every 4 years, in 
113

order to better meet Agency needs. EPA has determined 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 proposed 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 below the threshold during the 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 period to the next. Therefore, the 

1–year snapshot of production volume does not provide an accurate picture 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 frequent 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 comment 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 the +/- 10 percent standard of 

precision. All commenters opposed changing the 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 range of variation. 

Source: (0187-0244) (0187-0364) (0187-0098) (0187-0092) 

Response H.2.b: EPA is replacing “provided that the reported figures are within +/-10% 

of the actual volume” currently found in 40 CFR 710.52(c)(3)(iv) with “This amount must be 

reported to two significant figures of accuracy.” The deleted phrase 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 and 
114

the industry burden associated with data collection. In the 2006 IUR data collection, nearly all 

manufacturers reported production volumes in greater precision (i.e., more significant figures) 

than is required for 2012 reporting. Based on years of experience assessing chemical risks 

through programs such as the New Chemicals Program, the Agency believes requiring reporting 

to two or more significant figures is appropriate to facilitate the Agency’s initial exposure 

screens of chemical substances, and to prioritize and make basic risk management decisions 

about those chemical substances of greatest concern. 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 assumed that the proposed rule will impact only 

chemical manufacturers. The commenter noted that 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. The 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 substances annually in amounts of 25,000 lb or greater that 

are listed on the TSCA Inventory will report under this rule. Chemical users and processors who 

may manufacture a byproduct chemical substance for a commercial purpose, e.g., utilities, paper 

manufacturers, primary metal manufacturers, and 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 reporting 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 from 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 additional manufacturers. 

2. Overall Burden, Underlying Data, Future-Cycle Burden, and Methodology 
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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” details that go into reporting. Some 

commenters asserted that the reporting burden of the proposed rule will be between two and six 

times greater than the burden for reporting in 2006. One commenter stated that the average cost 

increase per site to comply with all of the new requirements 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 underestimates 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 document 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 track and appropriately 

maintain (including organization and verification) records of production volumes and other 

information for all chemical substances manufactured 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, commenters 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 reporting in 2012 will be, on average, greater than that 

estimated in the Agency’s analysis. 

Comment I.2.a-2: According to one commenter, provisions 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 amended 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 and 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 burden and/or cost may be either underestimated 

or overestimated. Such statements regarding limitations of the study serve to make the analysis 

more transparent and are standard practice. In response to the comment that the EA uses 

assumptions and past data instead of current information, 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 Agency 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, growth, 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 reporting 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 relates to factors such as reduced 

staff turnover and retention of rule familiarity, and information transferable from one collection 

or reporting period to the next 
117

Source: (0187-0069) 

 Response I.2.b: As explained in the Economic Analysis, the burden reduction estimates 

of 20 and 80 percent are taken from the 2002 EA estimates for a four-year reporting cycle. These 

estimates are based on industry information. The comment stated that sliding 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 annual reporting in this final rule. EPA expects little efficiency 

gains after the second reporting cycle, as most industry learning 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 transferable 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 asserted 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 necessitating that the site complete and submit a Form 

U. The EA assumes all sites that report under the IUR incur the same average cost for 

compliance determination regardless of the number 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 given site. Therefore, EPA expects that the burden 

associated with compliance determination should not be substantial. The commenters appear to 

have interpreted EPA’s compliance determination burden as including the burden of actually 

reporting for the chemical substances subject 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 submit a Form U. If a person at any single site 

manufacturers at least one chemical 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 production volume for each chemical substance 

manufactured at a given site. The burden for that activity is accounted for 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 included in a given year’s report. 
118

In addition, once a submitter has made a compliance determination that it has reporting 

obligations under the IUR, it can rely on production 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 this 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 ultimately 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 cost estimate of all modifications combined) to better illustrate 

the comparison between the baseline and post-amendment costs. That is, under a 25-year period, 

both the four-year (amended) reporting cycles and five-year (baseline) reporting cycle would end 

in the same year. The analysis would therefore capture an entire reporting cycle and not stop 

mid-cycle in the comparison. The economic analyses prepared for IUR rule amendments in 2002 

and 2006 used a 20-year period, which suggests that 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 for inorganic chemical substances, 

because while inorganic chemical manufacturers were exempt from submitting downstream 

processing and use information in the 2006 reporting cycle, they were required to submit Parts I 

and II of Form U, and therefore are included in the baseline number of reports. 

