50816 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 704, 710, and 711 

[EPA–HQ–OPPT–2009–0187; FRL–8872–9] 

RIN 2070–AJ43 

TSCA Inventory Update Reporting 

Modifications; Chemical Data 

Reporting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is amending the Toxic 

Substances Control Act (TSCA) section 

8(a) Inventory Update Reporting (IUR) 

rule and changing its name to the 

Chemical Data Reporting (CDR) rule. 

The CDR enables EPA to collect and 

publish information on the 

manufacturing, processing, and use of 

commercial chemical substances and 

mixtures (referred to hereafter as 

chemical substances) on the TSCA 

Chemical Substance Inventory (TSCA 

Inventory). This includes current 

information on chemical substance 

production volumes, manufacturing 

sites, and how the chemical substances 

are used. This information helps the 

Agency determine whether people or 

the environment are potentially exposed 

to reported chemical substances. EPA 

publishes submitted CDR data that is 

not Confidential Business Information 

(CBI). EPA is amending this rule to 

require submission of information that 

will better address Agency and public 

information needs, improve the 

usability and reliability of the reported 

data, and ensure that data are available 

in a timely manner. EPA is requiring 

electronic reporting of CDR information 

and modifying reporting requirements, 

including certain circumstances that 

trigger reporting, the specific data to be 

reported, the reporting standard for 

processing and use information, and CBI 

reporting procedures. 

DATES: This final rule is effective 

September 15, 2011. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2009–0187. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Chenise 

Farquharson, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–7768; e-mail address: 

farquharson.chenise@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; e-mail address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture 

(including manufacture as a byproduct) 

or import, for commercial purposes, 

chemical substances listed on the TSCA 

Inventory (under TSCA section 3, 

‘‘import’’ is included in the definition of 

manufacture). Potentially affected 

entities may include, but are not limited 

to: 

• Chemical substance manufacturers 

and importers (NAICS codes 325 and 

324110; e.g., chemical substance 

manufacturing and processing and 

petroleum refineries). 

• Chemical substance users and 

processors who, in addition to 

manufacturers described in this unit, 

may manufacture a byproduct chemical 

substance (NAICS codes 22, 322, 331, 

and 3344; e.g., utilities, paper 

manufacturing, primary metal 

manufacturing, and semiconductor and 

other electronic component 

manufacturing). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 

II. Background 

A. What action is the agency taking? 

In this action, EPA is promulgating 

several amendments to the IUR rule, 

taking into consideration comments 

received on the proposed rule and is 

changing its name to the CDR rule. The 

amendments were proposed in the 

Federal Register issue of August 13, 

2010 (Ref. 1). The amendments 

contained in this final rule, as well as 

the TSCA Inventory update provisions 

of 40 CFR part 710, subpart C, 

unchanged by these amendments, 

appear in a new part, 40 CFR part 711. 

The following is a brief listing of the 

primary amendments. These 

amendments are described in more 

detail in Unit III. 

1. EPA is amending 40 CFR 710.59, 

which appears in the new 40 CFR part 

711 as 40 CFR 711.35, to require 

electronic reporting of the CDR data, 

using an Agency-provided, web-based 

reporting tool (e-CDRweb) to submit 

CDR reports through the Internet to 

EPA’s Central Data Exchange (CDX). 

After the final rule’s effective date (see 

DATES), paper submissions will no 

longer be accepted. 

2. EPA is adding a new definition 

section, which appears in the new 40 

CFR part 711 as 40 CFR 711.3, revising 

the definition for manufacture and site; 

and making other needed definitional 

modifications and additions. 

3. EPA is amending 40 CFR 710.53, 

which appears in the new 40 CFR part 

711 as 40 CFR 711.20, to change the 

reporting frequency from every 5 years 

to every 4 years. 

4. EPA is amending 40 CFR 710.48(a), 

which appears in the new 40 CFR part 

711 as 40 CFR 711.8(a), to modify the 

method used to determine whether a 

manufacturer (including importer) is 

subject to CDR reporting. The method 

will be effective after the 2012 

submission period. Subsequent to 2012, 

reporting is required if the production 

volume of a chemical substance met or 

exceeded the 25,000 pound (lb) 

threshold in any calendar year since the 

last principal reporting year (e.g., 2011). 


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5. EPA is amending 40 CFR 710.52(c), 

which appears in the new 40 CFR part 

711 as 40 CFR 711.15(b), to replace the 

300,000 lb reporting threshold for 

processing and use information by 

phasing in a lower threshold. For the 

2012 submission period, the threshold 

for reporting processing and use 

information is 100,000 lb. In subsequent 

submission periods, the reporting 

threshold will be 25,000 lb. 

6. EPA is amending 40 CFR 710.48(a), 

which appears in the new 40 CFR part 

711 as 40 CFR 711.8(b), to replace the 

25,000 lb threshold for specific 

chemical substances that are the subject 

of particular TSCA rules and/or orders. 

The new reporting threshold for these 

chemical substances is 2,500 lb, which 

is effective for the 2016 submission 

period and subsequent submission 

periods. 

7. EPA is amending 40 CFR 710.46, 

which appears in the new 40 CFR part 

711 as 40 CFR 711.6, to make chemical 

substances for which an enforceable 

consent agreement (ECA) to conduct 

testing has been made under 40 CFR 

part 790 ineligible for exemptions, to 

provide a full exemption from CDR 

requirements for water, and to remove 

polymers, which are already fully 

exempt from the partially exempt list of 

chemical substances at 40 CFR 

710.46(b)(2)(iv), which appears in the 

new 40 CFR part 711 as 40 CFR 

711.6(b)(2)(iv). 

8. EPA is amending 40 CFR 710.52(c), 

which appears in the new 40 CFR part 

711 as 40 CFR 711.15(b), to modify the 

reporting requirements for certain 

manufacturing data elements. 

Specifically, manufacturers (including 

importers) are required to report: 

a. The name and address belonging to 

the parent company. 

b. The current Chemical Abstracts 

(CA) Index Name, as used to list the 

chemical substance on the TSCA 

Inventory, as part of the chemical 

identity. 

c. For the 2012 submission period 

only, the production volume for 

calendar year 2010. 

d. The production volume for each of 

the years since the last principal 

reporting year. This requirement will be 

effective after the 2012 reporting cycle 

(i.e., for the 2016 submission period and 

subsequent submission periods). 

e. The volume of a manufactured 

(including imported) chemical 

substance used at the reporting site. 

f. Whether an imported chemical 

substance is physically present at the 

reporting site. 

g. The volume directly exported and 

not domestically processed or used. 

h. When a manufactured chemical 

substance, such as a byproduct, is being 

recycled, remanufactured, reprocessed, 

or reused. 

9. EPA is replacing the ‘‘readily 

obtainable’’ reporting standard used for 

the reporting of processing and use 

information required by 40 CFR 

710.52(c)(4), which appears in the new 

40 CFR part 711 as 40 CFR 711.15(b)(4), 

with the ‘‘known to or reasonably 

ascertainable by’’ reporting standard. 

10. EPA is amending 40 CFR 710.58, 

which appears in the new 40 CFR part 

711 as 40 CFR 711.30, to require upfront 

substantiation when processing and use 

information required by 40 CFR 

710.52(c)(4), which appears in the new 

40 CFR part 711 as 40 CFR 711.15(b)(4), 

is claimed as CBI. 

11. EPA will disallow confidentiality 

claims for processing and use data 

elements identified as not ‘‘known to or 

reasonably ascertainable by’’ (40 CFR 

710.52(c)(4)), which appears in the new 

40 CFR part 711 as 40 CFR 711.15(b)(4). 

12. EPA is revising the list of 

industrial function categories for the 

reporting of processing and use 

information. EPA is also amending 40 

CFR 710.52(c)(4)(i)(C), which appears in 

the new 40 CFR part 711 as 40 CFR 

711.15(b)(4)(i)(B), to replace the 5-digit 

NAICS codes with 48 Industrial Sector 

(IS) codes. 

13. EPA is amending 40 CFR 

710.52(c)(4)(ii), which appears in the 

new 40 CFR part 711 as 40 CFR 

711.15(b)(4)(ii), to revise the list of 

consumer and commercial product 

categories for the reporting of consumer 

and commercial use information. EPA is 

also requiring the separate reporting for 

consumer or commercial categories and 

the reporting of the number of 

commercial workers reasonably likely to 

be exposed to the subject chemical 

substance. 

14. EPA is eliminating the gaps in the 

ranges used to report concentration in 

40 CFR 710.52(c)(3) and (c)(4), which 

appear in the new 40 CFR part 711 as 

40 CFR 711.15(b)(3) and (b)(4). 

B. What is the agency’s authority for 

taking this action? 

EPA is required under TSCA section 

8(b), 15 U.S.C. 2607(b), to compile and 

keep current an inventory of chemical 

substances manufactured or processed 

in the United States. This inventory is 

known as the TSCA Chemical Substance 

Inventory (TSCA Inventory). The 

Agency maintains the Master Inventory 

File as the authoritative list of all the 

chemical substances reported to EPA for 

inclusion on the TSCA Inventory. In 

1977, EPA promulgated a rule published 

in the Federal Register issue of 

December 23, 1977 (Ref. 2) under TSCA 

section 8(a), 15 U.S.C. 2607(a), to 

compile an inventory of chemical 

substances in commerce at that time. In 

1986, EPA promulgated the initial IUR 

rule under TSCA section 8(a) at 40 CFR 

part 710, published in the Federal 

Register issue of June 12, 1986 (Ref. 3), 

to facilitate the periodic updating of 

information on chemical substances 

listed on the TSCA Inventory and to 

support activities associated with the 

implementation of TSCA. In 2003, EPA 

promulgated extensive amendments to 

the IUR rule, published in the Federal 

Register issue of January 7, 2003 (2003 

IUR Amendments) (Ref. 4), to collect 

exposure-related information associated 

with the manufacturing, processing, and 

use of eligible chemical substances and 

to make certain other changes. 

Section 8(a)(1) of TSCA authorizes the 

EPA Administrator to promulgate rules 

under which manufacturers and 

processors of chemical substances must 

maintain such records and submit such 

information as the EPA Administrator 

may reasonably require. Section 8(a) of 

TSCA generally excludes small 

manufacturers and processors of 

chemical substances from the reporting 

requirements established in TSCA 

section 8(a). However, EPA is 

authorized by TSCA section 

8(a)(3)(A)(ii) to require TSCA section 

8(a) reporting from small manufacturers 

and processors with respect to any 

chemical substance that is the subject of 

a rule proposed or promulgated under 

TSCA section 4, 5(b)(4), or 6, or that is 

the subject of an order in effect under 

TSCA section 5(e), or that is the subject 

of relief granted pursuant to a civil 

action under TSCA section 5 or 7. The 

standard for determining whether an 

entity qualifies as a small manufacturer 

for purposes of 40 CFR part 710, which 

appears in the new 40 CFR part 711, is 

found at 40 CFR 704.3. Processors are 

not currently subject to the rules at 40 

CFR part 710, which appears in the new 

40 CFR part 711. 

This document renames the IUR as 

CDR and promulgates the CDR as 40 

CFR part 711, which includes 

provisions copied from the existing 

regulations in 40 CFR part 710, subpart 

C, that are not substantively changed as 

a part of this rulemaking, and the new 

provisions in this final rule. Failure to 

comply fully with any provision of this 

final rule will be a violation of TSCA 

section 15 and will subject the violator 

to the penalties of TSCA sections 16 and 

17. 


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C. What was the TSCA inventory update 

reporting (IUR) rule prior to these 

modifications? 

The IUR rule, as modified by the 2003 

IUR Amendments, required U.S. 

manufacturers (including importers) of 

chemical substances listed on the TSCA 

Inventory to report the identity of 

chemical substances manufactured 

(including imported) during the 

reporting year in quantities of 25,000 lb 

or greater at any single site they own or 

control to EPA every 5 years. IUR data 

were collected five times prior to the 

2003 IUR Amendments: 1986, 1990, 

1994, 1998, and 2002, and one time after 

the 2003 IUR Amendments, in 2006. 

EPA uses the TSCA Inventory and data 

reported under the IUR rule to support 

many TSCA-related activities and to 

support a number of EPA and other 

Federal health, safety, and 

environmental protection activities. The 

Agency also makes the data available to 

the public, to the extent possible given 

CBI claims. 

Persons manufacturing (including 

importing) chemical substances were 

required to report information such as 

company name, site location and other 

identifying information, production 

volume of the reportable chemical 

substance, and exposure-related 

information associated with the 

manufacture of each reportable 

chemical substance. This exposurerelated information included the 

physical form and maximum 

concentration of the chemical substance 

and the number of potentially exposed 

workers. Several groups of chemical 

substances were and will continue to be 

generally excluded from the reporting 

requirements: e.g., polymers, 

microorganisms, naturally occurring 

chemical substances, and certain natural 

gas substances. 

Manufacturers (including importers) 

of chemical substances in larger 

volumes (i.e., 300,000 lb or greater 

manufactured (including imported) 

during the reporting year at any single 

site) were required also to report certain 

processing and use information for the 

2006 submission. This information 

includes process or use category; NAICS 

code; industrial function category; 

percent production volume associated 

with each process or use category; 

number of use sites; number of 

potentially exposed workers; and 

consumer/commercial information such 

as use category, use in or on products 

intended for use by children, and 

maximum concentration. 

The 2006 submission was the first 

instance where manufacturers 

(including importers) of inorganic 

chemical substances were required to 

report under the IUR rule. For the 2006 

submission only, inorganic chemical 

substances were partially exempted 

from the IUR rule, and manufacturers of 

such chemical substances were required 

to report the manufacturing information 

and not the processing and use 

information, regardless of production 

volume. Under the previous rule, for 

future collections (i.e., for 2011 or 2016 

collections, etc.), the partial exemption 

for inorganic chemical substances 

would have no longer been applicable 

and submitters would have reported in 

the same manner as was required for 

organic chemical substances, including 

processing and use information. In 

addition, starting with the 2006 

collection and for future collections, 

specifically listed petroleum process 

streams and other specifically listed 

chemical substances were partially 

exempt, and manufacturers of such 

chemical substances were not required 

to report processing and use 

information. These partial exemptions 

will continue in subsequent submission 

periods under the CDR as revised in this 

final rule (including the 2012 

collection), for as long as the chemical 

substances remain on these partial 

exemption lists 40 CFR 711.6(b)(1) and 

(b)(2). 

Non-confidential data, including both 

searchable and separately downloadable 

databases, and the 2006 IUR data 

summary report are available to the 

public on the CDR Web site (http:// 

www.epa.gov/iur). 

D. Why is the agency amending the IUR 

rule? 

EPA has modified the IUR rule to 

meet four primary goals: 

1. To tailor the information collected 

to better meet the Agency’s overall 

information needs. 

2. To increase its ability to effectively 

provide public access to the 

information. 

3. To obtain new and updated 

information relating to potential 

exposures to a subset of chemical 

substances listed on the TSCA 

Inventory. 

4. To improve the usefulness of the 

information reported. EPA believes that 

expanding the range of chemical 

substances for which more in-depth 

processing and use information is to be 

reported and adjusting the specific 

reported information, the method and 

frequency of collecting the information, 

and CBI requirements will accomplish 

these goals. 

These goals are supported by a policy 

outlined in TSCA section 2, which is 

that ‘‘adequate data should be 

developed with respect to the effect of 

chemical substances and mixtures on 

health and the environment and that the 

development of such data should be the 

responsibility of those who manufacture 

and those who process such chemical 

substances and mixtures’’ (TSCA 

section 2(b)(1)). Modifications to the 

IUR requirements by the 2003 IUR 

Amendments provided many 

improvements to the data collected 

through that rule, and EPA’s efforts to 

use the 2006 IUR data identified areas 

where further improvements are 

needed. The modifications described in 

this final rule change some of the 

reporting requirements in an effort by 

EPA to ensure the required information 

is properly reported and that the 

information in the Agency’s database 

reflects the information provided in the 

IUR reports; increase the usability of the 

collected information; increase the 

availability of information for the 

public; and focus reporting on 

information that is most needed by the 

Agency. 

In addition, these changes will enable 

EPA and other Federal agencies to 

improve their risk screening 

capabilities, enabling them to better 

assess and manage risk, and improve 

public awareness of basic information 

about a large number of chemical 

substances. 

EPA provided reporting software for 

the 2006 IUR submission period and 

encouraged electronic reporting through 

the Internet, using the Agency’s CDX. 

EPA’s experience with populating the 

IUR database and with using the 2006 

IUR data provided insight into how well 

both the reporting software and 

submission methods worked. For 

instance, because of validations built 

into the reporting software, electronic 

submissions were able to be quickly 

assimilated into the IUR database. Other 

forms of submission required the 

documents to be scanned in or hand 

entered, and resulted in many 

introduced errors during the data entry 

process. Additionally, for the 2006 IUR, 

certain types of submissions (e.g., joint 

submissions) could not be reported 

electronically. Other problems, such as 

incorrect chemical identities, delayed 

the inclusion of the data into the 

database, resulting in the Agency’s 

inability to begin using the 2006 IUR 

data and providing public access in a 

timely manner. The modifications in 

this final rule associated with reporting 

methods and changes to the reporting 

software will better ensure the 

information reported to the Agency is 

accurate and in compliance with the 

IUR requirements. 


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During the development of the 2003 

IUR Amendments, the Agency 

considered the data accuracy and 

reliability needed for screening level 

exposure analyses and took several 

steps to ensure the IUR data met those 

needs. Screening level data need not be 

precise, but should be accurate and 

reliable enough for the Agency to 

develop screening level assessments. 

The 2003 IUR Amendments supplied 

exposure-related information the 

Agency did not previously possess, 

recognizing that industry has a greater 

knowledge than EPA about its own 

operations and the uses of chemical 

substances it manufactures and sells. 

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. In 2007, the Agency began 

to develop and post screening-level 

hazard, exposure, and risk 

characterizations for high production 

volume (HPV) chemical substances, 

which are those chemical substances 

produced nationally at aggregated 

volumes of one million lb or more per 

year. In developing these 

characterizations, EPA identified areas 

where the IUR data collection can be 

improved and enhanced. Improvements 

would allow EPA to better identify and 

take follow-up action on chemical 

substances that may pose potential risks 

to human health or the environment. 

During its review of the IUR data, EPA 

identified numerous examples of CBI 

claims where the same or similar 

information to that claimed as CBI was 

already available to the public. In 

several cases, information on 

production volume and uses for a 

chemical substance or group of 

chemical substances was claimed CBI 

on Form U, while the same or similar 

information was submitted voluntarily 

by the company without such a claim 

under the HPV Challenge Program. In 

those cases, EPA had previously made 

the information publicly available 

through the High Production Volume 

Information System (HPVIS) or on 

EPA’s Existing Chemicals Program Web 

site. More detailed CBI substantiation 

requirements will encourage the correct 

designation of non-confidential reported 

information, thereby facilitating 

reporting of this information to the 

public. 

EPA Administrator Lisa P. Jackson 

has made it a priority to strengthen the 

Agency’s chemical management 

program, including the development of 

new regulatory risk management 

actions, the development of Chemical 

Action Plans targeting the Agency’s risk 

management efforts, requiring the 

reporting of information needed to 

understand chemical substance risks, 

and increasing public access to 

information about chemical substances 

(Ref. 5). The IUR provides exposurerelated data needed to understand 

chemical substance risks. The 

modifications to the IUR rule will 

enhance the capabilities of the Agency 

to ensure risk management actions are 

taken on chemical substances which 

may pose the greatest concern. More indepth reporting of the processing and 

use data, more careful consideration of 

the need for confidentiality claims, and 

adjustments to the specific data 

elements are important aspects of this 

action. By enhancing the data supplied 

to the Agency, EPA expects to more 

effectively and expeditiously identify 

and address potential risks posed by 

chemical substances and provide 

improved access and information to the 

public. 

An important and anticipated result 

of this action is that EPA will receive 

more publicly available, non-CBI 

information, therefore increasing the 

transparency and public accessibility of 

the chemical substance use, and 

exposure information and ensuring 

consistency with the President’s policy 

goals for government reliance on and 

public availability of scientific 

information. 

As part of this action, EPA is also 

renaming the IUR to CDR. This name 

change is intended to better reflect the 

distinction between this data collection 

(which includes exposure-related data) 

and the TSCA Inventory itself (which 

only involves chemical identification 

information). Identifying this data 

collection as ‘‘CDR’’ will make it easier 

for the public to understand what 

information is available to them through 

the data collection. The name change 

thereby contributes to the Agency’s 

current chemicals management program 

by increasing transparency and 

facilitating public access to information 

about chemical substances. 

E. When is reporting required? 

EPA promulgated a final rule, 

published in the Federal Register issue 

of May 11, 2011 (Ref. 6), to suspend the 

2011 submission period. EPA 

suspended the submission period to 

allow additional time to finalize the 

proposed modifications, and to provide 

sufficient time for companies to comply 

with the CDR reporting requirements. 

This action supersedes the suspension 

of the 2011 submission period by 

establishing a new sequence of 

submission periods, beginning with a 

submission period in 2012. For the 2012 

CDR, all information reported to EPA in 

response to 40 CFR part 711 must be 

submitted between February 1, 2012, 

and June 30, 2012. Beginning in 2016 

and for each subsequent submission 

period, the submission period will begin 

June 1 and end September 30 (40 CFR 

711.20). 

III. What are the revised requirements 

of the CDR? 

EPA is making a number of revisions 

to the IUR, as described in this unit. The 

regulatory text of this document 

describes the full specific CDR reporting 

requirements and includes both the 

modified and the unmodified portions 

of the regulatory text (see 40 CFR part 

711). EPA has also developed guidance 

documents with specific reporting 

instructions, questions and answers, 

and case studies, and intends to conduct 

a webinar to help potential CDR 

submitters become familiar with the 

revised reporting form (Form U) and 

amended reporting requirements. 

Guidance documents and information 

on the webinar are available on the CDR 

Web site (http://www.epa.gov/iur). 

A. What technical modifications have 

been made to the regulatory text? 

The Agency is making several 

technical modification related to 

moving the regulatory text to its own 

part in the CFR. The chemical 

substances that are covered by the CDR 

rule are on the Master Inventory File, 

which includes chemical substances 

from the original TSCA Inventory 

compilation and those added 

subsequently through the notice 

requirements of TSCA section 5. 

Because the CDR rule applies to a list of 

chemical substances included on the 

original TSCA Inventory plus additional 

chemical substances added 

subsequently, and because the Agency 

from time to time has modified the CDR 

rule, the Agency believes the regulatory 

text associated with the CDR rule 

should be in its own part in the CFR, 

distinct from both the original TSCA 

Inventory rules and from the TSCA 

section 5 requirements. 

1. Move the IUR regulatory text from 

40 CFR part 710, subpart C, to 40 CFR 

part 711 and eliminate subpart 

divisions. Subpart C (40 CFR 710.43 to 

710.59) of 40 CFR part 710 contains the 

IUR regulatory text. EPA is moving all 

of the subpart C text from 40 CFR part 

710 to a new 40 CFR part 711 and 

adding a new scope and compliance 

section (40 CFR 711.1). 


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TABLE 1—DISTRIBUTION TABLE FOR 40 

CFR PART 710, SUBPART C, REGULATORY TEXT

Old CFR citation New CFR citation 

40 CFR 710.43 40 CFR 711.3 

40 CFR 710.45 40 CFR 711.5 

40 CFR 710.46 40 CFR 711.6 

40 CFR 710.48 40 CFR 711.8 

40 CFR 710.49 40 CFR 711.9 

40 CFR 710.50 40 CFR 711.10 

40 CFR 710.52 40 CFR 711.15 

40 CFR 710.53 40 CFR 711.20 

40 CFR 710.55 40 CFR 711.22 

40 CFR 710.57 40 CFR 711.25 

40 CFR 710.58 40 CFR 711.30 

40 CFR 710.59 40 CFR 711.35 

Because all of the text of subpart C 

was moved to 40 CFR part 711, 40 CFR 

part 710 no longer has a subpart C. 

Neither 40 CFR part 710 nor 40 CFR part 

711 have any subparts. 

2. Consolidate definitions. As part of 

moving the regulatory text from 40 CFR 

part 710, subpart C, to 40 CFR part 711, 

EPA is consolidating definitions copied 

from 40 CFR 710.3 and 40 CFR 710.43 

into the new 40 CFR 711.3, except 

where an appropriate definition is 

already in place in TSCA section 3 or 

at 40 CFR 704.3, and an additional 

definition of the term in 40 CFR 711.3 

was therefore unnecessarily duplicative. 

The definitions in TSCA section 3 and 

at 40 CFR 704.3 are included in 40 CFR 

711.3, except insofar as 40 CFR 711.3 

provides a modified definition of a term 

also defined at 40 CFR 704.3. 

The term mixture is defined in both 

40 CFR 710.3 and TSCA section 3. For 

purposes of the CDR rule, EPA is 

including the definition of mixture from 

TSCA section 3 with the definitions at 

40 CFR 711.3. The TSCA mixture 

definition differs from the definition in 

40 CFR 710.3 and 40 CFR 720.3, the 

regulations used to determine the 

chemical substances listed on the TSCA 

Inventory, in that it does not specifically 

address hydrates. A hydrate is a mixture 

of water and an anhydrous chemical 

substance. Because they are mixtures, 

hydrates are not listed as such on the 

TSCA Inventory. For this reason, EPA 

believes it is superfluous to include a 

specific discussion of hydrates in the 

CDR definition of mixture. Please see 

the Instructions for the 2012 TSCA 

Chemical Data Reporting (Instructions 

document) for additional discussion 

(Ref. 7). 

Unit III.C. contains further 

discussions about changes to specific 

definitions, in relation to the 

modifications included in this final 

rule. A summary of all CDR-related 

definitions is available in the docket 

(Ref. 8). 

3. Remove ‘‘non-isolated 

intermediate’’ definition from 40 CFR 

710.3. EPA added a definition to 40 CFR 

710.43 for the term non-isolated 

intermediate as part of the 2003 IUR 

Amendments. Subsequently, as part of 

the IUR Revisions Rule, published in 

the Federal Register issue of December 

19, 2005 (Ref. 9), EPA erroneously 

moved the definition to 40 CFR 710.3 

from 40 CFR 710.43. EPA is removing 

the definition from 40 CFR 710.3 as this 

definition was not associated with the 

original TSCA Inventory, and therefore 

does not belong in 40 CFR 710.3. A 

definition of this term, codified 

elsewhere at 40 CFR 704.3, is included 

with the CDR definitions at 40 CFR 

711.3. 

4. Remove 40 CFR part 710, subpart 

B. EPA is removing the regulatory text 

contained in 40 CFR part 710, subpart 

B (40 CFR 710.23 to 710.39). This text 

refers to IUR submission periods of 2002 

and earlier and is obsolete. As noted in 

40 CFR 710.1, the Agency expressed its 

intent to remove 40 CFR part 710, 

subpart B, once the 2002 update was 

complete. 

5. Remove superfluous text associated 

with reporting production volumes. EPA 

is removing the phrase ‘‘provided that 

the reported figures are within ±10% of 

the actual volume’’ from the production 

volume reporting requirements found in 

40 CFR 710.52(c)(3)(iv), which appears 

in the new 40 CFR part 711 as 40 CFR 

711.15(b)(3)(iv). The revised wording 

would be ‘‘This amount must be 

reported to two significant figures of 

accuracy.’’ The phrase that was removed 

is superfluous because any number 

reported accurately to two significant 

figures is within 10% of the correct 

value. 

6. Correct text associated with 

reporting number of sites and number of 

workers. EPA is replacing the phrase 

‘‘less than’’ with the phrase ‘‘fewer 

than’’ in the ranges used to report the 

number of workers found in the table in 

40 CFR 710.52(c)(3)(v), which appears 

in the new 40 CFR part 711 as 40 CFR 

711.15(b)(3)(vii) and the number of sites 

found in the table in 40 CFR 

710.52(c)(4)(i)(E), which appears in the 

new 40 CFR part 711 as 40 CFR 

711.15(b)(4)(i)(E). This change makes 

the phrases describing the ranges 

grammatically correct. 

B. What are the changes to the method 

of submission? 

EPA is requiring the mandatory use of 

Agency-provided, web-based reporting 

tool (e-CDRweb) and CDX to submit the 

completed Form U to the Agency. After 

the final rule’s effective date, EPA will 

no longer accept paper submissions or 

electronic media (i.e., as a file on a CD– 

ROM) for any CDR submission. 

In order to submit electronically to 

EPA via CDX, individuals acting on 

behalf of the submitter must first 

register with CDX. CDX registration is a 

requirement for all electronic 

submissions using CDX; this 

requirement predates this final rule. 

EPA has modified the 2006 Electronic 

Signature Agreement (ESA) Form to 

identify more clearly the individual(s) 

required to sign the ESA Form (Ref. 10). 

Each CDR submission must have an 

authorized official associated with the 

submission, who is the person signing 

the certification statement and 

submitting the CDR report via CDX. The 

authorized official must complete both 

an ESA Form and the CDX registration 

process. Companies can access the 

reporting tool upon completion of their 

CDX registration. The instruction 

manual and other guidance materials 

are available on EPA’s Web site 

(http://www.epa.gov/iur). 

C. What definitions have been modified 

or added to clarify the reporting 

requirements? 

As part of developing the definition 

section for 40 CFR part 711, EPA is 

modifying six definitions associated 

with the CDR rule and adding four new 

definitions. In 40 CFR 704.3 and 40 CFR 

710.3, EPA is also modifying the 

definition of importer by removing the 

citation to 19 CFR 1.11. 

1. Manufacture and manufacturer. To 

improve the information submitted 

through the CDR rule, EPA is modifying 

the definition of manufacture by 

including elements from the 40 CFR 

720.3 definition for manufacturer. The 

Agency is also adding a simple 

definition for the term manufacturer to 

40 CFR 711.3. In addition to the change 

to the definition of manufacture, EPA is 

adding a paragraph (c) to the regulation 

at 40 CFR 711.22 to clarify the reporting 

relationship between the contracting 

company and the toll manufacturer. The 

contracting company and the toll 

manufacturer should confer with each 

other to avoid duplicate reporting, and 

both the contracting company and the 

toll manufacturer are liable if no report 

is made. EPA agreed with comments 

that the ‘‘primarily responsible’’ 

language that was proposed was 

confusing and needed to be revised. As 

a result, EPA modified paragraph (c) of 

40 CFR 711.22 to clarify that the 

contracting company and the toll 

manufacturer should determine among 

themselves who should submit the 

required report for the site. EPA also 

added ‘‘per site’’ in two places in 

paragraph (c) of 40 CFR 711.22 to 


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specify that there is supposed to be one 

report per chemical substance, per site. 

See Unit III.C.2., for further discussion 

of the site for contract manufacturing 

situations. 

This final rule defines the term 

manufacture under the CDR to mean: 

To manufacture, produce, or import, for 

commercial purposes. Manufacture includes 

the extraction, for commercial purposes, of a 

component chemical substance from a 

previously existing chemical substance or a 

complex combination of substances. When a 

chemical substance, manufactured other than 

by import, is: 

(1) Produced exclusively for another 

person who contracts for such production, 

and 

(2) That other person specifies the identity 

of the chemical substance and controls the 

total amount produced and the basic 

technology for the plant process, then that 

chemical substance is co-manufactured by 

the producing manufacturer and the person 

contracting for such production. 

This final rule defines the term 

manufacturer under the CDR to mean ‘‘a 

person who manufactures a chemical 

substance.’’ 

2. Site. EPA is amending the 

definition of site to clarify that the 

importer’s site must be a U.S. address; 

accommodate manufacturing under 

contract; and accommodate portable 

manufacturing units. See Unit III.J., for 

a further discussion of this final rule as 

it relates to importers. 

This final rule defines the term site 

under the CDR to mean: 

A contiguous property unit. Property divided 

only by a public right-of-way shall be 

considered one site. More than one plant may 

be located on a single site. 

(1) For chemical substances manufactured 

under contract, i.e., by a toll manufacturer, 

the site is the location where the chemical 

substance is physically manufactured. 

(2) The site for an importer who imports 

a chemical substance described in 40 CFR 

711.5 is the U.S. site of the operating unit 

within the person’s organization that is 

directly responsible for importing the 

chemical substance. The import site, in some 

cases, may be the organization’s headquarters 

in the United States. If there is no such 

operating unit or headquarters in the United 

States, the site address for the importer is the 

U.S. address of an agent acting on behalf of 

the importer who is authorized to accept 

service of process for the importer. 

(3) For portable manufacturing units sent 

out to different locations from a single 

distribution center, the distribution center 

shall be considered the site. 

3. Electronic-reporting related 

definitions. EPA is adding two new 

terms, Central Data Exchange (CDX) 

and e-CDRweb. The Agency is adding 

these terms to provide clarity to the 

requirement for electronic reporting of 

CDR data. The term CDX means ‘‘EPA’s 

centralized electronic document 

receiving system, or its successors.’’ The 

term e-CDRweb means the ‘‘electronic, 

web-based CDR tool provided by EPA 

for the completion and submission of 

the CDR data.’’ 

4. Processing and use-related 

definitions. EPA is amending the 

definitions of the terms commercial use 

and consumer use in order to make 

them more consistent with the 

definitions developed collaboratively by 

the United States and Canada. See Unit 

III.G.8.a., for further information. While 

the definitions for these two terms differ 

in their precise wording from the 

Canadian version (to preserve the use of 

terminology defined in CDR and related 

regulations), EPA does not expect the 

basic application of these two terms to 

differ from the basic application of the 

Canadian definitions (Ref. 11). The term 

commercial use means ‘‘the use of a 

chemical substance or a mixture 

containing a chemical substance 

(including as part of an article) in a 

commercial enterprise providing 

saleable goods or services.’’ Examples 

included in the 40 CFR 710.43 

definition have been eliminated. The 

slightly modified definition of consumer 

use is ‘‘the use of a chemical substance 

or a mixture containing a chemical 

substance (including as part of an 

article) when sold to or made available 

to consumers for their use.’’ The 

restrictions associated with where a 

consumer would use the product have 

been removed. 

