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 chemicals.
    EPA has an obligation under TSCA to protect human health and the
environment from unreasonable risks associated with chemical substances
under its jurisdiction. EPA is amending the IUR rule to improve and
enhance data reporting requirements under IUR reporting beyond that
required during the 2006 submission period. There were problems
associated with many 2006 IUR data submissions that severely limited
EPA's ability to screen chemical substances for exposure and risks and
to make data available to the public. These problems included the fact
that many submissions were incomplete or improperly completed,
contained invalid chemical identities, and/or inappropriately or
incorrectly claimed certain data elements as CBI. EPA anticipates that
this final rule will
    a. Ensure the required information is properly reported and that
the information in the Agency's database reflects the information
provided in the IUR reports.
    b. Increase the usability of the collected information.
    c. Increase the availability of information for the public.
    d. Focus reporting on information that is most needed by the
Agency.
    Additionally, EPA believes that the modifications in this final
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 an understanding of the volume of chemical
substances produced or imported into the United States, how the
chemical substances 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 further tailors 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 TCSA 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 under TSCA sections 4 or
8, 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 IUR 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. More detailed discussions are in the Responses to Comments
document (Ref. 12).
    2. Transitioning to 2012. Commenters stated the new requirements
are overly burdensome and unrealistic considering the time constraints.
Commenters supported delaying the submission period in a variety of
ways, including:
    a. Extending by several months and delaying the implementation of
changes until the next submission period,
    b. Delaying the submission period until 9 to 12 months following
the promulgation of the final rule, or
    c. Moving the submission period to 2012 and changing the principal
reporting year to 2011.
    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 final rule (Ref. 6) to
suspend the 2011 submission period. In this final rule, EPA supersedes
the suspension of the submission period by establishing a new sequence
of submission period, beginning with one from February 1, 2012, through
June 30, 2012. EPA believes that the timing of the 2012 submission
period provides companies sufficient time to collect and submit the
required data, and that steps taken by the Agency have provided 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-CDRweb electronic reporting tool. A
recording of the workshop and a summary of the questions and answers is
available on the IUR Web site (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-CDRweb, for
stakeholders to test a pre-release version of the tool. EPA 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 e-CDRweb 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 (see Unit V.E.1.).
    One commenter suggested that EPA continue under the old IUR rule
for this submission period. 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 updated IUR reporting
requirements 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. 17). In order to fulfill the EPA
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 submission period. As described on EPA's Web
site (http://www.epa.gov/opptintr/existingchemicals/pubs/enhanchems.html), EPA's comprehensive approach to enhancing the
Agency's current chemicals management program includes obtaining
information needed to understand chemical substance risks and
increasing transparency and public access to information about chemical
substances. The 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 reporting processing and use
information for all chemical substances addresses the identified lack
or insufficiency of such information for most chemical substances--
including HPV chemical substances. EPA's efforts to understand and
prioritize chemical substances based on risk, using the 2006 IUR data,
were instrumental in identifying the needed changes to the IUR
requirements. These included:
     EPA's Risk-Based Prioritization (RBP) process was
developed to take the hazard data assembled for HPV chemical substances
under EPA's HPV Challenge Program to conduct screening-level hazard
assessments and use the 2006 IUR data to develop screening-level
exposure assessments, with the goal of using the two types of
assessments to develop screening-level risk prioritizations for the HPV
chemical substances with fairly complete Screening Information Data
Sets (SIDS). EPA quickly discovered that while the hazard data allowed
EPA to make a screening-level conclusion about hazard, the 2006 IUR
data rarely provided sufficient information for EPA to reach a
screening-level conclusion about exposure.
     EPA discovered with the 2006 IUR that a larger than
expected portion of HPV chemical substance manufacturers produced below
the 300,000 lb threshold at individual sites, resulting in many
submitters not being required to provide processing and use information
for those volumes. In some cases, all of the reporters fell below the
threshold.
     For MPV chemical substances, with national production
volumes between 25,000 and one million lbs, even fewer individual sites
reported production volumes over the 300,000 lb threshold. Although EPA
desired to include these chemical substances in its risk-based
prioritization process, the screening-level exposure information was
not available.