Comment I.2.e-2: One commenter questioned whether EPA has adjusted the baseline 

estimates to account for new manufacturing facilities that never reported previously under the 

IUR rule, the elimination the 300,000 lb threshold for processing and use data, and the change in 

the method of determining the eligibility to report. 

Source: (0187-0103) 

 Response I.2.e-2: The 2006 IUR submission data provide the best estimate of the 

number of reports that would be submitted 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 a 
119

basis for calculating the incremental 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 elimination of the 300,000 lb threshold for processing 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 costs for any new companies submitting data (see 

Section 4.2.2). 

f. Underlying Assumptions and Data: Use of 2002 Industry Burden Survey 

Comment I.2.f: Commenters question EPA’s reliance on burden estimates from an 

industry survey conducted in 1996 for the 2002 Economic 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 rulemaking, 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 computer recordkeeping and vast consolidation of 

many oil and petroleum companies. According to the commenter, electronic recordkeeping and 

transfer have lead to increases in productivity, making the 1996 estimates overestimates. The 

commenter also asserted that if industry consolidation has increased the number of big and small 

companies and reduced the number of medium companies, 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 associated with IUR data 

collection and reporting. While changes in the industry over the past 14 years have both 

increased and decreased the burden of reporting for some sites, estimates used in the EA are 

meant to represent an average site burden, meaning that some sites may have a higher or lower 

burden. For example, EPA’s average estimates are intended to cover companies of varying sizes. 

While the Agency agrees that improvements in electronic recordkeeping and transfer have lead 

to increases in productivity, EPA has chosen to use more conservative estimates, rather than 

attempt to adjust the baseline burden estimates 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 volume, volume of 

chemical substances used on-site, and volume exported data could and likely 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 increase EPA’s burden slightly, the EA 

estimates the amendments will save EPA approximately $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 currently only publicly 

reports national production volume in ranges for each chemical substance and does not provide 

production volumes by site to the public. Therefore, 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 places 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 also 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 Order 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 the benefits of the proposed rule would require 

more specific information about each user’s use patterns and preferences, and the changes in the 

use patterns and preferences which would result from the additional information made available 

under the proposed rule. These data are not readily available, and collecting such data would be 

cost-prohibitive. Any direct cost-to-benefit ratio, therefore, is also impossible to calculate. EPA 

agrees with the comment that industry also stands to benefit from effective government policies 

and programs that provide the public and market with greater confidence 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 and contributing to better assessments of potential 

chemical risks and risk management decisions. Other Federal and state agencies will also be able 

to make use of the data in their programs to manage 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 rule 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 Economic Analysis describes several 

chemical risk-screening and management programs that have used IUR data in the past and are 

expected to continue to do so. See also the response to comment at section I.2.h-1. 

3. Burden and Cost by Specific Data Element 

a. Method for Determining Whether a Manufacturer 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 reporting cycle, rather than wait until the following 

cycle, should be relatively small. The commenter also noted that EPA has not provided an 

indication of how many companies would be affected.

Source: (0187-0069) 

 Response I.3.a: The commenter is correct in stating that EPA did not indicate the 

number of companies that would be affected if EPA implemented 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 under the IUR rule during non-principal reporting 

years currently is not available to EPA, the percentage 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 Threshold 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 result of the proposed modification to eliminate the 

300,000 lb threshold for processing and use information. EPA based this estimate on the best 

data available, including the 2002 industry burden 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 manufactured above the 300,000 lb threshold in 2006.
122

Comment I.3.b-2: One commenter stated that lowering the 300,000 lb threshold would 

triple the burden associated with reporting downstream processing and use information. Other 

commenters believed the burden associated with 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 substantiated 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 threshold. The commenter who suggested that EPA 

recalculate the burden associated with this modification 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 modification because the rule will now include 

manufacturing sectors that recycle 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 for commercial purposes are treated 

by IUR as chemical manufacturers, and are not newly subject to IUR. EPA notes that the Agency 

is not changing a legal regime; it is only interpreting 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 for all prior years in the reporting cycle. 