EPA is adding a definition for the 

term industrial function. For the 2006 

IUR, EPA defined industrial use and did 

not define industrial function. The 

inclusion of both definitions provides 

clarity for the industrial processing and 

use reporting requirements and makes 

the Agency’s requirements consistent 

with those collaboratively developed 

with Canada (Ref. 11). Additional 

discussion of those requirements is in 

Unit III.G.7. With this final rule, 

industrial function means ‘‘the intended 

physical or chemical characteristic for 

which a chemical substance or mixture 

is consumed as a reactant; incorporated 

into a formulation, mixture, reaction 

product, or article; repackaged; or 

used.’’ 

5. Principal reporting year and 

submission period. As described in Unit 

II.A., EPA is changing the reporting 

frequency from every 5 years to every 

4 years and requiring the reporting of 

production volumes for each calendar 

year since the last principal reporting 

year. EPA is modifying the terms 

reporting year and submission period to 

reflect these changes. 

The term reporting year is modified to 

add the term ‘‘principal’’ and to replace 

the word ‘‘information’’ with 

‘‘manufacturing, processing and use 

data.’’ These changes are to indicate that 

the principal reporting year is the year 

in which most of the reported data are 

based. Under the final rule, the 

principal reporting year is the latest 

complete calendar year preceding the 

submission period. Additionally, EPA is 

removing the reference to ‘‘the calendar 

year at 5-year intervals thereafter’’ and 

removing the reference to ‘‘calendar 

year 2005.’’ With these changes, the 

term principal reporting year is defined 

as ‘‘the latest complete calendar year 

preceding the submission period.’’ 

The term submission period is 

modified by removing the phrase 

‘‘generated during the reporting year.’’ 

With this change, the definition of 

submission period reflects that data for 

years in addition to the principal 

reporting year would be reported. With 

this change, the definition of submission 

period means ‘‘the period in which 

manufacturing, processing, and use data 

are submitted to EPA.’’ 

D. Has the reporting frequency been 

changed? 

As proposed, EPA has changed the 

reporting frequency to every 4 years. 

The Agency has determined that 

reporting every 5 years is too infrequent 

and believes that returning reporting to 

every 4 years will provide data 

sufficiently current to meet Agency and 

public needs. After the 2012 submission 

period, the next submission period 

under the CDR rule will occur in 2016. 

The submission period will continue to 

occur in the year following the principal 

reporting year. 

E. How have the reporting thresholds 

changed? 

Reporting thresholds are used to 

determine when CDR reporting is 

required for a subject chemical 

substance at a manufacturing (including 

importing) site. EPA has made three 

changes related to the reporting 

thresholds: 

• Determination of whether you meet 

the 25,000 lb threshold. 

• Replacement of the 300,000 lb 

threshold for reporting information in 

Part III of Form U. 

• Reduction of the 25,000 lb 

threshold for certain chemical 

substances. 

1. Method for determining whether a 

person is subject to CDR reporting 

requirements. For the 2012 submission 

period, manufacturers (including 

importers) are required to report under 

the CDR rule if they manufacture 


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(including import) a chemical substance 

listed on the TSCA Inventory during the 

principal reporting year (i.e., 2011 for 

the 2012 submission period); the 

chemical substance is not otherwise 

exempt; and the associated production 

volume (domestically manufactured 

plus imported volumes) at a site met or 

exceeded 25,000 lb during the principal 

reporting year (i.e., 2011 for the 2012 

submission period). 

For submission periods subsequent to 

the 2012 submission period, the 

determination of the need to report is 

based on whether, for any calendar year 

since the last principal reporting year, a 

chemical substance was manufactured 

(including imported) at a site in 

production volumes of 25,000 lb or 

greater. For example, for the 2016 

submission period, it would be 

necessary to examine the annual 

production volumes for the calendar 

years 2012 to 2015 for the site. If the 

production volume for a reportable 

chemical substance were 25,000 lb or 

greater for any calendar year during that 

4-year period, then it would be 

necessary to report the chemical 

substance, unless it were otherwise 

exempt. For instance, a subject chemical 

substance with production volumes of 

5,000 lb in 2015 and 35,000 lb in 2012 

would be reported for the 2016 CDR. 

Regardless of the 2015 production 

volume, in this example scenario the 

2016 CDR submission would contain 

detailed information based on the 

production volume during the 2015 

calendar year and production volume 

information only for the years 2012 

through 2014. See Unit III.D.1. of the 

proposed rule (Ref. 1) for further 

discussion. 

EPA is finalizing this change because 

of the mounting evidence that many 

chemical substances, even larger 

production volume chemical 

substances, often experience wide 

fluctuations in production volume from 

year to year. (See Unit III.D.1. of the 

proposed rule (Ref. 1).) This can result 

in the production volume of a chemical 

substance exceeding the threshold for 

several years, then falling below the 

threshold during the CDR principal 

reporting year. EPA believes that using 

production volume reporting for all 

years since the last principal reporting 

year to determine reporting obligations 

will yield a much more accurate picture 

of the chemical substances currently in 

commerce, ensuring proper review 

under EPA’s risk screening, assessment, 

and management activities and 

providing better information to the 

public. This issue is addressed further 

in Unit V.C. as well as in the ‘‘Summary 

of EPA’s Responses to Public Comments 

Submitted in Response to Proposed 

TSCA Inventory Update Reporting 

Modifications Rule’’ (Responses to 

Comments document) (Ref. 12). 

2. Replacement of the 300,000 lb 

threshold for processing and use 

information. EPA is replacing the 

300,000 lb threshold for processing and 

use information by phasing in a lower 

reporting threshold. For the 2012 CDR, 

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. Subsequent to the 

2012 submission period, the reporting 

threshold will be 25,000 lb (or 2,500 lb 

for chemical substances subject to 40 

CFR 711.8(b)). EPA is replacing the 

300,000 lb reporting threshold in order 

to collect information necessary to 

complete screening-level exposure 

characterizations for CDR reportable 

chemical substances. EPA is phasing in 

the lower threshold in order to give 

chemical manufacturers time to comply 

with the modified reporting 

requirements. 

In order to select a threshold for 

processing and use reporting, EPA 

considered the burden of reporting as 

well as the Agency’s needs for 

processing and use information on the 

maximum number of chemical 

substances. As discussed elsewhere in 

this preamble and other supporting 

documents, EPA identified that the 

processing and use data received from 

the 2006 IUR was not sufficient in part 

because it did not include information 

on many HPV and most moderate 

production volume (MPV) chemical 

substances that EPA was trying to 

assess. Therefore, in its proposal, EPA 

proposed lowering the processing and 

use reporting threshold from 300,000 lb 

to 25,000 lb in order to enable the 

Agency to collect exposure-related 

information needed to screen and 

prioritize the HPV and MPV chemical 

substances. EPA received comments 

suggesting that the Agency adopt a 

phased-in approach for reducing the 

threshold, similar to the approach used 

for introducing the requirement for 

reporting information for inorganic 

chemical substances. Manufacturers 

reporting for inorganic chemical 

substances were provided a one-time 

partial exemption for those substances 

for the 2006 IUR, thereby phasing in 

reporting. Other commenters suggested 

that because reporting of processing and 

use information for inorganic chemicals 

was not required for the 2006 IUR, the 

industry sector is still inexperienced 

with reporting such information and 

therefore should be given an 

opportunity to report under the existing 

thresholds. Another commenter 

suggested that EPA lower the processing 

and use threshold to 100,000 lb, which 

is consistent with one of the triggers for 

the small business exemption. 

EPA agrees with a phased-in approach 

because it provides submitters with an 

opportunity to become familiar with the 

reporting requirements, while at the 

same time providing much needed and 

more complete processing and use 

information on chemical substances of 

interest to the Agency. Future reporting 

of the processing and use information 

by all submitters 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. In the future, 

EPA may find it necessary to collect 

information on chemical substances at 

reporting thresholds below the 

thresholds introduced in this action. 

Using the 2006 IUR data, EPA looked 

at the effect of setting the processing 

and use reporting threshold at various 

levels. Based on this information, 

lowering the threshold to 25,000 lb 

would not have brought in a significant 

number of new reporters for the 2012 

submission period, because about 89% 

of companies and 86% of sites reported 

at least one chemical substance with a 

production volume of 300,000 lb or 

more in 2006 (Ref. 13). Therefore, most 

companies would be expected to be 

generally aware of the processing and 

use reporting requirements because the 

company would have reported such 

information on at least one chemical 

substance. 

On a chemical-by-chemical basis, 

EPA’s examination of the 2006 IUR data 

revealed that approximately 66% of the 

individual reports were above the 

300,000 lb threshold, and that these 

reports covered approximately 60% of 

the chemical substances reported for the 

2006 IUR. Lowering the threshold to 

25,000 lb would result in processing 

and use information on 40% more 

chemicals and would have greatly 

informed EPA’s Existing Chemicals 

Program. As discussed earlier, EPA 

recognized the need to allow companies 

time to become familiar with reporting 

the processing and use information, and 

therefore considered alternate reporting 

thresholds for the 2012 CDR. Lowering 

the threshold to 100,000 lb results in 

processing and use information on 

approximately 23% more chemical 

substances than the 300,000 lb 

threshold, while increasing the number 

of reports by only approximately 18%. 

EPA believes that the 100,000 lb 

threshold, as an interim threshold, 

provides an appropriate balance 


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between increasing the number of 

chemicals with processing and use 

information and increasing the reporting 

burden on industry. See the ‘‘Economic 

Analysis for the Final Inventory Update 

Reporting (IUR) Modifications Rule’’ 

(Economic Analysis) (Ref. 14) for further 

discussion. 

The exposure information is an 

essential part of developing risk 

evaluations and, based on its experience 

in using this information, the Agency 

believes that collecting this exposure 

information is critical to its mission of 

characterizing exposure, identifying 

potential risks, and noting uncertainties 

for these lower production volume 

chemical substances. In addition, the 

lower thresholds will provide the public 

with information on a greater number of 

chemical substances. This issue is 

addressed further in Unit V.C.2., as well 

as in the Responses to Comments 

document (Ref. 12). 

3. Reduction of the 25,000 lb 

threshold for specific regulated 

chemical substances. For the 2012 CDR, 

EPA is maintaining the 25,000 lb 

reporting threshold for chemical 

substances that are the subject of 

particular TSCA rules and/or orders. For 

future CDR collections, EPA is reducing 

the threshold (including the threshold 

for the collection of processing and use 

information) to 2,500 lb for those 

chemical substances (40 CFR 711.8(b)). 

EPA proposed to eliminate the 

threshold, which would have required 

manufacturers (including importers) of 

such chemical substances to report 

under the CDR rule, regardless of the 

production volume. A number of 

commenters supported the proposal to 

eliminate the reporting threshold while 

others felt the requirement would be 

overly burdensome, especially for 

imported chemical substances or 

mixtures. In its proposal, EPA 

specifically asked for comment on 

whether a de minimis production 

volume threshold should be set for these 

chemical substances and how best to set 

such a de minimis threshold. Some 

commenters opposed setting a de 

minimis threshold and others suggested 

a variety of methods for establishing 

one. 

For many of the reasons identified by 

commenters (e.g., the expense and 

burden of collecting the information, 

and difficulty in knowing whether lowconcentration chemical substances are 

present in formulated mixtures), EPA 

has decided to set a de minimis 

threshold and to delay its 

implementation. Beginning with the 

2016 submission period, the reporting 

threshold will be reduced to 2,500 lb for 

those chemical substances that are: 

• The subject of a rule proposed or 

promulgated under TSCA section 

5(a)(2), 5(b)(4), or 6, 

• The subject of an order issued 

under TSCA section 5(e) or 5(f), or 

• The subject of relief that has been 

granted under a civil action under TSCA 

section 5 or 7. 

(40 CFR 711.8(b)) 

For the 2016 submission period and 

submission periods thereafter, a 

manufacturer (including importer) of 

such chemical substances is required to 

report manufacturing information on the 

chemical substances if they are 

manufactured (including imported) in 

volumes of 2,500 lb or more during any 

of the years since the last principal 

reporting year (e.g., 2011). Information 

on the processing and use of the 

chemical substances must be reported if 

they were manufactured (including 

imported) in volumes of 2,500 lb or 

more during any of the years since the 

last principal reporting year. In addition 

to the manufacturing, processing, and 

use information for the principal 

reporting year (e.g., 2015), the 

production volumes for each year since 

the last principal reporting year must 

also be reported. For the 2016 

submission period, for example, a 

manufacturer (including importer) must 

consider the manufactured or imported 

volume during the years 2012 through 

2015 to determine the need to report; 

must report the production volumes for 

each year from 2012 to 2015; and must 

report the full manufacturing, 

processing, and use information for 

2015. 

Chemical substances that are the 

subject of these particular TSCA actions 

are of demonstrated high interest to the 

Agency. EPA is promulgating this 

change to help reduce the reporting 

burden for submitters and to ensure the 

availability of current information when 

the Agency has expressed a concern in 

the form of regulatory action on those 

chemical substances. EPA will use the 

CDR data associated with these specific 

regulated chemical substances to 

monitor chemical substance production 

and compliance with the particular 

TSCA actions. In the future, EPA may 

find it necessary to collect information 

on chemical substances at a reporting 

threshold below the 2,500 lb threshold 

introduced in this action. Although the 

2,500 lb threshold is higher than the 

proposed threshold of zero, the 

enhanced information that will be 

gathered during the 2016 submission 

period will enable the Agency and 

others to more efficiently identify those 

chemical substances warranting further, 

more in-depth review, as well as 

chemical substances of lesser concern. 

See Unit V.C.3., for further discussion. 

As under the 2006 IUR, if a 

manufacturer qualifies for the small 

manufacturer exemption at 40 CFR 

711.9, it is exempt from CDR reporting. 

Nothing in this final rule affects the 

scope of this exemption at 40 CFR 

711.9. However, because the reduction 

in the reporting threshold to 2,500 lb is 

generally applicable to all 

manufacturers of the subject chemical 

substances, for the 2016 submission 

period and subsequent submission 

periods, it may affect small 

manufacturers to the extent they are 

non-exempt under 40 CFR 711.9. As 

under the 2006 IUR, small 

manufacturers are generally exempt 

from CDR reporting but are specifically 

subject to reporting with respect to any 

chemical substance that is the subject of 

a rule proposed or promulgated under 

TSCA section 4, 5(b)(4), or 6, or is the 

subject of an order in effect under TSCA 

section 5(e), or is the subject of relief 

that has been granted under a civil 

action under TSCA section 5 or 7 (40 

CFR 711.9). With the exception of rules 

proposed or promulgated under TSCA 

section 4, the same TSCA actions that 

make small manufacturers ineligible for 

a CDR exemption under 40 CFR 711.9 

(with respect to the particular chemical 

substance that is the subject of the 

action) will also make those small 

manufacturers subject to the 2,500 lb 

reporting threshold in the 2016 

submission period and subsequent 

submission periods (40 CFR 711.8(b)). 

The proposal or promulgation of a rule 

under TSCA section 4 affects the small 

manufacturer exemption but it does not 

affect the applicable reporting threshold 

under CDR. 

In the proposed rule, EPA specifically 

sought comment on whether 

circumstances triggering an exception to 

the 25,000 lb reporting threshold for a 

chemical substance should include the 

proposal of certain rules for the 

chemical substance, under TSCA 

section 5(a)(2), 5(b)(4), or 6. EPA 

explained that such an approach would 

more closely parallel the exception 

language in the introductory paragraph 

to 40 CFR 711.6 and in 40 CFR 711.9. 

(See Unit III.D.3. of the proposed rule 

(Ref. 1)). Including these types of 

proposed rules in the list of triggering 

circumstances is also more consistent 

with reporting obligations under other 

parts of TSCA, such as 12(b). Among 

other situations, reporting under TSCA 

12(b) is required when any rule under 

TSCA section 5 or 6 is proposed or 

promulgated. In response to the 

comments received, EPA has 

determined that chemical substances 


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subject to a rule proposed under TSCA 

section 5(a)(2), 5(b)(4), or 6 will be 

excepted from the 25,000 lb reporting 

threshold, and thus will be reportable at 

2,500 lb beginning with the 2016 CDR. 

See Unit V.C.3., for further discussion. 

F. What are the changes to the chemical 

substances covered by CDR? 

1. Water. EPA is fully exempting all 

(both naturally occurring and 

manufactured) water (Chemical 

Abstracts Service Registry Number 

(CASRN) 7732–18–5) (40 CFR 

711.6(a)(4)) from reporting under the 

CDR rule. 

2. Fully exempt polymers removed 

from partially exempt list. Polymers are 

a class of chemical substances for which 

CDR reporting is not required (40 CFR 

711.6(a)(1)). However, three polymers 

were previously listed in the partially 

exempt list of chemical substances at 40 

CFR 710.46(b)(2)(iv): Starch (CASRN 

9005–25–8), dextrin (CASRN 9004–53– 

9), and maltodextrin (CASRN 9050–36– 

6). EPA has removed from the partially 

exempt list of chemical substances at 40 

CFR 711.6(b)(2)(iv) these three chemical 

substances which, as polymers, are fully 

exempt from reporting. 

3. Chemical substances that are the 

subject of an ECA are ineligible for 

exemptions. EPA may enter into an 

ECA, pursuant to procedures at 40 CFR 

part 790, with a manufacturer of a 

chemical substance to obtain testing 

where a consensus exists among EPA, 

affected manufacturers and/or 

processors, and interested members of 

the public concerning the need for and 

scope of testing. Chemical substances 

that are the subject of an ECA are now 

included in the list of chemical 

substances that are ineligible for a CDR 

exemption, in the introductory 

paragraph of 40 CFR 711.6, along with 

the other chemical substances that are 

likewise not eligible for a CDR 

exemption. The paragraph states that a 

chemical substance ‘‘is not exempted 

from any of the reporting requirements 

of this part if that substance is the 

subject of a rule proposed or 

promulgated under section 4, 5(a)(2), 

5(b)(4), or 6 of the Act, or is the subject 

of a consent agreement developed under 

the procedures of 40 CFR part 790, or 

is the subject of an order issued under 

section 5(e) or 5(f) of the Act, or is the 

subject of relief that has been granted 

under a civil action under section 5 or 

7 of the Act.’’ 

G. What changes have been made to 

reportable data elements? 

1. Parent company and site identity. 

Manufacturers (including importers) are 

required to report the company name 

and Dun & Bradstreet D–U–N–S® 

((D&B) number) to identify the company 

associated with the plant site, and also 

to report the site name, address, and 

D&B number. If the company associated 

with the plant site does not have a D&B 

number, the manufacturer (including 

importer) must obtain one for the 

company. Likewise, if the plant site 

does not have a D&B number, the 

manufacturer (including importer) must 

obtain one for the site. EPA received a 

variety of questions concerning the 

correct company name to report during 

the 2006 IUR submission period. EPA is 

now clarifying what is meant by 

company name, by requiring at 40 CFR 

711.15(b)(2)(ii) that the company name 

provided be the 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.’’ As noted in the 

proposed rule (Ref. 1), EPA believes that 

using an approach that is consistent 

with the Toxics Release Inventory (TRI) 

reporting requirements would be most 

clear both for reporters and users of the 

data. The CDR 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). The 2006 IUR 

submissions from different reporting 

sites contained varying D&B numbers 

for parent companies that appeared to 

be the same company. In order to better 

identify when reporting sites are under 

the same parent company, EPA is 

requiring the address as well as the D&B 

number of the parent company. 

2. Technical contact. Manufacturers 

(including importers) are required to 

provide a technical contact for their 

CDR submission. The technical contact 

does not have to be a person located at 

the manufacturing (including importing) 

site, but must be a person who can 

answer questions EPA may have about 

the reported chemical substance. In the 

proposed rule, EPA had stated that the 

technical contact should be a person 

located at the manufacturing (including 

importing) site. EPA has decided, 

however, to not impose limitations on 

where the technical contact can be 

located. Therefore, companies may use 

their discretion in selecting a technical 

contact or multiple technical contacts, 

as provided by the new e-CDRweb tool. 

Submitters should consider, in selecting 

the technical contact, that EPA may 

have follow-up questions about a CDR 

submission, one or more years after the 

submission date. 

3. Chemical identification. 

Manufacturers (including importers) are 

required to submit the correct chemical 

identity for each subject chemical 

substance. 

a. Chemical name. EPA is requiring 

the reporting of the Chemical Abstracts 

(CA) Index Name currently used to list 

the chemical substance on the TSCA 

Inventory as the chemical name 

reported for CDR. The reporting tool 

will be directly linked to the nonconfidential portion of the TSCA 

Inventory through the Agency’s 

Substance Registry Services (SRS) 

database, which lists all chemical 

substances on the TSCA Inventory. This 

link will enable submitters to select the 

correct CA Index Name for their 

reportable chemical substance(s) from 

SRS. EPA believes that using SRS to 

select the chemical name as currently 

listed on the TSCA Inventory will 

greatly reduce the number of incorrectly 

identified chemical substances and 

allow the data to be released more 

quickly to the public. See the discussion 

in Unit III.G.3.c. regarding identifying 

confidential chemical substances. 

Manufacturers (including importers) are 

allowed to supply, as part of a joint 

submission, an alternate chemical name, 

and in the case of importers, a trade 

name, in those instances where a 

supplier will not disclose to the 

submitter the specific chemical name of 

the imported TSCA Inventory chemical 

substance or a reactant used to 

manufacture the TSCA Inventory 

chemical substance. In these cases, the 

manufacturer (including importer) and 

the supplier may report the information 

required in this part in a joint 

submission. In order to clarify this 

requirement, EPA is amending 40 CFR 

part 711.15(b)(3)(i), to state that the 

importer must ask the supplier of the 

confidential chemical substance to 

directly provide EPA with the correct 

chemical identity, in a joint submission 

with the manufacturer. Similarly, in the 

event a manufacturer submitting a Form 

U cannot provide the whole chemical 

identity because the reportable chemical 

substance is manufactured using a 

reactant having an unknown specific 

chemical identity claimed as 

confidential by its supplier, the 

manufacturer must ask that the supplier 

directly provide to EPA the correct 

chemical identity of the confidential 

reactant in a joint submission. Nothing 

in 40 CFR 711.15(b)(3)(i) relieves a 

manufacturer (including an importer) of 

its obligation to report information that 

it actually knows or can reasonably 

ascertain. See Unit III.J.2., for additional 

information regarding joint submissions. 


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Detailed instructions regarding joint 

submissions are included in the 

Instructions document included in the 

docket (Ref. 7). 

b. Chemical identifying number. As 

part of the chemical identity, submitters 

provide a chemical identifying number 

associated with the correct CA Index 

Name, as described in Unit III.G.3.a. 

EPA is requiring that submitters report 

only the CASRN as a chemical 

identifying number, except in the case 

of confidential chemical substances. In 

the case of confidential chemical 

substances, EPA is requiring that 

submitters report only the TSCA 

Accession Number as a chemical 

identifying number. EPA is removing 

the Premanufacture Notification (PMN) 

number as an allowed chemical 

identifying number because each TSCA 

Inventory chemical substance has either 

(or both) a CASRN or a TSCA Accession 

Number, which are likely to be already 

known to the submitter. Submitters 

who, in the past, have reported using 

the PMN number of a confidential 

substance can identify the TSCA 

Accession Number from SRS by 

searching on the PMN number. Those 

submitters who are not able to identify 

the TSCA Accession Number by 

searching SRS may contact EPA in 

writing, if necessary, to learn the TSCA 

Accession Number assigned when the 

Notice of Commencement (NOC) was 

submitted to the Agency. Specific 

information is included in the 

Instructions document (Ref.7). 

c. Chemical identity for chemical 

substances listed on the confidential 

portion of the TSCA Inventory. In cases 

where a chemical substance is listed on 

the confidential portion of the TSCA 

Inventory, submitters are to report the 

chemical substance’s TSCA Accession 

Number and generic name, which are 

listed on the non-confidential portion of 

the TSCA Inventory and are included in 

SRS. In order to continue to protect the 

confidentiality of the underlying 

specific chemical identification 

information (i.e., the CASRN and 

specific chemical name), the submitter 

must claim the chemical identity as CBI 

and complete the upfront 

substantiation. Doing so will maintain a 

confidentiality claim for the underlying 

CASRN and specific chemical name on 

the confidential portion of the TSCA 

Inventory (the TSCA Accession Number 

and generic chemical name remain nonconfidential). Failure to identify the 

chemical identity as CBI and complete 

the upfront substantiation will waive 

any CBI claim to the chemical identity 

and will result in the transfer of the 

chemical substance from the 

confidential portion of the TSCA 

Inventory to the non-confidential, 

publicly releasable, portion of the TSCA 

Inventory. 

4. Production volume. Manufacturers 

(including importers) are required to 

report production volume information 

for each chemical substance for which 

they submit a CDR report. EPA has 

made a number of changes to the 

reporting of production volume and 

associated information. 

a. Report production volume for each 

of the years since the last principal 

reporting year. In addition to the 

production volume for the principal 

reporting year, EPA is requiring the 

reporting of production volume for 2010 

for the 2012 submission period and for 

each of the years since the last principal 

reporting year beginning with the 2016 

submission period. More specifically, 

for the 2012 submission period, 

manufacturers (including importers) 

will be required to report the total 

annual volume (domestically 

manufactured and imported volumes in 

pounds) of each reportable chemical 

substance at each site during calendar 

year 2010. For submission periods 

subsequent to the 2012 submission 

period, manufacturers (including 

importers) will be required to report 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 CDR 

principal reporting year. For example, 

for the 2016 submission period, 

manufacturers (including importers) of a 

reportable chemical substance will 

report the production volume of that 

chemical substance for each of the 

following calendar years: 2015, 2014, 

2013, and 2012. 

EPA had proposed that this 

requirement begin in full starting with 

the current submission period, which 

would have required submitters to 

report production volumes for 2006 

through 2010 for the 2012 submission 

period. Several commenters supported 

the proposed change while others stated 

that the requirement would be overly 

burdensome, especially for the 

submission period immediately 

following promulgation of this rule. 

Some commenters recommended that 

EPA delay the implementation of the 

requirement until the next reporting 

cycle to allow companies sufficient time 

to prepare for the additional data 

collection effort. In response to the 

comments received, EPA believes its 

decision to defer this requirement until 

the next reporting cycle is warranted in 

light of other simultaneous changes to 

the CDR rule which increase reporting 

burden. The Agency also believes the 

delay will give companies adequate 

time to establish systems to collect and 

compile the required information. 

For the principal reporting year, e.g., 

2011, the domestic manufacture and the 

import production volume will continue 

to be reported separately on the same 

report. EPA review and analysis of the 

2006 IUR data has revealed that some 

submitters are erroneously submitting 

multiple reports for the same chemical 

substance, at times reporting the 

information associated with domestic 

manufacturing and importing in 

different reports. Submitters should 

complete only one report for each 

chemical substance. 

b. Volume of chemical substance used 

on-site. EPA is requiring that submitters 

report the volume of a manufactured 

(including imported) chemical 

substance used at the reporting site. The 

requirement to report the volume used 

on-site is replacing the requirement to 

indicate that the chemical substance is 

site-limited. Under this final rule, either 

domestically manufactured or imported 

chemical substances can be reported as 

used at the reporting site. 

c. Indicate whether imported 

chemical substances are physically at 

the reporting site. EPA is adding a 

requirement to indicate whether an 

imported chemical substance is 

physically at the reporting site. Often, 

the site reporting an imported chemical 

substance never physically receives the 

chemical substance, but instead ships it 

directly to another location such as a 

warehouse, a processing or use site, or 

a customer’s site. 

d. Report volume exported. EPA is 

adding a requirement to report the 

production volume directly exported 

and not domestically processed or used. 

This will allow EPA to better identify 

the proportion of the production volume 

accounted for by the processing and use 

reporting, given that such downstream 

reporting is not required for directly 

exported chemical substances. 

5. Identify whether a chemical 

substance is to be recycled, 

remanufactured, reprocessed, or reused. 

In the proposed rule, EPA sought 

comment on adding a checkbox 

indicating whether a manufactured 

chemical substance was recycled, 

remanufactured, reprocessed, reused, or 

reworked. In response to the comments 

received, EPA has determined that the 

term ‘‘reworked’’ may be interpreted 

and applied too broadly to provide the 

type of information that EPA needs to 

collect and has removed ‘‘reworked’’ 

from the list of recycling synonyms, but 

has chosen to otherwise finalize this 

reporting requirement as proposed. 

Consequently, EPA is adding a 


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requirement to indicate whether a 

manufactured chemical substance, such 

as a byproduct, is to be recycled, 

remanufactured, reprocessed, or reused. 

Submitters should indicate whether 

their manufactured chemical substance, 

which otherwise would be disposed of 

as a waste, is being removed from the 

waste stream and has a commercial 

purpose (i.e., it is being recycled, 

remanufactured, reprocessed, or 

reused). Indicating that a manufactured 

chemical substance, such as a 

byproduct, is to be recycled, 

remanufactured, reprocessed, or reused 

does not affect the reporting 

requirements associated with any 

chemical substance manufactured from 

the byproduct. See Unit IV.2., for 

detailed information on byproduct 

reporting. 

6. Concentration ranges. EPA is 

eliminating gaps in the ranges used to 

report concentration in 40 CFR 

711.15(b)(3) and (b)(4). The ranges are 

now: 

• Less than 1% by weight. 

• At least 1% but less than 30% by 

weight. 

• At least 30% but less than 60% by 

weight. 

• At least 60% but less than 90% by 

weight. 

• At least 90% by weight. 

7. Industrial processing and use 

information reporting. EPA is revising 

the list of industrial function categories 

and replacing the NAICS codes with 

industrial sector categories, as described 

in Unit III.G.7.a. and b. 

a. Industrial function categories. EPA 

is revising the list of industrial function 

categories by combining categories that 

lead to common exposure scenarios and 

adding categories where the Agency 

believes the existing categories do not 

adequately describe potential uses. EPA 

worked with Environment Canada and 

Health Canada to develop the set of 

categories, which will be used by both 

the United States and Canada for 

inventory reporting (Ref. 11). 

EPA is adding eight new industrial 

function categories and removing six 

existing categories from the previous 

list; the total number of industrial 

function categories has increased to 35. 

Also, EPA is renaming several of the 

industrial function categories to provide 

a more informative description of the 

function of chemical substances that 

should be reported in that category. 

Lastly, EPA is requiring that if a 

submitter selects the category ‘‘Other,’’ 

the submitter must provide its own 

description of the industrial function of 

the chemical substance. EPA is using 

the industrial function categories listed 

in Table 2 of this unit: 

TABLE 2—CODES FOR REPORTING INDUSTRIAL FUNCTION CATEGORIES

Code Category 

U001 .......................... Abrasives. 

U002 .......................... Adhesives and sealant chemicals. 

U003 .......................... Adsorbents and absorbents. 

U004 .......................... Agricultural chemicals (non-pesticidal). 

U005 .......................... Anti-adhesive agents. 

U006 .......................... Bleaching agents. 

U007 .......................... Corrosion inhibitors and anti-scaling agents. 

U008 .......................... Dyes. 

U009 .......................... Fillers. 

U010 .......................... Finishing agents. 

U011 .......................... Flame retardants. 

U012 .......................... Fuels and fuel additives. 

U013 .......................... Functional fluids (closed systems). 

U014 .......................... Functional fluids (open systems). 

U015 .......................... Intermediates. 

U016 .......................... Ion exchange agents. 

U017 .......................... Lubricants and lubricant additives. 

U018 .......................... Odor agents. 

U019 .......................... Oxidizing/reducing agents. 

U020 .......................... Photosensitive chemicals. 

U021 .......................... Pigments. 

U022 .......................... Plasticizers. 

U023 .......................... Plating agents and surface treating agents. 

U024 .......................... Process regulators. 

U025 .......................... Processing aids, specific to petroleum production. 

U026 .......................... Processing aids, not otherwise listed. 

U027 .......................... Propellants and blowing agents. 

U028 .......................... Solids separation agents. 

U029 .......................... Solvents (for cleaning or degreasing). 

U030 .......................... Solvents (which become part of product formulation or mixture). 

U031 .......................... Surface active agents. 

U032 .......................... Viscosity adjustors. 

U033 .......................... Laboratory chemicals. 

U034 .......................... Paint additives and coating additives not described by other categories. 

U999 .......................... Other (specify). 

b. IS codes. EPA is replacing the 

5-digit NAICS codes with 48 IS codes 

(Ref. 16). The sectors were adapted from 

the European Union’s (EU’s) ‘‘Guidance 

on Information Requirements and 

Chemical Safety Assessment.’’ The IS 

codes divide the entire range of NAICS 

codes into sectors so that there is a 

sector corresponding to any NAICS code 

(see the Instructions document, Ref. 7). 

The use of the sectors will reduce the 

number of unique combinations, 

thereby increasing the usability of the 

data, and also reducing the CDR 

reporting burden. 

EPA is using the 48 sectors listed in 

Table 3 of this unit: 


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TABLE 3—INDUSTRIAL SECTORS

Code Sector description 

IS1 ............................. Agriculture, Forestry, Fishing and Hunting. 

IS2 ............................. Oil and Gas Drilling, Extraction, and support activities. 

IS3 ............................. Mining (except Oil and Gas) and support activities. 

IS4 ............................. Utilities. 

IS5 ............................. Construction. 

IS6 ............................. Food, beverage, and tobacco product manufacturing. 

IS7 ............................. Textiles, apparel, and leather manufacturing. 

IS8 ............................. Wood Product Manufacturing. 

IS9 ............................. Paper Manufacturing. 

IS10 ........................... Printing and Related Support Activities. 

IS11 ........................... Petroleum Refineries. 

IS12 ........................... Asphalt Paving, Roofing, and Coating Materials Manufacturing. 

IS13 ........................... Petroleum Lubricating Oil and Grease Manufacturing. 

IS14 ........................... All other Petroleum and Coal Products Manufacturing. 

IS15 ........................... Petrochemical Manufacturing. 

IS16 ........................... Industrial Gas Manufacturing. 

IS17 ........................... Synthetic Dye and Pigment Manufacturing. 

IS18 ........................... Carbon Black Manufacturing. 

IS19 ........................... All Other Basic Inorganic Chemical Manufacturing. 