     For those chemical substances for which EPA had some
processing and use data, the Agency had difficulty evaluating exposure
for commercial workers and consumers because the 2006 IUR data did not
differentiate between these populations. The separation of these
populations for future IUR collections, and including other information
such as that related to children's use of the chemical substances, will
help EPA better identify potential risks to more targeted populations.
    These examples illustrate several obstacles EPA encountered in
understanding chemical substance risks, which stemmed from the scope of
the 2006 IUR data collection. They also illustrate how the revised IUR
data collection will increase the Agency's ability to understand
exposure concerns so that EPA will be better able to identify steps
needed to manage risks associated with chemical substances. Not only
will the revised IUR data collection provide information that would
have been helpful for past programs, it is directly applicable to the
Agency's current and future programs. EPA will be able to use the 2012
IUR data to identify additional chemical substances for its Chemical
Action Plan program, will also be able to identify if any of the
current Action Plans may need to be revised, and will be able to
develop other aspects of the enhanced existing chemical substance
management program that are associated with understanding chemical
substance risk.
    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 EPA
Administrator's commitment to increase public access to information on
chemical substances.
    3. EPA's use of IUR data. The Agency received comments related to
how IUR data can best be used to assist in assessing, prioritizing, and
taking action on chemical substances that pose unreasonable risks.
Commenters 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 information.
Commenters also expressed interest in providing input on using the IUR
and the Agency's prioritization process.
    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 lbs or greater a year.
Based on those characterizations, EPA developed either an 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 needed exposure-related information. 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 and the resulting prioritization decision was primarily
hazard-based, as opposed to risk-based, as evidenced by statements in
many of the RBP as well as HBP documents that EPA developed (available
on-line 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 current 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.
    EPA is considering using other regulatory tools and authorities to
collect more in-depth information, but believes the IUR is the correct
mechanism for the data collection finalized in this document. EPA also
is considering ways to obtain public input on its use of the IUR data
and its chemical substance prioritization process, as suggested by the
commenters.
    4. Canada's prioritization approach. Some commenters recommended
that EPA adopt Canada's prioritization approach. 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 chemical substances 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 reporting period (Ref. 18). 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 ways,
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.

B. Comments on Electronic Reporting

    EPA received various comments on the proposed requirement to use
the reporting tool, e-CDRweb, to submit all IUR submissions. In
general, comments were submitted on the reporting tool phasing-in
electronic reporting registering with CDX, and electronic signatures.
See section B. in the Responses to Comments document (Ref. 12) for
further discussion on electronic reporting.
    1. Comments on the reporting tool and phasing-in electronic
reporting. In general, commenters supported electronic reporting. 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 to be able to upload 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. 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 the 2012 electronic reporting tool (e-
CDRweb). 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, e-CDRweb 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-CDRweb 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-CDRweb and
ePMN systems. ePMN registrations using the current eTSCA will be
acceptable e-CDRweb 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. EPA has
provided training opportunities and guidance materials to facilitate
electronic reporting, as well as 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-CDRweb electronic reporting tool.
The workshop, which was recorded live as a webinar, was posted to the
IUR Web site 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-CDRweb 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 e-
CDRweb tool, which EPA will address. Additionally, EPA has published a
revised Instructions document (Ref. 7) explaining the reporting
requirements and how to complete Form U using the reporting tool.
    Electronic reporting was first offered as an option for the 2006
IUR. As explained in the preamble to the proposed rule and the
Responses to Comments 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 the Responses to
Comments document), EPA does not believe it is reasonable to phase in
electronic reporting over another reporting period and is confident
that submitters will be able to successfully use the e-CDRweb tool to
electronically report under the CDR rule in 2012.
    2. Comments on registering with CDX and providing electronic
signatures. Commenters thought the modified ESA Form, in particular the
need for multiple notarized signatures, was burdensome and unnecessary.
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. sites. The commenters
noted that the actual preparer/drafter would rarely be the signatory.
Another respondent noted that companies should be allowed, but not
required, to have the same authorized official for the PMN and IUR
submission.
    EPA understands and is cognizant of the concerns presented by
industry regarding the revised ESA Form. An ESA Form is required for
CDX registration and is necessary to submit electronic data to EPA.