Many commenters stated that EPA has not accounted for the difficulty and expense of 

recalibrating current tracking systems, which sites have programmed to meet the 2006 IUR 

requirements, to retroactively gather data, or the costs that companies 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 commenter claimed that the proposed amendment 

would quadruple the number of imported 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 believes that production volumes for 

recent past years are generally tracked under standard business practices, and in many instances 

is required under other TSCA rules, so most sites should be able to gather this information 
123

without a substantial effort. In many instances, production volumes for recent past years are 

tracked under standard business practices. For example, EPA believes it is standard business 

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. EPA also notes that 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 required to maintain records of production volume for 

the first three years of production or import, including but not limited to the names, addresses of 

any person to whom the chemical substance is distributed (information includes 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 companies would also 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 indicated that they archived these records. 

d. Reporting Production Volume Exported 

Comment I.3.d: Commenters claimed that the Economic 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 Analysis underestimated the burden of 

reporting total volumes exported, and believes some commenters misunderstood the reporting 

requirement. As described elsewhere in this document and in the preamble, EPA is requiring 

only the volume of the chemical substance directly exported. Any volume that is processed or 

otherwise used domestically is not directly exported and therefore is not included in the directly 

exported volume. Export volume is data a company is likely tracking and maintaining for their 

records as part of standard business 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 recognize that new revisions to the 

consumer and use codes will increase the reporting 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 provide any specific suggestions on how EPA's estimates should 

be further revised or improved.
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Comment I.3.e-2: One commenter noted that replacing 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 together 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 based 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 large number of unique combinations increases the 

difficulty and time required by EPA to sort and classify chemical substances because EPA either 

would need to develop exposure scenarios for 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 combinations, thereby increasing 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—Replacement 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 likely 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 estimates 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 alternative estimate. EPA reminds commenters that 

they are required to report only data according 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. Additionally, the standard does not 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 will 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” 
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by them if applicable. As discussed in response I.3.f-1, EPA does not expect IUR reporters to 

conduct a survey of their customers to comply with the IUR requirements.

g. Upfront Substantiation for Processing and Use Information CBI Claims 

Comment I.3.g: Commenters stated that the requirement for an upfront substantiation for 

processing and use information, combined with the replacement of the “readily obtainable” 

standard with the “known to or reasonably ascertainable by” standard, 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 determine 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 stated that the upfront substantiation requirement 

will “substantially increase” the reporting burden only when combined with the new ‘‘known to 

or reasonably ascertainable by” standard. However, because estimates of upfront substantiation 

in the Economic Analysis are based on results 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 EPA has underestimated the burden 

associated with mandatory electronic reporting and CDX registration costs and electronic 

signature costs have not 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 with learning the new reporting system, making 

adjustments to internal collection and reporting systems, and collecting 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 associated 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 explained or otherwise substantiated. 

Comment I.4-2: One commenter implied that it is not the 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 that companies will face.
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Source: (0187-0354) 

 Response I.4-2: EPA notes that while Section 4.4.27 of the Economic Analysis addresses 

the specific costs associated with submitting IUR report information 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 information 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 associated with reporting chemical production volumes from 

imported chemical mixtures. Commenters expressed particular concern about sites importing 

mixtures; these sites would presumably be required to determine the chemical substances in the 

mixture that are subject to IUR reporting, calculate 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 threshold. 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 tracking 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; therefore the estimate of 1.51 hours per report for an 

average company is the best burden estimate available to EPA. As described in Section 4.2.2 of 

the Economic Analysis, EPA calculated the estimate of 1.51 hours based on industry data 

provided for the 2002 EA survey. 

The IUR rule amendments specify that IUR reporting is required of entities that 

manufacture (i.e. produce or import) 25,000 lb or more of an IUR-reportable chemical substance 

at a single site in a year. The requirement that 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 difficulty that sometimes may be associated with 

requesting ingredient information from foreign manufacturers, and notes that U.S. importers are 

required only to report such information as it is known to or reasonably 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 reporting cycle and imposing an increased burden on industry, and that 

EPA has underestimated the burden that more frequent reporting places on the industry.
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Source: (0187-0064) (0187-0088) (0187-0103) (0187-0187) (0187-0354) (0187-0355) 

(0187-0359) 

 

Response I.6-1: As one commenter stated, less frequent 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, contrary 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 using outdated information. EPA, therefore, is 

returning to the previous frequency 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 rule and response H.1 for further explanation. 