IS20 ........................... Cyclic Crude and Intermediate Manufacturing. 

IS21 ........................... All Other Basic Organic Chemical Manufacturing. 

IS22 ........................... Plastics Material and Resin Manufacturing. 

IS23 ........................... Synthetic Rubber Manufacturing. 

IS24 ........................... Organic Fiber Manufacturing. 

IS25 ........................... Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing. 

IS26 ........................... Pharmaceutical and Medicine Manufacturing. 

IS27 ........................... Paint and Coating Manufacturing. 

IS28 ........................... Adhesive Manufacturing. 

IS29 ........................... Soap, Cleaning Compound, and Toilet Preparation Manufacturing. 

IS30 ........................... Printing Ink Manufacturing. 

IS31 ........................... Explosives Manufacturing. 

IS32 ........................... Custom Compounding of Purchased Resins. 

IS33 ........................... Photographic Film, Paper, Plate, and Chemical Manufacturing. 

IS34 ........................... All Other Chemical Product and Preparation Manufacturing. 

IS35 ........................... Plastics Product Manufacturing. 

IS36 ........................... Rubber Product Manufacturing. 

IS37 ........................... Non-metallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime, gypsum, and other non-metallic mineral product manufacturing). 

IS38 ........................... Primary Metal Manufacturing. 

IS39 ........................... Fabricated Metal Product Manufacturing. 

IS40 ........................... Machinery Manufacturing. 

IS41 ........................... Computer and Electronic Product Manufacturing. 

IS42 ........................... Electrical Equipment, Appliance, and Component Manufacturing. 

IS43 ........................... Transportation Equipment Manufacturing. 

IS44 ........................... Furniture and Related Product Manufacturing. 

IS45 ........................... Miscellaneous Manufacturing. 

IS46 ........................... Wholesale and Retail Trade. 

IS47 ........................... Services. 

IS48 ........................... Other (requires additional information). 

When the category reported for the IS 

code is ‘‘Other,’’ the submitter is 

required to provide a written 

description of the use of the chemical 

substance, which may include the 

NAICS code. 

8. Consumer and commercial use 

reporting. EPA is making four changes 

to the consumer and commercial 

information required to be reported: 

• Revising and expanding the list of 

consumer and commercial product 

categories. 

• Requiring the provision of a 

description when the product category 

‘‘Other’’ is reported. 

• Identifying whether the use is a 

consumer or a commercial use, or both. 

• Reporting the number of 

commercial workers reasonably likely to 

be exposed while using the reported 

chemical substance. 

Reporting associated with children’s 

use, the maximum concentration, and 

the percent production volume remains 

unchanged. 

a. Consumer and commercial product 

categories. EPA is revising the list of 

consumer and commercial product 

categories by combining categories that 

lead to common exposure scenarios and 

adding categories that were not 

adequately described in the initial set of 

categories. EPA worked with 

Environment Canada and Health Canada 

to develop the categories. Harmonized 

categories will facilitate consistent 

reporting of chemical substance use 

information by industry in the United 

States and Canada (Ref. 11). 

The list includes 33 product 

categories, including ‘‘Other.’’ Examples 

of new categories which have been 

added include explosive materials, 

building/construction products not 

covered elsewhere, and air care 

products. The glass and ceramic 

products category had relatively few 

2006 IUR submissions and overlaps 

with the new categories, and so has 

been eliminated. Also, several of the 

consumer and commercial product 

categories have been renamed to better 

describe the products that should be 


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reported in those categories. In addition 

to revising the overall product 

categories, narrower definitions and 

expanded lists of examples of products 

in which the chemical substance would 

be used will be added to each category 

descriptor. The examples were selected 

to include items that could have fit into 

other categories in order to address the 

overlap inherent in any product 

category list. The product categories 

were then placed into several broader 

groupings, e.g., ‘‘Chemicals with 

Agriculture and Outdoor Uses’’ based 

on the similarities of products. EPA 

believes that the user will find the 

current groupings easier to use than the 

alphabetical listing used for the 2006 

IUR. EPA is also requiring that if a 

submitter chooses the product category 

‘‘Other,’’ the submitter must include a 

text description for the consumer and 

commercial product containing the 

chemical substance. 

EPA is using the consumer and 

commercial product categories listed in 

Table 4 of this unit: 

TABLE 4—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES

Code Category 

Chemical Substances in Furnishing, Cleaning, Treatment Care Products 

C101 .......................... Floor Coverings. 

C102 .......................... Foam Seating and Bedding Products. 

C103 .......................... Furniture and Furnishings not covered elsewhere. 

C104 .......................... Fabric, Textile, and Leather Products not covered elsewhere. 

C105 .......................... Cleaning and Furnishing Care Products. 

C106 .......................... Laundry and Dishwashing Products. 

C107 .......................... Water Treatment Products. 

C108 .......................... Personal Care Products. 

C109 .......................... Air Care Products. 

C110 .......................... Apparel and Footwear Care Products. 

Chemical Substances in Construction, Paint, Electrical, and Metal Products 

C201 .......................... Adhesives and Sealants. 

C202 .......................... Paints and Coatings. 

C203 .......................... Building/Construction Materials—Wood and Engineered Wood Products. 

C204 .......................... Building/Construction Materials not covered elsewhere. 

C205 .......................... Electrical and Electronic Products. 

C206 .......................... Metal Products not covered elsewhere. 

C207 .......................... Batteries. 

Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products 

C301 .......................... Food Packaging. 

C302 .......................... Paper Products. 

C303 .......................... Plastic and Rubber Products not covered elsewhere. 

C304 .......................... Toys, Playground, and Sporting Equipment. 

C305 .......................... Arts, Crafts, and Hobby Materials. 

C306 .......................... Ink, Toner, and Colorant Products. 

C307 .......................... Photographic Supplies, Film, and Photochemicals. 

Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products 

C401 .......................... Automotive Care Products. 

C402 .......................... Lubricants and Greases. 

C403 .......................... Anti-Freeze and De-icing Products. 

C404 .......................... Fuels and Related Products. 

C405 .......................... Explosive Materials. 

C406 .......................... Agricultural Products (non-pesticidal). 

C407 .......................... Lawn and Garden Care Products. 

Chemical Substances in Products not Described by Other Codes 

C980 .......................... Non-TSCA Use. 

C909 .......................... Other (specify). 

b. Designation of consumer or 

commercial use. EPA is requiring 

submitters to designate, via a checkbox, 

whether the indicated product category 

is a consumer or a commercial use, or 

both. 

c. Number of commercial workers 

reasonably likely to be exposed. EPA is 

requiring that submitters report the total 

number of commercial workers, 

including those at sites not under the 

submitter’s control, that are reasonably 

likely to be exposed while using the 

reportable chemical substance, with 

respect to each commercial use. The 

approximate number of workers should 

be reported using the same definitions 

and ranges used for manufacturing and 

industrial processing and use workers 

required by 40 CFR 711.15(b)(3)(vii) and 

(b)(4)(i)(F), respectively. The ranges are: 

• Fewer than 10 workers. 

• At least 10 but fewer than 25 

workers. 

• At least 25 but fewer than 50 

workers. 

• At least 50 but fewer than 100 

workers. 

• At least 100 but fewer than 500 

workers. 


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• At least 500 but fewer than 1,000 

workers. 

• At least 1,000 but fewer than 10,000 

workers. 

• At least 10,000 workers. 

H. What changes have been made to the 

standard for the reporting of processing 

and use information? 

In order to collect more complete 

information regarding industrial 

processing and use, and commercial and 

consumer use of chemical substances, 

EPA is, in 40 CFR 711.15(b)(4), 

replacing the ‘‘readily obtainable’’ 

reporting standard used for reporting 

under 40 CFR 710.52(c)(4) with the 

‘‘known to or reasonably ascertainable 

by’’ reporting standard set forth under 

TSCA section 8(a)(2). This is the same 

standard that applied to the reporting of 

information described in the regulations 

at 40 CFR 710.52(c)(1), (c)(2), and (c)(3) 

for the 2006 IUR submission, and this 

standard continues to apply to the 

reporting of such information under 40 

CFR 711.15(b)(1), (b)(2), and (b)(3). This 

standard covers 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. 

Under the standard, a submitter 

would therefore prepare its report 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 information 

which the manufacturer (including 

importer) may have in their possession 

or control, plus all information that a 

reasonable person similarly situated 

might be expected to possess, control, or 

know. The inquiry would be as 

extensive as a reasonable person, 

similarly situated, might be expected to 

perform. The standard does not 

necessarily require that the 

manufacturer conduct an exhaustive 

survey of all employees. 

‘‘Known to or reasonably 

ascertainable’’ information includes, but 

is not limited to, information that may 

be possessed by employees or other 

agents of the company reporting under 

the CDR rule, including persons 

involved in the research, development, 

manufacturing, or marketing of a 

chemical substance and includes 

knowledge gained through discussions, 

symposia, and technical publications. 

Examples of types of information that 

are considered to be in a person’s 

possession or control, or that a 

reasonable person similarly situated 

might be expected to posses, control, or 

know, include files maintained by the 

submitter, such as marketing studies, 

sales reports, or customer surveys; 

information contained in standard 

references, such as MSDSs, that contain 

use information or concentrations of 

chemicals in mixtures; and information 

from the CASRN and from the D&B 

number. 

The following hypothetical examples 

illustrate the anticipated application of 

the ‘‘known to or reasonably 

ascertainable standard,’’ in the specific 

context of the collection of processing 

and use data under the CDR. Because 

the standard applies on a case-by-case 

basis, however, these examples cannot 

substitute for a complete analysis of a 

submitter’s particular circumstances: 

Company XYZ discovers that it has no 

knowledge of how a particular 

reportable chemical substance (chemical 

substance #1) is processed or used by its 

customers. Company XYZ usually 

maintains marketing data documenting 

customers’ use of its chemicals, in line 

with the reasonable business practices 

typical of comparable manufacturers, 

but it irrevocably lost these data for 

chemical substance #1 due to an 

inadvertent computer malfunction. 

Company XYZ has many customers, but 

it expects that it could substantially 

reconstruct this missing information by 

briefly contacting its largest customer 

and asking that customer how chemical 

substance #1 is generally used. 

Company XYZ contacts this customer, 

reports on the basis of the processing 

and use. data that the customer was 

willing to provide. Company XYZ has 

likely fulfilled its duties under the 

reporting standard. Company XYZ 

would not have fulfilled its duties under 

the reporting standard if it had not 

endeavored to supplement the 

information it already knew. 

Company XYZ has never maintained 

information on how a particular 

reportable chemical substance (chemical 

substance #2) is processed or used by its 

customers. However, it is typical for 

comparable manufacturers to collect 

such information as part of their 

reasonable business practices. Company 

XYZ has many customers but it expects 

that it could substantially fill this data 

gap by reviewing the public Web site of 

its largest customer. Company XYZ 

reviews this Web site, and reports on 

the basis of the information contained in 

the Web site. Company XYZ has likely 

fulfilled its duties under the reporting 

standard. Company XYZ would not 

have fulfilled its duties under the 

reporting standard if it had not 

endeavored to supplement the 

information it already knew. 

Company ABC maintains seasonal 

marketing data on changes in use 

patterns for a particular chemical 

substance (chemical substance #3). 

Comparable manufacturers typically 

only maintain such data on an annual 

basis, in line with reasonable business 

practices. Company ABC irrevocably 

loses its summer marketing data for 

Substance #3, due to an inadvertent 

computer malfunction. Company ABC 

expects that it could substantially 

reconstruct the missing summer 

marketing data by contacting its largest 

customer and asking the customer what 

it used or processed chemical substance 

#3 for in the past summer. Nevertheless, 

instead of attempting to reconstruct the 

summer data in this manner, Company 

ABC reports on the basis of the 

processing and use data that it already 

knows (regarding the winter, spring, and 

fall of the year). Company ABC has 

likely fulfilled its duties under the 

reporting standard. Company ABC 

would not have fulfilled its duties under 

the reporting standard if it designated 

the information as ‘‘not known or 

reasonably ascertainable’’ simply 

because one of the seasonal marketing 

reports was missing. 

Company ABC has never maintained 

information on how a particular 

reportable chemical substance (chemical 

substance #4) is processed or used by its 

customers. However, it is typical for 

comparable manufacturers to collect 

such information as part of their 

reasonable business practices. Company 

ABC has one major customer and ten 

minor customers. Company ABC asks its 

major customer to supply information 

about how chemical substance #4 is 

processed and used, but that customer 

is unwilling to supply this information. 

Company ABC reasonably expects that 

the only remaining way to substantially 

fill this data gap would be to send a 

survey to its ten minor customers. 

Company ABC reports that the 

information is ‘‘not known or 

reasonably ascertainable’’ to it. 

Company ABC has likely fulfilled its 

duties under the reporting standard. 

EPA would like furthermore to clarify 

that submitters are not required to 

conduct a new or additional customer 

survey (i.e., to pose a comprehensive set 

of identical questions to multiple 

customers) under this standard. If 

particular information cannot be 

derived or reasonably estimated from 

the information available to the 

company without conducting further 

customer surveys, it is not ‘‘known to or 

reasonably ascertainable’’ to the 

submitter for purposes of the CDR. 

However, to the extent that customer 

surveys are already in the submitter’s 

possession or control, and to the extent 

that reasonable efforts to analyze or 


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derive information from alreadyavailable customer surveys may inform 

processing and use information that is 

reported, the information is generally 

‘‘known to or reasonably ascertainable.’’ 

See Unit V.E.1., and the Responses to 

Comments document (Ref. 12) for 

further discussion. EPA’s reporting tool 

permits submitters to enter or select 

‘‘NKRA’’ on Form U to address 

circumstances where the information is 

not known to or reasonably 

ascertainable by the submitter. 

I. What changes have been made to 

requirements for making CBI claims? 

EPA is making several changes to the 

requirements for claiming information 

as confidential. Submitters may claim 

certain information reported under the 

CDR as CBI in accordance with 40 CFR 

part 2 and CDR rules at 40 CFR 711.30. 

Claims of confidentiality may be made 

for chemical identity, site identity, and 

processing and use information, and 

submitters must substantiate these 

claims at the time information is 

submitted to EPA. EPA’s procedures for 

handling information claimed as 

confidential are set forth at 40 CFR part 

2, subpart B. EPA strongly encourages 

submitters to review confidentiality 

claims carefully to ensure that the 

information in question falls within the 

parameters of TSCA section 14. EPA 

cautions submitters that they may be 

subject to criminal penalties under 18 

U.S.C. 1001 if they knowingly and 

willfully make a false statement in 

connection with the assertion of a CBI 

claim. CBI claims should be limited to 

only those data elements the release of 

which would likely cause substantial 

harm to the business’ competitive 

position. Interested persons are 

reminded that with regard to chemical 

substance use information, EPA is 

interested in aggregated, general uses, 

not detailed uses associated with 

specific customers. 

To claim information as confidential, 

a submitter must indicate its claim by 

both checking the appropriate box and 

signing the certification statement on 

the reporting form, and may also be 

required (depending on the data 

element) to provide substantiation of the 

claim at the time it is made. A submitter 

must indicate its claims at the time the 

information is submitted. If a submitter 

fails to follow these procedures, EPA 

may release the information to the 

public without further notice to the 

submitter. By signing the certification 

statement the submitter attests to the 

secrecy and value of the information for 

which confidentiality claims have been 

asserted. 

1. Chemical identity CBI claims. 

There is no substantive change to 

submitters’ ability to make 

confidentiality claims for chemical 

identity in the CDR. As in the past, a 

submitter may assert a claim of 

confidentiality for the identity of the 

reported chemical substance only when 

the chemical substance is listed on the 

confidential portion of the TSCA 

Inventory. Submitters who assert a 

confidentiality claim for chemical 

identity must also provide 

substantiation for the claim at time of 

filing. See 40 CFR 711.30(b). 

However, in response to comments, 

this final rule includes some changes to 

the process that must be used to make 

this type of CBI claim. The proposed 

rule, at 40 CFR 711.15(b)(3)(i), provided 

that ‘‘[a] submitter under this part may 

use an EPA-designated TSCA Accession 

Number for a confidential chemical 

substance in lieu of a CASRN when a 

CASRN is not known to or reasonably 

ascertainable by the submitter.’’ In the 

proposed rule, EPA also noted that up 

to 5% of the reports submitted under 

the 2006 IUR contained chemical 

identity problems. EPA therefore 

proposed to require that submitters 

report using the CA Index Name 

currently used to list the chemical 

substance on the TSCA inventory. EPA 

further indicated that it would include 

CASRNs and CA Index Names into the 

e-CDRweb tool, to the extent possible 

without jeopardizing confidentiality 

claims. EPA believes that selecting 

chemical identity from a pre-populated 

list, rather than keying in the chemical 

identity information, will significantly 

improve the accuracy and consistency 

of submitted reports. 

EPA received several comments from 

industry groups requesting that the eCDRweb tool include security 

safeguards to adequately protect CBI. In 

light of the security concerns expressed 

in public comments, EPA has decided 

not to include CASRNs and CA Index 

Names for chemical substances on the 

confidential portion of the TSCA 

Inventory into the portions of the eCDRweb tool that will be publicly 

accessible. However, EPA still believes 

it is important to require that all 

chemical identities be selected from a 

pre-populated list, to avoid repeating 

the chemical identity problems 

experienced with the 2006 IUR. 

Therefore, 40 CFR 711.15(a)(3)(i) has 

been revised in this final rule to require 

that submitters who wish to report 

chemical substances listed on the 

confidential portion of the TSCA 

Inventory use the chemical substance’s 

TSCA Accession Number and generic 

name. Requiring the use of TSCA 

Accession Numbers and generic names 

will allow EPA to adequately protect 

confidential CASRNs and CA Index 

Names (by omitting them from the prepopulated selection list) while still 

obtaining the improvements in reporting 

accuracy it sought in the proposed rule. 

In SRS, a submitter can readily find 

a cross-reference list that displays the 

TSCA Accession Number, generic 

chemical name, and the PMN case 

number (or for an initial TSCA 

Inventory chemical substance, the TSCA 

Inventory reporting form number) for 

any confidential chemical substance 

listed on the TSCA Inventory. 

Submitters who wish to retain the CBI 

claim for the chemical substance 

identified by the TSCA Accession 

Number must assert and substantiate the 

claim at time of filing. Submitters who 

do not wish to retain the CBI claim for 

the chemical substance identity, and 

who wish the chemical substance to be 

listed on the public portion of the TSCA 

Inventory, should not assert a CBI claim 

or provide substantiation. Submitters 

who fail to follow the required 

procedures for asserting CBI claims for 

chemical identity will waive the claims, 

and EPA may release the information 

without further notice to the submitter. 

See the regulatory text at 40 CFR 

711.30(e). 

2. Upfront substantiation for 

processing and use information CBI 

claims. Under the CDR, a submitter may 

assert a claim of confidentiality for data 

associated with the processing and use 

of its chemical substance if the 

submitter has reason to believe that 

release of the information would reveal 

trade secrets, or confidential 

commercial or financial information, as 

provided by TSCA section 14 and 40 

CFR part 2. Under this final rule, EPA 

is requiring upfront substantiation for 

CBI claims for processing and use 

information. 

In order to submit a claim of 

confidentiality for processing and use 

information data elements, the 

submitter is required (in addition to 

signing the certification statement) to 

both check the appropriate box on the 

reporting form and substantiate the 

claim in writing, within the reporting 

tool, by answering certain questions 

provided in 40 CFR 711.30(d). EPA 

revised the substantiation question at 40 

CFR 711.30(d)(1)(ii), respecting 

competitive harm, to include harmful 

effect ‘‘to your customer’s competitive 

position.’’ Where a submitter fails to 

submit substantiation of the processing 

and use CBI claim in accordance with 

the applicable rules (i.e., the submitter 

does not provide an answer to all the 

required questions associated with the 


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claim on the Form U it submits via eCDRweb), EPA will consider the 

information not subject to a 

confidentiality claim and may make the 

information available to the public 

without further notice to the submitter. 

3. Prohibition of confidentiality 

claims for data elements identified as 

‘‘not known or reasonably 

ascertainable.’’ EPA is prohibiting 

claims of confidentiality pertaining to 

the designation that information is ‘‘not 

known or reasonably ascertainable.’’ As 

described in Unit II.A., for the 2012 and 

future CDR collections, submitters will 

be required to report processing and use 

information to the extent that it is 

known to or reasonably ascertainable by 

them. 

For the 2006 IUR collection, EPA 

observed that, on occasion, processing 

and use information was claimed as 

confidential when a submitter 

determined that the information was not 

readily obtainable. Section 14 of TSCA 

limits the disclosure of information 

entitled to confidential treatment under 

exemption 4 of the Freedom of 

Information Act (FOIA). EPA has 

considered the NKRA designation and 

its relationship to a potential CBI or 

trade secret claim. Given that a NKRA 

assertion is an assertion that no 

information is available, the Agency 

does not believe that the designation 

conveys trade secret or confidential 

commercial or financial information. 

J. What changes specifically affect 

importers? 

1. Importer site address. Submitters 

report CDR data on chemical substances 

that they manufacture domestically and 

that they import into the United States. 

Previously, the regulations defining the 

site for importer reporting were found in 

both the definition for site in 40 CFR 

710.3 and in paragraph 40 CFR 

710.48(b). EPA is eliminating 

unnecessary duplication in the CDR 

regulation by moving the additional 

information regarding the importer site 

from 40 CFR 710.48(b) into a revised 

definition for site at 40 CFR 711.3, as 

described in Unit III.C.2., and 

eliminating 40 CFR 710.48(b). 

In addition, EPA has observed that 

submitters occasionally use a foreign 

address as the site address for the 

importer. EPA now is requiring that 

submitters report a U.S. site address, by 

modifying the definition for site to state 

specifically that the site must be a U.S. 

site. The U.S. address of an agent acting 

on behalf of the importer, and 

authorized to accept service of process 

for the importer, may be reported as the 

importer’s site address if the operating 

unit that is directly responsible for 

importing the chemical substance and 

that controls the import transaction has 

no U.S. address. The Agency expects 

that all importers will have a U.S. site, 

as defined in the 40 CFR 711.3 

definition for site, because, under 

Customs regulations at 19 CFR 141.18, 

a non-resident corporation is not 

permitted to enter merchandise for 

consumption unless it has a resident 

agent in the State where the port of 

entry is located, who is authorized to 

accept service of process against the 

corporation. 

2. Joint submissions. For purposes of 

CDR, submitters are allowed to report 

the CDR information jointly with the 

foreign supplier of a reportable chemical 

substance whose chemical identity is 

unknown to the importer. Previously, 

joint submissions could not be made 

electronically. EPA is now requiring 

that submitters use CDX and e-CDRweb 

for preparation and submission of joint 

submissions. See 40 CFR 

711.15(b)(3)(i)(C). Therefore, the 

authorized officials of the jointly 

submitting companies will need to 

register with CDX in order to submit a 

joint report to EPA. 

Importers may not know the specific 

chemical identity of a chemical 

substance because the foreign supplier 

chooses to keep it confidential. In such 

a situation, the importer must use eCDRweb to ask the foreign supplier to 

submit the chemical identity 

information directly to EPA through a 

joint report. To submit a joint report, the 

importer completes the majority of the 

required information, and supplies a 

trade name or other designation to 

identify the chemical substance, and 

provides contact information for the 

foreign supplier. The importer then uses 

e-CDRweb to contact the foreign 

supplier and request that the foreign 

supplier report the specific chemical 

identity information directly to EPA. 

The importer must submit a copy of 

such request to EPA, along with the rest 

of its CDR submission for the chemical 

substance. As a general matter, EPA 

expects that importers will supply the 

information described at 40 CFR 

711.15(b)(3)(i)(A), rather than an 

‘‘NKRA’’ designation, when importers 

do not know the confidential chemical 

identity of a chemical substance they 

import. EPA believes that an NKRA 

designation would generally only be 

appropriate in the unlikely event that an 

importer did not know, and could not 

reasonably ascertain, the information 

needed to link its submission with a 

secondary report from the supplier. 

In an acceptable joint submission, the 

secondary submitter supplies the 

chemical identity, as well as its 

technical contact and company 

information, and provides the primary 

submitter’s site information. EPA will 

not accept joint submissions that are not 

submitted electronically using eCDRweb and CDX. All information will 

be saved by the reporting tool and both 

submissions will be matched based 

upon company and chemical substance 

information. Once the forms are linked, 

EPA will process the joint submission as 

one report for the reported chemical 

substance. See the Instruction document 

(Ref. 7), for detailed instructions on 

submitting a joint report. 

IV. What clarifications have been made 

to reporting requirements? 

1. Clarification of the relationship 

between company name and site 

identity CBI claims. Under the CDR, 

submitters are able to separately claim 

as CBI the company name and site 

identity associated with a chemical 

substance for which they are reporting 

under the CDR. The submitter is 

required to provide an upfront 

substantiation for CBI claims for the site 

identity. EPA believes there is some 

confusion as to what is considered 

confidential when such claims are 

made, and is taking this opportunity to 

provide clarification. 

The CBI claim protects the link 

between the company and/or site 

identity and the particular chemical 

substance. If the company or site 

identity associated with a particular 

chemical substance is not claimed as 

CBI, EPA may make that information 

available to the public without further 

notice to the submitter. EPA will not 

impute the existence of a CBI claim for 

company identity or for site identity 

from a CBI claim associated with a 

different chemical substance. 

Company and site identity CBI claims 

are separate claims, and in some cases 

one type of claim may be justified while 

the other is not. Therefore, a submitter 

is permitted to assert its CBI claim for 

the company identity, the site identity, 

or both the company and site identity. 

Such claims must be made for each 

chemical substance for which such 

claims are being made. Because the 

circumstances for each chemical 

substance can vary, the CDR rule does 

not allow for blanket claims covering all 

chemical substances in a site’s CDR 

report. 

Likewise, the submitter must provide 

separately the required upfront 

substantiation for the site identity CBI 

claims associated with each chemical 

substance. For instance, if the submitter 

is reporting for five chemical substances 

and wishes to claim its site information 

confidential for three of the five 


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chemical substances, it must assert the 

claim and provide separate upfront 

substantiation three times, once for each 

of the three chemical substances. 

EPA has also observed that submitters 

sometimes claim only their company 

identity, and not their site identity, as 

confidential. If the site identity for a 

particular chemical substance is not 

claimed as CBI, or is claimed but not 

substantiated pursuant to 40 CFR 

711.30(c), EPA may make that 

information available to the public 

without further notice to the submitter. 

EPA will not impute the existence of a 

CBI claim for site identity from a CBI 

claim for company identity, even if the 

company name appears within the site 

identity information. To help ensure 

that submitters consider this issue, the 

e-CDRweb reporting tool provides a 

warning whenever the company identity 

is claimed as CBI for a particular 

chemical substance and the site identity 

is not also claimed as CBI for that 

chemical substance. 

2. Explanation of byproduct reporting. 

During the 2006 submission period, 

EPA received questions about the 

requirements for reporting byproducts. 

The questions included whether 

byproduct manufacturers (including 

importers) were required to report the 

byproducts under the IUR rule. Based 

on those and subsequent inquiries, and 

from the public comments from the 

proposed rule, it is apparent that scope 

of the CDR obligation to report 

byproducts is not well understood by 

industry. The scope of byproduct 

reporting has become a particularly 

pertinent issue because (by the terms of 

the 2003 IUR Amendments) inorganic 

chemical substances are now no longer 

exempt from reporting under CDR, 

including (beginning with the 2012 

CDR) the information collection 

requirements for processing and use 

information. Inorganic chemical 

substances are often recycled, which 

may trigger the need to report a 

byproduct substance that is recycled. In 

an effort to further clarify reporting 

obligations, EPA is providing additional 

information on byproduct reporting, 

including circumstances under which 

reporting is not required, in two 

guidance documents included in the 

docket for this final rule (Refs. 7 and 16) 

and on EPA’s Web site at http:// 

www.epa.gov/iur. For purposes of CDR, 

a byproduct is a chemical substance 

produced without a separate 

commercial intent during the 

manufacture, processing, use, or 

disposal of another chemical substance 

or mixture (40 CFR 704.3). Thus, for 

example, when a chemical substance or 

mixture is used for the purpose of 

manufacturing an article, and that 

manufacture results in the production of 

a different chemical substance, that 

different chemical substance is a 

byproduct for purposes of the CDR. 

Chemical substances that are 

byproducts of the manufacture, 

processing, use, or disposal of another 

chemical substance or mixture, like any 

other manufactured chemical 

substances, are subject to CDR reporting 

if they are listed on the TSCA Inventory, 

are not otherwise excluded from 

reporting, and their manufacturer is not 

specifically exempted from CDR 

reporting requirements. 

The 40 CFR 704.3 definition of 

manufacture for commercial purposes 

states that ‘‘[m]anufacture for 

commercial purposes also applies to 

substances that are produced 

coincidentally during the manufacture, 

processing, use, or disposal of another 

substance or mixture, including both 

byproducts that are separated from that 

other substance or mixture and 

impurities that remain in that substance 

or mixture. Such byproducts and 

impurities may, or may not, in 

themselves have commercial value. 

They are nonetheless produced for the 

purpose of obtaining a commercial 

advantage since they are part of the 

manufacture of a chemical product for 

a commercial purpose.’’ Thus, 

byproducts of the manufacture, 

processing, use, or disposal of another 

chemical substance or mixture for a 

commercial purpose are themselves 

both ‘‘manufactured’’ and 

‘‘manufactured for commercial 

purposes.’’ Also, considering the overall 

context of this definition, EPA interprets 

‘‘chemical product’’ broadly to include 

any product of the manufacturing, 

processing, use, or disposal of another 

chemical substance or mixture, other 

than a byproduct. 

Byproducts that are manufactured 

(including imported) in volumes of 

25,000 lb or more at a single site are 

potentially subject to CDR requirements. 

However, 40 CFR 711.10(c) excludes 

from reporting those chemical 

substances meeting the requirements of 

40 CFR 720.30(g) or (h). Manufacturers 

(including importers) of byproducts are 

not required to report the manufacture 

(including import) of a byproduct if the 

byproduct is not used for commercial 

purposes. See 40 CFR 720.30(h)(2). 

Thus, even where a byproduct is 

manufactured (including imported) for a 

commercial purpose, if the byproduct is 

not subsequently put to use for another 

commercial purpose, the byproduct is 

excluded from CDR reporting. 

Furthermore, if the byproduct’s ‘‘only 

commercial purpose is for use by public 

or private organizations that: (1) Burn it 

as a fuel, (2) dispose of it as a waste, 

including in a landfill or for enriching 

soil, or (3) extract component chemical 

substances from it for commercial 

purposes,’’ 40 CFR 720.30(g), that 

byproduct is also excluded from CDR 

reporting. This exclusion applies only to 

the byproduct; it does not apply to the 

component chemical substances 

extracted from the byproduct. The 

Instructions document (Ref. 7) includes 

a decision tree to assist a byproduct 

manufacturer (including importer) in its 

determination of the need to report its 

byproduct chemicals. 

Some manufacturers (including 

importers) of byproducts have expressed 

a belief that a chemical substance that 

is regulated by another EPA program, 

such as under the Resource 

Conservation and Recovery Act (RCRA), 

or that is exempt from certain 

requirements by the other program 

based on certain treatments or disposals, 

should not be required to be reported for 

CDR purposes. However, under this 

final rule, when such chemical 

substances have a commercial purpose 

not exempted by 40 CFR 720.30(g), the 

manufacturer (including importer) of 

such a chemical substance may have 

CDR reporting obligations, and is not 

relieved of those obligations based on 

exemptions under other laws. 

Although the need to report for 

byproduct chemical substances is not a 

new requirement, EPA recognizes that 

there were many comments and 

concerns raised about byproduct 

chemical substances, as stated earlier in 

this unit, and that there may be 

byproduct manufacturers that remain 

unsure of their reporting obligations 

under the CDR. In particular, the 

Agency recognizes that this may be an 

issue for those byproduct manufacturers 

who recycle byproducts by sending 

them off-site to a recycler. The Agency 

is committed to helping byproduct 

manufacturers report according to the 

CDR requirements and views the 2012 

reporting cycle as an opportunity for the 

Agency and byproduct manufacturers to 

work together. Among other things, the 

Agency will use this opportunity to 

determine whether additional guidance 

tailored to these manufacturers is 

needed. In addition, EPA intends to 

provide training specific to byproduct 

reporting and to make available Agency 

personnel to answer questions on an 

individual basis. 

EPA also intends to continue to work 

with industry and the interested public. 

EPA encourages recycling. The Agency 

intends to examine the collected 

information related to byproducts, 

recognizing the importance of recycling, 


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to identify whether there are segments 

of byproduct manufacturing for which 

EPA can determine that there is no need 

for the CDR information for the 2016 or 

other future reporting cycles. 

V. Public Comments 

EPA carefully considered the 

comments it received on the proposed 

IUR modifications. Major comments are 

discussed in this unit. Additional 

comment summaries and more detailed 

responses, including responses to most 

of the additional issues that EPA 

requested comment on, are contained in 

the Responses to Comments document 

(Ref. 12). 

As part of this action, EPA is changing 

the identification of the regulation from 

IUR to CDR. Elsewhere in this 

document, EPA has retained the use of 

the term ‘‘IUR’’ to reflect historical 

terminology, and has used the term 

‘‘CDR’’ to describe the revised reporting 

requirements and future submission 

periods. However, in order to enhance 

understanding of the responses to the 

public comments, EPA is retaining the 

use of the IUR acronym for this unit, 

even where referring to revised 

reporting requirements and future 

submission periods. The reader should 

recognize that where IUR is used to refer 

to the 40 CFR part 711 regulations or to 

future IUR submission periods, IUR and 

CDR are synonymous. 