Regarding the prior need for multiple notarized signatures, EPA has
determined that requiring a notarized signature as part of the ESA Form
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-CDRweb tool allows for more than
one individual to edit a submission. Ultimately, EPA's goal is to
provide one ESA Form across all TSCA programs and is exploring the
reuse of electronic signatures issued under the New Chemicals Program,
as well as other EPA programs.

C. Comments on Reporting Thresholds

    1. Method for determining whether you must report. EPA proposed to
modify the method used to determine whether a person is subject to IUR
reporting. The new method requires persons to report under the IUR if
they manufactured (including imported) 25,000 lb or more of a chemical
substance at any single site in any calendar year since the last
principal reporting year. This method becomes effective after the 2012
submission period. (Note: There is also a lowered production volume
threshold for certain chemical substances, effective after the 2012
submission period. See 40 CFR 711.8(b).) Several commenters believed
the change is appropriate and should be implemented for the submission
period following the upcoming submission period (i.e., in the
submission period following the 2011 submission period described in the
proposed rule). 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 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 after the 2011 submission period
described in the proposed rule, 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 believes 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 4 out of 5 years. 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, production
volumes of chemical substances vacillating above and below reporting
thresholds in different IUR reporting periods resulted in a change of
approximately 30% in the composition of the chemical substances being
reported from one IUR reporting period 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. 19). 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 chemical substances identified by 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 Program for
completion of SIDS datasets. In 1998 and 2006, CASRN 68921-51-7's
production volumes have been above one million lb, making 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 and so
they were included in a cluster for an HBP as opposed to 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 provides a more
detailed discussion of these comments (Ref. 1).
    EPA believes that most sites will be able to gather production
volume information 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 3 years of production or import and in certain
circumstances, including but not limited to the names and addresses of
any person to whom the chemical substance is distributed. 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 types of TSCA actions, such as TSCA section 5(a)(2)
SNURs and TSCA section 5(e) orders also require that production volume
records be kept for 5 years for certain chemical substances, and
several commenters indicated that they archived these records.
    2. Elimination of the 300,000 lb threshold. The Agency received a
substantial number of comments on the proposed elimination of the
300,000 lb threshold for reporting processing and use information.
Comments submitted on various topics are described in this unit.
    a. Increased numbers of covered chemical substances. Commenters
asserted that the inclusion of inorganic chemical substances, coupled
with the threshold change for processing and use information, will
result in a 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. One commenter
suggested the Agency use a phased-in approach to adequately collect and
process the increased information.
    In response to these comments 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 for processing and use information will be the same as for
other types of information: 25,000 lb (or 2,500 lb for chemicals
subject to 40 CFR 711.8(b)). Thus, there will be no separate threshold
for the reporting of production 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. While it is true that the
amount of data in the IUR reports is expected to increase substantially
in the 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-CDRweb 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-CDRweb tool will eliminate most or all of the
problems EPA had with missing information (which necessitated phone
calls and e-mails 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

e-CDRweb tool, the Agency is confident that the increase in data
submissions will be easily managed for the 2012 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. Numerous commenters were concerned about the
increased reporting burden, particularly for smaller companies, and the
complexity of Form U, Part III. One commenter stated that EPA should
assess the benefits of the additional reporting requirements to
establish a cost justification of the proposal. Other commenters were
concerned that the lowered threshold would increase the number of
imported mixtures and that it would be difficult to calculate and
aggregate across products for lower volume chemical substances.
    EPA analyzed the potential impacts of this requirement to all
submitters, including potential burden to small businesses, in the
Economic Analysis (Ref. 14). 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 with comments suggesting 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. 14), 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.