EPA’s Economic Analysis includes an estimate of the industry burden for the increased 

reporting frequency. The estimate includes an evaluation of the burden over a 25-year period in 

order to capture the long-term increase in burden due to increased reporting frequency. The 

commenters have not provided any additional information to support their claim that EPA has 

underestimated the burden of more frequent reporting. See 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 this per-cycle reduction does not 

make up for the increased costs generated by more frequent reporting over time 

Source: (0187-0088) (0187-0354) and 0187-0359) 

 Response I.6-2: EPA does acknowledge that more frequent reporting results in higher 

costs over several reporting cycles. EPA calculates the incremental cost to industry associated 

with increasing the reporting frequency from every 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 frequent reporting (a 20 or 80 percent reduction 

depending on the data element) which are incorporated after the first reporting cycle, and the 

increased cost to industry over time 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 burden 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 submitters and have not been gathering this 

data. In addition, the commenter explains that calculating the volume of a given chemical in each 

byproduct is not a straightforward process; for example, electronics manufacturers must 

determine the production volume of each component chemical substance in all the byproducts 

recycled in a single year. Therefore, according to the commenter, EPA’s estimate of the total 
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burden for providing production volumes is not even close to being appropriate 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 reportable under the IUR rule, many byproducts 

generators would be reporting for the first time. Electronics manufacturers have not been 

tracking or collecting data on production volumes of byproducts they manufacture, and have 

never considered the byproducts they generate to be chemical substances. 

Source: (0187-0103) 

 Response I.7: As described in the comment response associated with byproduct 

reporting, this commenter appears to have misunderstood how to properly name and report 

byproduct chemical substances. As with other aspects of the economic analysis, the burden 

associated with reporting represents average burdens and may not match an individual’s 

experience. In addition, EPA’s burden estimate (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 previously, EPA does not believe that the burden 

estimate of 1.51 hours is an underestimate for an average site. See comment response F.3.a-1 for 

further discussion regarding properly identifying 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 data. The commenter noted that there are clear 

efficiencies to be gained from annual reporting and annual reporting would 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 frequent 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 reporting every four years is the most reasonable option. 

b. Comments on Changing the Threshold for Reporting to 10,000 lb 

Comment I.8.b: EPA failed to assess the considerable 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 commenter 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 industry 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 chemical substances that would be reporting if EPA were to lower 

the reporting threshold to 10,000 lb. However, again, the Agency must balance the costs of an 

option with the benefits, and has determined that 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 duplicative reporting and is, therefore, in violation of the Paperwork 

Reduction Act. The duplicative reporting cited is: (1) the requirement of manufacturers 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 the IUR is duplicative, and therefore 

in violation of the PRA. With respect to the first issue raised by the commenter, EPA disagrees 

that worker exposure data collected under the IUR rule is duplicative 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 sampling it undertakes as part of its compliance 

monitoring program. OSHA and EPA are collecting different 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 manufacturing and processing), and includes results of personal (sampling 

device was being wore by a person) 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 duplicative reporting by the manufacturer and the recycler of the 

byproduct. As discussed in the Q&A Document (Ref. 26), under 40 CFR 720.30(g)(3) the 
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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 reports the component chemical substances under 

the IUR, and the manufacturer of the byproduct does not. Thus, there 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 chemical bonds to convert a component chemical 

substance in the byproduct into a different chemical substance (which 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 these 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 paragraph above, there is no 

duplicative reporting. The reporting by the manufacturer of the byproduct and the reporting by 

the recycler of the byproduct are not duplicative because they relate to different chemical 

substances. 