A. General Comments 

1. Justification for proposed 

modifications. Several commenters 

supported many of EPA’s proposed 

reporting changes, stating that the 

changes will facilitate EPA’s ability to 

track chemical substances used and 

made in the United States, which would 

strengthen EPA’s ability to identify 

chemical substances for further 

assessment. They also noted that the 

IUR data not only supports activities 

under EPA authorities, but is also used 

by other Federal agencies, the States, 

and other interested stakeholders to 

identify potential chemical substances 

of concern. Other commenters 

expressed the view that EPA has not 

provided adequate justification 

supporting the Agency’s need for the 

IUR data and has not sufficiently 

tailored the requested information to 

meet EPA’s goals. One commenter did 

not agree that the modifications will 

increase the ‘‘usability of collected 

information’’ or ‘‘focus reporting’’ on 

what is ‘‘most needed’’ by EPA. Another 

commenter mentioned that the Agency 

does not explain how the existing IUR 

fails to meet these goals or why an IUR 

expansion is needed to carry out its 

Congressionally mandated TSCA duties. 

Additionally, commenters suggested 

that EPA should clearly indicate how 

the IUR data will be utilized in 

programs that systematically review 

hazard and exposure of existing 

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 


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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 postpromulgation 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 screeninglevel 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, 


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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 followup 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 (eCDRweb). 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 


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submission period. In addition, eCDRweb 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 


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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 timeconsuming and resulted in many 

mistakes. Given the requirement for 

mandatory electronic submissions and 

the corresponding improvements to the 


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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 chemicalspecific information regarding imported 

mixtures under other EPA-administered 

statutes, such as the Emergency 

Planning and Community Right-ToKnow 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 


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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 exposurerelated 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 selfregulation 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 


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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-ahaystack 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 


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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-bychemical 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. 


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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 


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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 crossreference 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 multicomponent 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 


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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 multiyear 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 


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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 sitelimited 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 exposurerelated data elements that will be 

reported under the IUR. Exposurerelated 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 exposurerelated 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 sitelimited 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’’ 


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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 


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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 screeninglevel 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 threecode 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 


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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 chemicalspecific 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 screeninglevel 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 prereporting 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. 


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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 byproductrelated 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) (crossreferenced 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 


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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 

data sets are different. While the data 

sets are not duplicative, EPA recognizes 

that there may be limited circumstances 

where particular elements of the data 

sets overlap. EPA strives to reduce such 

overlap, while ensuring that it is 

administratively feasible to collect and 

collate the data that are needed for 

TSCA purposes. The TSCA program is 

continuing its work with the RCRA 

program to maintain coordination 

between the two programs. It is 

important to note that the application of 

RCRA regulations varies state-by-state, 

and recent changes to RCRA regulations 

have not been adopted by all states. 

Therefore the overlap between RCRA 

reporting and IUR reporting may vary 

depending upon the state in which a 

submitter’s site is located. 

A similar situation exists for some 

sites that meet the requirements to 

report under both TRI and IUR. The TRI 

program goal is to provide communities 

with information about toxic chemical 

substance releases and waste 

management, and the TRI reporting 

requirements are designed to address 

that goal. Because the IUR program 

goals differ, the specific information 

collected under each program is not the 

same. Where a person must report for 

both for the same site, EPA and the 

public will have a broader picture of the 

exposure scenarios at that site, 

including environmental releases from 

that site; while the two information 

collections may be complementary, 

neither is an adequate substitute for the 

other. A more in-depth discussion is 

provided in the Responses to Comments 

document (Ref. 12). 

EPA believes that commenters’ 

concern that reporting under IUR would 

be a disincentive to recycle reflects 

certain misunderstandings of the IUR 

requirements. The Agency expects that 

revised byproduct guidance materials, 

as well as EPA’s responses to the 

comments concerning, for instance, 

byproduct chemical identification 

requirements, will help to alleviate the 

majority of those concerns. EPA believes 

that many factors play into whether a 

company chooses to recycle, including 

the value of the recovered materials, the 

expense of disposal, desire to maintain 

or build a ‘‘green’’ reputation, technical 

limitations or flexibility, state and local 

requirements or incentives, and the 

incentives offered or requirements 

imposed by other federal laws (such as 

RCRA). EPA strongly believes that the 

benefits of recycling usually outweigh 

the burden associated with IUR 

reporting for these materials, and, just as 

with any other chemical substance 

whose manufacture must be reported 

under the IUR, production volume, 

worker exposure and other IUR data 

collected on byproduct chemical 

substances support the Agency’s 

mandate to protect human health and 

the environment. 

c. Concerns about how to identify the 

byproduct chemical substance and with 

reporting both the byproduct and a 

chemical substance extracted from the 

byproduct. Commenters stated that it is 

very difficult to identify the chemical 

substances in a byproduct mixture, and 

that the mixture can vary over time, 

depending upon the specific 

manufacturing situation. Commenters 

also argued that there would be 

duplicative reporting by the byproduct 

manufacturer and the recycler/processor 

who extracted a component chemical 

substance from the byproduct mixture. 

The comments reflect a misperception 

that characterizing the identity of 

complex chemical substances, as are 

found in or comprise many byproducts, 

necessarily involves a detailed analysis 

of the ‘‘individual components of the 

chemical substance.’’ In reality, a 

byproduct may be listed on the TSCA 

Inventory as a single chemical substance 

that represents, for TSCA purposes, 

what may be a complex composition of 

chemical substances. In this way, the 

chemical identity of a byproduct may 

represent a chemical substance process 

stream. Complex chemical substances 

are listed (or can be listed) on the TSCA 

Inventory as chemical substances of 

Unknown or Variable composition, 

Complex reaction products and 

Biological materials (‘‘UVCB’’ chemical 

substances). As described by the 

commenters, the byproduct ‘‘mixture’’ is 

often complex and varies over time, 

making the identification of the 

individual components a very difficult 

task. This description itself indicates 

that the proper identification of such a 

reaction product is as a UVCB chemical 

substance. As stated in EPA’s on-line 

guidance, ‘‘Each combination of 

substances resulting from a reaction is 

considered by the Agency to be either 

(1) a mixture, composed of two or more 

well-defined chemical substances to be 

named and listed separately, or (2) a 

reaction product, to be listed as a single 

chemical substance, using one name 

that collectively describes the products, 

or, failing that, the reactants used to 

make the products.’’ (See http:// 

www.epa.gov/oppt/newchems/pubs/ 

rxnprods.txt.) Situations may exist 

where the byproduct substance is 

actually a mixture, but as further 

described in the aforementioned 

guidance, ‘‘A combination of products 

resulting from a chemical reaction is 

considered a mixture provided that all 

of the component product substances 

are unambiguously identified and are 

represented as forming each time the 

reaction is run.’’ 

UVCB chemical substances in some 

cases include a TSCA Inventory 

definition to further describe the 

chemical substance. Here is one 

example from EPA’s on-line guidance 

(see http://www.epa.gov/oppt/ 

newchems/pubs/uvcb.txt): 

Dust, iron-ore, sinter 

CASRN 69012–53–9 

Definition: Dust generated during the 

making, breaking and handling of 

sinter which is recovered through the 

use of pollution abatement 

equipment. 

A byproduct manufacturer, therefore, 

would potentially report the UVCB 

name for the byproduct composition, 

while the subsequent recycler of the 

byproduct would potentially report the 

specific chemical identity of the 

chemical substance they chemically 

manufacture from the byproduct. EPA 

does not agree that such reporting is 

duplicative, because reporting will fall 

into one of following two scenarios. If 

the chemical substance manufactured 

from the UVCB byproduct is already 

present as a constituent of the UVCB 

byproduct, then the byproduct 

manufacturer need not report the 

byproduct that is sent for such 

processing/recycling. If the chemical 

substance manufactured from the UVCB 


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byproduct is distinct from any chemical 

substance present in the UVCB 

byproduct as a constituent, then the 

separate reporting by the byproduct 

manufacturer and the processor/recycler 

reflects a change in chemical 

composition. Either way, there is no 

duplication of reporting between the 

manufacturer of the UVCB byproduct 

and the processor/recycler. As a general 

matter, if there is to be appropriate 

stewardship of potential chemical 

substance risks, EPA believes that 

chemical substance manufacturers, 

processors, and users should know and 

understand the identities of chemical 

substances they handle. 

Some commenters stated that many 

byproduct mixtures in the metals 

industry are processed to recover the 

metal values and indicated that the 

metal value should be considered a 

component chemical substance (i.e., 

that if Nickel (II) hydroxide (Ni(OH)2) is 

present in a byproduct mixture, then the 

elemental substance Nickel (Ni) should 

be considered the component chemical 

substance). EPA disagrees with this 

statement. (See Ref. 27 for a precedent 

from a 1991 prenotice communication.) 

Under TSCA, Ni(OH)2 and elemental Ni 

are two different chemical substances, 

with separate listings on the TSCA 

Inventory. If the byproduct contains 

Ni(OH)2 but not elemental Ni, only 

Ni(OH)2 is considered a component 

chemical substance of the byproduct. 

The manufacture of elemental Ni from 

either the Ni(OH)2—bearing byproduct 

(or Ni(OH)2 itself) results in a potential 

need to report under IUR. That is, if the 

extracted component substance is an 

oxide and used as an intermediate to 

form an elemental metal, then both the 

oxide and elemental metal are subject to 

reporting by their manufacturer(s). Note 

that information pertaining to 

manufacture of a chemical substance 

need only be reported to the extent that 

the information is known to or 

reasonably ascertainable by the 

submitter. 

A second example of a metalcontaining byproduct is: 

Electrolytes, copper-manufg., spent 

CASRN 69012–54–0 

Definition: Spent copper sulfate 

electrolyte consisting of copper 

sulfate and sulfuric acid resulting 

from the electrolytic refining of 

copper. 

This spent material is a UVCB 

chemical substance that is likely to be 

recycled. If the only commercial 

purpose for this spent material is to 

extract the component chemical 

substance copper sulfate, then the 

manufacture of the spent material is 

exempted from reporting (but the 

manufacture of the copper sulfate [via 

extraction from the byproduct] is subject 

to reporting). On the other hand, if the 

spent material is used directly to 

manufacture elemental copper, then 

both the spent material and the 

elemental copper are subject to 

reporting under the IUR by their 

respective manufacturers, because 

elemental copper is not a component 

chemical substance in the spent 

material byproduct. 

d. Concerns regarding determining 

when a byproduct is manufactured. 

Commenters stated that clarification is 

needed regarding purification and 

extraction and when a chemical 

substance is considered manufactured 

versus purified. Commenters asserted 

that where there is no change in 

chemical identity, only a change in 

purity, a chemical substance should not 

be considered manufactured, regardless 

of the method of purification. 

Much of the commenters’ confusion 

regarding the differences between 

purification and extraction appears to 

concern whether extraction or 

purification involves a change in 

chemical identity; the potential for a 

change in chemical identity is closely 

linked with the proper identification of 

the manufactured substance, as 

described in the previous comment 

response. Where there is no change in 

chemical identity but rather just a 

change in purity (an impure chemical 

substance correctly identified for TSCA 

purposes as ‘‘chemical substance A,’’ for 

example, undergoing purification to a 

more pure form of ‘‘chemical substance 

A’’), the Agency agrees with the 

commenter that, for purposes of IUR, 

the chemical substance is not being 

manufactured. The chemical substance 

that appears on the TSCA Inventory 

may actually represent a category 

consisting of the same chemical 

substance in various degrees of purity. 

For example, if a company 

manufactures a specific, discrete 

chemical substance at 90% purity and it 

is correctly identified as that discrete 

substance (not having a UVCB name), 

then increasing the purity of the 

chemical substance (such that it retains 

its chemical identity) is considered 

purification and, for purposes of IUR, 

such purification is not considered 

manufacture. 

Note, however, that the extraction of 

component chemical substances from 

certain complex byproduct mixtures or 

process streams (i.e., UVCB chemical 

substances), is not considered 

purification, because the complex 

byproduct mixture and the extracted 

substance do not have the same 

chemical identity. For example, a 

manufacturing process involving the use 

of solvent A results in the manufacture 

of a spent solvent. As a variable, 

complex mixture of solvent A, finished 

product, unreacted reactants, individual 

byproduct substances, and other 

impurities, the spent solvent is 

considered to be a UVCB chemical 

substance. It is not unusual for the 

manufacturer to extract solvent A from 

this UVCB chemical substance. In such 

a case, the extracted solvent A is 

considered to be manufactured, and 

therefore is reportable for purposes of 

IUR. When the spent solvent is a 

byproduct whose only commercial 

purpose is the extraction of a 

component chemical substance, solvent 

A, the byproduct exemption at 40 CFR 

720.30(g)(3) can be applied and the 

spent solvent byproduct does not need 

to be reported. The extracted solvent A 

is nevertheless reportable for purposes 

of IUR. 

3. Definitions of ‘‘manufacture’’ and 

‘‘manufacturer.’’ EPA received several 

comments on the definition of 

manufacture, asserting that the 

definition of manufacture included in 

the proposed rule was inconsistent with 

past definitions, over-broad, and 

confusing. 

EPA disagrees, except with respect to 

minor typographical errors noted in this 

unit. EPA consolidated existing 

definitions into a single manufacture 

definition to reduce confusion. EPA also 

added a very short clarifying definition 

that ‘‘a manufacturer is a person who 

manufactures a chemical substance,’’ to 

direct the reader to the relevant 

language in the definition of 

manufacture, and to avoid confusion 

with an existing definition of 

manufacturer in 40 CFR 704.3. The 

definition of manufacture is consistent 

with established regulatory and 

statutory definitions, and is sufficiently 

flexible to accommodate the actual 

allocation of knowledge between toll 

manufacturers and contracting 

companies. EPA has separately 

addressed the comments received 

relating to the extraction of component 

chemical substances. (See the 

discussion on reporting byproducts and 

recycling in this unit.) 

The first part of the definition of 

manufacture in this final rule is as 

follows: ‘‘Manufacture means to 

manufacture, produce, or import, for 

commercial purposes. Manufacture 

includes the extraction, for commercial 

purposes, of a component chemical 

substance from a previously existing 

chemical substance or complex 

combination of substances.’’ It is similar 

to the definitions of manufacture and 


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manufacturer used for past IUR 

reporting (Ref. 31). For example, the 

definition of manufacturer in effect for 

the 2006 IUR reporting period is in 40 

CFR 704.3: ‘‘Manufacturer means a 

person who imports, produces, or 

manufactures a chemical substance. A 

person who extracts a component 

chemical substance from a previously 

existing chemical substance or a 

complex combination of substances is a 

manufacturer of that component 

chemical substance.’’ The two similar 

definitions of manufacture in effect for 

the 2006 IUR reporting period were 

found in 40 CFR 710.3 (‘‘to 

manufacture, produce, or import for 

commercial purposes,’’ and 40 CFR 

704.3 (‘‘to manufacture for commercial 

purposes’’). The 40 CFR part 711 

definition of manufacture is also 

consistent with the established 

definition of manufacturer used for 

purposes of PMN reporting, at 40 CFR 

720.3. Existing 40 CFR 704.3, which was 

not modified in this final rule, also 

includes a definition of manufacture: 

‘‘Manufacture means to manufacture for 

commercial purposes,’’ and a definition 

of ‘‘manufacture for commercial 

purposes’’ that makes clear that 

byproducts produced during 

manufacturer are also ‘‘manufactured 

for a commercial purpose.’’ 

The definition of manufacture in this 

final rule is also similar to and 

consistent with TSCA’s definition of 

manufacture at TSCA section 3: 

‘‘ ‘manufacture’ means to import in the 

customs territory of the United States, 

produce, or manufacture,’’ and TSCA 

section 8: ‘‘For purposes of this section, 

the term ‘manufacture’ * * * mean[s] 

manufacture * * * for commercial 

purposes.’’ Finally, EPA disagrees with 

one commenter’s suggestion that a new 

definition of produce is necessary to 

clarify that production involves a 

chemical substance that is ‘‘chemically 

different’’ from the chemical substance 

in the starting materials. ‘‘Chemically 

different’’ is itself an undefined term, so 

it would not bring additional clarity to 

a new definition of ‘‘produce.’’ 

Furthermore, the difference between 

one chemical substance and another 

(and hence, the question of whether a 

chemical substance is being produced) 

already has a basis in the statutory 

definition of chemical substance at 

TSCA section 3(2), and in the 

differences between the entries of the 

TSCA Inventory. 

The second part of the definition, as 

noted in the preamble to the proposed 

rule, adds an explanation, derived from 

the definition of manufacturer in 40 

CFR part 720, of the conditions under 

which a contract manufacturer would be 

considered to ‘‘manufacture,’’ and 

therefore be responsible for IUR 

reporting. Persons contracting with a 

toll manufacturer and toll 

manufacturers are now considered to be 

co-manufacturers of what is produced at 

the toll manufacturer’s site. Consistent 

with 40 CFR 711.22(c), such parties 

should coordinate amongst themselves 

to submit a single report, rather than 

duplicative individual reports, 

respecting what they have comanufactured. The joint submission 

mechanism, under 40 CFR 

711.15(b)(3)(i), is not available to comanufacturers. The joint submission 

mechanism addresses distinct 

circumstances: Those in which one 

party is the manufacturer/importer, and 

a second party (not a manufacturer of 

the chemical substance in question) 

possesses confidential information 

needed to determine the chemical 

identity of what the first party has 

manufactured/imported. In the final 

rule, EPA uses the term comanufactured rather than the proposed 

term jointly manufactured. This change 

of terminology is intended to avoid 

confusion between the reporting 

provisions at 40 CFR 711.22(c) and 

those at 40 CFR 711.15(b)(3)(i). 

EPA notes that one change to the 

definition of manufacture was made to 

correct a typographical error in the 

definition as proposed and to address a 

comment that the definition used 

confusing syntax. The words ‘‘and’’ and 

‘‘then’’ were added to make clear that 

the conditions in paragraph (1), and the 

conditions in paragraph (2) (up to the 

comma), must both be satisfied before a 

chemical substance will be considered 

‘‘co-manufactured’’ by the producing 

manufacturer (i.e., the toll 

manufacturer) and the person 

contracting for such production (i.e., the 

contracting company). 

Several commenters suggested that 

the toll manufacturer should be 

primarily or solely responsible for IUR 

reporting, or expressed concern that the 

rule would compel contracting 

companies to submit information on 

behalf of toll manufacturers. Another 

commenter supported the assignment of 

responsibility as proposed. Some 

commenters also suggested that EPA 

should ‘‘acknowledge the complexity of 

contractual mechanisms and not offer a 

blanket, ‘one size fits all’ requirement 

for reporting responsibilities.’’ 

EPA agrees that a diversity of 

contractual arrangements may exist, and 

notes that there was nothing in the 

proposed rule to prevent toll and 

contracting manufacturers from sharing 

information and agreeing between 

themselves that one or the other will 

undertake all or a portion of the work 

associated with IUR reporting for a 

given chemical substance, though 

comments indicated that there was 

some confusion caused by EPA’s 

assignment of ‘‘primary’’ responsibility 

for reporting to the contracting 

manufacturer (see 40 CFR 711.22(c)). 

EPA expects that in most instances, a 

person that contracts with a toll 

manufacturer will generally know more 

about the particular chemical 

substances, and will usually be a better 

position to report on industrial 

processing and use of a chemical 

substance, and on commercial and 

consumer uses of products containing 

the chemical substance. Similarly, EPA 

expects that the toll manufacturer will 

generally be in a better position to 

report on the number of workers and 

other information about their plant. In 

light of the contracting company’s 

control over the ‘‘total amount produced 

and the basic technology for the plant 

process,’’ and based on EPA’s 

expectations of the relative knowledge 

of the contracting company, EPA 

initially indicated, in proposed 40 CFR 

711.22(c), that the contracting company 

would be ‘‘primarily responsible’’ for 

IUR reporting. However, given the 

confusion introduced by indicating that 

one party or the other is ‘‘primarily’’ 

responsible for reporting, and not 

wishing to interfere in contractual 

agreements to the contrary, EPA has 

decided not to allocate ‘‘primary’’ 

responsibility to either party in the final 

rule. Conforming changes have been 

made to 40 CFR 711.22(c) in this final 

rule. However, the enforceability of the 

final rule requires EPA to specify the 

persons who are legally responsible for 

reporting. In fairness, EPA has chosen to 

make both parties responsible for 

reporting on the chemical substances 

they have co-manufactured, as specified 

in the proposed rule. 

4. Definition of ‘‘site.’’ Several 

commenters asserted that the proposed 

revision to the definition of ‘‘site’’ 

would force different companies that are 

at the same site to report together. EPA 

disagrees with this assertion. In the 

proposed rule, EPA added explanations 

to accommodate manufacturing under 

contract and for portable manufacturing 

units, and clarified that an importer’s 

site must be a U.S. address. The 

definition of site used in the past, at 40 

CFR 710.3, was not otherwise 

significantly changed. The old 

definition states that ‘‘Site means a 

contiguous property unit. Property 

divided only by a public right-of-way 

will be considered one site. There may 

be more than one manufacturing plant 


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on a single site. * * *’’ This portion of 

the definition was retained, with slight 

wording change (‘‘More than one plant 

may be located on a single site.’’), in the 

proposed rule. 

The statement ‘‘More than one plant 

may be located on a single site’’ is 

meant to guide companies that have 

multiple plants at one site to sum 

production volumes and other IURreportable data across all of their plants 

at one site and produce one report for 

each reportable substance at each site 

(not at each plant). The definition does 

not require different companies located 

at the same site to report together. 

5. Processing and use-related 

definitions. EPA received comments in 

favor of the amended definitions for 

commercial use and consumer use. 

However, a commenter indicated that 

the definitions of ‘‘industrial,’’ 

‘‘commercial,’’ ‘‘function,’’ and ‘‘use,’’ 

were unclear and referred to problems 

in reporting both product- and 

substance-level information. EPA 

appreciates the support for amending 

the terms commercial use and consumer 

use to harmonize the definitions 

developed by the United States and 

Canada. 

EPA feels the terms ‘‘industrial’’ and 

‘‘commercial’’ are adequately defined. 

To clarify, EPA defines industrial 

function as ‘‘the intended physical or 

chemical characteristic for which a 

chemical substance or mixture is 

consumed as a reactant; incorporated 

into a formulation, mixture, reaction 

product, or article; repackaged; or 

used.’’ This definition can be found in 

the ‘‘IUR Modifications Rule: 

Development of Definitions for 

Proposed 40 CFR 711.3’’ (Ref. 8). EPA 

also notes that the terms use, industrial 

use, consumer use, and commercial use 

have already been in use for IUR and 

were previously defined in 40 CFR 

710.43 (relocated in this final rule to 40 

CFR 711.3). 

F. Confidential Business Information 

1. Release of information not validly 

claimed as CBI. The Agency received 

comments about the proposed change to 

make information claimed as CBI 

available to the public without further 

notice to the submitter, in the 

circumstance that the required 

substantiation is not submitted with the 

claim. Opponents of the change are 

concerned that a reporting error could 

result in public release of legitimate 

CBI. They suggested notifying the 

submitter if further substantiation is 

needed prior to releasing data to the 

public. The commenters are in favor of 

a warning system that would allow 

submitters time to provide additional 

substantiation on CBI claims before the 

Agency determines the data is non-CBI 

and releases it as public information. 

There are three situations during 

which the Agency will release IUR 

information claimed as CBI without 

further notice to the submitter. First is 

the circumstance that a CBI claim is 

made for the identity of a chemical 

substance already listed on the nonconfidential portion of the Master 

Inventory File. Any such CBI claims 

were invalid under the previous IUR 

regulations (applicable to the 2006 and 

earlier submission periods). 

The second is the circumstance that a 

submission lacks the certification 

required under 40 CFR 711.15(b)(1). 40 

CFR 711.15(b)(1) requires a certification 

stating that the submitted information 

has been completed in compliance with 

the requirements of this part and that 

the confidentiality claims made on the 

Form U are true and correct. The 

certification must be signed and dated 

by the authorized official for the 

submitter company, and provide that 

person’s name, official title, and e-mail 

address. Consistent with this regulatory 

provision, the e-CDRweb tool is 

designed to entirely block the 

submission of a Form U lacking an 

appropriate certification. 

The third is the circumstance that a 

particular CBI claim is not accompanied 

by upfront substantiation required 

under 40 CFR 711.30(b), (c), or (d) (e.g., 

upfront substantiation of processing and 

use information). The e-CDRweb 

reporting tool is designed to protect 

against a company not providing an 

upfront substantiation. When a CBI 

claim is made and substantiation is 

required, the reporting tool will open 

the substantiation question page. 

Should the submitter choose not to 

complete the substantiation at that time, 

or to only partially complete it, the 

validation portion of the tool will again 

alert the submitter to the need for 

substantiation. The tool also includes 

warnings that information with 

unsubstantiated CBI claims will be 

released without further notice to the 

submitter. EPA believes these reminders 

provide sufficient notice to the 

submitter of the need to substantiate 

these claims. 

2. Upfront substantiation for 

processing and use information. The 

Agency received comments both for and 

against the proposed upfront 

substantiation requirement when 

processing and use information is 

claimed as confidential. Commenters 

opposing the proposed change 

explained that processing and use 

information is often considered 

confidential by customers to protect 

their competitive positions in the 

market. Commenters voiced concern 

that the proposed change will impact 

their ability to remain competitive or 

will reduce innovation. These 

commenters were concerned that the 

manufacturers of the chemical 

substances would not correctly identify 

CBI associated with downstream uses, 

and that confidentiality agreements 

between the chemical substance 

manufacturer and the downstream users 

would not provide sufficient 

substantiation for the processing and 

use information. The Agency believes 

that the processing and use information 

in the publicly released IUR reports is 

sufficiently agglomerated to address 

these concerns. However, the Agency 

also recognizes that there are 

circumstances when the release of 

information about a particular use could 

harm the competitive position of the 

submitter’s customer. Therefore, EPA 

has modified the substantiation 

question at proposed 40 CFR 

711.30(d)(1)(ii) to include information 

about harm to the submitter’s 

competitive position ‘‘or to your 

customer’s competitive position.’’ EPA 

also notes that under its confidentiality 

regulations, the Agency normally 

solicits input from all affected 

businesses when making a final 

confidentiality determination respecting 

information claimed as CBI. 

Some commenters stated that 

providing written explanations for 

multiple scenarios would be 

burdensome. Another commenter 

argued, however, that requiring such 

explanations will help to limit CBI 

claims to information that in fact 

warrants protection as a legitimate trade 

secret. The commenter asserted that the 

frequency with which site information 

was claimed as CBI dropped from 28% 

to 7% after EPA added an upfront 

substantiation requirement for that data 

element, and suggested that the drop 

represented an elimination of 

‘‘excessive’’ trade secrecy claims. 

The Agency recognizes that there is a 

burden associated with providing 

written explanations. However, based 

on the significant number of CBI claims 

for processing and use information in 

the last information collection, EPA 

believes that allowing submitters to 

assert CBI claims merely by checking a 

box encourages submitters to assert such 

claims without sufficiently considering 

whether there is a basis for the claim. 

While EPA believes that such claims are 

appropriate under certain 

circumstances, the Agency wants to 

ensure that all such claims are carefully 

considered and only information that is 

truly confidential, the release of which 


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would substantially injure the 

competitive position of the submitter, is 

claimed as CBI. A substantiation 

requirement for such claims helps 

ensure that this consideration takes 

place. 

3. Prohibition of confidentiality 

claims for data elements designated as 

‘‘not known or reasonably 

ascertainable.’’ Commenters agreed 

with prohibiting CBI claims for 

processing and use information when 

designated as ‘‘not known or reasonably 

ascertainable.’’ The primary reason cited 

by supporters was that the proposed 

change will reduce the potential for 

unwarranted CBI claims. 

G. Administrative Comments 

1. Changes to reporting frequency. 

The Agency received comments 

regarding the proposed change to 

increase the IUR reporting frequency 

from every 5 years to every 4 years. 

Some commenters suggested a change to 

the reporting frequency would still 

present a burden to industry and that 

EPA has not provided adequate 

justification to warrant or support any 

increase in the reporting frequency. 

Other commenters expressed support 

for the return to the reporting frequency 

of every 4 years but some felt that to 

increase the frequency further would be 

problematic. Additional commenters 

suggesting even more frequent reporting 

cycles and these comments are 

addressed in more detail in the 

Responses to Comments document (Ref. 

12). 

In the 2003 IUR Amendments, EPA 

changed its reporting requirement from 

every 4 years to every 5 years to lessen 

the burden associated with complying 

with the amendments. However, EPA 

has decided to return to the reporting 

frequency of every 4 years, in order to 

better meet Agency needs. EPA has 

determined that reporting every 5 years 

is too infrequent, and does not provide 

enough data to sufficiently cover the 

Agency’s and public’s needs. As 

discussed in Unit III.D.1. of the 

proposed rule, many chemical 

substances, even larger volume 

chemical substances, often experience 

wide fluctuations in manufacturing 

volume from year to year. This can 

result in the production volume of a 

chemical substance exceeding the 

threshold for several years, then falling 

below the threshold during the IUR 

principal reporting year. A review of the 

previous reporting under the IUR 

indicates an approximately 30% change 

in the chemical substances that are 

reported from one reporting period to 

the next. Therefore, the 1-year snapshot 

of production volume does not provide 

an accurate picture of the chemical 

substances in commerce, and may 

provide an erroneous view of the 

exposure scenarios associated with a 

particular chemical substance. In 

addition, EPA has been criticized for 

using outdated information, which will 

be remedied with more frequent 

reporting. As such, EPA has determined 

that the value gained through obtaining 

more current and useful data is essential 

to fulfilling the Agency’s statutory 

obligations under TSCA, and outweighs 

the incremental burden to submitters. 

2. Remove superfluous text regarding 

production volume. The Agency 

received comments on the proposal to 

remove superfluous text associated with 

reporting production volumes, in 

particular the ± 10% standard of 

precision. All commenters opposed 

changing the current language. Several 

commenters indicated that reporting 

accurately to two significant figures is 

not equivalent to reporting to a 

precision of ± 10%. One commenter 

indicated that, if reporting to two 

significant figures, at higher production 

volumes there would be a narrower 

allowable range of variation. 

EPA is replacing ‘‘provided that the 

reported figures are within ± 10% of the 

actual volume’’ currently found in 40 

CFR 710.52(c)(3)(iv) with ‘‘This amount 

must be reported to two significant 

figures of accuracy.’’ The phrase that 

was removed is superfluous because any 

number reported accurately to two 

significant figures is within 10% of the 

correct value. EPA recognizes some 

commenters’ concern that this will 

result in a sliding precision scale 

between 1% and 10% that is solely 

based on the reported digits. However, 

EPA believes that reporting to two 

significant figures will maintain a 

balance between data needs for 

exposure screening and the industry 

burden associated with data collection. 

In the 2006 IUR data collection, nearly 

all manufacturers reported production 

volumes in greater precision (i.e., more 

significant figures) than is required for 

2012 reporting. Based on years of 

experience assessing chemical 

substance risks through programs such 

as the New Chemicals Program, the 

Agency believes requiring reporting to 

two or more significant figures is 

appropriate to facilitate the Agency’s 

initial exposure screens of chemical 

substances, and to prioritize and make 

basic risk management decisions about 

those chemical substances of greatest 

concern. Those decisions then can 

prompt more detailed assessments as 

necessary. 

H. Economic Impact Estimates 

1. General burden comments. The 

Agency received a number of comments 

expressing concerns about the Economic 

Analysis (Ref. 14); the majority of which 

suggest that the Agency has significantly 

underestimated the effort required to 

collect, organize, verify and report IUR 

data. Commenters disagreed with EPA’s 

burden estimates for several proposed 

modifications to the rule, including the 

retroactive reporting of production 

volumes, reporting on imported 

mixtures, mandatory electronic 

submission, the lowering of the 

threshold for downstream processing 

and use information, the change in the 

standard of reporting from ‘‘readily 

obtainable’’ to ‘‘known to or reasonably 

ascertainable by,’’ and the change in the 

reporting cycle from every 5 to every 

4 years. Several commenters asserted 

that the reporting burden will increase 

to between two and six times the burden 

for reporting in 2006. However, few 

commenters provided specific reasons 

for why they believe that the Agency’s 

estimates were low, and no commenters 

provided any analytical basis for 

revising EPA’s estimates or 

substantiated their alternative estimates. 

The Agency has used the best available 

data to estimate the burden associated 

with the modifications to the IUR rule, 

and disagrees with the commenters. The 

burden estimates presented in the 

economic analysis are reasonable 

estimates for the average IUR submitter. 

a. Identification of affected entities. In 

general, commenters stated that the 

Economic Analysis (Ref. 14) does not 

identify all affected entities, and EPA 

has inaccurately assumed that the 

proposed rule will affect only chemical 

substance manufacturers. Another 

commenter noted that a wide range of 

industries manufacture byproducts, so 

to accurately estimate the burden of the 

proposed rule, EPA must identify all 

affected industries and facilities. The 

commenter further stated that 

byproducts sent for recycling are new 

chemical substances reportable under 

the IUR rule and the Economic Analysis 

fails to identify these manufacturers. 

The Economic Analysis assumes that 

all companies manufacturing (including 

importing) chemical substances 

annually in amounts of 25,000 lb or 

greater that are listed on the TSCA 

Inventory will report under this rule. 

Chemical substance users and 

processors who may manufacture a 

byproduct chemical substance for a 

commercial purpose, e.g., utilities, 

paper manufacturers, primary metal 

manufacturers, and semiconductor and 

other electronic component 


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manufacturers (NAICS codes 22, 322, 

331, and 3344), are considered to be 

chemical substance manufacturers for 

the purposes of the IUR rule. Sites that 

manufactured a byproduct in a volume 

above the 25,000 lb threshold during the 

2006 submission period were required 

to report under IUR, and therefore are 

included in the 2006 baseline estimates. 

b. Total industry compliance 

determination burden. Commenters 

made a number of specific points 

regarding the compliance determination 

burden. According to one commenter, 

provisions requiring reporting of more 

data for many chemical substances, 

replacing NAICS codes with EU IS 

codes, and requiring upfront 

substantiation for CBI claims for Part III, 

Form U, information will contribute to 

the increased effort required to report. 