    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 more
imported mixtures. However, 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 an 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 RCRA. While reporting under the IUR
differs in many significant respects from reporting under the EPCRA and
RCRA programs, in all cases the importer is 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,
Authorisation and Restriction of Chemicals] REACH we recently
implemented an application that is capable of tracking volumes of
individual 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 substance'' (Ref. 20). 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.
    c. Justification for data. Several commenters strongly supported
EPA's proposed change, stating 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. Additional commenters generally
supported the change, but wanted it to take effect after the 2011
reporting cycle. Other commenters had concerns about the value of the
information that is reported in Part III of Form U. 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. Another commenter believes that EPA should provide more
specificity on its needs and explain why other, more tailored, options
do not provide the necessary data. 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 commercial and
consumer uses of chemical substances. The information will also help to
provide an accurate and readily available source of, as noted in Unit
V.A.1., basic exposure-related information for a subset of chemical
substances listed on the TSCA Inventory. Furthermore, collection of
this data is consistent with the EPA Administrator's strong commitment
to provide the public with more information on a greater number of
chemical substances.
    As EPA discusses in this unit and elsewhere, the 2006 IUR
information did not provide sufficient 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
exposure-related information needed to continue efforts begun with the
2012 data. 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 Program. For example, an RBP was prepared
for the chlorobenzenes category, which consisted of four chlorobenzenes
sponsored under the HPV Challenge Program (Ref. 21). 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 substance 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 priority
determination risk-based. EPA believes that the lowering of the
reporting threshold will provide more exposure-related information on a
greater number of MPV chemical substances. EPA disagrees with the
comment that it has not made public documentation of the past use of
processing and use information to address screening and prioritization
of chemical substances. As discussed in Unit V.A.3., EPA used 2006 IUR
data starting in 2007 in its development of RBPs and HBPs which it has
made available on its Web site. 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 data were
not sufficiently complete to be useful. 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. By
lowering the reporting threshold for processing and use information to
25,000 lb in 2016, EPA is increasing consistency for the IUR with
reporting requirements of the TRI program. Under the TRI program,
chemical substances that are not chemical substances of special concern
listed at 40 CFR 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 list of toxic
chemicals may be different from those reported under the IUR, an
analysis showed that over 80% of the sites that reported under the 2006
IUR also reported under TRI in 2006. Given that there is some overlap
in the companies that report and the information collected on
activities and uses of chemical substances under both programs, EPA
believes that many companies are already accustomed to reporting on
lower volume chemical substances.
    d. Lack of data for chemical substances. 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. Another commenter asserted that the lowered
threshold will not enhance the quality or integrity of the resulting
IUR data due to uncertainties in making estimates. 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 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. 6) 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 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 reporting periods, and EPA notes that this final 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.
    3. Eliminate 25,000 lb threshold for specific regulated chemical
substances. EPA proposed to eliminate the 25,000 lb reporting threshold
for chemical substances subject to particular TSCA rules and/or orders
and to require manufacturers (including importers) of such chemical
substances to report under the IUR, regardless of the production
volume. Comments submitted on various topics are described in this
unit.
    a. Burden. One commenter stated that companies not expecting this
significant change will be unprepared to gather required information.
Several commenters expressed the view that the requirement will
increase the burden upon industry without any real benefit to the
environment and will create a situation where manufacturers (including
importers) are responsible for knowing all byproducts of their process,
no matter how small. Others felt that enacting this requirement without
a de minimis concentration threshold would add an unnecessary
additional layer of complexity to IUR analysis and would result in each
reporting entity responsible for a far greater number of Form U
submittals.
    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. 14).
    EPA disagrees that the increased burden will not yield any real
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 EPA Administrator's
commitment to increase the availability of chemical substance
information to the public.
    b. Imports and mixtures. Commenters thought this requirement will
be difficult to meet in practice, particularly for imported chemical
substances or mixtures. One commenter felt the requirement 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.
Other commenters believed that 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 Material Safety Data Sheets (MSDS). 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 it is importing is
not being imported in violation of TSCA; an importer must, therefore,
have knowledge of the regulatory status of the chemical substances it
is importing. If an importer does not know, or can't reasonably
ascertain that a particular chemical substance is present in a mixture,
it is not required to report the chemical substance. 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 it is importing that ingredient. Therefore, no IUR report for that
ingredient would be required. In addition, manufacturers (including
importers) are not required to report impurities.