2. Environmental Justice 

Comment J.2: One commenter asserted that the requirement to report under the IUR rule 

could discourage recycling, and that EPA had failed to analyze the environmental justice 

implications of the IUR rule (such as is required under EO 12898, Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income 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 discourage recycling generally. While as an Agency, 

EPA encourages recycling, the IUR rule is not intended or likely to influence chemical 

manufacturing industry waste management practices. EPA 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 limitations or 

flexibility, state and local requirements or incentives, and the incentives offered or requirements 

imposed by other federal laws. EPA has no evidence to suggest that IUR reporting requirements 

generally discourage chemical manufacturers from recycling, let alone evidence that alternative 

waste disposal methods would have a disproportionate adverse impact on low-income or 

minority populations. 

In fact, the information collected under the IUR rule is intended to enhance EPA’s ability 

to identify at-risk populations and areas. As explained in the 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 associated 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 the 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 benefit potentially at-risk communities, including lowincome and minority communities, and especially vulnerable populations, such as children. The 
131

rule is directed at manufacturers (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 capabilities in conducting screening level exposure assessments of 

chemical substances reported to the IUR. EPA also solicited suggestions for any supplemental 

data elements that could be used for the improvement of our assessment tools and 

methodologies. 

a. General Comment 

Comment K.1.a: One commenter stated that the bulk 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 address many potential exposure scenarios (e.g., TRI 

release reporting and emission reporting under various permits, MSHA and OSHA workplace 

safety requirements). 

Source: (0187-0104) 

 Response K.1.b: While it may seem that some federal regulatory programs require the 

submission of similar information, actually each federal regulatory program has different goals 

which result in different types of information being reported and the programs are not 

duplicative. EPA discusses the relationship 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 possible triggers of TRI 

reporting obligations is manufacturing above a specified level, the TRI does not require that the 

production volume be reported. TRI data also reflect 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 information on the manufacturing, processing, and use 

of chemical substances manufactured 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 require," under TSCA 8(a), not by a fixed 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 potential for worker exposure may be determined. 

Additionally, information characterizing the subsequent processing and use of the chemical 
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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 comment regarding the collection of 

information related to the manufacturing operations 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 report 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 IUR 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 authority) for collecting additional exposure-related 

data. EPA's intent is to develop the best method in which to collect this information. EPA has 

committed significant resources to strengthening its CBI management procedures and is 

continually exploring ways to better protect information claimed as confidential. The Agency has 

no reason to believe that the collection of this additional 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 collection of information on worker 

exposures because it would help track worker chemical exposures in the U.S. The commenter 

stated that no other data collection exists for 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 engineering 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 this data would assist the Agency in 

developing screening level estimates of chemical exposures to potentially 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 approaches 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 exposure data, and this comment was opposed to the 

proposed change. The letter stated that the intent of section 8(a) is only to keep the list of 

chemical substances in commerce current, and that Congress did not intend for updates to the 

TSCA Inventory to be used to collect detailed 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 the word "Inventory" in the title, it does not 

actually operate to update what chemical substances are included on the TSCA Inventory. 

Instead, it provides periodically updated information about chemical substances that are on the 

Inventory, and that are currently in commerce and being produced above certain specified 

thresholds. In contrast, the PAIR rule is a one-time collection of a different set of data on a much 

smaller set of chemical substances, which may have 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 information should be collected from processors 

separately from the IUR, under different timelines 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 believe that processors may be more 

familiar with the processing and use of chemical substances than manufactures (including 

importers). Collecting information from processors, manufacturers, and importers will provide 

the Agency with more complete and accurate exposure-related data about chemical substances. 

EPA will continue to consider these comments for future rulemakings. 

b. Reporting Burden 
134

Comment K.3.b-1: Commenters contended that adding processors to the IUR reporting 

cycle would make the IUR even more complicated and cumbersome. One commenter indicated 

that before this decision is made, the Agency should 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 considered 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 proxy 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 information 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 total 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 thought 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 event 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 information from processors would not be 

useful to the Agency. However, some commenters noted that in order to gain a full 

understanding of the flow of chemical substances through the economy, public health, and the 

environment, it is essential to collect information from downstream processors. This information 

would ensure robust processing and use information, 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 manufacturers 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 (including importers) are responsible for 

providing information required by the IUR rule. Section 8(a) of TSCA enables the Agency also 

to collect information from processors. In agreement with the commenter, EPA believes that 

processors may be more familiar with the processing 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 businesses. 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 should 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 suggest 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 earlier 10,000 lb limit, as noted in the proposal, EPA is not including 

this change in the final rule. As EPA noted when it raised the general reporting 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. The commenter said that the stated purpose in 

the 2003 IUR amendments was to align the IUR reporting threshold with the threshold 

established for the TRI and the Low Volume Exemption (LVE) threshold under EPA's New 
136