EPA disagrees that the Economic 

Analysis underestimates the reporting 

costs and burdens of this final rule 

amendments as asserted by the 

commenters. EPA does agree that many 

of the amended rule requirements, 

including provisions requiring reporting 

of more data for many chemical 

substances, replacing NAICS codes with 

Industrial Sector codes, and requiring 

upfront substantiation for CBI claims for 

Part III, Form U, information, will cause 

an increase in burden and cost. While 

EPA does state throughout the 

Economic Analysis that the burdens and 

costs may be overestimated, the analysis 

also says that they may be 

underestimated. The statements 

regarding limitations of the study serve 

to make the analysis more transparent. 

EPA does not have the ability to take 

into account the effects of individual 

company circumstances concerning 

downsizing, growth, mergers and 

acquisitions, on estimates of reporting 

burden and cost, as mentioned by one 

commenter. 

Several commenters asserted that EPA 

underestimated the burden associated 

with IUR compliance determination by 

estimating the burden on a per-report 

basis. According to the comments, this 

methodology does not capture the 

burden associated with tracking, 

screening, and keeping records for 

chemical substances that ultimately are 

not required to be reported to IUR 

because they are manufactured or 

imported in quantities below the 

reporting threshold. 

Compliance determination occurs on 

a per-site basis and is based on a 

manufacturer (including importer) 

determining that it manufactures at least 

one chemical substance at or above the 

threshold, thus necessitating that the 

site complete and submit a Form U. The 

Economic Analysis assumes all sites 

that report to the IUR incur the same 

average cost for compliance 

determination regardless of the number 

of chemical substances reported. EPA 

expects that it is standard company 

practice to track and maintain records of 

production volumes for all chemical 

substances manufactured at a given site. 

Therefore, EPA expects that the burden 

associated with compliance 

determination should not be substantial. 

The commenters appear to have 

misinterpreted EPA’s compliance 

determination burden to include the 

burden of actually reporting for the 

chemical substances subject to the IUR, 

but this is not the case. See section 4.2.2 

of the Economic Analysis (Ref. 14) for 

further clarification. 

Finally, EPA notes that the IUR does 

not require submitters to retain 

documentation showing that particular 

chemical substances did not need to be 

included in a given year’s report. In 

addition, once a submitter has made a 

compliance determination that it has 

reporting obligations under the IUR, it 

can rely on production volume 

information already reasonably 

available, in the ordinary course of 

business, to determine that particular 

chemical substances do not need to be 

reported under the IUR. For this reason, 

EPA believes it is unreasonable to 

attribute to the rule the costs of tracking, 

screening, and keeping records of the 

various production volumes of chemical 

substances that ultimately are not 

required to be reported to IUR because 

they are below the reporting threshold. 

c. Underlying assumptions and data: 

Baseline costs. Commenters questioned 

the baseline number of reports EPA 

used in calculating baseline costs. One 

commenter questioned whether EPA’s 

estimate included inorganic substances. 

Another commenter questioned whether 

EPA has adjusted the baseline estimates 

to account for new manufacturing 

facilities that never previously reported 

under the IUR rule, the elimination the 

300,000 lb threshold for processing and 

use data, and the change in the method 

of determining the eligibility to report. 

The 2006 IUR submission data 

provide the best estimate for the number 

of reports that would be submitted 

under the baseline scenario. The 

baseline scenario in the Economic 

Analysis assumes no changes have been 

made to the 2006 reporting 

requirements. This cost is used as a 

basis on which to calculate the 

incremental cost of the rule. Therefore, 

in the baseline, the number of reports 

should not be adjusted to account for 

any proposed modifications. The 

Economic Analysis does estimate the 

additional number of Part III of Form U 

reports that will be submitted as a result 

of this final rule, including the 

elimination of the 300,000 lb threshold 

(see section 4.4.4 of the Economic 

Analysis (Ref. 14)), as well as the 

additional number of reports submitted 

as a result of the change in the method 

of determining the eligibility to report 

(see section 4.4.3 of the Economic 

Analysis (Ref. 14)). In addition, the 

Economic Analysis accounts for rule 

familiarization costs for any new 

companies submitting data (see section 

4.2.2 of the Economic Analysis (Ref. 

14)). The 2006 data do include reports 

for inorganic chemical substances, 

because while inorganic chemical 

substance manufacturers were exempt 

from submitting downstream processing 

and use information in the 2006 

submission period, they were required 

to submit Parts I and II of Form U, and 

therefore are included in the baseline 

number of reports. 

I. Request for Comment on Additional 

Issues 

EPA requested comment on several 

additional topics in Unit V. of the 

proposed rule (Ref. 1, p. 49676). The 

comment summaries and responses to 

these issues are contained in the 

Responses to Comments document (Ref. 

12). 

VI. References 

As indicated under ADDRESSES, a 

docket has been established for this 

rulemaking under docket ID number 

EPA–HQ–OPPT–2009–0187. The 

following is a listing of the documents 

that are specifically referenced in this 

document. The docket includes these 

documents and other information 

considered by EPA in developing this 

final rule, including documents that are 

referenced within the documents that 

are included in the docket, even if the 

referenced document is not physically 

located in the docket. For assistance in 

locating these other documents, please 

consult the technical person listed 

under FOR FURTHER INFORMATION

CONTACT. 

1. EPA. TSCA Inventory Update Reporting 

Modifications; Proposed Rule. Federal 

Register (75 FR 49656, August 13, 2010) 

(FRL–8833–5). 

2. EPA. Inventory Reporting Regulations; 

Final Rule. Federal Register (42 FR 

64572, December 23, 1977) (FRL–817–1). 

3. EPA. Partial Updating of TSCA Inventory 

Data Base; Production and Site Reports; 

Final Rule. Federal Register (51 FR 

21438, June 12, 1986) (FRL–2973–3). 

4. EPA. TSCA Inventory Update Rule 

Amendments; Final Rule. Federal 

Register (68 FR 848, January 7, 2003) 

(FRL–6767–4). 


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5. EPA. OPPT. Enhancing EPA’s Chemical 

Management Program. Available on-line 

at http://www.epa.gov/oppt/existing

chemicals/pubs/enhanchems.html. 

6. EPA. TSCA Inventory Update Reporting 

Modifications; Submission Period 

Suspension; Final Rule. Federal Register 

(76 FR 27271, May 11, 2011) (FRL–8874– 

2). 

7. EPA. Instructions for the 2012 TSCA 

Chemical Data Reporting. July 2011. Also 

available on-line at http://www.epa.gov/ 

cdr. 

8. EPA. OPPT. IUR Modifications Rule: 

Development of Definitions for Proposed 

40 CFR 711.3. July 8, 2010. 

9. EPA. TSCA Inventory Update Reporting 

Revisions; Final Rule. Federal Register 

(70 FR 75059, December 19, 2005) (FRL– 

7743–9). 

10. EPA. OPPT. Electronic Signature 

Agreement. August 2009. 

11. EPA/Environment Canada/Health 

Canada, Overview of Harmonized U.S.- 

Canada Industrial Function and 

Consumer and Commercial Product 

Codes for Chemical Inventory Reporting. 

November 2009. 

12. EPA. OPPT. Summary of EPA’s 

Responses to Public Comments 

Submitted in Response to Proposed 

TSCA Inventory Update Reporting 

Modifications Rule. 

13. EPA. OPPT. 2006 IUR Database Statistics 

for the IUR Modifications Rule. 

December 17, 2008. 

14. EPA. OPPT. Economics, Exposure and 

Technology Division (EETD). Economic 

Analysis for the Final Inventory Update 

Reporting (IUR) Modifications Rule. July 

2011. 

15. EPA. Toxic Chemical Release Inventory 

Reporting Forms and Instructions. 

October 2009. Available on-line at 

http://www.epa.gov/tri/report/rfi/

ry2009rfi121709.pdf. 

16. EPA. OPPT. EETD. Inventory Update 

Reporting (IUR) Technical Support 

Document—Replacement of 5-digit 

NAICS Codes with Industrial Sector (IS) 

Codes. October 2009. 

17. Environmental Defense Fund, Letter to 

Docket ID Number EPA–HQ–OPPT– 

2009–0187 (on behalf of 32 

organizations), from Richard Denison, 

PhD, October 12, 2010. 

18. Proposal for Priority Setting for Existing 

Substances on the Domestic Substances 

List under the Canadian Environmental 

Protection Act, 1999. Greatest Potential 

for Human Exposure. Canada, 2003. 

19. EPA. OPPT. Screening-Level Hazard 

Characterization and Prioritization 

Document. March 2009. Available online at http://www.epa.gov/chemrtk/

hpvis/rbp/Butenedioic%

20Acid%20Dialkyl%20Esters_HBP_

March%202009.pdf. 

20. NOVA Chemicals, Letter to Docket ID No. 

EPA–HQ–OPPT–2009–0187, from Linda 

Santry. October 7, 2010. 

21. EPA. OPPT. Initial Risk-Based 

Prioritization of High Production 

Volume (HPV) Chemicals. April 2009. 

Available on-line at http://www.epa.gov/ 

chemrtk/hpvis/rbp/

Category_Chlorobenzenes_Web_April%

202009.pdf. 

22. European Commission. REACH. January 

2011. Available on-line at http://ec.

europa.eu/environment/chemicals/

reach/reach_intro.htm. 

23. H.R. Rep. 94–1679, 94th Congress, 2d 

Session (1976), reprinted in 

Environmental and Natural Resources 

Policy Division of the Library of 

Congress, 94th Congress, 2d Session, A 

Legislative History of the Toxic 

Substances Control Act, (Committee 

Print 1976) (Legislative History, pp. 667– 

721). 

24. EPA. Recordkeeping and Reporting 

Requirements; Recodification; Final 

Rule. Federal Register (48 FR 23420, 

May 25, 1983) (FRL–2370–70). 

25. EPA. Premanufacture Notification; 

Premanufacture Notice Requirements 

and Review Procedures; Final Rule. 

Federal Register (48 FR 21722, May 13, 

1983) (FRL 2998–5). 

26. EPA. Comprehensive Assessment 

Information Rule; Final Rule. Federal 

Register (53 FR 51698, December 22, 

1988) (FRL–3368–1). 

27. Prenotice Communication Letter from 

Mary E. Cushmac, EPA. July 29, 1991. 

28. Letter from Susan Sharkey, EPA, to 

Robert P. Strieter, The Aluminum 

Association. October 24, 2006. 

29. Letter from Charles M. Auer, EPA, to Fern 

Abrams, IPC. August 27, 2008. 

30. EPA. OPPT. Q&A Document: Recycling 

and the TSCA Chemical Substance 

Inventory—Premanufacture Notification 

and Chemical Data Reporting 

Requirements. May 2011. 

31. EPA. Table of Comparison of 2012 CDR 

v 2006 IUR Definitions. February 9, 

2011. 

32. EPA. Agency Information Collection 

Activities; Final Collection; Partial 

Update of the TSCA Section 8(b) 

Inventory Data Base, Production and Site 

Reports; EPA ICR No. 1884.05, OMB 

Control No. 2070–0162. 

VII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

Under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

Review’’ (58 FR 51735, October 4, 1993), 

this action has been designated a 

‘‘significant regulatory action’’ by the 

Office of Management and Budget 

(OMB). Accordingly, EPA submitted 

this action to OMB for review under 

Executive Order 12866 and any changes 

made in response to OMB 

recommendations have been 

documented in the docket for this 

action. 

In addition, EPA has prepared an 

economic analysis of the potential 

impacts associated with this action. A 

copy of this Economic Analysis (Ref. 14) 

is available in the docket and is briefly 

summarized in this unit. The Agency, in 

promulgating this final rule, is required 

under TSCA to consider the potential 

costs and benefits associated with IUR. 

The analysis was therefore used by the 

decisionmakers to help in the selection 

of the final rule requirements presented 

in this document. 

The amendments in this final rule 

affect the number of reports submitted 

during a submission period, the burden 

to prepare a report, and the reporting 

frequency. EPA estimates that the 

combined impact of all the amendments 

will increase the total burden and cost 

to industry associated with IUR 

reporting. 

In its Economic Analysis, EPA 

estimated industry cost and burden on 

a per-report and a per-site basis and at 

the industry level. Industry cost and 

burden are incurred by performing 

activities to comply with the 

amendments, including compliance 

determination, rule familiarization, 

preparation and submission of reports, 

and recordkeeping. 

On a per-report basis, EPA estimated 

incremental increases of 0.47 hours and 

$118 for a site to complete a partial 

report for 1 chemical substance and 

13.57 hours and $1,176 to complete a 

full report for 1 chemical substance, in 

the first reporting cycle after the 

effective date of the final rule 

amendments. A partial report includes 

Parts I and II of Form U. A full report 

includes Parts I, II, and III of Form U. 

For future reporting cycles, EPA 

estimated incremental increases of 2.26 

hours and $212 for a site to complete a 

partial report for 1 chemical substance 

and 11.96 hours and $1,012 to complete 

a full report for 1 chemical substance. 

As a result of the amendments, EPA 

estimates that the average site will 

submit approximately 0.90 and 2.01 

fewer partial reports in the first 

reporting cycle and future reporting 

cycles, respectively. An increase in full 

reports per site of 0.89 in the first 

reporting period and 2.88 in future 

reporting periods is expected. For the 

average site, this will increase the 

burden by 121 hours during the first 

reporting cycle and 249 hours for all 

subsequent reporting cycles. EPA 

estimates that the average site will incur 

a net cost increase of $9,000 during the 

first reporting cycle and $16,551 during 

all future reporting cycles. 

At the industry level for all sites 

submitting a Form U, EPA estimates a 

net total burden increase of 0.50 million 

hours in the first reporting cycle, and 

1.14 million hours for all subsequent 

reporting cycles. EPA estimates a net 

cost increase of $36.76 million in the 

first reporting cycle of the final rule, and 

$75.12 million in all subsequent 

reporting cycles. 


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EPA estimates that the Agency will 

experience a reduction in both burden 

and cost to administer the IUR rule as 

a result of the amendments. 

Specifically, EPA expects to experience 

a net burden reduction of 940 hours in 

the first reporting cycle and 1,678 in 

subsequent reporting cycles. The 

Agency estimates it will experience a 

net savings of approximately $68,000 

during the first reporting cycle and 

$175,000 in subsequent reporting 

cycles. This information will be 

reflected in the ICR that is submitted 

every 3 years to OMB under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq. 

EPA believes that this final rule 

represents an appropriate balance 

between the burden placed on industry 

to provide information and the Agency’s 

need for that information to fill its 

statutory obligations and fulfill its 

mission under TSCA and, as part of that 

mission, to provide information needed 

by other agencies (OSHA, NIOSH, 

CPSC, etc.). 

B. Paperwork Reduction Act 

The information collection 

requirements in 40 CFR part 710 related 

to the submission of Form Us are 

already approved by OMB under PRA. 

That ICR has been assigned EPA ICR No. 

1884 and OMB control no. 2070–0162. 

Because this final rule involves new or 

revised information collection activities 

that require additional OMB approval, 

EPA has prepared an addendum to the 

currently approved ICR (Ref. 32). An 

agency may not conduct or sponsor, and 

a person is not required to respond to 

an information collection request 

subject to PRA, unless it displays a 

currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations are listed in 40 CFR part 9 

and included on any related collection 

instrument (e.g., on the form or survey). 

Under PRA, the term ‘‘burden’’ is 

interpreted as the total time, effort, or 

financial resources expended by people 

to generate, maintain, retain, disclose, or 

provide information to or for a Federal 

agency. This includes the time needed 

by regulated entities to review 

instructions and to develop, acquire, 

install, and use technology and systems 

to collect, validate, verify, and disclose 

information. Time taken to adjust 

existing ways to comply with any 

previously applicable instructions and 

requirements and to train personnel to 

respond to the information collection 

task is also included. In this analysis, 

total industry burden hours represent 

the sum of time spent on reporting and 

on other administrative activities. 

Industry will spend time on the 

following activities associated with the 

IUR rule: Compliance determination, 

rule familiarization, preparation and 

submission of reports, and 

recordkeeping. 

As presented in the Economic 

Analysis (Ref. 14) and the addendum 

ICR (Ref. 32), EPA estimates that the 

final rule would generate a total 

incremental industry burden of 0.50 

million hours in the first reporting 

cycle. The burden for a site to complete 

a full IUR report for one chemical 

substance in the first reporting cycle is 

estimated to be 136.57 hours, which is 

an incremental burden increase of 13.57 

hours over the current estimated 

burden. The burden for a site to 

complete a partial IUR report for one 

chemical substance in the first reporting 

cycle is estimated to be 53.55 hours, 

which is an incremental burden 

increase of 0.47 hours over the current 

estimated burden. For future reporting 

cycles, EPA estimates that the final rule 

would create a total incremental 

industry burden of 1.14 million hours. 

The burden to complete a full report is 

estimated to be 94.01 hours, which is an 

incremental increase of 11.94 hours over 

the current estimated future burden. 

The burden for a partial report is 

estimated to be 28.38 hours, which is an 

incremental increase of 2.24 hours over 

the current estimate. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that this action will not have a 

significant adverse economic impact on 

a substantial number of small entities. 

The Agency’s basis is briefly 

summarized here and is detailed in the 

Economic Analysis (Ref. 14). 

Under RFA, small entities include 

small businesses, small organizations, 

and small governmental jurisdictions. 

For purposes of assessing the impacts of 

this final rule on small entities, small 

entity is defined as: 

1. A small business, as defined by the 

SBA’s regulations at 13 CFR 121.201. 

The SBA definitions typically are based 

upon either a sales or an employment 

level, depending on the nature of the 

industry. Companies engaged in 

chemical substance manufacturing 

(NAICS code 325) or petroleum refining 

(NAICS code 324110) are the most likely 

to report under the IUR rule. These 

employee size standards range from 500 

employees to 1,500 employees for 

NAICS codes 325 and 324110. 

2. A small governmental jurisdiction 

that is a government of a city, county, 

town, school district, or special district 

with a population of less than 50,000. 

3. A small organization that is any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field. 

Since the regulated community does 

not include small governmental 

jurisdictions or small not-for-profit 

organizations, the analysis focuses on 

small businesses. 

The existing IUR rule, at 40 CFR 

710.49, generally exempts from 

reporting small businesses, defined at 

40 CFR 704.3 as entities with annual 

sales of less than $40 million and less 

than 100,000 lb production of any given 

chemical substance at a site; or annual 

sales of less than $4 million. This 

exemption is maintained in this final 

rule. A small business would be 

required to report under the final rule, 

however, if it produces any chemical 

substance that is the subject of a 

regulation proposed or promulgated 

under TSCA section 4, 5(b)(4), or 6, or 

that is the subject of an order under 

TSCA section 5(e), or that is the subject 

of relief that has been granted pursuant 

to a civil action under TSCA section 5 

or 7 (40 CFR 711.9 and TSCA section 

8(a)(3)(A)(ii)). A small business may 

also report voluntarily. 

EPA analyzed potential small 

business impacts from this final rule 

using both the SBA employee size 

standards and the TSCA sales-based 

definition of small business. EPA 

estimates that 466 small firms 

potentially would be affected by this 

final rule using the employment-based 

definition, and 280 small firms 

potentially would be affected using the 

sales-based definition. Based on costs 

annualized over a 4-year period and 

average sales data for the parent 

companies, EPA estimated that the costto-sales ratio of the final rule would be 

less than 0.1% for an average small 

company subject to the rule. For a 

company to have a cost-to-sales ratio 

larger than 1%, company sales would 

have to be less than $0.81 million. 

Because the small businesses affected by 

the final rule have average sales of more 

than $412.7 million under the 

employment-based definition, and $116 

million under the sales-based definition, 

small entities will not be affected by the 

amendments to the IUR rule at a costto-sales ratio of greater than 1% (Ref. 

14). 

D. Unfunded Mandates Reform Act 

This action does not contain any 

Federal mandates for State, local, or 

Tribal governments or the private sector 

under the provisions of Title II of the 

Unfunded Mandates Reform Act 

(UMRA), 2 U.S.C. 1531–1538. EPA has 

determined that this regulatory action 


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will not result in annual expenditures of 

$100 million or more for State, local, 

and Tribal governments, in the 

aggregate, or for the private sector. The 

costs associated with this action are 

briefly described in Unit V.A., and is 

contained in the Economic Analysis 

(Ref. 14). 

Based on EPA’s past experience, 

State, local, and Tribal governments 

have not been affected by this reporting 

requirement, and EPA does not have 

any reason to believe that any State, 

local, or Tribal government will be 

affected by this final rule. As such, EPA 

has determined that this final rule does 

not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect on small 

governments. Accordingly, this final 

rule is not subject to the requirements 

of sections 202, 203, or 205 of UMRA. 

E. Executive Order 13132 

Pursuant to Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999), EPA has determined 

that this final rule does not have 

federalism implications because it will 

not have substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in the 

Executive Order. This final rule simply 

amends the IUR rule in several ways to 

provide information to better address 

Agency and public information needs, 

improve the usability and reliability of 

the reported data, and ensure that data 

are available in a timely manner. 

Because EPA has no information to 

indicate that any State or local 

government manufactures or processes 

the chemical substances covered by this 

action, the final rule does not apply 

directly to States and localities and will 

not affect State and local governments. 

Thus, Executive Order 13132 does not 

apply to the final rule. 

F. Executive Order 13175 

As required by Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000), EPA has determined that this 

final rule does not have Tribal 

implications because it will not have 

any effect on Tribal governments, on the 

relationship between the Federal 

Government and the Indian Tribes, or 

on the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes, as 

specified in the Order. Thus, Executive 

Order 13175 does not apply to this final 

rule. 

G. Executive Order 13045 

EPA interprets Executive Order 

13045, entitled ‘‘Protection of Children 

from Environmental Health Risks and 

Safety Risks’’ (62 FR 19885, April 23, 

1997), as applying only to those 

regulatory actions that concern health or 

safety risks, such that the analysis 

required under section 5–501 of 

Executive Order 13045 has the potential 

to influence the regulation. This action 

is not subject to Executive Order 13045 

because it does not establish an 

environmental standard intended to 

mitigate health or safety risks. 

Nevertheless, the information obtained 

by the reporting required by this final 

rule will be used to inform the Agency’s 

decisionmaking process regarding 

chemical substances to which children 

may be disproportionately exposed. 

This information will also assist the 

Agency and others in determining 

whether the chemical substances in this 

final rule present potential risks, 

allowing the Agency and others to take 

appropriate action to investigate and 

mitigate those risks. 

H. Executive Order 13211 

This action is not a ‘‘significant 

energy action’’ as defined in Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), because it is not likely to have 

a significant adverse effect on the 

supply, distribution, or use of energy as 

described in the Executive Order. 

I. National Technology Transfer and 

Advancement Act 

Since this action does not involve any 

technical standards, section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (NTTAA), 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note), does not apply to this 

action. 

J. Executive Order 12898 

The final rule does not have an 

adverse impact on the environmental 

and health conditions in low-income 

and minority communities that require 

special consideration by the Agency 

under Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). The Agency believes that the 

information collected under this final 

rule will assist EPA and others in 

determining the potential hazards and 

risks associated with the chemical 

substances covered by the final rule. 

Because the IUR rule is an information 

collection requirement, the information 

that will become available through the 

rule will enable the Agency to target 

educational, regulatory, or enforcement 

activities towards industries or chemical 

substances that pose the greatest risks 

and/or to target programs for geographic 

areas that are at the highest risk. Thus, 

the information to be gathered under the 

final rule will help EPA make decisions 

that will benefit potentially at-risk 

communities, some of which may be 

disadvantaged. 

The final rule is directed at 

manufacturers (including importers) of 

chemical substances. All consumers of 

these chemical products and all workers 

who come into contact with these 

chemical substances could benefit if 

data regarding the chemical substances’ 

health and environmental effects were 

developed. Therefore, it does not appear 

that the costs and the benefits of the 

final rule will be disproportionately 

distributed across different geographic 

regions or among different categories of 

individuals. 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Parts 704, 

710, and 711 

Environmental protection, Chemicals, 

Confidential Business Information (CBI), 

Hazardous materials, Importer, 

Manufacturer, Reporting and 

recordkeeping requirements. 

Dated: August 1, 2011. 

Stephen A. Owens, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 704—[AMENDED] 

■ 1. The authority citation for part 704 

continues to read as follows: 

Authority: 15 U.S.C. 2607(a). 

§ 14;704.3 [Amended] 

■ 2. In § 14;704.3, remove the phrase 

‘‘(as defined in 19 CFR 1.11)’’ in 


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paragraph (1)(ii) of the definition 

importer. 

PART 710—COMPILATION OF THE 

TSCA CHEMICAL SUBSTANCE 

INVENTORY 

■ 3. The authority citation for part 710 

continues to read as follows: 

Authority: 15 U.S.C. 2607(a). 

■ 4. Revise the heading for part 710 to 

read as set forth above. 

■ 5. Remove the heading ‘‘Subpart A— 

General Provisions.’’ 

■ 6. Revise paragraph (b) of § 14;710.1 to 

read as follows: 

§ 14;710.1 Scope and compliance. 

* * * * * 

(b) This part applies to the activities 

associated with the compilation of the 

TSCA Chemical Substance Inventory 

(TSCA Inventory) and the update of 

information on a subset of the chemical 

substances included on the TSCA 

Inventory. 

* * * * * 

■ 7. Section 710.3 is amended as 

follows: 

■ i. Revise the introductory text. 

■ ii. Remove the phrase ‘‘(as defined in 

19 CFR 1.11)’’ in paragraph (2) of the 

definition importer. 

■ iii. Remove the definition nonisolated intermediate. 

The revision reads as follows: 

§ 14;710.3 Definitions. 

For purposes of this part: 

* * * * * 

Subpart B (§§ 14;710.23–710.39) 

[Removed] 

■ 8. Remove subpart B, consisting of 

§§ 14;710.23–710.39. 

Subpart C (§§ 14;710.43–710.59) 

[Removed] 

■ 9. Remove subpart C, consisting of 

§§ 14;710.43–710.59. 

■ 10. Add new part 711 to subchapter R 

to read as follows: 

PART 711—TSCA CHEMICAL DATA 

REPORTING REQUIREMENTS 

Sec. 

711.1 Scope and compliance. 

711.3 Definitions. 

711.5 Chemical substances for which 

information must be reported. 

711.6 Chemical substances for which 

information is not required. 

711.8 Persons who must report. 

711.9 Persons not subject to this part. 

711.10 Activities for which reporting is not 

required. 

711.15 Reporting information to EPA. 

711.20 When to report. 

711.22 Duplicative reporting. 

711.25 Recordkeeping requirements. 

711.30 Confidentiality claims. 

711.35 Electronic filing. 

Authority: 15 U.S.C. 2607(a). 

§ 711.1 Scope and compliance. 

(a) This part specifies reporting and 

recordkeeping procedures under section 

8(a) of the Toxic Substances Control Act 

(TSCA) (15 U.S.C. 2607(a)) for certain 

manufacturers (including importers) of 

chemical substances. Section 8(a) of 

TSCA authorizes the EPA Administrator 

to require reporting of information 

necessary for administration of TSCA, 

including issuing regulations for the 

purpose of compiling and keeping 

current the TSCA Chemical Substance 

Inventory (TSCA Inventory) as required 

by TSCA section 8(b). In accordance 

with TSCA section 8(b), EPA amends 

the TSCA Inventory to include new 

chemical substances manufactured 

(including imported) in the United 

States and reported under TSCA section 

5(a)(1). EPA also revises the categories 

of chemical substances and makes other 

amendments as appropriate. 

(b) This part applies to the activities 

associated with the periodic update of 

information on a subset of the chemical 

substances included on the TSCA 

Inventory. 

(c) Section 15(3) of TSCA makes it 

unlawful for any person to fail or refuse 

to submit information required under 

this part. In addition, TSCA section 

15(3) makes it unlawful for any person 

to fail to keep, and permit access to, 

records required by this part. Section 16 

of TSCA provides that any person who 

violates a provision of TSCA section 15 

is liable to the United States for a civil 

penalty and may be criminally 

prosecuted. Pursuant to TSCA section 

17, the Federal Government may seek 

judicial relief to compel submission of 

TSCA section 8(a) information and to 

otherwise restrain any violation of 

TSCA section 15. (EPA does not intend 

to concentrate its enforcement efforts on 

insignificant clerical errors in 

reporting.) 

(d) Each person who reports under 

this part must maintain records that 

document information reported under 

this part and, in accordance with TSCA, 

permit access to, and the copying of, 

such records by EPA officials. 

§ 711.3 Definitions. 

The definitions in this section and the 

definitions in TSCA section 3 apply to 

this part. In addition, the definitions in 

40 CFR 704.3 also apply to this part, 

except the definitions manufacture and 

manufacturer in 40 CFR 704.3. 

CDX or Central Data Exchange means 

EPA’s centralized electronic document 

receiving system, or its successors. 

Commercial use means the use of a 

chemical substance or a mixture 

containing a chemical substance 

(including as part of an article) in a 

commercial enterprise providing 

saleable goods or services. 

Consumer use means the use of a 

chemical substance or a mixture 

containing a chemical substance 

(including as part of an article) when 

sold to or made available to consumers 

for their use. 

e-CDRweb means the electronic, webbased tool provided by EPA for the 

completion and submission of the CDR 

data. 

Industrial function means the 

intended physical or chemical 

characteristic for which a chemical 

substance or mixture is consumed as a 

reactant; incorporated into a 

formulation, mixture, reaction product, 

or article; repackaged; or used. 

Industrial use means use at a site at 

which one or more chemical substances 

or mixtures are manufactured (including 

imported) or processed. 

Intended for use by children means 

the chemical substance or mixture is 

used in or on a product that is 

specifically intended for use by children 

age 14 or younger. A chemical substance 

or mixture is intended for use by 

children when the submitter answers 

‘‘yes’’ to at least one of the following 

questions for the product into which the 

submitter’s chemical substance or 

mixture is incorporated: 

(1) Is the product commonly 

recognized (i.e., by a reasonable person) 

as being intended for children age 14 or 

younger? 

(2) Does the manufacturer of the 

product state through product labeling 

or other written materials that the 

product is intended for or will be used 

by children age 14 or younger? 

(3) Is the advertising, promotion, or 

marketing of the product aimed at 

children age 14 or younger? 

Manufacture means to manufacture, 

produce, or import, for commercial 

purposes. Manufacture includes the 

extraction, for commercial purposes, of 

a component chemical substance from a 

previously existing chemical substance 

or complex combination of chemical 

substances. When a chemical substance, 

manufactured other than by import, is: 

(1) Produced exclusively for another 

person who contracts for such 

production, and 

(2) That other person specifies the 

identity of the chemical substance and 


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controls the total amount produced and 

the basic technology for the plant 

process, then that chemical substance is 

co-manufactured by the producing 

manufacturer and the person 

contracting for such production. 

Manufacturer means a person who 

manufactures a chemical substance. 

Master Inventory File means EPA’s 

comprehensive list of chemical 

substances which constitutes the TSCA 

Inventory compiled under TSCA section 

8(b). It includes chemical substances 

reported under 40 CFR part 710 and 

substances reported under 40 CFR part 

720 for which a Notice of 

Commencement of Manufacture or 

Import has been received under 40 CFR 

720.120. 

Principal reporting year means the 

latest complete calendar year preceding 

the submission period. 

Reasonably likely to be exposed 

means an exposure to a chemical 

substance which, under foreseeable 

conditions of manufacture (including 

import), processing, distribution in 

commerce, or use of the chemical 

substance, is more likely to occur than 

not to occur. Such exposures would 

normally include, but would not be 

limited to, activities such as charging 

reactor vessels, drumming, bulk loading, 

cleaning equipment, maintenance 

operations, materials handling and 

transfers, and analytical operations. 

Covered exposures include exposures 

through any route of entry (inhalation, 

ingestion, skin contact, absorption, etc.), 

but excludes accidental or theoretical 

exposures. 

Repackaging means the physical 

transfer of a chemical substance or 

mixture, as is, from one container to 

another container or containers in 

preparation for distribution of the 

chemical substance or mixture in 

commerce. 

Reportable chemical substance means 

a chemical substance described in 

§ 14;711.5. 

Site means a contiguous property 

unit. Property divided only by a public 

right-of-way shall be considered one 

site. More than one manufacturing plant 

may be located on a single site. 

(1) For chemical substances 

manufactured under contract, i.e., by a 

toll manufacturer, the site is the location 

where the chemical substance is 

physically manufactured. 

(2) The site for an importer who 

imports a chemical substance described 

in § 14;711.5 is the U.S. site of the 

operating unit within the person’s 

organization that is directly responsible 

for importing the chemical substance. 

The import site, in some cases, may be 

the organization’s headquarters in the 

United States. If there is no such 

operating unit or headquarters in the 

United States, the site address for the 

importer is the U.S. address of an agent 

acting on behalf of the importer who is 

authorized to accept service of process 

for the importer. 

(3) For portable manufacturing units 

sent to different locations from a single 

distribution center, the distribution 

center shall be considered the site. 

Site-limited means a chemical 

substance is manufactured and 

processed only within a site and is not 

distributed for commercial purposes as 

a chemical substance or as part of a 

mixture or article outside the site. 

Imported chemical substances are never 

site-limited. Although a site-limited 

chemical substance is not distributed for 

commercial purposes outside the site at 

which it is manufactured and processed, 

the chemical substance is considered to 

have been manufactured and processed 

for commercial purposes. 

Submission period means the period 

in which the manufacturing, processing, 

and use data are submitted to EPA. 

U.S. parent company means the 

highest level company, located in the 

United States, that directly owns at least 

50% of the voting stock of the 

manufacturer. 

Use means any utilization of a 

chemical substance or mixture that is 

not otherwise covered by the terms 

manufacture or process. Relabeling or 

redistributing a container holding a 

chemical substance or mixture where no 

repackaging of the chemical substance 

or mixture occurs does not constitute 

use or processing of the chemical 

substance or mixture. 

§ 711.5 Chemical substances for which 

information must be reported. 

Any chemical substance that is in the 

Master Inventory File at the beginning 

of a submission period described in 

§ 14;711.20, unless the chemical 

substance is specifically excluded by 

§ 14;711.6. 

§ 711.6 Chemical substances for which 

information is not required. 