    If an importer does not know and cannot reasonably ascertain that a
particular chemical substance is present in an imported mixture, it is
not required to report the chemical substance under the IUR. 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 it 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 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 chemical 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 chemical substances, 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
chemical substances 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 potentially subject to reporting, as described in this
unit. A UVCB chemical substance is an indefinite combination of
chemical substances, 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 chemical substances is subject to reporting under
IUR and is

considered a single chemical substance. Generally, the determination of
whether a combination of chemical substances is a mixture or a UVCB
chemical substance is made by the time that chemical 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:
    i. ``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.
    ii. ``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.
    c. List of subject chemical substances. 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. EPA provides just such a list. It is
titled ``Chemical Substances that are the Subject of Certain TSCA
Orders, Proposed or Final TSCA Rules, or Relief Granted under Civil
Actions.'' It can be found in Appendix B of the Instructions document
(Ref. 7). The pertinent chemicals are listed both by CASRNs (for non-
confidential chemical substances) or by TSCA Accession Numbers (for
confidential substances) that are the subject of a rule. The
Instructions document, which was updated for the 2012 IUR reporting, is
available in the docket for this final rule and on EPA's IUR Web site
at http://www.epa.gov/iur. This list is intended to be a helpful
information resource, but it is not legally determinative of the status
of any particular chemical substance.
    d. Reporting for chemical substances subject to a proposed rule.
Some commenters supported EPA's suggestion to eliminate the 25,000 lb
threshold for certain chemical substances that are the subject of a
rule proposed under TSCA section 5(a)(2), 5(b)(4), or 6. Another
commenter believed it was inappropriate to impose expanded reporting
requirements on chemical substances subject to proposed rules which
might not be finalized. The Agency generally agrees with the commenters
who stated that if chemical substances that 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 in Unit
III.E.3., 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 section 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 in this unit represents an appropriate circumstance to
trigger enhanced information collection under the IUR. EPA issues a
proposed rule under TSCA section 5, or 6 only after making proposed
findings under TSCA section 6 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 to 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 when a rule is
proposed. 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 volume. EPA asked for comment on whether a
de minimis production volume threshold should be set for these chemical
substances. Several commenters supported the concept of a de minimis
threshold, although one of the commenters indicated that it would be
difficult to choose an appropriate level to decrease the reporting
burden due to the difficulty associated with definitively identifying a
production volume level below which there are not chemicals of
interest. 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 EU's REACH
regulations. One commenter thought a de minimis volume should be set on
a chemical-by-chemical basis for chemicals for which EPA needs specific
information. Some commenters opposed setting a de minimis threshold,
either because they felt that there should be no reporting threshold or
they felt that the threshold should remain at 25,000 lb. One commenter
specifically opposed a de minimis threshold for any persistent,
bioaccumulative and toxic (PBT) chemical substances.
    EPA agrees with some commenters who noted that a 2,500 lb threshold
would provide sufficient data for the Agency to monitor production and
compliance with certain proposed or promulgated rules and/or relief
granted pursuant to 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
known 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. 22).
    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
action under TSCA would be appropriate.

D. Comments on Specific Data Elements

    1. Parent company and site identity. Two comments were received in
support of using the company name, address, and D&B 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)(i), which only referred to ``parent company name.''
    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 has
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. 1), 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%
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. 15). EPA provides
further clarification regarding the correct domestic (U.S.) parent
company name in the Instructions document (Ref. 7).
    2. Technical contact. EPA requested comment on requiring that the
technical contact be a person knowledgeable about the reported chemical
substance and be located at the manufacturing (including importing)
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.
    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-CDRweb 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. Comments on imported chemical
substances and joint submissions. EPA received several comments
regarding its proposal to require that importers ensure that their
supplier completes the joint reporting of the CA Index Name currently
used to list the chemical substance on the TSCA Inventory. The comments
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.
    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 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-CDRweb, 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 requirements to more clearly
reflect, see proposed rule (Ref. 1), 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.''
    b. Comments on reporting International Union of Pure and Applied
Chemistry (IUPAC) names as an alternate. 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 because the commenter was concerned that
submitters would be required to go through a particular fee-based
service to obtain CA Index Names for chemical substances.
    The Agency disagrees that IUPAC names should be allowed as a
substitute for 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 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 on the TSCA Inventory. These
data can then be electronically copied back to the IUR reporting tool.