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 for TRI-listed chemicals were first established by 

section 313(f) of EPCRA and not by EPA pursuant to a specific rationale. These statutory 

thresholds are 25,000 lb for manufacturing a toxic 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 the 2003 IUR amendments that 

the 25,000 lb threshold for IUR reporting would 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 threshold in order to reduce the number of 

reports filed, thus reducing the overall industry burden associated with this regulation. 

The new reporting threshold does 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 three years, biennially, or annually. Some commenters were in 

favor of more frequent reporting and stated that the proposed change would improve the quality 

of data on the manufacturing and use of chemical substances in commerce and capture year-toyear fluctuation in production and import volume. Three commenters thought IUR data should 

be reported at least annually. Other commenters felt the Agency 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 commenters 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 TRI and IUR. It stated that the 

TRI report is a completely different report. That is, TRI involves a very finite 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 production facilities down the entire value chain. 

The commenter said they needed additional information 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 will continue to consider them 

as it explores any further changes to the reporting 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 reporting is restricted to domestic facilities, 

quantities of toxic chemicals imported by covered facilities are subject to TRI reporting. In fact, 

the statutory definition of “manufacturing” 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 was necessary for the proper performance of the 

functions of the Agency, including whether the 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 reporting rule requires its company to report its 

“manufacturing” of many naturally occurring minerals, even though most mining and mineral 

processing consists of merely removing and concentrating naturally occurring substances. The 

commenter indicated that it supported more limited and focused IUR reporting for the mining 

industry because of the activities with 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. With respect to the mining industry, EPA provided 

detailed responses to comments about IUR coverage of the mining industry as part of its 

discussion of phasing in IUR reporting for all inorganic chemicals in the 2006 IUR rule. As EPA 

noted in the 2003 Response to Comments document, although naturally occurring minerals are 

excluded from IUR reporting, many mined mineral are listed on the TSCA Inventory because at 

least some of the time they are produced by “non-natural” means. EPA also noted that while the 

hazard potential for metals is relatively well established, EPA needs exposure information to 

screen these chemicals for potential risk. Risk is composed of both hazard and exposure. Metals 

such as zinc and copper which appear in trace 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 discussion of this issue, please refer to the 

earlier 2003 Response to Comments 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, information 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 data 
138

collected under IUR and other chemical monitoring 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 information collected on water supplies to reduce 

contamination. 

Source: (0187-0100) (0187-0349) (0187-097) (0187-0095) 

Response L.1: EPA appreciates the additional recommendations for improving the IUR 

data collection process. The Agency continually strives to coordinate data collection activities 

with other agencies and other EPA programs to achieve 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 comprehensive 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 proposal did not make any mention or 

provide provisions specific to an important, critical emerging class of chemical substances 

subject to TSCA, nanomaterials. Another commenter stated that engineered nanomaterials 

should meet the same IUR reporting requirements, 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 require the submission of additional information on 

nanoscale materials. 

Comment L.3: One commenter stated that the IUR reports should be publicly accessible 

within two months. 

Source: (0187-0349) 

Response L.3: EPA recognizes the need to make the data publicly available as quickly as 

possible, and will strive to do so. The requirement 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 publication 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 list of industrial sector codes, EPA 

acknowledges that there may be some FDA-regulated activities included and acknowledges that 
139

FDA-regulated chemicals are not reportable under IUR; however, in developing the IS codes and 

NAICS codes crosswalk, included in the “Instructions 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” reporting is minimized. EPA will use the 2012 data to 

further evaluate the need for adding or removing IS codes as well as industrial function 

categories. 
140

References

A docket was established for the final IUR Modifications 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 Reporting Modifications; Submission Period Suspension; Final rule. 