The following groups or categories of 

chemical substances are exempted from 

some or all of the reporting 

requirements of this part, with the 

following exception: A chemical 

substance described in paragraph (a)(1), 

(a)(2), or (a)(4), or (b) of this section is 

not exempted from any of the reporting 

requirements of this part if that 

chemical substance is the subject of a 

rule proposed or promulgated under 

TSCA section 4, 5(a)(2), 5(b)(4), or 6, or 

is the subject of an enforceable consent 

agreement (ECA) developed under the 

procedures of 40 CFR part 790, or is the 

subject of an order issued under TSCA 

section 5(e) or 5(f), or is the subject of 

relief that has been granted under a civil 

action under TSCA section 5 or 7. 

(a) Full exemptions. The following 

categories of chemical substances are 

exempted from the reporting 

requirements of this part. 

(1) Polymers—(i) Any chemical 

substance described with the word 

fragments ‘‘*polym,’’ ‘‘*alkyd,’’ or 

‘‘*oxylated’’ in the Chemical Abstracts 

(CA) Index Name in the Master 

Inventory File, where the asterisk (*) in 

the listed word fragments indicates that 

any sets of characters may precede, or 

follow, the character string defined. 

(ii) Any chemical substance that is 

identified in the Master Inventory File 

as an enzyme, lignin, a polysaccharide 

(cellulose, gum, starch), a protein 

(albumin, casein, gelatin, gluten, 

hemoglobin), rubber, siloxane and 

silicone, or silsesquioxane. 

(iii) This exclusion does not apply to 

a polymeric substance that has been 

depolymerized, hydrolyzed, or 

otherwise chemically modified, except 

in cases where the intended product of 

this reaction is totally polymeric in 

structure. 

(2) Microorganisms. Any combination 

of chemical substances that is a living 

organism, and that meets the definition 

of microorganism at 40 CFR 725.3. Any 

chemical substance produced from a 

living microorganism is reportable 

under this part unless otherwise 

excluded. 

(3) Naturally occurring chemical 

substances. Any naturally occurring 

chemical substance, as described in 40 

CFR 710.4(b). The applicability of this 

exclusion is determined in each case by 

the specific activities of the person who 

manufactures the chemical substance in 

question. Some chemical substances can 

be manufactured both as described in 40 

CFR 710.4(b) and by means other than 

those described in 40 CFR 710.4(b). If a 

person described in § 14;711.8 

manufactures a chemical substance by 

means other than those described in 40 

CFR 710.4(b), the person must report 

regardless of whether the chemical 

substance also could have been 

produced as described in 40 CFR 

710.4(b). Any chemical substance that is 

produced from such a naturally 

occurring chemical substance described 

in 40 CFR 710.4(b) is reportable unless 

otherwise excluded. 

(4) Certain forms of natural gas and 

water. Chemical substances with the 

following Chemical Abstracts Service 

Registry Number (CASRN): CASRN 

7732–18–5, water; CASRN 8006–14–2, 

natural gas; CASRN 8006–61–9, 


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gasoline, natural; CASRN 64741–48–6, 

natural gas (petroleum), raw liq. mix; 

CASRN 68410–63–9, natural gas, dried; 

CASRN 68425–31–0, gasoline (natural 

gas), natural; and CASRN 68919–39–1, 

natural gas condensates. 

(b) Partial exemptions. The following 

groups of chemical substances are 

partially exempted from the reporting 

requirements of this part (i.e., the 

information described in 

§ 14;711.15(b)(4) need not be reported 

for these chemical substances). Such 

chemical substances are not excluded 

from the other reporting requirements 

under this part. 

(1) Petroleum process streams. EPA 

has designated the chemical substances 

listed in Table 1 of this paragraph by 

CASRN, as partially exempt from 

reporting under the IUR. 

TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING

CASRN Product 

8002–05–9 ................. Petroleum. 

8002–74–2 ................. Paraffin waxes and hydrocarbon waxes. 

8006–20–0 ................. Fuel gases, low and medium B.T.U. 

8008–20–6 ................. Kerosine (petroleum). 

8009–03–8 ................. Petrolatum. 

8012–95–1 ................. Paraffin oils. 

8030–30–6 ................. Naphtha. 

8032–32–4 ................. Ligroine. 

8042–47–5 ................. White mineral oil (petroleum). 

8052–41–3 ................. Stoddard solvent. 

8052–42–4 ................. Asphalt. 

61789–60–4 ............... Pitch. 

63231–60–7 ............... Paraffin waxes and hydrocarbon waxes, microcryst. 

64741–41–9 ............... Naphtha (petroleum), heavy straight-run. 

64741–42–0 ............... Naphtha (petroleum), full-range straight-run. 

64741–43–1 ............... Gas oils (petroleum), straight-run. 

64741–44–2 ............... Distillates (petroleum), straight-run middle. 

64741–45–3 ............... Residues (petroleum), atm. tower. 

64741–46–4 ............... Naphtha (petroleum), light straight-run. 

64741–47–5 ............... Natural gas condensates (petroleum). 

64741–49–7 ............... Condensates (petroleum), vacuum tower. 

64741–50–0 ............... Distillates (petroleum), light paraffinic. 

64741–51–1 ............... Distillates (petroleum), heavy paraffinic. 

64741–52–2 ............... Distillates (petroleum), light naphthenic. 

64741–53–3 ............... Distillates (petroleum), heavy naphthenic. 

64741–54–4 ............... Naphtha (petroleum), heavy catalytic cracked. 

64741–55–5 ............... Naphtha (petroleum), light catalytic cracked. 

64741–56–6 ............... Residues (petroleum), vacuum. 

64741–57–7 ............... Gas oils (petroleum), heavy vacuum. 

64741–58–8 ............... Gas oils (petroleum), light vacuum. 

64741–59–9 ............... Distillates (petroleum), light catalytic cracked. 

64741–60–2 ............... Distillates (petroleum), intermediate catalytic cracked. 

64741–61–3 ............... Distillates (petroleum), heavy catalytic cracked. 

64741–62–4 ............... Clarified oils (petroleum), catalytic cracked. 

64741–63–5 ............... Naphtha (petroleum), light catalytic reformed. 

64741–64–6 ............... Naphtha (petroleum), full-range alkylate. 

64741–65–7 ............... Naphtha (petroleum), heavy alkylate. 

64741–66–8 ............... Naphtha (petroleum), light alkylate. 

64741–67–9 ............... Residues (petroleum), catalytic reformer fractionator. 

64741–68–0 ............... Naphtha (petroleum), heavy catalytic reformed. 

64741–69–1 ............... Naphtha (petroleum), light hydrocracked. 

64741–70–4 ............... Naphtha (petroleum), isomerization. 

64741–73–7 ............... Distillates (petroleum), alkylate. 

64741–74–8 ............... Naphtha (petroleum), light thermal cracked. 

64741–75–9 ............... Residues (petroleum), hydrocracked. 

64741–76–0 ............... Distillates (petroleum), heavy hydrocracked. 

64741–77–1 ............... Distillates (petroleum), light hydrocracked. 

64741–78–2 ............... Naphtha (petroleum), heavy hydrocracked. 

64741–79–3 ............... Coke (petroleum). 

64741–80–6 ............... Residues (petroleum), thermal cracked. 

64741–81–7 ............... Distillates (petroleum), heavy thermal cracked. 

64741–82–8 ............... Distillates (petroleum), light thermal cracked. 

64741–83–9 ............... Naphtha (petroleum), heavy thermal cracked. 

64741–84–0 ............... Naphtha (petroleum), solvent-refined light. 

64741–85–1 ............... Raffinates (petroleum), sorption process. 

64741–86–2 ............... Distillates (petroleum), sweetened middle. 

64741–87–3 ............... Naphtha (petroleum), sweetened. 

64741–88–4 ............... Distillates (petroleum), solvent-refined heavy paraffinic. 

64741–89–5 ............... Distillates (petroleum), solvent-refined light paraffinic. 

64741–90–8 ............... Gas oils (petroleum), solvent-refined. 

64741–91–9 ............... Distillates (petroleum), solvent-refined middle. 


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TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

64741–92–0 ............... Naphtha (petroleum), solvent-refined heavy. 

64741–95–3 ............... Residual oils (petroleum), solvent deasphalted. 

64741–96–4 ............... Distillates (petroleum), solvent-refined heavy naphthenic. 

64741–97–5 ............... Distillates (petroleum), solvent-refined light naphthenic. 

64741–98–6 ............... Extracts (petroleum), heavy naphtha solvent. 

64741–99–7 ............... Extracts (petroleum), light naphtha solvent. 

64742–01–4 ............... Residual oils (petroleum), solvent-refined. 

64742–03–6 ............... Extracts (petroleum), light naphthenic distillate solvent. 

64742–04–7 ............... Extracts (petroleum), heavy paraffinic distillate solvent. 

64742–05–8 ............... Extracts (petroleum), light paraffinic distillate solvent. 

64742–06–9 ............... Extracts (petroleum), middle distillate solvent. 

64742–07–0 ............... Raffinates (petroleum), residual oil decarbonization. 

64742–08–1 ............... Raffinates (petroleum), heavy naphthenic distillate decarbonization. 

64742–09–2 ............... Raffinates (petroleum), heavy paraffinic distillate decarbonization. 

64742–10–5 ............... Extracts (petroleum), residual oil solvent. 

64742–11–6 ............... Extracts (petroleum), heavy naphthenic distillate solvent. 

64742–12–7 ............... Gas oils (petroleum), acid-treated. 

64742–13–8 ............... Distillates (petroleum), acid-treated middle. 

64742–14–9 ............... Distillates (petroleum), acid-treated light. 

64742–15–0 ............... Naphtha (petroleum), acid-treated. 

64742–16–1 ............... Petroleum resins. 

64742–18–3 ............... Distillates (petroleum), acid-treated heavy naphthenic. 

64742–19–4 ............... Distillates (petroleum), acid-treated light naphthenic. 

64742–20–7 ............... Distillates (petroleum), acid-treated heavy paraffinic. 

64742–21–8 ............... Distillates (petroleum), acid-treated light paraffinic. 

64742–22–9 ............... Naphtha (petroleum), chemically neutralized heavy. 

64742–23–0 ............... Naphtha (petroleum), chemically neutralized light. 

64742–24–1 ............... Sludges (petroleum), acid. 

64742–25–2 ............... Lubricating oils (petroleum), acid-treated spent. 

64742–26–3 ............... Hydrocarbon waxes (petroleum), acid-treated. 

64742–27–4 ............... Distillates (petroleum), chemically neutralized heavy paraffinic. 

64742–28–5 ............... Distillates (petroleum), chemically neutralized light paraffinic. 

64742–29–6 ............... Gas oils (petroleum), chemically neutralized. 

64742–30–9 ............... Distillates (petroleum), chemically neutralized middle. 

64742–31–0 ............... Distillates (petroleum), chemically neutralized light. 

64742–32–1 ............... Lubricating oils (petroleum), chemically neutralized spent. 

64742–33–2 ............... Hydrocarbon waxes (petroleum), chemically neutralized. 

64742–34–3 ............... Distillates (petroleum), chemically neutralized heavy naphthenic. 

64742–35–4 ............... Distillates (petroleum), chemically neutralized light naphthenic. 

64742–36–5 ............... Distillates (petroleum), clay-treated heavy paraffinic. 

64742–37–6 ............... Distillates (petroleum), clay-treated light paraffinic. 

64742–38–7 ............... Distillates (petroleum), clay-treated middle. 

64742–39–8 ............... Neutralizing agents (petroleum), spent sodium carbonate. 

64742–40–1 ............... Neutralizing agents (petroleum), spent sodium hydroxide. 

64742–41–2 ............... Residual oils (petroleum), clay-treated. 

64742–42–3 ............... Hydrocarbon waxes (petroleum), clay-treated microcryst. 

64742–43–4 ............... Paraffin waxes (petroleum), clay-treated. 

64742–44–5 ............... Distillates (petroleum), clay-treated heavy naphthenic. 

64742–45–6 ............... Distillates (petroleum), clay-treated light naphthenic. 

64742–46–7 ............... Distillates (petroleum), hydrotreated middle. 

64742–47–8 ............... Distillates (petroleum), hydrotreated light. 

64742–48–9 ............... Naphtha (petroleum), hydrotreated heavy. 

64742–49–0 ............... Naphtha (petroleum), hydrotreated light. 

64742–50–3 ............... Lubricating oils (petroleum), clay-treated spent. 

64742–51–4 ............... Paraffin waxes (petroleum), hydrotreated. 

64742–52–5 ............... Distillates (petroleum), hydrotreated heavy naphthenic. 

64742–53–6 ............... Distillates (petroleum), hydrotreated light naphthenic. 

64742–54–7 ............... Distillates (petroleum), hydrotreated heavy paraffinic. 

64742–55–8 ............... Distillates (petroleum), hydrotreated light paraffinic. 

64742–56–9 ............... Distillates (petroleum), solvent-dewaxed light paraffinic. 

64742–57–0 ............... Residual oils (petroleum), hydrotreated. 

64742–58–1 ............... Lubricating oils (petroleum), hydrotreated spent. 

64742–59–2 ............... Gas oils (petroleum), hydrotreated vacuum. 

64742–60–5 ............... Hydrocarbon waxes (petroleum), hydrotreated microcryst. 

64742–61–6 ............... Slack wax (petroleum). 

64742–62–7 ............... Residual oils (petroleum), solvent-dewaxed. 

64742–63–8 ............... Distillates (petroleum), solvent-dewaxed heavy naphthenic. 

64742–64–9 ............... Distillates (petroleum), solvent-dewaxed light naphthenic. 

64742–65–0 ............... Distillates (petroleum), solvent-dewaxed heavy paraffinic. 

64742–67–2 ............... Foots oil (petroleum). 

64742–68–3 ............... Naphthenic oils (petroleum), catalytic dewaxed heavy. 


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TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

64742–69–4 ............... Naphthenic oils (petroleum), catalytic dewaxed light. 

64742–70–7 ............... Paraffin oils (petroleum), catalytic dewaxed heavy. 

64742–71–8 ............... Paraffin oils (petroleum), catalytic dewaxed light. 

64742–72–9 ............... Distillates (petroleum), catalytic dewaxed middle. 

64742–73–0 ............... Naphtha (petroleum), hydrodesulfurized light. 

64742–75–2 ............... Naphthenic oils (petroleum), complex dewaxed heavy. 

64742–76–3 ............... Naphthenic oils (petroleum), complex dewaxed light. 

64742–78–5 ............... Residues (petroleum), hydrodesulfurized atmospheric tower. 

64742–79–6 ............... Gas oils (petroleum), hydrodesulfurized. 

64742–80–9 ............... Distillates (petroleum), hydrodesulfurized middle. 

64742–81–0 ............... Kerosine (petroleum), hydrodesulfurized. 

64742–82–1 ............... Naphtha (petroleum), hydrodesulfurized heavy. 

64742–83–2 ............... Naphtha (petroleum), light steam-cracked. 

64742–85–4 ............... Residues (petroleum), hydrodesulfurized vacuum. 

64742–86–5 ............... Gas oils (petroleum), hydrodesulfurized heavy vacuum. 

64742–87–6 ............... Gas oils (petroleum), hydrodesulfurized light vacuum. 

64742–88–7 ............... Solvent naphtha (petroleum), medium aliph. 

64742–89–8 ............... Solvent naphtha (petroleum), light aliph. 

64742–90–1 ............... Residues (petroleum), steam-cracked. 

64742–91–2 ............... Distillates (petroleum), steam-cracked. 

64742–92–3 ............... Petroleum resins, oxidized. 

64742–93–4 ............... Asphalt, oxidized. 

64742–94–5 ............... Solvent naphtha (petroleum), heavy arom. 

64742–95–6 ............... Solvent naphtha (petroleum), light arom. 

64742–96–7 ............... Solvent naphtha (petroleum), heavy aliph. 

64742–97–8 ............... Distillates (petroleum), oxidized heavy. 

64742–98–9 ............... Distillates (petroleum), oxidized light. 

64742–99–0 ............... Residual oils (petroleum), oxidized. 

64743–00–6 ............... Hydrocarbon waxes (petroleum), oxidized. 

64743–01–7 ............... Petrolatum (petroleum), oxidized. 

64743–02–8 ............... Alkenes, C > 10 .alpha.-. 

64743–03–9 ............... Phenols (petroleum). 

64743–04–0 ............... Coke (petroleum), recovery. 

64743–05–1 ............... Coke (petroleum), calcined. 

64743–06–2 ............... Extracts (petroleum), gas oil solvent. 

64743–07–3 ............... Sludges (petroleum), chemically neutralized. 

64754–89–8 ............... Naphthenic acids (petroleum), crude. 

64771–71–7 ............... Paraffins (petroleum), normal C > 10. 

64771–72–8 ............... Paraffins (petroleum), normal C5–20. 

67254–74–4 ............... Naphthenic oils. 

67674–12–8 ............... Residual oils (petroleum), oxidized, compounds with triethanolamine. 

67674–13–9 ............... Petrolatum (petroleum), oxidized, partially deacidified. 

67674–15–1 ............... Petrolatum (petroleum), oxidized, Me ester. 

67674–16–2 ............... Hydrocarbon waxes (petroleum), oxidized, partially deacidified. 

67674–17–3 ............... Distillates (petroleum), oxidized light, compounds with triethanolamine. 

67674–18–4 ............... Distillates (petroleum), oxidized light, Bu esters. 

67891–79–6 ............... Distillates (petroleum), heavy arom. 

67891–80–9 ............... Distillates (petroleum), light arom. 

67891–81–0 ............... Distillates (petroleum), oxidized light, potassium salts. 

67891–82–1 ............... Hydrocarbon waxes (petroleum), oxidized, compounds with ethanolamine. 

67891–83–2 ............... Hydrocarbon waxes (petroleum), oxidized, compounds with isopropanolamine. 

67891–85–4 ............... Hydrocarbon waxes (petroleum), oxidized, compounds with triisopropanolamine. 

67891–86–5 ............... Hydrocarbon waxes (petroleum), oxidized, compds. with diisopropanolamine. 

68131–05–5 ............... Hydrocarbon oils, process blends. 

68131–49–7 ............... Aromatic hydrocarbons, C6–10, acid-treated, neutralized. 

68131–75–9 ............... Gases (petroleum), C3–4. 

68153–22–0 ............... Paraffin waxes and Hydrocarbon waxes, oxidized. 

68187–57–5 ............... Pitch, coal tar-petroleum. 

68187–58–6 ............... Pitch, petroleum, arom. 

68187–60–0 ............... Hydrocarbons, C4, ethane-propane-cracked. 

68307–98–2 ............... Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber. 

68307–99–3 ............... Tail gas (petroleum), catalytic polymn. naphtha fractionation stabilizer. 

68308–00–9 ............... Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer, hydrogen sulfide-free. 

68308–01–0 ............... Tail gas (petroleum), cracked distillate hydrotreater stripper. 

68308–02–1 ............... Tail gas (petroleum), distn., hydrogen sulfide-free. 

68308–03–2 ............... Tail gas (petroleum), gas oil catalytic cracking absorber. 

68308–04–3 ............... Tail gas (petroleum), gas recovery plant. 

68308–05–4 ............... Tail gas (petroleum), gas recovery plant deethanizer. 

68308–06–5 ............... Tail gas (petroleum), hydrodesulfurized distillate and hydrodesulfurized naphtha fractionator, acid-free. 

68308–07–6 ............... Tail gas (petroleum), hydrodesulfurized vacuum gas oil stripper, hydrogen sulfide-free. 

68308–08–7 ............... Tail gas (petroleum), isomerized naphtha fractionation stabilizer. 


erowe on DSK5CLS3C1PROD with RULES_2
50864 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

68308–09–8 ............... Tail gas (petroleum), light straight-run naphtha stabilizer, hydrogen sulfide-free. 

68308–10–1 ............... Tail gas (petroleum), straight-run distillate hydrodesulfurizer, hydrogen sulfide-free. 

68308–11–2 ............... Tail gas (petroleum), propane-propylene alkylation feed prep deethanizer. 

68308–12–3 ............... Tail gas (petroleum), vacuum gas oil hydrodesulfurizer, hydrogen sulfide-free. 

68308–27–0 ............... Fuel gases, refinery. 

68333–22–2 ............... Residues (petroleum), atmospheric. 

68333–23–3 ............... Naphtha (petroleum), heavy coker. 

68333–24–4 ............... Hydrocarbon waxes (petroleum), oxidized, compds. with triethanolamine. 

68333–25–5 ............... Distillates (petroleum), hydrodesulfurized light catalytic cracked. 

68333–26–6 ............... Clarified oils (petroleum), hydrodesulfurized catalytic cracked. 

68333–27–7 ............... Distillates (petroleum), hydrodesulfurized intermediate catalytic cracked. 

68333–28–8 ............... Distillates (petroleum), hydrodesulfurized heavy catalytic cracked. 

68333–29–9 ............... Residues (petroleum), light naphtha solvent extracts. 

68333–30–2 ............... Distillates (petroleum), oxidized heavy thermal cracked. 

68333–81–3 ............... Alkanes, C4–12. 

68333–88–0 ............... Aromatic hydrocarbons, C9–17. 

68334–30–5 ............... Fuels, diesel. 

68409–99–4 ............... Gases (petroleum), catalytic cracked overheads. 

68410–00–4 ............... Distillates (petroleum), crude oil. 

68410–05–9 ............... Distillates (petroleum), straight-run light. 

68410–12–8 ............... Distillates (petroleum), steam-cracked, C5–10 fraction, high-temperature stripping products with light steam-cracked petroleum naphtha C5 fraction polymers. 

68410–71–9 ............... Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts. 

68410–96–8 ............... Distillates (petroleum), hydrotreated middle, intermediate boiling. 

68410–97–9 ............... Distillates (petroleum), light distillate hydrotreating process, low-boiling. 

68410–98–0 ............... Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer overheads. 

68411–00–7 ............... Alkenes, C > 8. 

68425–29–6 ............... Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-blending. 

68425–33–2 ............... Petrolatum (petroleum), oxidized, barium salt. 

68425–34–3 ............... Petrolatum (petroleum), oxidized, calcium salt. 

68425–35–4 ............... Raffinates (petroleum), reformer, Lurgi unit-sepd. 

68425–39–8 ............... Alkenes, C > 10 .alpha.-, oxidized. 

68441–09–8 ............... Hydrocarbon waxes (petroleum), clay-treated microcryst., contg. polyethylene, oxidized. 

68459–78–9 ............... Alkenes, C18–24 .alpha.-, dimers. 

68475–57–0 ............... Alkanes, C1–2. 

68475–58–1 ............... Alkanes, C2–3. 

68475–59–2 ............... Alkanes, C3–4. 

68475–60–5 ............... Alkanes, C4–5. 

68475–61–6 ............... Alkenes, C5, naphtha-raffinate pyrolyzate-derived. 

68475–70–7 ............... Aromatic hydrocarbons, C6–8, naphtha-raffinate pyrolyzate-derived. 

68475–79–6 ............... Distillates (petroleum), catalytic reformed depentanizer. 

68475–80–9 ............... Distillates (petroleum), light steam-cracked naphtha. 

68476–26–6 ............... Fuel gases. 

68476–27–7 ............... Fuel gases, amine system residues. 

68476–28–8 ............... Fuel gases, C6–8 catalytic reformer. 

68476–29–9 ............... Fuel gases, crude oil distillates. 

68476–30–2 ............... Fuel oil, no. 2. 

68476–31–3 ............... Fuel oil, no. 4. 

68476–32–4 ............... Fuel oil, residues-straight-run gas oils, high-sulfur. 

68476–33–5 ............... Fuel oil, residual. 

68476–34–6 ............... Fuels, diesel, no. 2. 

68476–39–1 ............... Hydrocarbons, aliph.-arom.-C4–5-olefinic. 

68476–40–4 ............... Hydrocarbons, C3–4. 

68476–42–6 ............... Hydrocarbons, C4–5. 

68476–43–7 ............... Hydrocarbons, C4–6, C5-rich. 

68476–44–8 ............... Hydrocarbons, C > 3. 

68476–45–9 ............... Hydrocarbons, C5–10 arom. conc., ethylene-manuf.-by-product. 

68476–46–0 ............... Hydrocarbons, C3–11, catalytic cracker distillates. 

68476–47–1 ............... Hydrocarbons, C2–6, C6–8 catalytic reformer. 

68476–49–3 ............... Hydrocarbons, C2–4, C3-rich. 

68476–50–6 ............... Hydrocarbons, C ≥ 5, C5–6-rich. 

68476–52–8 ............... Hydrocarbons, C4, ethylene-manuf.-by-product. 

68476–53–9 ............... Hydrocarbons, C ≥ 20, petroleum wastes. 

68476–54–0 ............... Hydrocarbons, C3–5, polymn. unit feed. 

68476–55–1 ............... Hydrocarbons, C5-rich. 

68476–56–2 ............... Hydrocarbons, cyclic C5 and C6. 

68476–77–7 ............... Lubricating oils, refined used. 

68476–81–3 ............... Paraffin waxes and Hydrocarbon waxes, oxidized, calcium salts. 

68476–84–6 ............... Petroleum products, gases, inorg. 

68476–85–7 ............... Petroleum gases, liquefied. 

68476–86–8 ............... Petroleum gases, liquefied, sweetened. 


erowe on DSK5CLS3C1PROD with RULES_2
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 50865 

TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

68477–25–8 ............... Waste gases, vent gas, C1–6. 

68477–26–9 ............... Wastes, petroleum. 

68477–29–2 ............... Distillates (petroleum), catalytic reformer fractionator residue, high-boiling. 

68477–30–5 ............... Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling. 

68477–31–6 ............... Distillates (petroleum), catalytic reformer fractionator residue, low-boiling. 

68477–33–8 ............... Gases (petroleum), C3–4, isobutane-rich. 

68477–34–9 ............... Distillates (petroleum), C3–5, 2-methyl-2-butene-rich. 

68477–35–0 ............... Distillates (petroleum), C3–6, piperylene-rich. 

68477–36–1 ............... Distillates (petroleum), cracked steam-cracked, C5–18 fraction. 

68477–38–3 ............... Distillates (petroleum), cracked steam-cracked petroleum distillates. 

68477–39–4 ............... Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8–10 fraction. 

68477–40–7 ............... Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10–12 fraction. 

68477–41–8 ............... Gases (petroleum), extractive, C3–5, butadiene-butene-rich. 

68477–42–9 ............... Gases (petroleum), extractive, C3–5, butene-isobutylene-rich. 

68477–44–1 ............... Distillates (petroleum), heavy naphthenic, mixed with steam-cracked petroleum distillates C5–12 fraction. 

68477–47–4 ............... Distillates (petroleum), mixed heavy olefin vacuum, heart-cut. 

68477–48–5 ............... Distillates (petroleum), mixed heavy olefin vacuum, low-boiling. 

68477–53–2 ............... Distillates (petroleum), steam-cracked, C5–12 fraction. 

68477–54–3 ............... Distillates (petroleum), steam-cracked, C8–12 fraction. 

68477–55–4 ............... Distillates (petroleum), steam-cracked, C5–10 fraction, mixed with light steam-cracked petroleum naphtha C5 fraction. 

68477–58–7 ............... Distillates (petroleum), steam-cracked petroleum distillates, C5–18 fraction. 

68477–59–8 ............... Distillates (petroleum), steam-cracked petroleum distillates cyclopentadiene conc. 

68477–60–1 ............... Extracts (petroleum), cold-acid. 

68477–61–2 ............... Extracts (petroleum), cold-acid, C4–6. 

68477–62–3 ............... Extracts (petroleum), cold-acid, C3–5, butene-rich. 

68477–63–4 ............... Extracts (petroleum), reformer recycle. 

68477–64–5 ............... Gases (petroleum), acetylene manuf. off. 

68477–65–6 ............... Gases (petroleum), amine system feed. 

68477–66–7 ............... Gases (petroleum), benzene unit hydrodesulfurizer off. 

68477–67–8 ............... Gases (petroleum), benzene unit recycle, hydrogen-rich. 

68477–68–9 ............... Gases (petroleum), blend oil, hydrogen-nitrogen-rich. 

68477–69–0 ............... Gases (petroleum), butane splitter overheads. 

68477–70–3 ............... Gases (petroleum), C2–3. 

68477–71–4 ............... Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-rich acid-free. 

68477–72–5 ............... Gases (petroleum), catalytic-cracked naphtha debutanizer bottoms, C3–5-rich. 

68477–73–6 ............... Gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-rich acid-free. 

68477–74–7 ............... Gases (petroleum), catalytic cracker. 

68477–75–8 ............... Gases (petroleum), catalytic cracker, C1–5-rich. 

68477–76–9 ............... Gases (petroleum), catalytic polymd. naphtha stabilizer overhead, C2–4-rich. 

68477–77–0 ............... Gases (petroleum), catalytic reformed naphtha stripper overheads. 

68477–79–2 ............... Gases (petroleum), catalytic reformer, C1–4-rich. 

68477–80–5 ............... Gases (petroleum), C6–8 catalytic reformer recycle. 

68477–81–6 ............... Gases (petroleum), C6–8 catalytic reformer. 

68477–82–7 ............... Gases (petroleum), C6–8 catalytic reformer recycle, hydrogen-rich. 

68477–83–8 ............... Gases (petroleum), C3–5 olefinic-paraffinic alkylation feed. 

68477–84–9 ............... Gases (petroleum), C2-return stream. 

68477–85–0 ............... Gases (petroleum), C4-rich. 

68477–86–1 ............... Gases (petroleum), deethanizer overheads. 

68477–87–2 ............... Gases (petroleum), deisobutanizer tower overheads. 

68477–88–3 ............... Gases (petroleum), deethanizer overheads, C3-rich. 

68477–89–4 ............... Distillates (petroleum), depentanizer overheads. 

68477–90–7 ............... Gases (petroleum), depropanizer dry, propene-rich. 

68477–91–8 ............... Gases (petroleum), depropanizer overheads. 

68477–92–9 ............... Gases (petroleum), dry sour, gas-concentration concn.-unit-off. 

68477–93–0 ............... Gases (petroleum), gas concn. reabsorber distn. 

68477–94–1 ............... Gases (petroleum), gas recovery plant depropanizer overheads. 

68477–95–2 ............... Gases (petroleum), Girbatol unit feed. 

68477–96–3 ............... Gases (petroleum), hydrogen absorber off. 

68477–97–4 ............... Gases (petroleum), hydrogen-rich. 

68477–98–5 ............... Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen rich. 

68477–99–6 ............... Gases (petroleum), isomerized naphtha fractionater, C4-rich, hydrogen sulfide-free. 

68478–00–2 ............... Gases (petroleum), recycle, hydrogen-rich. 

68478–01–3 ............... Gases (petroleum), reformer make-up, hydrogen-rich. 

68478–02–4 ............... Gases (petroleum), reforming hydrotreater. 

68478–03–5 ............... Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich. 

68478–04–6 ............... Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich. 

68478–05–7 ............... Gases (petroleum), thermal cracking distn. 

68478–08–0 ............... Naphtha (petroleum), light steam-cracked, C5-fraction, oligomer conc. 

68478–10–4 ............... Naphtha (petroleum), light steam-cracked, debenzenized, C8–16-cycloalkadiene conc. 

68478–12–6 ............... Residues (petroleum), butane splitter bottoms. 

68478–13–7 ............... Residues (petroleum), catalytic reformer fractionator residue distn. 


erowe on DSK5CLS3C1PROD with RULES_2
50866 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

68478–15–9 ............... Residues (petroleum), C6–8 catalytic reformer. 

68478–16–0 ............... Residual oils (petroleum), deisobutanizer tower. 

68478–17–1 ............... Residues (petroleum), heavy coker gas oil and vacuum gas oil. 

68478–18–2 ............... Residues (petroleum), heavy olefin vacuum. 

68478–19–3 ............... Residual oils (petroleum), propene purifn. splitter. 

68478–20–6 ............... Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free. 

68478–22–8 ............... Tail gas (petroleum), catalytic cracked naphtha stabilization absorber. 

68478–24–0 ............... Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurizer combined fractionater. 

68478–25–1 ............... Tail gas (petroleum), catalytic cracker refractionation absorber. 

68478–26–2 ............... Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer. 

68478–27–3 ............... Tail gas (petroleum), catalytic reformed naphtha separator. 

68478–28–4 ............... Tail gas (petroleum), catalytic reformed naphtha stabilizer. 

68478–29–5 ............... Tail gas (petroleum), cracked distillate hydrotreater separator. 

68478–30–8 ............... Tail gas (petroleum), hydrodesulfurized straight-run naphtha separator. 

68478–31–9 ............... Tail gas (petroleum), isomerized naphtha fractionates, hydrogen sulfide-free. 

68478–32–0 ............... Tail gas (petroleum), saturate gas plant mixed stream, C4-rich. 

68478–33–1 ............... Tail gas (petroleum), saturate gas recovery plant, C1–2-rich. 

68478–34–2 ............... Tail gas (petroleum), vacuum residues thermal cracker. 

68512–61–8 ............... Residues (petroleum), heavy coker and light vacuum. 

68512–62–9 ............... Residues (petroleum), light vacuum. 

68512–78–7 ............... Solvent naphtha (petroleum), light arom., hydrotreated. 

68512–91–4 ............... Hydrocarbons, C3–4-rich, petroleum distillates. 

68513–02–0 ............... Naphtha (petroleum), full-range coker. 

68513–03–1 ............... Naphtha (petroleum), light catalytic reformed, arom.-free. 

68513–11–1 ............... Fuel gases, hydrotreater fractionation, scrubbed. 

68513–12–2 ............... Fuel gases, saturate gas unit fractionater-absorber overheads. 

68513–13–3 ............... Fuel gases, thermal cracked catalytic cracking residue. 

68513–14–4 ............... Gases (petroleum), catalytic reformed straight-run naphtha stabilizer overheads. 

68513–15–5 ............... Gases (petroleum), full-range straight-run naphtha dehexanizer off. 

68513–16–6 ............... Gases (petroleum), hydrocracking depropanizer off, hydrocarbon-rich. 

68513–17–7 ............... Gases (petroleum), light straight-run naphtha stabilizer off. 

68513–18–8 ............... Gases (petroleum), reformer effluent high-pressure flash drum off. 

68513–19–9 ............... Gases (petroleum), reformer effluent low-pressure flash drum off. 