    4. Chemical identifying number. Some commenters were opposed to
removing the PMN number as an allowed identifying number, suggesting
that the Agency might be inundated with requests for TSCA 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 numbers to TSCA Accession Numbers
so that the information can be easily obtained without additional
burden on industry and the Agency.
    The Agency has added PMN numbers to the SRS listing to provide a
cross-reference list, as suggested by the commenters. The e-CDRweb
reporting tool allows the user to search SRS using the PMN number in
order to populate the IUR report with the pertinent chemical
identification information for confidential chemical substances listed
on the TSCA Inventory.
    There are certain circumstances where a submitter occasionally may
not be sure of the particular PMN case number and TSCA Accession Number
the Agency has assigned to one of its confidential 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 substances.
This could also happen if a certain PMN represented a mixture of two or
more confidential substances, such that multiple TSCA Accession Numbers
were assigned to the different substances reported in that single PMN,
and the submitter didn't already request the particular TSCA Accession
Numbers from EPA for the individual chemical substances comprising that
multi-component type of PMN. In such circumstances, a submitter should
contact EPA in writing, well before initiating IUR reporting, to obtain
the required TSCA 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 EPA for such information in
sufficient time to allow for the Agency to respond.
    5. Production volume--a. Report production volume for each year.
EPA requested comment on the requirement to report production volume
for each of the 5 years since the last IUR principal reporting year.
Comments submitted on various topics are described in this unit.
    i. Insufficient time to collect data. Most commenters stated that
companies were prepared to compile and report the required information
for the 2010 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 one
submission period would change to include production data from previous
years, but that the reporting of production data from previous years
would take effect in an earlier submission period.
    EPA acknowledges the possibility that certain information
respecting past production volume, for the years between 2006 and 2009,
might not be known or reasonably ascertainable to a submitter in 2012.
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. 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) 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

a 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.
    ii. Reporting burden. Several commenters stated that the
requirement is overly burdensome, especially for chemical substance
importers and manufacturers who (according to the commenters) will need
to analyze all products to track the volumes of all component
chemicals. 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 this 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. 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 commenter acknowledged
that the information will still be available to EPA for consideration,
but was concerned that the burden on EPA of keeping the information
confidential will increase substantially due to the potential number of
CBI claims.
    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 encompass 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 section F.3. of the Responses to
Comments document (Ref. 12). The Agency does expect that the reporting
burden will decrease in reporting cycles beyond 2016, as submitters put
additional recordkeeping procedures into practice.
    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 (Ref. 14). CBI claims on production volumes are unlikely to
create any significant burden beyond what is estimated in the Economic
Analysis. CBI claims do, however, prevent valuable information about
chemical substance manufacture (including import) from becoming
publicly available.
    iii. Retroactive reporting. 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.
    EPA disagrees with commenters' suggestion that requiring 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.''
    iv. Alternate approaches. A few commenters suggested that 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 substances with a history of
fluctuations in chemical substance manufacture and import practices or
substances that are considered hazardous.
    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. 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
exposure-related 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.
    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 substances with a ``history'' of fluctuations
would not capture the industry variability that EPA is seeking.
    b. Volume of chemical substances used on site. One commenter stated
that this data element was essential to improving accuracy and utility
of the reported production volume and 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 screening-level 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 chemicals used in synthesis or also to
chemicals that were repackaged; and the need to identify the amount of
a chemical substance present on site during a specific time period.
    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
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 screening-
level risk assessments for regulatory decisionmaking under TSCA section
5. The reporting obligation and the phrase ``site use'' applies to all
nonexempt 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 because the imported
chemical substance, by definition, is brought onto the site from
outside of the United States, and therefore is not physically
manufactured and used at the reporting site) or reporting the same
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 substance 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 for 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
that 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 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
substance, any use at the importing site (e.g., consumed in a reaction
or cross-linked or cured in an article) 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 site-limited check box, submitters
provided information about the use of a chemical substance in both the
manufacturing and industrial processing and use sections of the Form U.