Federal Register (76 FR 27271, May 11, 2011) (FRL–8874–2). 

2. Environmental Defense Fund, Letter to Docket # EPA-HQ-OPPT-2009-0187 (on behalf of 

32 organizations), from Richard Denison, PhD, October 12, 2010. 

3. EPA. OPPT. Enhancing EPA’s Chemical Management Program. Available on-line at: 

http://www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html.

4. Health Canada. Proposal for Priority Setting for Existing Substances on the Domestic 

Substances List under the Canadian Environmental Protection Act, 1999. Greatest Potential 

for Human Exposure, Canada, 2003. 

5. U.S. General Accounting Office, Toxic Substances: EPA should Focus Its Chemical Use 

Inventory on Suspected Harmful Substances (1995) (GAO Report).

6. EPA. TSCA Inventory Update Rule 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 Reporting 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 Characterization and Prioritization Document. March 

2009. Available on-line at: 

http://www.epa.gov/chemrtk/hpvis/rbp/Butenedioic%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 Association, Comments submitted to Docket ID 

No. EPA-HQ-OPPT-2008-0785 from Daniel Newton, January 23, 2009. 

15. EPA. OPPT. Economics, Exposure and Technology Division (EETD). Economic Analysis 

for the Proposed Inventory Update Reporting (IUR) Modifications Rule, July 20, 2010. 

16. NOVA Chemicals Corporations, Letter to Docket ID No. EPA-HQ-OPPT-2009-0187 from 

Linda J. Santry, PhD., October 7, 2010. 

17. EPA. OPPT. Initial Risk-Based Prioritization of High Production Volume (HPV) Chemicals. 

April 2009. Available on-line at: 

http://www.epa.gov/chemrtk/hpvis/rbp/Category_Chlorobenzenes_Web_April%202009.pdf. 

18. EPA. TSCA Inventory Update Reporting Modifications; Final Rule. Federal Register

(August 16, 2011). 

19. EPA. OPPT. Toxic Substances Control Act Inventory Representation for Chemical 

Substances of Unknown or Variable Composition, 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 Representation for Combinations of Two or 

More Substances: Complex Reaction Products. Available on-line at: 

http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt. 

21. European Commission. Registration, 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. European Commission. REACH, 2011. Available 

on-line at: http://ec.europa.eu/environment/chemicals/reach/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 Inventory Reporting Forms and Instructions. Available 

on-line at: http://www.epa.gov/tri/report/rfi/ry2009rfi121709.pdf.

24. EPA. OPPT. EETD. Inventory Update Reporting (IUR) Technical Support Document 

Replacement of 5-digit NAICS Codes with Industrial 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 Act, (Com. Print 1976) ("Leg. Hist.") at 667-721. 

26. EPA. OPPT. Draft Q&A Document: Recycling and the TSCA Inventory of Chemical 

Substances Premanufacture Notification and Inventory Update Reporting Requirements, July 

2010. 
142

27. EPA. Recordkeeping and Reporting Requirements. 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. Premanufacture 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 Mary 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 Act, (Com. Print 1976) ("Leg. Hist.") at 407-517. 

35. EPA. General provisions and Inventory reporting 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 letter to Fern Abrams, IPC, Nov. 30, 2007. 

39. EPA. Notification Requirements; Reportable Quantity Adjustments; Final Rule. Federal 

Register (50 FR 13456, April 04, 1985) (FRL-2665-6(b)). 

40. EPA. OPPT. IUR Modifications Rule: Development of Definitions for 40 CFR 711.3, July 8, 

2010. 

41. EPA. OPPT. 2006 Inventory Update Reporting: 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 Amendments (64 FR 46772), November 20, 2002. 
144

Appendix A: Commenter Reference 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 Association 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 Plastics 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 Association 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 Association 
145

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 Recycling 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 Arkema 
146

Appendix B: Commenter Reference List by Company 

FDMS ID Company/Organization 

0187-0358 3M 

0187-0085 AkzoNobel 

0187-0066 Alcoa, Inc. 

0187-0074 Aluminum Association 

0187-0071 American Association 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 Association 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 Recycling 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 Plastics 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.