68513–62–2 ............... Disulfides, C5–12-alkyl. 

68513–63–3 ............... Distillates (petroleum), catalytic reformed straight-run naphtha overheads. 

68513–65–5 ............... Butane, branched and linear. 

68513–66–6 ............... Residues (petroleum), alkylation splitter, C4-rich. 

68513–67–7 ............... Residues (petroleum), cyclooctadiene bottoms. 

68513–68–8 ............... Residues (petroleum), deethanizer tower. 

68513–69–9 ............... Residues (petroleum), steam-cracked light. 

68513–74–6 ............... Waste gases, ethylene oxide absorber-reactor. 

68514–15–8 ............... Gasoline, vapor-recovery. 

68514–29–4 ............... Hydrocarbons, amylene feed debutanizer overheads non-extractable raffinates. 

68514–31–8 ............... Hydrocarbons, C1–4. 

68514–32–9 ............... Hydrocarbons, C10 and C12, olefin-rich. 

68514–33–0 ............... Hydrocarbons, C12 and C14, olefin-rich. 

68514–34–1 ............... Hydrocarbons, C9–14, ethylene-manuf.-by-product. 

68514–35–2 ............... Hydrocarbons, C14–30, olefin-rich. 

68514–36–3 ............... Hydrocarbons, C1–4, sweetened. 

68514–37–4 ............... Hydrocarbons, C4–5-unsatd. 

68514–38–5 ............... Hydrocarbons, C4–10-unsatd. 

68514–39–6 ............... Naphtha (petroleum), light steam-cracked, isoprene-rich. 

68514–79–4 ............... Petroleum products, hydrofiner-powerformer reformates. 

68515–25–3 ............... Benzene, C1–9-alkyl derivs. 

68515–26–4 ............... Benzene, di-C12–14-alkyl derivs. 

68515–27–5 ............... Benzene, di-C10–14-alkyl derivs., fractionation overheads, heavy ends. 

68515–28–6 ............... Benzene, di-C10–14-alkyl derivs., fractionation overheads, light ends. 

68515–29–7 ............... Benzene, di-C10–14-alkyl derivs., fractionation overheads, middle cut. 

68515–30–0 ............... Benzene, mono-C20–48-alkyl derivs. 

68515–32–2 ............... Benzene, mono-C12–14-alkyl derivs., fractionation bottoms. 

68515–33–3 ............... Benzene, mono-C10–12-alkyl derivs., fractionation bottoms, heavy ends. 

68515–34–4 ............... Benzene, mono-C12–14-alkyl derivs., fractionation bottoms, heavy ends. 

68515–35–5 ............... Benzene, mono-C10–12-alkyl derivs., fractionation bottoms, light ends. 

68515–36–6 ............... Benzene, mono-C12–14-alkyl derivs., fractionation bottoms, light ends. 

68516–20–1 ............... Naphtha (petroleum), steam-cracked middle arom. 

68526–52–3 ............... Alkenes, C6. 

68526–53–4 ............... Alkenes, C6–8, C7-rich. 

68526–54–5 ............... Alkenes, C7–9, C8-rich. 

68526–55–6 ............... Alkenes, C8–10, C9-rich. 

68526–56–7 ............... Alkenes, C9–11, C10-rich. 

68526–57–8 ............... Alkenes, C10–12, C11-rich. 


erowe on DSK5CLS3C1PROD with RULES_2
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 50867 

TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

68526–58–9 ............... Alkenes, C11–13, C12-rich. 

68526–77–2 ............... Aromatic hydrocarbons, ethane cracking scrubber effluent and flare drum. 

68526–99–8 ............... Alkenes, C6–9 .alpha.-. 

68527–00–4 ............... Alkenes, C8–9 .alpha.-. 

68527–11–7 ............... Alkenes, C5. 

68527–13–9 ............... Gases (petroleum), acid, ethanolamine scrubber. 

68527–14–0 ............... Gases (petroleum), methane-rich off. 

68527–15–1 ............... Gases (petroleum), oil refinery gas distn. off. 

68527–16–2 ............... Hydrocarbons, C1–3. 

68527–18–4 ............... Gas oils (petroleum), steam-cracked. 

68527–19–5 ............... Hydrocarbons, C1–4, debutanizer fraction. 

68527–21–9 ............... Naphtha (petroleum), clay-treated full-range straight-run. 

68527–22–0 ............... Naphtha (petroleum), clay-treated light straight-run. 

68527–23–1 ............... Naphtha (petroleum), light steam-cracked arom. 

68527–26–4 ............... Naphtha (petroleum), light steam-cracked, debenzenized. 

68527–27–5 ............... Naphtha (petroleum), full-range alkylate, butane-contg. 

68553–00–4 ............... Fuel oil, no. 6. 

68553–14–0 ............... Hydrocarbons, C8–11. 

68602–79–9 ............... Distillates (petroleum), benzene unit hydrotreater dipentanizer overheads. 

68602–81–3 ............... Distillates, hydrocarbon resin prodn. higher boiling. 

68602–82–4 ............... Gases (petroleum), benzene unit hydrotreater depentenizer overheads. 

68602–83–5 ............... Gases (petroleum), C1–5, wet. 

68602–84–6 ............... Gases (petroleum), secondary absorber off, fluidized catalytic cracker overheads fractionater. 

68602–96–0 ............... Distillates (petroleum), oxidized light, strong acid components, compds. with diethanolamine. 

68602–97–1 ............... Distillates (petroleum), oxidized light, strong acid components, sodium salts. 

68602–98–2 ............... Distillates (petroleum), oxidized light, strong acid components. 

68602–99–3 ............... Distillates (petroleum), oxidized light, strong acid-free. 

68603–00–9 ............... Distillates (petroleum), thermal cracked naphtha and gas oil. 

68603–01–0 ............... Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg. 

68603–02–1 ............... Distillates (petroleum), thermal cracked naphtha and gas oil, dimerized. 

68603–03–2 ............... Distillates (petroleum), thermal cracked naphtha and gas oil, extractive. 

68603–08–7 ............... Naphtha (petroleum), arom.- contg. 

68603–09–8 ............... Hydrocarbon waxes (petroleum), oxidized, calcium salts. 

68603–10–1 ............... Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts. 

68603–11–2 ............... Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts. 

68603–12–3 ............... Hydrocarbon waxes (petroleum), oxidized, Me esters, sodium salts. 

68603–13–4 ............... Petrolatum (petroleum), oxidized, ester with sorbitol. 

68603–14–5 ............... Residual oils (petroleum), oxidized, calcium salts. 

68603–31–6 ............... Alkenes, C10, tert-amylene concentrator by-product. 

68603–32–7 ............... Alkenes, C15–20 .alpha.-, isomerized. 

68606–09–7 ............... Fuel gases, expander off. 

68606–10–0 ............... Gasoline, pyrolysis, debutanizer bottoms. 

68606–11–1 ............... Gasoline, straight-run, topping-plant. 

68606–24–6 ............... Hydrocarbons, C4, butene concentrator by-product. 

68606–25–7 ............... Hydrocarbons, C2–4. 

68606–26–8 ............... Hydrocarbons, C3. 

68606–27–9 ............... Gases (petroleum), alkylation feed. 

68606–28–0 ............... Hydrocarbons, C5 and C10-aliph. and C6–8-arom. 

68606–31–5 ............... Hydrocarbons, C3–5, butadiene purification (purifn.) by-product. 

68606–34–8 ............... Gases (petroleum), depropanizer bottoms fractionation off. 

68606–36–0 ............... Hydrocarbons, C5-unsatd. rich, isoprene purifn. by-product. 

68607–11–4 ............... Petroleum products, refinery gases. 

68607–30–7 ............... Residues (petroleum), topping plant, low-sulfur. 

68608–56–0 ............... Waste gases, from carbon black manuf. 

68647–60–9 ............... Hydrocarbons, C > 4. 

68647–61–0 ............... Hydrocarbons, C4–5, tert-amylene concentrator by-product. 

68647–62–1 ............... Hydrocarbons, C4–5, butene concentrator by-product, sour. 

68650–36–2 ............... Aromatic hydrocarbons, C8, o-xylene-lean. 

68650–37–3 ............... Paraffin waxes (petroleum), oxidized, sodium salts. 

68782–97–8 ............... Distillates (petroleum), hydrofined lubricating-oil. 

68782–98–9 ............... Extracts (petroleum), clarified oil solvent, condensed-ring-arom.-contg. 

68782–99–0 ............... Extracts (petroleum), heavy clarified oil solvent, condensed-ring-arom.-contg. 

68783–00–6 ............... Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc. 

68783–01–7 ............... Extracts (petroleum), heavy naphthenic distillate solvent, paraffinic conc. 

68783–02–8 ............... Extracts (petroleum), intermediate clarified oil solvent, condensed-ring-arom.-contg. 

68783–04–0 ............... Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent. 

68783–05–1 ............... Gases (petroleum), ammonia-hydrogen sulfide, water-satd. 

68783–06–2 ............... Gases (petroleum), hydrocracking low-pressure separator. 

68783–07–3 ............... Gases (petroleum), refinery blend. 

68783–08–4 ............... Gas oils (petroleum), heavy atmospheric. 

68783–09–5 ............... Naphtha (petroleum), catalytic cracked light distd. 


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50868 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

68783–12–0 ............... Naphtha (petroleum), unsweetened. 

68783–13–1 ............... Residues (petroleum), coker scrubber, condensed-ring-arom.-contg. 

68783–15–3 ............... Alkenes, C6–7 .alpha.-. 

68783–61–9 ............... Fuel gases, refinery, sweetened. 

68783–62–0 ............... Fuel gases, refinery, unsweetened. 

68783–64–2 ............... Gases (petroleum), catalytic cracking. 

68783–65–3 ............... Gases (petroleum), C2–4, sweetened. 

68783–66–4 ............... Naphtha (petroleum), light, sweetened. 

68814–47–1 ............... Waste gases, refinery vent. 

68814–67–5 ............... Gases (petroleum), refinery. 

68814–87–9 ............... Distillates (petroleum), full-range straight-run middle. 

68814–89–1 ............... Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted. 

68814–90–4 ............... Gases (petroleum), platformer products separator off. 

68814–91–5 ............... Alkenes, C5–9 .alpha.-. 

68855–57–2 ............... Alkenes, C6–12 .alpha.-. 

68855–58–3 ............... Alkenes, C10–16 .alpha.-. 

68855–59–4 ............... Alkenes, C14–18 .alpha.-. 

68855–60–7 ............... Alkenes, C14–20 .alpha.-. 

68911–58–0 ............... Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off. 

68911–59–1 ............... Gases (petroleum), hydrotreated sour kerosine flash drum. 

68915–96–8 ............... Distillates (petroleum), heavy straight-run. 

68915–97–9 ............... Gas oils (petroleum), straight-run, high-boiling. 

68918–69–4 ............... Petrolatum (petroleum), oxidized, zinc salt. 

68918–73–0 ............... Residues (petroleum), clay-treating filter wash. 

68918–93–4 ............... Paraffin waxes and Hydrocarbon waxes, oxidized, alkali metal salts. 

68918–98–9 ............... Fuel gases, refinery, hydrogen sulfide-free. 

68918–99–0 ............... Gases (petroleum), crude oil fractionation off. 

68919–00–6 ............... Gases (petroleum), dehexanizer off. 

68919–01–7 ............... Gases (petroleum), distillate unifiner desulfurization stripper off. 

68919–02–8 ............... Gases (petroleum), fluidized catalytic cracker fractionation off. 

68919–03–9 ............... Gases (petroleum), fluidized catalytic cracker scrubbing secondary absorber off. 

68919–04–0 ............... Gases (petroleum), heavy distillate hydrotreater desulfurization stripper off. 

68919–05–1 ............... Gases (petroleum), light straight run gasoline fractionation stabilizer off. 

68919–06–2 ............... Gases (petroleum), naphtha unifiner desulfurization stripper off. 

68919–07–3 ............... Gases (petroleum), platformer stabilizer off, light ends fractionation. 

68919–08–4 ............... Gases (petroleum), preflash tower off, crude distn. 

68919–09–5 ............... Gases (petroleum), straight-run naphtha catalytic reforming off. 

68919–10–8 ............... Gases (petroleum), straight-run stabilizer off. 

68919–11–9 ............... Gases (petroleum), tar stripper off. 

68919–12–0 ............... Gases (petroleum), unifiner stripper off. 

68919–15–3 ............... Hydrocarbons, C6–12, benzene-recovery. 

68919–16–4 ............... Hydrocarbons, catalytic alkylation, by-products, C3–6. 

68919–17–5 ............... Hydrocarbons, C12–20, catalytic alkylation by-products. 

68919–19–7 ............... Gases (petroleum), fluidized catalytic cracker splitter residues. 

68919–20–0 ............... Gases (petroleum), fluidized catalytic cracker splitter overheads. 

68919–37–9 ............... Naphtha (petroleum), full-range reformed. 

68920–06–9 ............... Hydrocarbons, C7–9. 

68920–07–0 ............... Hydrocarbons, C < 10-linear. 

68920–64–9 ............... Disulfides, di-C1–2-alkyl. 

68921–07–3 ............... Distillates (petroleum), hydrotreated light catalytic cracked. 

68921–08–4 ............... Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads. 

68921–09–5 ............... Distillates (petroleum), naphtha unifiner stripper. 

68921–67–5 ............... Hydrocarbons, ethylene-manuf.-by-product distn. residues. 

68952–76–1 ............... Gases (petroleum), catalytic cracked naphtha debutanizer. 

68952–77–2 ............... Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer. 

68952–78–3 ............... Tail gas (petroleum), catalytic hydrodesulfurized distillate fractionation stabilizer, hydrogen sulfide-free. 

68952–79–4 ............... Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator. 

68952–80–7 ............... Tail gas (petroleum), straight-run naphtha hydrodesulfurizer. 

68952–81–8 ............... Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber. 

68952–82–9 ............... Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabilizer, petroleum coking. 

68953–80–0 ............... Benzene, mixed with toluene, dealkylation product. 

68955–27–1 ............... Distillates (petroleum), petroleum residues vacuum. 

68955–28–2 ............... Gases (petroleum), light steam-cracked, butadiene conc. 

68955–31–7 ............... Gases (petroleum), butadiene process, inorg. 

68955–32–8 ............... Natural gas, substitute, steam-reformed desulfurized naphtha. 

68955–33–9 ............... Gases (petroleum), sponge absorber off, fluidized catalytic cracker and gas oil desulfurizer overhead fractionation. 

68955–34–0 ............... Gases (petroleum), straight-run naphtha catalytic reformer stabilizer overhead. 

68955–35–1 ............... Naphtha (petroleum), catalytic reformed. 

68955–36–2 ............... Residues (petroleum), steam-cracked, resinous. 

68955–76–0 ............... Aromatic hydrocarbons, C9–16, biphenyl deriv.-rich. 

68955–96–4 ............... Disulfides, dialkyl and di-Ph, naphtha sweetening. 


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Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 50869 

TABLE 1—CASRNS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED ‘‘PETROLEUM PROCESS STREAMS’’ FOR

PURPOSES OF INVENTORY UPDATE REPORTING—Continued 

CASRN Product 

68956–47–8 ............... Fuel oil, isoprene reject absorption. 

68956–48–9 ............... Fuel oil, residual, wastewater skimmings. 

68956–52–5 ............... Hydrocarbons, C4–8. 

68956–54–7 ............... Hydrocarbons, C4-unsatd. 

68956–55–8 ............... Hydrocarbons, C5-unsatd. 

68956–70–7 ............... Petroleum products, C5–12, reclaimed, wastewater treatment. 

68988–79–4 ............... Benzene, C10–12-alkyl derivs., distn. residues. 

68988–99–8 ............... Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. scrubber residues. 

68989–88–8 ............... Gases (petroleum), crude distn. and catalytic cracking. 

68990–35–2 ............... Distillates (petroleum), arom., hydrotreated, dicyclopentadiene-rich. 

68991–49–1 ............... Alkanes, C10–13, arom.-free desulfurized. 

68991–50–4 ............... Alkanes, C14–17, arom.-free desulfurized. 

68991–51–5 ............... Alkanes, C10–13, desulfurized. 

68991–52–6 ............... Alkenes, C10–16. 

69013–21–4 ............... Fuel oil, pyrolysis. 

69029–75–0 ............... Oils, reclaimed. 

69430–33–7 ............... Hydrocarbons, C6–30. 

70024–88–3 ............... Ethene, thermal cracking products. 

70528–71–1 ............... Distillates (petroleum), heavy distillate solvent ext. heart-cut. 

70528–72–2 ............... Distillates (petroleum), heavy distillate solvent ext. vacuum overheads. 

70528–73–3 ............... Residues (petroleum), heavy distillate solvent ext. vacuum. 

70592–76–6 ............... Distillates (petroleum), intermediate vacuum. 

70592–77–7 ............... Distillates (petroleum), light vacuum. 

70592–78–8 ............... Distillates (petroleum), vacuum. 

70592–79–9 ............... Residues (petroleum), atm. tower, light. 

70693–00–4 ............... Hydrocarbon waxes (petroleum), oxidized, sodium salts. 

70693–06–0 ............... Aromatic hydrocarbons, C9–11. 

70913–85–8 ............... Residues (petroleum), solvent-extd. vacuum distilled atm. residuum. 

70913–86–9 ............... Alkanes, C18–70. 

70955–08–7 ............... Alkanes, C4–6. 

70955–09–8 ............... Alkenes, C13–14 .alpha.-. 

70955–10–1 ............... Alkenes, C15–18 .alpha.-. 

70955–17–8 ............... Aromatic hydrocarbons, C12–20. 

71243–66–8 ............... Hydrocarbon waxes (petroleum), clay-treated, microcryst., oxidized, potassium salts. 

71302–82–4 ............... Hydrocarbons, C5–8, houdry butadiene manuf. by-product. 

71329–37–8 ............... Residues (petroleum), catalytic cracking depropanizer, C4-rich. 

71808–30–5 ............... Tail gas (petroleum), thermal cracking absorber. 

72230–71–8 ............... Distillates (petroleum), cracked steam-cracked, C5–17 fraction. 

72623–83–7 ............... Lubricating oils (petroleum), C > 25, hydrotreated bright stock-based. 

72623–84–8 ............... Lubricating oils (petroleum), C15–30, hydrotreated neutral oil-based, contg. solvent deasphalted residual oil. 

72623–85–9 ............... Lubricating oils (petroleum), C20–50, hydrotreated neutral oil-based, high-viscosity. 

72623–86–0 ............... Lubricating oils (petroleum), C15–30, hydrotreated neutral oil-based. 

72623–87–1 ............... Lubricating oils (petroleum), C20–50, hydrotreated neutral oil-based. 

73138–65–5 ............... Hydrocarbon waxes (petroleum), oxidized, magnesium salts. 

92045–43–7 ............... Lubricating oils (petroleum), hydrocracked non-arom. solvent deparaffined. 

92045–58–4 ............... Naphtha (petroleum), isomerization, C6-fraction. 

92062–09–4 ............... Slack wax (petroleum), hydrotreated. 

93762–80–2 ............... Alkenes, C15–18. 

98859–55–3 ............... Distillates (petroleum), oxidized heavy, compds. with diethanolamine. 

98859–56–4 ............... Distillates (petroleum), oxidized heavy, sodium salts. 

101316–73–8 ............. Lubricating oils (petroleum), used, non-catalytically refined. 

164907–78–2 ............. Extracts (petroleum), asphaltene-low vacuum residue solvent. 

164907–79–3 ............. Residues (petroleum), vacuum, asphaltene-low. 

178603–63–9 ............. Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, hydrogenated, C10–25. 

178603–64–0 ............. Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, hydrogenated, C15–30, branched and cyclic.

178603–65–1 ............. Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, hydrogenated, C20–40, branched and cyclic.

178603–66–2 ............. Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, hydrogenated, C25–55, branched and cyclic.

212210–93–0 ............. Solvent naphtha (petroleum), heavy arom., distn. residues. 

221120–39–4 ............. Distillates (petroleum), cracked steam-cracked, C5–12 fraction. 

445411–73–4 ............. Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, hydrogenated, C10–25, branched and cyclic 

(2) Specific exempted chemical 

substances—(i) Exemption. EPA has 

determined that, at this time, the 

information in § 711.15(b)(4) associated 

with the chemical substances listed in 

paragraph (b)(2)(iv) of this section is of 

low current interest. 

(ii) Considerations. In making its 

determination of whether this partial 

exemption should apply to a particular 

chemical substance, EPA will consider 

the totality of information available for 

the chemical substance in question, 

including but not limited to, one or 

more of the following considerations: 

(A) Whether the chemical substance 

qualifies or has qualified in past IUR 

collections for the reporting of the 

information described in § 711.15(b)(4). 


erowe on DSK5CLS3C1PROD with RULES_2
50870 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 

(B) The chemical substance’s 

chemical and physical properties or 

potential for persistence, 

bioaccumulation, health effects, or 

environmental effects (considered 

independently or together). 

(C) The information needs of EPA, 

other Federal agencies, Tribes, States, 

and local governments, as well as 

members of the public. 

(D) The availability of other 

complementary risk screening 

information. 

(E) The availability of comparable 

processing and use information. 

(F) Whether the potential risks of the 

chemical substance are adequately 

managed. 

(iii) Amendments. EPA may amend 

the chemical substance list in paragraph 

(b)(2)(iv) of this section on its own 

initiative or in response to a request 

from the public based on EPA’s 

determination of whether the 

information in § 711.15(b)(4) is of low 

interest. 

(A) Any person may request that EPA 

amend the chemical substance list in 

Table 2 in paragraph (b)(2)(iv) of this 

section. Your request must be in writing 

and must be submitted to the following 

address: OPPT IUR Submission 

Coordinator (7407M), Attention: 

Inventory Update Reporting, Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. Requests must identify 

the chemical substance in question, as 

well as its CASRN or other chemical 

identification number as identified in 

§ 711.15(b)(3)(i), and must contain a 

written rationale for the request that 

provides sufficient specific information, 

addressing the considerations listed in 

§ 711.6(b)(2)(ii), including cites and 

relevant documents, to demonstrate to 

EPA that the collection of the 

information in § 711.15(b)(4) for the 

chemical substance in question either is 

or is not of low current interest. If a 

request related to a particular chemical 

substance is resubmitted, any 

subsequent request must clearly identify 

new information contained in the 

request. EPA may request other 

information that it believes necessary to 

evaluate the request. EPA will issue a 

written response to each request within 

120 days of receipt of the request, and 

will maintain copies of these responses 

in a docket that will be established for 

each reporting cycle. 

(B) As needed, the Agency will 

initiate rulemaking to make revisions to 

Table 2 in paragraph (b)(2)(iv) of this 

section. 

(C) To assist EPA in reaching a 

decision regarding a particular request 

prior to a given principal reporting year, 

requests must be submitted to EPA no 

later than 12 months prior to the start 

of the next principal reporting year. 

(iv) List of chemical substances. EPA 

has designated the chemical substances 

listed in Table 2 of this paragraph by 

CASRN, as partially exempt from 

reporting under the IUR. 

TABLE 2—CASRN OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES

CASRN Chemical 

50–70–4 ...................... D-glucitol. 

50–81–7 ...................... L-ascorbic acid. 

50–99–7 ...................... D-glucose. 

56–81–5 ...................... 1,2,3-Propanetriol. 

56–87–1 ...................... L-lysine. 

57–50–1 ...................... .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl. 

58–95–7 ...................... 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-, acetate, (2R)-. 

59–02–9 ...................... 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-, (2R)-. 

59–51–8 ...................... Methionine. 

69–65–8 ...................... D-mannitol. 

87–79–6 ...................... L-sorbose. 

87–99–0 ...................... Xylitol. 

96–10–6 ...................... Aluminum, chlorodiethyl-. 

97–93–8 ...................... Aluminum, triethyl-. 

100–99–2 .................... Aluminum, tris(2-methylpropyl)-. 

123–94–4 .................... Octadecanoic acid, 2,3-dihydroxypropyl ester. 

124–38–9 .................... Carbon dioxide. 

137–08–6 .................... .beta.-Alanine, N-[(2R)-2,4-dihydroxy-3,3-dimethyl-1-oxobutyl]-, calcium alt (2:1). 

142–47–2 .................... L-glutamic acid, monosodium salt. 

150–30–1 .................... Phenylalanine. 

563–43–9 .................... Aluminum, dichloroethyl-. 

1070–00–4 .................. Aluminum, trioctyl-. 

1116–70–7 .................. Aluminum, tributyl-. 

1116–73–0 .................. Aluminum, trihexyl-. 

1191–15–7 .................. Aluminum, hydrobis(2-methylpropyl)-. 

1317–65–3 .................. Limestone. 

1333–74–0 .................. Hydrogen. 

1592–23–0 .................. Octadecanoic acid, calcium salt. 

7440–37–1 .................. Argon. 

7440–44–0 .................. Carbon. 

7727–37–9 .................. Nitrogen. 

7782–42–5 .................. Graphite. 

7782–44–7 .................. Oxygen. 

8001–21–6 .................. Sunflower oil. 

8001–22–7 .................. Soybean oil. 

8001–23–8 .................. Safflower oil. 

8001–26–1 .................. Linseed oil. 

8001–29–4 .................. Cottonseed oil. 

8001–30–7 .................. Corn oil. 

8001–31–8 .................. Coconut oil. 

8001–78–3 .................. Castor oil, hydrogenated. 

8001–79–4 .................. Castor oil. 


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Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations 50871 

TABLE 2—CASRN OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES—Continued 

CASRN Chemical 

8002–03–7 .................. Peanut oil. 

8002–13–9 .................. Rape oil. 

8002–43–5 .................. Lecithins. 

8002–75–3 .................. Palm oil. 

8006–54–0 .................. Lanolin. 

8016–28–2 .................. Lard, oil. 

8016–70–4 .................. Soybean oil, hydrogenated. 

8021–99–6 .................. Charcoal, bone. 

8029–43–4 .................. Syrups, hydrolyzed starch. 

11103–57–4 ................ Vitamin A. 

12075–68–2 ................ Aluminum, di-.mu.-chlorochlorotriethyldi-. 

12542–85–7 ................ Aluminum, trichlorotrimethyldi-. 

16291–96–6 ................ Charcoal. 

26836–47–5 ................ D-glucitol, monooctadecanoate. 

61789–44–4 ................ Fatty acids, castor-oil. 

61789–97–7 ................ Tallow. 

61789–99–9 ................ Lard. 

64147–40–6 ................ Castor oil, dehydrated. 

64755–01–7 ................ Fatty acids, tallow, calcium salts. 

65996–63–6 ................ Starch, acid-hydrolyzed. 

65996–64–7 ................ Starch, enzyme-hydrolyzed. 

67701–01–3 ................ Fatty acids, C12–18. 

68002–85–7 ................ Fatty acids, C14–22 and C16–22-unsatd. 

68131–37–3 ................ Syrups, hydrolyzed starch, dehydrated. 

68188–81–8 ................ Grease, poultry. 

68308–36–1 ................ Soybean meal. 

68308–54–3 ................ Glycerides, tallow mono-, di- and tri-, hydrogenated. 

68334–00–9 ................ Cottonseed oil, hydrogenated. 

68334–28–1 ................ Fats and glyceridic oils, vegetable, hydrogenated. 

68409–76–7 ................ Bone meal, steamed. 

68424–45–3 ................ Fatty acids, linseed-oil. 

68424–61–3 ................ Glycerides, C16–18 and C18-unsatd. mono- and di-. 

68425–17–2 ................ Syrups, hydrolyzed starch, hydrogenated. 

68439–86–1 ................ Bone, ash. 

68442–69–3 ................ Benzene, mono-C10–14-alkyl derivs. 

68476–78–8 ................ Molasses. 

68514–27–2 ................ Grease, catch basin. 

68514–74–9 ................ Palm oil, hydrogenated. 

68525–87–1 ................ Corn oil, hydrogenated. 

68648–87–3 ................ Benzene, C10–16-alkyl derivs. 

68918–42–3 ................ Soaps, stocks, soya. 

68952–94–3 ................ Soaps, stocks, vegetable-oil. 

68956–68–3 ................ Fats and glyceridic oils, vegetable. 

68989–98–0 ................ Fats and glyceridic oils, vegetable, residues. 

73138–67–7 ................ Lard, hydrogenated. 

120962–03–0 .............. Canola oil. 

129813–58–7 .............. Benzene, mono-C10–13-alkyl derivs. 

129813–59–8 .............. Benzene, mono-C12–14-alkyl derivs. 

129813–60–1 .............. Benzene, mono-C14–16-alkyl derivs. 

§ 14;711.8 Persons who must report. 

Except as provided in §§ 711.9 and 

711.10, the following persons are 

subject to the requirements of this part. 

Persons must determine whether they 

must report under this section for each 

chemical substance that they 

manufacture (including import) at an 

individual site. 

(a) Persons subject to recurring 

reporting—(1) For the 2012 submission 

period, any person who manufactured 

(including imported) for commercial 

purposes 25,000 lb (11,340 kilogram 

(kg)) or more of a chemical substance 

described in § 711.5 at any single site 

owned or controlled by that person 

during the principal reporting year (i.e., 

calendar year 2011) is subject to 

reporting. 

(2) For the submission periods 

subsequent to the 2012 submission 

period, any person who manufactured 

(including imported) for commercial 

purposes 25,000 lb (11,340 kg) or more 

of a chemical substance described in 

§ 711.5 at any single site owned or 

controlled by that person during any 

calendar year since the last principal 

reporting year (e.g., for the 2016 

submission period, consider calendar 

years 2012, 2013, 2014, and 2015, given 

that 2011 was the last principal 

reporting year). 

(b) Exceptions. For the 2016 

submission period and subsequent 

submission periods, any person who 

manufactured (including imported) for 

commercial purposes any chemical 

substance that is the subject of a rule 

proposed or promulgated under TSCA 

section 5(a)(2), 5(b)(4), or 6, or is the 

subject of an order in effect under TSCA 

section 5(e) or 5(f), or is the subject of 

relief that has been granted under a civil 

action under TSCA section 5 or 7 is 

subject to reporting as described in 

§ 711.8(a), except that the applicable 

production volume threshold is 2,500 lb 

(1,134 kg). 

§ 14;711.9 Persons not subject to this part. 

A person described in § 711.8 is not 

subject to the requirements of this part 


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if that person qualifies as a small 

manufacturer as that term is defined in 

40 CFR 704.3. Notwithstanding this 

exclusion, a person who qualifies as a 

small manufacturer is subject to this 

part with respect to any chemical 

substance that is the subject of a rule 

proposed or promulgated under TSCA 

section 4, 5(b)(4), or 6, or is the subject 

of an order in effect under TSCA section 

5(e), or is the subject of relief that has 

been granted under a civil action under 

TSCA section 5 or 7. 

§ 14;711.10 Activities for which reporting 

is not required. 

A person described in § 711.8 is not 

subject to the requirements of this part 

with respect to any chemical substance 

described in § 711.5 that the person 

solely manufactured or imported under 

the following circumstances: 

(a) The person manufactured or 

imported the chemical substance 

described in § 711.5 solely in small 

quantities for research and 

development. 

(b) The person imported the chemical 

substance described in § 711.5 as part of 

an article. 

(c) The person manufactured the 

chemical substance described in § 711.5 

in a manner described in 40 CFR 

720.30(g) or (h). 

§ 14;711.15 Reporting information to EPA. 

For the 2012 submission period, any 

person who must report under this part, 

as described in § 711.8, must submit the 

information described in this section for 

each chemical substance described in 

§ 711.5 that the person manufactured 

(including imported) for commercial 

purposes in an amount of 25,000 lb 

(11,340 kg) or more at any one site 

during the principal reporting year (i.e., 

calendar year 2011). For the submission 

periods subsequent to the 2012 

submission period, any person who 

must report under this part, as described 

in § 711.8, must submit the information 

described in this section for each 

chemical substance described in § 711.5 

that the person manufactured (including 

imported) for commercial purposes in 

an amount of 25,000 lb (11,340 kg) or 

more (or in an amount of 2,500 lb (1,134 

kg) or more for chemical substances 

subject to the rules, orders, or actions 

described in § 711.8(b)) at any one site 

during any calendar year since the last 

principal reporting year (e.g., for the 

2016 submission period, consider 

calendar years 2012, 2013, 2014, and 

2015, because 2011 was the last 

principal reporting year). The principal 

reporting year for each submission 

period is the previous calendar year 

(e.g., the principal reporting year for the 

2016 submission period is calendar year 

2015). For all submission periods, a 

separate report must be submitted for 

each chemical substance at each site for 

which the submitter is required to 

report. A submitter of information under 

this part must report information as 

described in this section to the extent 

that such information is known to or 

reasonably ascertainable by that person. 

(a) Reporting information to EPA. Any 

person who reports information to EPA 

must do so using the e-CDRweb 

reporting tool provided by EPA at the 

address set forth in § 711.35. The 

submission must include all 

information described in paragraph (b) 

of this section. Persons must submit a 

separate Form U for each site for which 

the person is required to report. The eCDRweb reporting tool is described in 

the instructions available from EPA at 

the Web site set forth in § 711.35. 

(b) Information to be reported. For the 

2012 submission period, manufacturers 

(including importers) of a reportable 

chemical substance in an amount of 

25,000 lb (11,340 kg) or more at a site 

during the principal reporting year (i.e., 

2011) must report the information 

described in paragraphs (b)(1), (b)(2), 

and (b)(3) of this section. For the 2012 

submission period, manufacturers 

(including importers) of a reportable 

chemical substance in an amount of 

100,000 lb (45,359 kg) or more at a site 

during the principal reporting year (i.e., 

2011) must additionally report the 

information described in paragraph 

(b)(4) of this section. For submission 

periods subsequent to the 2012 

submission period, the information 

described in paragraphs (b)(1), (b)(2), 

(b)(3), and (b)(4) of this section must be 

reported for each chemical substance 

manufactured (including imported) in 

an amount of 25,000 lb (11,340 kg) or 

more (or in an amount of 2,500 lb (1,134 

kg) or more for chemical substances 

subject to the rules, orders, or actions 

described in § 711.8(b)) at any one site 

during any calendar year since the last 

principal reporting year. The 

requirement to report information 

described in paragraph (b)(4) of this 

section is subject to exemption as 

described in § 711.6. 