The information reported under the manufacturing section identifies
that this substance is processed or used at that particular site and
reports the number of workers associated with the manufacture of that
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 used and, in the event that a
substance has a use identified by the same combination of use,
function, and NAICS code by another site, the production volumes,
sites, and workers would be combined with the information describing
the other sites' processing or uses.
    c. Report volume exported. The majority of the comments against
reporting the volume directly exported stated that capturing the
volumes for each chemical substance in each exported product was
difficult and burdensome. These comments indicated a misunderstanding
of the reporting requirement, and 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
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. ``Directly Exported'' and ``Domestically Processed or Used'' are
mutually exclusive designations; only one designation applies to any
particular portion of the production volume.
    6. Identify whether a chemical substance is to be recycled,
remanufactured, reprocessed, reused, or reworked. 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.
    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 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 (e.g., if EPA knows enough about exposures to a chemical
substance from an on-site recycling use, EPA could 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 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.
    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. 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. Two commenters expressed concern that revealing
whether a chemical substance they manufactured was recycled would
reveal CBI. In such a situation, the submitter will be able to claim
the information as confidential. Another commenter suggested that EPA
collect information about recycling under a separate rulemaking. 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.
    7. Industrial processing and use information--a. Industrial
function categories. 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 changes and
supported EPA's efforts to work collaboratively with Canada to align
the categories. Other commenters said that this 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, including additional
definitions to ensure that activities are consistently coded across
companies. Commenters stated that providing a description for ``other''
will be challenging, may not provide useful information (e.g., due to
lack of information from the downstream customers), and would require
additional burden to report. One commenter felt that the list of
Industrial Function Category (IFC) codes is too limited for inorganic
chemical substances, and suggested that the Agency add an IFC code for
``Solid Manufacturing Materials.'' The comment stated that such a code
would alleviate the need to address many industrial uses in the
``other'' category, thereby reducing reporting burden.
    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. Such
information is contained in the 2012 IUR Instructions document (Ref.
7).
    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 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.
    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. IS codes. EPA proposed to replace the 5-digit NAICS code with a
new code, Industrial Sector (IS), to describe the industrial setting.
Some commenters were in favor of this change, noting that using code
harmonized with Canadian codes would be helpful to both industry and
data users. Other commenters stated that many companies have already
begun the process of data collection based on the former system, which
has precedent. 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. Commenters also asserted that the Agency should recognize
that these changes will result in increased reporting burden and time.
    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. Both
the e-CDRweb reporting tool and the 2012 IUR Instructions document
(Ref. 7) contain cross-walk tables for submitters to use to determine
the proper IS code, based on the NAICS code information they may
already have collected.
    Information on the Agency's development of the IS codes is
described in the technical support

document ``Inventory Update Reporting (IUR) Technical Support
Document--Replacement of 5-digit NAICS Codes with Industrial Sector
(IS) Codes'' (Ref. 16). 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 5-digit NAICS
codes. In the 2006 IUR, the three-code combination of processing and
use (P/U) code, NAICS code, and IFC codes 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.
    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.
    8. Consumer and commercial use--a. Consumer and commercial product
categories. Many commenters supported revising the list of consumer and
commercial product categories for consumer and commercial use
information. Those commenters stated that harmonizing codes with
Canada, revising the product categories, and requiring descriptive
information when the ``Other'' category is reported are essential to
improving the consumer and commercial data. The commenters stated also
that these changes will provide a better understanding of how chemical
substances are used in downstream products and will help facilitate
consistent reporting of chemical substance use information in the
United States and Canada. Other commenters wanted more explanation as
to why the categories are being revised and requested that the Agency
provide more descriptive information for each product category,
including a table identifying how the new categories relate to the
previous categories. Some commenters stated that providing a
description for the category ``Other'' will be challenging and may not
provide useful information. One commenter stated that the Agency should
not further complicated downstream reporting, noting that was already
challenging to choose the top ten categories for substances with a
large number of uses.
    EPA appreciates the support for the harmonized consumer and
commercial product categories, and agrees that the changes finalized in
this rule will improve the IUR data. As described in Unit III.G.8.a.,
information from data collected during the 2006 IUR and from Canada was
used to develop a more useable listing of product categories. EPA
eliminated categories for which few chemical substances were reported,
added categories identified as needed, and eliminated overlap in
categories. In addition, some categories were renamed to better match
their definitions, other categories descriptors were improved, and
categories were grouped to allow for easier identification. EPA
believes these changes will make reporting easier for the submitter,
and does not agree that these changes result in more complicated
reporting. The Agency is providing more detailed descriptive
information in the 2012 IUR Instructions document (Ref. 7) and other
guidance materials.