(1) A certification statement signed 

and dated by an authorized official of 

the submitter company. The authorized 

official must certify that the submitted 

information has been completed in 

compliance with the requirements of 

this part and that the confidentiality 

claims made on the Form U are true and 

correct. The certification must be signed 

and dated by the authorized official for 

the submitter company, and provide 

that person’s name, official title, and 

e-mail address. 

(2) Company and plant site 

information. The following currently 

correct company and plant site 

information must be reported for each 

site at which a reportable chemical 

substance is manufactured (including 

imported) above the applicable 

production volume threshold, as 

described in this section (see § 711.3 for 

the ‘‘site’’ for importers): 

(i) The U.S. parent company name, 

address, and Dun and Bradstreet 

D–U–N–S® (D&B) number. A submitter 

under this part must obtain a D&B 

number for the U.S. parent company if 

none exists. 

(ii) The name of a person who will 

serve as technical contact for the 

submitter company, and who will be 

able to answer questions about the 

information submitted by the company 

to EPA, the contact person’s full mailing 

address, telephone number, and e-mail 

address. 

(iii) The name and full street address 

of each site. A submitter under this part 

must include the appropriate D&B 

number for each plant site reported, and 

the county or parish (or other 

jurisdictional indicator) in which the 

plant site is located. A submitter under 

this part must obtain a D&B number for 

the site reported if none exists. 

(3) Chemical-specific information. 

The following chemical-specific 

information must be reported for each 

reportable chemical substance 

manufactured (including imported) 

above the applicable production volume 

threshold, as described in paragraph (b) 

of this section: 

(i) The specific, currently correct CA 

Index name as used to list the chemical 

substance on the TSCA Inventory and 

the correct corresponding CASRN for 

each reportable chemical substance at 

each site. A submitter under this part 

may use an EPA-designated TSCA 

Accession Number for a chemical 

substance in lieu of a CASRN when a 

CASRN is not known to or reasonably 

ascertainable by the submitter. 

Submitters who wish to report chemical 

substances listed on the confidential 

portion of the TSCA Inventory will need 

to report the chemical substance using 

a TSCA Accession Number. 

In addition to reporting the number 

itself, submitters must specify the type 

of number they are reporting by 

selecting from among the codes in Table 

3 of this paragraph. 


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TABLE 3—CODES TO SPECIFY TYPE

OF CHEMICAL IDENTIFYING NUMBER

Code Number type 

A ............ TSCA Accession Number. 

C ............ Chemical Abstracts Service Registry Number (CASRN). 

(A) If an importer submitting a report 

cannot provide the information 

specified in § 711.15(b)(3)(i) because it 

is unknown to the importer and claimed 

as confidential by the supplier of the 

chemical substance or mixture, the 

importer must use e-CDRweb to ask the 

supplier to provide the correct chemical 

identity information directly to EPA in 

a joint submission. Such request must 

include instructions for submitting 

chemical identity information 

electronically, using e-CDRweb and 

CDX (see § 711.35), and for clearly 

referencing the importer’s submission. 

Contact information for the supplier, a 

trade name or other designation for the 

chemical substance or mixture, and a 

copy of the request to the supplier must 

be included with the importer’s 

submission respecting the chemical 

substance. 

(B) If a manufacturer submitting a 

report cannot provide the information 

specified in § 711.15(b)(3)(i) because the 

reportable chemical substance is 

manufactured using a reactant having a 

specific chemical identity that is 

unknown to the manufacturer and 

claimed as confidential by its supplier, 

the manufacturer must use e-CDRweb to 

ask the supplier of the confidential 

reactant to provide the correct chemical 

identity of the confidential reactant 

directly to EPA in a joint submission. 

Such request must include instructions 

for submitting chemical identity 

information electronically using eCDRweb and CDX (see § 711.35), and for 

clearly referencing the manufacturer’s 

submission. Contact information for the 

supplier, a trade name or other 

designation for the chemical substance, 

and a copy of the request to the supplier 

must be included with the importer’s 

submission respecting the chemical 

substance. 

(C) EPA will only accept joint 

submissions that are submitted 

electronically using e-CDRweb and CDX 

(see § 711.35) and that clearly reference 

the primary submission to which they 

refer. 

(ii) For the principal reporting year 

only, a statement indicating, for each 

reportable chemical substance at each 

site, whether the chemical substance is 

manufactured in the United States, 

imported into the United States, or both 

manufactured in the United States and 

imported into the United States. 

(iii) For the principal reporting year, 

the total annual volume (in pounds) of 

each reportable chemical substance 

domestically manufactured or imported 

at each site. The total annual 

domestically manufactured volume (not 

including imported volume) and the 

total annual imported volume must be 

separately reported. These amounts 

must be reported to two significant 

figures of accuracy. In addition, for the 

2012 submission period only, the total 

annual volume (domestically 

manufactured plus imported volumes in 

pounds) of each reportable chemical 

substance at each site during calendar 

year 2010. In addition, for submission 

periods subsequent to the 2012 

submission period, the total annual 

volume (domestically manufactured 

plus imported volumes in pounds) of 

each reportable chemical substance at 

each site for each complete calendar 

year since the last principal reporting 

year. 

(iv) For the principal reporting year 

only, the volume used on site and the 

volume directly exported of each 

reportable chemical substance 

domestically manufactured or imported 

at each site. These amounts must be 

reported to two significant figures of 

accuracy. 

(v) For the principal reporting year 

only, a designation indicating, for each 

imported reportable chemical substance 

at each site, whether the imported 

chemical substance is physically 

present at the reporting site. 

(vi) For the principal reporting year 

only, a designation indicating, for each 

reportable chemical substance at each 

site, whether the chemical substance is 

being recycled, remanufactured, 

reprocessed, reused, or otherwise used 

for a commercial purpose instead of 

being disposed of as a waste or included 

in a waste stream. 

(vii) For the principal reporting year 

only, the total number of workers 

reasonably likely to be exposed to each 

reportable chemical substance at each 

site. For each reportable chemical 

substance at each site, the submitter 

must select from among the ranges of 

workers listed in Table 4 of this 

paragraph and report the corresponding 

code (i.e., W1 through W8): 

TABLE 4—CODES FOR REPORTING

NUMBER OF WORKERS REASONABLY

LIKELY TO BE EXPOSED

Code Range 

W1 ......... Fewer than 10 workers. 

TABLE 4—CODES FOR REPORTING

NUMBER OF WORKERS REASONABLY

LIKELY TO BE EXPOSED—Continued 

Code Range 

W2 ......... At least 10 but fewer than 25 

workers. 

W3 ......... At least 25 but fewer than 50 

workers. 

W4 ......... At least 50 but fewer than 100 

workers. 

W5 ......... At least 100 but fewer than 500 

workers. 

W6 ......... At least 500 but fewer than 1,000 

workers. 

W7 ......... At least 1,000 but fewer than 

10,000 workers. 

W8 ......... At least 10,000 workers. 

(viii) For the principal reporting year 

only, the maximum concentration, 

measured by percentage of weight, of 

each reportable chemical substance at 

the time it is sent off-site from each site. 

If the chemical substance is site-limited, 

you must report the maximum 

concentration, measured by percentage 

of weight of the reportable chemical 

substance at the time it is reacted on-site 

to produce a different chemical 

substance. This information must be 

reported regardless of the physical 

form(s) in which the chemical substance 

is sent off-site/reacted on-site. For each 

chemical substance at each site, select 

the maximum concentration of the 

chemical substance from among the 

ranges listed in Table 5 of this 

paragraph and report the corresponding 

code (i.e., M1 through M5): 

TABLE 5—CODES FOR REPORTING

MAXIMUM CONCENTRATION OF

CHEMICAL SUBSTANCE

Code Concentration range (% weight) 

M1 .......... Less than 1% by weight. 

M2 .......... At least 1 but less than 30% by 

weight. 

M3 .......... At least 30 but less than 60% by 

weight. 

M4 .......... At least 60 but less than 90% by 

weight. 

M5 .......... At least 90% by weight. 

(ix) For the principal reporting year 

only, the physical form(s) of the 

reportable chemical substance as it is 

sent off-site from each site. If the 

chemical substance is site-limited, you 

must report the physical form(s) of the 

reportable chemical substance at the 

time it is reacted on-site to produce a 

different chemical substance. For each 

chemical substance at each site, the 

submitter must report as many physical 

forms as applicable from among the 

physical forms listed in this unit: 


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(A) Dry powder. 

(B) Pellets or large crystals. 

(C) Water- or solvent-wet solid. 

(D) Other solid. 

(E) Gas or vapor. 

(F) Liquid. 

(x) For the principal reporting year 

only, submitters must report the 

percentage, rounded off to the closest 

10%, of total production volume of the 

reportable chemical substance, reported 

in response to paragraph (b)(3)(iii) of 

this section, that is associated with each 

physical form reported under paragraph 

(b)(3)(ix) of this section. 

(4) Chemical-specific information 

related to processing and use. The 

following chemical-specific information 

must be reported for each reportable 

chemical substance manufactured 

(including imported) above the 

applicable production volume 

threshold, as described in this section. 

Persons subject to paragraph (b)(4) of 

this section must report the information 

described in paragraphs (b)(4)(i) and 

(b)(4)(ii) of this section for each 

reportable chemical substance at sites 

under their control and at sites that 

receive a reportable chemical substance 

from the submitter directly or indirectly 

(including through a broker/distributor, 

from a customer of the submitter, etc.). 

Information reported in response to this 

paragraph must be reported for the 

principal reporting year only and only 

to the extent that it is known to or 

reasonably ascertainable by the 

submitter. Information required to be 

reported under this paragraph is limited 

to domestic (i.e., within the customs 

territory of the United States) processing 

and use activities. If information 

responsive to a given data requirement 

under this paragraph, including 

information in the form of an estimate, 

is not known or reasonably 

ascertainable, the submitter is not 

required to respond to the requirement. 

(i) Industrial processing and use 

information—(A) A designation 

indicating the type of industrial 

processing or use operation(s) at each 

site that receives a reportable chemical 

substance from the submitter site 

directly or indirectly (whether the 

recipient site(s) are controlled by the 

submitter site or not). For each chemical 

substance, report the letters which 

correspond to the appropriate 

processing or use operation(s) listed in 

Table 6 of this paragraph. A particular 

designation may need to be reported 

more than once, to the extent that a 

submitter reports more than one sector 

(under paragraph (b)(4)(i)(B) of this 

section) that applies to a given 

designation under this paragraph. 

TABLE 6—CODES FOR REPORTING

TYPE OF INDUSTRIAL PROCESSING

OR USE OPERATION

Designation Operation 

PC ............. Processing as a reactant. 

PF .............. Processing—incorporation into 

formulation, mixture, or reaction product. 

PA .............. Processing—incorporation into 

article. 

PK .............. Processing—repackaging. 

U ................ Use—non-incorporative activities. 

(B) A code indicating the sector(s) that 

best describe the industrial activities 

associated with each industrial 

processing or use operation reported 

under paragraph (b)(4)(i)(A) of this 

section. For each chemical substance, 

report the code that corresponds to the 

appropriate sector(s) listed in Table 7 of 

this paragraph. A particular sector code 

may need to be reported more than 

once, to the extent that a submitter 

reports more than one industrial 

function code (under paragraph 

(b)(4)(i)(C) of this section) that applies to 

a given sector code under this 

paragraph. 

TABLE 7—CODES FOR REPORTING INDUSTRIAL SECTORS

Code Sector description 

IS1 ............................. Agriculture, forestry, fishing, and hunting. 

IS2 ............................. Oil and gas drilling, extraction, and support activities. 

IS3 ............................. Mining (except oil and gas) and support activities. 

IS4 ............................. Utilities. 

IS5 ............................. Construction. 

IS6 ............................. Food, beverage, and tobacco product manufacturing. 

IS7 ............................. Textiles, apparel, and leather manufacturing. 

IS8 ............................. Wood product manufacturing. 

IS9 ............................. Paper manufacturing. 

IS10 ........................... Printing and related support activities. 

IS11 ........................... Petroleum refineries. 

IS12 ........................... Asphalt paving, roofing, and coating materials manufacturing. 

IS13 ........................... Petroleum lubricating oil and grease manufacturing. 

IS14 ........................... All other petroleum and coal products manufacturing. 

IS15 ........................... Petrochemical manufacturing. 

IS16 ........................... Industrial gas manufacturing. 

IS17 ........................... Synthetic dye and pigment manufacturing. 

IS18 ........................... Carbon black manufacturing. 

IS19 ........................... All other basic inorganic chemical manufacturing. 

IS20 ........................... Cyclic crude and intermediate manufacturing. 

IS21 ........................... All other basic organic chemical manufacturing. 

IS22 ........................... Plastics material and resin manufacturing. 

IS23 ........................... Synthetic rubber manufacturing. 

IS24 ........................... Organic fiber manufacturing. 

IS25 ........................... Pesticide, fertilizer, and other agricultural chemical manufacturing. 

IS26 ........................... Pharmaceutical and medicine manufacturing. 

IS27 ........................... Paint and coating manufacturing. 

IS28 ........................... Adhesive manufacturing. 

IS29 ........................... Soap, cleaning compound, and toilet preparation manufacturing. 

IS30 ........................... Printing ink manufacturing. 

IS31 ........................... Explosives manufacturing. 

IS32 ........................... Custom compounding of purchased resins. 

IS33 ........................... Photographic film, paper, plate, and chemical manufacturing. 

IS34 ........................... All other chemical product and preparation manufacturing. 


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TABLE 7—CODES FOR REPORTING INDUSTRIAL SECTORS—Continued 

Code Sector description 

IS35 ........................... Plastics product manufacturing. 

IS36 ........................... Rubber product manufacturing. 

IS37 ........................... Non-metallic mineral product manufacturing (includes cement, clay, concrete, glass, gypsum, lime, and other non-metallic mineral product manufacturing). 

IS38 ........................... Primary metal manufacturing. 

IS39 ........................... Fabricated metal product manufacturing. 

IS40 ........................... Machinery manufacturing. 

IS41 ........................... Computer and electronic product manufacturing. 

IS42 ........................... Electrical equipment, appliance, and component manufacturing. 

IS43 ........................... Transportation equipment manufacturing. 

IS44 ........................... Furniture and related product manufacturing. 

IS45 ........................... Miscellaneous manufacturing. 

IS46 ........................... Wholesale and retail trade. 

IS47 ........................... Services. 

IS48 ........................... Other (requires additional information). 

(C) For each sector reported under 

paragraph (b)(4)(i)(B) of this section, 

code(s) from Table 8 of this paragraph 

must be selected to designate the 

industrial function category(ies) that 

best represents the specific manner in 

which the chemical substance is used. 

A particular industrial function category 

may need to be reported more than 

once, to the extent that a submitter 

reports more than one industrial 

processing or use operation/sector 

combination (under paragraphs 

(b)(4)(i)(A) and (b)(4)(i)(B) of this 

section) that applies to a given 

industrial function category under this 

paragraph. If more than 10 unique 

combinations of industrial processing or 

use operations/sector/industrial 

function categories apply to a chemical 

substance, submitters need only report 

the 10 unique combinations for the 

chemical substance that cumulatively 

represent the largest percentage of the 

submitter’s production volume for that 

chemical substance, measured by 

weight. If none of the listed industrial 

function categories accurately describes 

a use of a chemical substance, the 

category ‘‘Other’’ may be used, and must 

include a description of the use. 

TABLE 8—CODES FOR REPORTING INDUSTRIAL FUNCTION CATEGORIES

Code Category 

U001 .......................... Abrasives. 

U002 .......................... Adhesives and sealant chemicals. 

U003 .......................... Adsorbents and absorbents. 

U004 .......................... Agricultural chemicals (non-pesticidal). 

U005 .......................... Anti-adhesive agents. 

U006 .......................... Bleaching agents. 

U007 .......................... Corrosion inhibitors and anti-scaling agents. 

U008 .......................... Dyes. 

U009 .......................... Fillers. 

U010 .......................... Finishing agents. 

U011 .......................... Flame retardants. 

U012 .......................... Fuels and fuel additives. 

U013 .......................... Functional fluids (closed systems). 

U014 .......................... Functional fluids (open systems). 

U015 .......................... Intermediates. 

U016 .......................... Ion exchange agents. 

U017 .......................... Lubricants and lubricant additives. 

U018 .......................... Odor agents. 

U019 .......................... Oxidizing/reducing agents. 

U020 .......................... Photosensitive chemicals. 

U021 .......................... Pigments. 

U022 .......................... Plasticizers. 

U023 .......................... Plating agents and surface treating agents. 

U024 .......................... Process regulators. 

U025 .......................... Processing aids, specific to petroleum production. 

U026 .......................... Processing aids, not otherwise listed. 

U027 .......................... Propellants and blowing agents. 

U028 .......................... Solids separation agents. 

U029 .......................... Solvents (for cleaning or degreasing). 

U030 .......................... Solvents (which become part of product formulation or mixture). 

U031 .......................... Surface active agents. 

U032 .......................... Viscosity adjustors. 

U033 .......................... Laboratory chemicals. 

U034 .......................... Paint additives and coating additives not described by other categories. 

U999 .......................... Other (specify). 


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(D) The estimated percentage, 

rounded off to the closest 10%, of total 

production volume of the reportable 

chemical substance associated with 

each combination of industrial 

processing or use operation, sector, and 

industrial function category. Where a 

particular combination of industrial 

processing or use operation, sector, and 

industrial function category accounts for 

less than 5% of the submitter’s site’s 

total production volume of a reportable 

chemical substance, the percentage 

must not be rounded off to 0% if the 

production volume attributable to that 

industrial processing or use operation, 

sector, and industrial function category 

combination is 25,000 lb (11,340 kg) or 

more during the reporting year. Instead, 

in such a case, submitters must report 

the percentage, rounded off to the 

closest 1%, of the submitter’s site’s total 

production volume of the reportable 

chemical substance associated with the 

particular combination of industrial 

processing or use operation, sector, and 

industrial function category. 

(E) For each combination of industrial 

processing or use operation, sector, and 

industrial function category, the 

submitter must estimate the number of 

sites at which each reportable chemical 

substance is processed or used. For each 

combination associated with each 

chemical substance, the submitter must 

select from among the ranges of sites 

listed in Table 9 of this paragraph and 

report the corresponding code (i.e., S1 

through S7): 

TABLE 9—CODES FOR REPORTING NUMBERS OF SITES

Code Range 

S1 .............................. Fewer than 10 sites. 

S2 .............................. At least 10 but fewer than 25 sites. 

S3 .............................. At least 25 but fewer than 100 sites. 

S4 .............................. At least 100 but fewer than 250 sites. 

S5 .............................. At least 250 but fewer than 1,000 sites. 

S6 .............................. At least 1,000 but fewer than 10,000 sites. 

S7 .............................. At least 10,000 sites. 

(F) For each combination of industrial 

processing or use operation, sector, and 

industrial function category, the 

submitter must estimate the number of 

workers reasonably likely to be exposed 

to each reportable chemical substance. 

For each combination associated with 

each chemical substance, the submitter 

must select from among the worker 

ranges listed in paragraph (b)(3)(ii) of 

this section and report the 

corresponding code (i.e., W1 though 

W8). 

(ii) Consumer and commercial use 

information—(A) Using the codes listed 

in Table 10 of this paragraph, submitters 

must designate the consumer and 

commercial product category or 

categories that best describe the 

consumer and commercial products in 

which each reportable chemical 

substance is used (whether the recipient 

site(s) are controlled by the submitter 

site or not). If more than 10 codes apply 

to a chemical substance, submitters 

need only report the 10 codes for the 

chemical substance that cumulatively 

represent the largest percentage of the 

submitter’s production volume for that 

chemical, measured by weight. If none 

of the listed consumer and commercial 

product categories accurately describes 

the consumer and commercial products 

in which each reportable chemical 

substance is used, the category ‘‘Other’’ 

may be used, and must include a 

description of the use. 

TABLE 10—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES

Code Category 

Chemical Substances in Furnishing, Cleaning, Treatment Care Products 

C101 .......................... Floor coverings. 

C102 .......................... Foam seating and bedding products. 

C103 .......................... Furniture and furnishings not covered elsewhere. 

C104 .......................... Fabric, textile, and leather products not covered elsewhere. 

C105 .......................... Cleaning and furnishing care products. 

C106 .......................... Laundry and dishwashing products. 

C107 .......................... Water treatment products. 

C108 .......................... Personal care products. 

C109 .......................... Air care products. 

C110 .......................... Apparel and footwear care products. 

Chemical Substances in Construction, Paint, Electrical, and Metal Products 

C201 .......................... Adhesives and sealants. 

C202 .......................... Paints and coatings. 

C203 .......................... Building/construction materials—wood and engineered wood products. 

C204 .......................... Building/construction materials not covered elsewhere. 

C205 .......................... Electrical and electronic products. 

C206 .......................... Metal products not covered elsewhere. 

C207 .......................... Batteries. 

Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products 

C301 .......................... Food packaging. 

C302 .......................... Paper products. 


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TABLE 10—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES—Continued 

Code Category 

C303 .......................... Plastic and rubber products not covered elsewhere. 

C304 .......................... Toys, playground, and sporting equipment. 

C305 .......................... Arts, crafts, and hobby materials. 

C306 .......................... Ink, toner, and colorant products. 

C307 .......................... Photographic supplies, film, and photochemicals. 

Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products 

C401 .......................... Automotive care products. 

C402 .......................... Lubricants and greases. 

C403 .......................... Anti-freeze and de-icing products. 

C404 .......................... Fuels and related products. 

C405 .......................... Explosive materials. 

C406 .......................... Agricultural products (non-pesticidal). 

C407 .......................... Lawn and garden care products. 

Chemical Substances in Products not Described by Other Codes 

C980 .......................... Non-TSCA use. 

C909 .......................... Other (specify). 

(B) An indication, within each 

consumer and commercial product 

category reported under paragraph 

(b)(4)(ii)(A) of this section, whether the 

use is a consumer or a commercial use. 

(C) Submitters must determine, 

within each consumer and commercial 

product category reported under 

paragraph (b)(4)(ii)(A) of this section, 

whether any amount of each reportable 

chemical substance manufactured 

(including imported) by the submitter is 

present in (for example, a plasticizer 

chemical substance used to make 

pacifiers) or on (for example, as a 

component in the paint on a toy) any 

consumer products intended for use by 

children age 14 or younger, regardless of 

the concentration of the chemical 

substance remaining in or on the 

product. Submitters must select from 

the following options: The chemical 

substance is used in or on any consumer 

products intended for use by children, 

the chemical substance is not used in or 

on any consumer products intended for 

use by children, or information as to 

whether the chemical substance is used 

in or on any consumer products 

intended for use by children is not 

known to or reasonably ascertainable by 

the submitter. 

(D) The estimated percentage, 

rounded off to the closest 10%, of the 

submitter’s site’s total production 

volume of the reportable chemical 

substance associated with each 

consumer and commercial product 

category. Where a particular consumer 

and commercial product category 

accounts for less than 5% of the total 

production volume of a reportable 

chemical substance, the percentage 

must not be rounded off to 0% if the 

production volume attributable to that 

commercial and consumer product 

category is 25,000 lb (11,340 kg) or more 

during the reporting year. Instead, in 

such a case, submitters must report the 

percentage, rounded off to the closest 

1%, of the submitter’s site’s total 

production volume of the reportable 

chemical substance associated with the 

particular consumer and commercial 

product category. 

(E) Where the reportable chemical 

substance is used in consumer or 

commercial products, the estimated 

typical maximum concentration, 

measured by weight, of the chemical 

substance in each consumer and 

commercial product category reported 

under paragraph (b)(4)(ii)(A) of this 

section. For each chemical substance in 

each commercial and consumer product 

category reported under paragraph 

(b)(4)(ii)(A) of this section, submitters 

must select from among the ranges of 

concentrations listed in Table 5 in 

paragraph (b)(3)(viii) of this section and 

report the corresponding code (i.e., M1 

through M5). 

(F) Where the reportable chemical 

substance is used in a commercial 

product, the submitter must estimate the 

number of commercial workers 

reasonably likely to be exposed to each 

reportable chemical substance. For each 

combination associated with each 

substance, the submitter must select 

from among the worker ranges listed in 

Table 4 in paragraph (b)(3)(vii) of this 

section and report the corresponding 

code (i.e., W1 though W8). 

§ 711.20 When to report. 

All information reported to EPA in 

response to the requirements of this part 

must be submitted during an applicable 

submission period. For the 2012 IUR, 

the submission period is from February 

1, 2012 to June 30, 2012. Subsequent 

recurring submission periods are from 

June 1 to September 30 at 4-year 

intervals, beginning in 2016. In each 

submission period, any person 

described in § 711.8 must report as 

described in this part. 

§ 711.22 Duplicative reporting. 

(a) With regard to TSCA section 8(a) 

rules. Any person subject to the 

requirements of this part who 

previously has complied with reporting 

requirements of a rule under TSCA 

section 8(a) by submitting the 

information described in § 711.15 for a 

chemical substance described in § 711.5 

to EPA, and has done so within 1 year 

of the start of a submission period 

described in § 711.20, is not required to 

report again on the manufacture of that 

chemical substance at that site during 

that submission period. 

(b) With regard to importers. This part 

requires that only one report be 

submitted on each import transaction 

involving a chemical substance 

described in § 711.5. When two or more 

persons are involved in a particular 

import transaction and each person 

meets the Agency’s definition of 

‘‘importer’’ as set forth in 40 CFR 704.3, 

they may determine among themselves 

who should submit the required report; 

if no report is submitted as required 

under this part, EPA will hold each 

such person liable for failure to report. 

(c) Toll manufacturers and persons 

contracting with a toll manufacturer. 

This part requires that only one report 

per site be submitted on each chemical 

substance described in § 711.5. When a 

company contracts with a toll 


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manufacturer to manufacture a chemical 

substance, and each party meets the 

Agency’s definition of ‘‘manufacturer’’ 

as set forth in § 711.3, they may 

determine among themselves who 

should submit the required report for 

that site. However, both the contracting 

company and the toll manufacturer are 

liable if no report is made. 

§ 711.25 Recordkeeping requirements. 

Each person who is subject to the 

reporting requirements of this part must 

retain records that document any 

information reported to EPA. Records 

relevant to reporting during a 

submission period must be retained for 

a period of 5 years beginning on the last 

day of the submission period. 

Submitters are encouraged to retain 

their records longer than 5 years to 

ensure that past records are available as 

a reference when new submissions are 

being generated. 

§ 711.30 Confidentiality claims. 

(a) Confidentiality claims. Any person 

submitting information under this part 

may assert a business confidentiality 

claim for the information at the time it 

is submitted. Any such confidentiality 

claims must be made at the time the 

information is submitted. 

Confidentiality claims cannot be made 

when a response is left blank or 

designated as not known or reasonably 

ascertainable. These claims will apply 

only to the information submitted with 

the claim. New confidentiality claims, if 

appropriate, must be asserted with 

regard to information submitted during 

a different submission period. Guidance 

for asserting confidentiality claims is 

provided in the instructions identified 

in § 711.35. Information claimed as 

confidential in accordance with this 

section will be treated and disclosed in 

accordance with the procedures in 40 

CFR part 2. 

(b) Chemical identity. A person may 

assert a claim of confidentiality for the 

chemical identity of a specific chemical 

substance only if the identity of that 

chemical substance is treated as 

confidential in the Master Inventory File 

as of the time the report is submitted for 

that chemical substance under this part. 

The following steps must be taken to 

assert a claim of confidentiality for the 

identity of a reportable chemical 

substance: 

(1) The submitter must submit with 

the report detailed written answers to 

the following questions signed and 

dated by an authorized official. 

(i) What harmful effects to your 

competitive position, if any, or to your 

supplier’s competitive position, do you 

think would result from the identity of 

the chemical substance being disclosed 

in connection with reporting under this 

part? How could a competitor use such 

information? Would the effects of 

disclosure be substantial? What is the 

causal relationship between the 

disclosure and the harmful effects? 

(ii) How long should confidential 

treatment be given? Until a specific 

date, the occurrence of a specific event, 

or permanently? Why? 

(iii) Has the chemical substance been 

patented? If so, have you granted 

licenses to others with respect to the 

patent as it applies to the chemical 

substance? If the chemical substance has 

been patented and therefore disclosed 

through the patent, why should it be 

treated as confidential? 

(iv) Has the identity of the chemical 

substance been kept confidential to the 

extent that your competitors do not 

know it is being manufactured or 

imported for a commercial purpose by 

anyone? 

(v) Is the fact that the chemical 

substance is being manufactured 

(including imported) for a commercial 

purpose available to the public, for 

example in technical journals, libraries, 

or State, local, or Federal agency public 

files? 

(vi) What measures have been taken to 

prevent undesired disclosure of the fact 

that the chemical substance is being 

manufactured (including imported) for a 

commercial purpose? 

(vii) To what extent has the fact that 

this chemical substance is manufactured 

(including imported) for commercial 

purposes been revealed to others? What 

precautions have been taken regarding 

these disclosures? Have there been 

public disclosures or disclosures to 

competitors? 

(viii) Does this particular chemical 

substance leave the site of manufacture 

(including import) in any form, e.g., as 

product, effluent, emission? If so, what 

measures have been taken to guard 

against the discovery of its identity? 

(ix) If the chemical substance leaves 

the site in a product that is available to 

the public or your competitors, can the 

chemical substance be identified by 

analysis of the product? 

(x) For what purpose do you 

manufacture (including import) the 

chemical substance? 

(xi) Has EPA, another Federal agency, 

or any Federal court made any pertinent 

confidentiality determinations regarding 

this chemical substance? If so, please 

attach copies of such determinations. 

(2) If any of the information contained 

in the answers to the questions listed in 

paragraph (b)(1) of this section is 

asserted to contain confidential business 

information (CBI), the submitter must 

clearly identify the information that is 

claimed confidential by marking the 

specific information on each page with 

a label such as ‘‘confidential business 

information,’’ ‘‘proprietary,’’ or ‘‘trade 

secret.’’ 

(c) Site identity. A submitter may 

assert a claim of confidentiality for a site 

only if the linkage of the site with a 

reportable chemical substance is 

confidential and not publicly available. 

The following steps must be taken to 

assert a claim of confidentiality for a site 

identity: 

(1) The submitter must submit with 

the report detailed written answers to 

the following questions signed and 

dated by an authorized official: 

(i) Has site information been linked 

with a chemical identity in any other 

Federal, State, or local reporting 

scheme? For example, is the chemical 

identity linked to a facility in a filing 

under the Emergency Planning and 

Community Right-to-Know Act (EPCRA) 

section 311, namely through a Material 

Safety Data Sheet (MSDS)? If so, identify 

all such schemes. Was the linkage 

claimed as confidential in any of these 

instances? 

(ii) What harmful effect, if any, to 

your competitive position do you think 

would result from the identity of the site 

and the chemical substance being 

disclosed in connection with reporting 

under this part? How could a competitor 

use such information? Would the effects 

of disclosure be substantial? What is the 

causal relationship between the 

disclosure and the harmful effects? 

(2) If any of the information contained 

in the answers to the questions listed in 

paragraph (c)(1) of this section is 

asserted to contain CBI, the submitter 

must clearly identify the information 

that is claimed confidential by marking 

the specific information on each page 

with a label such as ‘‘confidential 

business information,’’ ‘‘proprietary,’’ or 

‘‘trade secret.’’ 

(d) Processing and use information. A 

submitter may assert a claim of 

confidentiality for each data element 

required by § 711.15(b)(4) only if the 

linkage of the information with a 

reportable chemical substance is 

confidential and not publicly available. 

The following steps must be taken to 

assert a claim of confidentiality for each 

data element, individually, required by 

§ 711.15(b)(4): 

(1) The submitter must submit with 

the report detailed written answers to 

the following questions signed and 

dated by an authorized official: 

(i) Is the identified use of this 

chemical substance publicly known? 

For example, is information on the use 

available in advertisements or other 


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marketing materials, professional 

journals or other similar materials, or in 

non-confidential mandatory or 

voluntary government filings or 

publications? Has your company ever 

provided use information on the 

chemical substance that was not 

claimed as confidential? 

(ii) What harmful effect, if any, to 

your competitive position or to your 

customer’s competitive position do you 

think would result from the information 

reported as required by § 711.15(b)(4) 

and the chemical substance being 

disclosed in connection with reporting 

under this part? How could a competitor 

use such information? Would the effects 

of disclosure be substantial? What is the 

causal relationship between the 

disclosure and the substantial harmful 

effects? 

(2) If any of the information contained 

in the answers to the questions listed in 

paragraph (d)(1) of this section is 

asserted to contain CBI, the submitter 

must clearly identify the information 

that is claimed confidential by marking 

the specific information on each page 

with a label such as ‘‘confidential 

business information,’’ ‘‘proprietary,’’ or 

‘‘trade secret.’’ 

(e) No claim of confidentiality. If no 

claim of confidentiality is indicated on 

Form U submitted to EPA under this 

part; if Form U lacks the certification 

required by § 711.15(b)(1); if 

confidentiality claim substantiation 

required under paragraphs (b), (c), and 

(d) of this section is not submitted with 

Form U; or if the identity of a chemical 

substance listed on the non-confidential 

portion of the Master Inventory File is 

claimed as confidential, EPA may make 

the information available to the public 

without further notice to the submitter. 

§ 711.35 Electronic filing. 

(a) You must use e-CDRweb to 

complete and submit Form U (EPA 

Form 7740–8). Submissions may only be 

made as set forth in this section. 

(b) Submissions must be sent 

electronically to EPA via CDX. 

(c) Access e-CDRweb and 

instructions, as follows: 

(1) By Web site. Go to the EPA 

Inventory Update Reporting Internet 

homepage at http://www.epa.gov/iur 

and follow the appropriate links. 

(2) By phone or e-mail. Contact the 

EPA TSCA Hotline at (202) 554–1404 or 

TSCA-Hotline@epa.gov for a CD–ROM 

containing the instructions. 

[FR Doc. 2011–19922 Filed 8–15–11; 8:45 am] 

BILLING CODE 6560–50–P 


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