    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.
    b. Designation of consumer or commercial use. Commenters had mixed
viewpoints regarding the need to designate whether the indicated
product category is consumer use, commercial use, or both. One
commenter strongly in support of making this designation stated that
such distinctions are critical to EPA's ability to assess exposure at
even the most basic level. Others did not oppose the added designation,
but did ask for further clarification between consumer and commercial
uses. Commenters opposing the added designation stated that they were
too removed from the consumer and commercial uses to have a clear
understanding of the uses at that level of distinction, especially for
commodity chemical substances with a large number of uses. One
commenter said suppliers to formulated products were less likely to
know the distinction because of the confidentiality of the downstream
user formulations.
    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.
    c. Number of commercial workers. Commenters strongly opposed EPA's
proposal to require that submitters report the number of commercial
workers reasonably likely to be exposed while using a product
containing a reportable substance. Most commenters indicated that they
do not have sufficient information about the work practices of eventual
commercial users to estimate this number, that such information is not
typically shared upstream, and that any such data EPA received would
be, at best, an educated guess. 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.
    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 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
report on downstream uses, including the information that would be
reported under IUR, based on what is known to or reasonably
ascertainable by the submitter. To reduce the burden in reporting, the
IUR provides that 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 obligation by providing 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.

E. Definitions and Clarification Requests

    1. Changing the reporting standard for processing and use
information to ``known to or reasonably ascertainable.'' A number of
commenters requested further clarification (beyond that offered in
section 4.0 of the Instructions document (Ref. 7)) 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 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.
    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'' (Ref. 4, p. 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 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 in Unit III.H.,
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
Unit III.H.
    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 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.

    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 TSCA section 8(a), 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. 23, p.
80). Thus, whether a particular level of diligence meets this standard
does not depend on the submitter's subjective view of what seems 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 expect to undertake. EPA believes it is
appropriate to define the standard consistently for all persons
reporting under TSCA section 8(a), 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 into 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.
    2. Clarifications to byproduct reporting--a. Concern that new
byproduct reporting requirements are being added. In general, some
commenters asserted that EPA's explanation of the IUR byproduct-related
reporting requirements reflect new requirements, inconsistent with
current byproduct exemptions.
    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. 24),
and have been applicable to the IUR since the IUR's inception in 1986
(Ref. 3, p. 21447 (incorporating definitions from 40 CFR 704.3)). 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.
25), and have also been applicable to the IUR since the IUR's inception
(Ref. 3, p. 21447). While this final rule is modifying the 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 definitions of manufacture and manufacturer at 40 CFR 704.3.
This specification of the scope of ``manufacture'' has been in force
for IUR purposes since 1988. (See Ref. 3, p. 21447 (1986 incorporation
of definitions from 40 CFR 704.3 into the IUR) and Ref. 26, p. 51716
(1988 revision to 40 CFR 704.3)).
    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
substances extracted from the byproduct. 40 CFR 720.30(g)(3).
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.
27). 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. See also the discussion in Unit IV.2. 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. 4),
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. 28). In 2008, EPA
provided similar guidance by letter to the Association Connecting
Electronics Industries (IPC), another trade group (Ref. 29).
    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 substance 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 (Refs. 7 and 30).
    b. Concerns about the IUR byproduct reporting requirements, in
relation to RCRA and the Toxics Release Inventory. Some commenters
asserted that byproducts should be regulated, if at all, under RCRA
and/or reported under TRI, and should not be subject to IUR reporting
requirements. One commenter suggested that EPA revisit the entire issue
of the management of recycled materials to determine the appropriate
roles for the TSCA and RCRA programs. Some commenters also asserted
that reporting under IUR presents a disincentive for recycling.
    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. (TSCA 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 substances or
manufacturing activities for which EPA has a low current interest. 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 TSCA

Inventory by filing a PMN and meeting certain other requirements.
    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 substance previously treated as a waste under RCRA can relieve the
manufacturer of that 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