# 84 FR 17692: TSCA Chemical Data Reporting Revisions and Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a)

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2019-07716

## Section

- **Citation:** 84 FR 17692
- **Heading:** TSCA Chemical Data Reporting Revisions and Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a)
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 84 / 84 FR 17692

## Text

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 704, 711, and 712 [EPA-HQ-OPPT-2018-0321; FRL-9982-16] RIN 2070-AK33 TSCA Chemical Data Reporting Revisions and Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a) AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Proposed rule.

SUMMARY:
EPA is proposing to amend the Toxic Substances Control Act (TSCA) section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every 4 years. EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce burden for certain CDR reporters. Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA section 8(a) rules, including CDR. The definitions may reduce burden on chemical manufacturers by increasing the number of manufacturers considered small. Overall, these regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner.

DATES:
Comments must be received on or before June 24, 2019.

ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0321, by one of the following methods:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments
f the reported data; and ensure that data are available in a timely manner.

DATES:
Comments must be received on or before June 24, 2019.

ADDRESSES:
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0321, by one of the following methods:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:

For technical information contact: Susan Sharkey, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8789; email address: sharkey.susan@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture (defined by statute at 15 U.S.C
sharkey.susan@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture (defined by statute at 15 U.S.C. 2602(9) to include import) chemical substances, including chemical users or processors who may manufacture byproduct chemical substances, and are therefore subject to either of the following: (1) Reporting under the TSCA Chemical Data Reporting (CDR) requirements at 40 CFR part 711 or (2) TSCA reporting and recordkeeping requirements at 40 CFR part 704 or other TSCA reporting requirements which reference the small manufacturer standards at 40 CFR 704.3. Any use of the term “manufacture” in this document will encompass “import,” the term “manufacturer” will encompass “importer,” and the term “chemical substance” will encompass “byproduct chemical substance,” unless otherwise stated.
The regulated community consists of entities that produce domestically or import into the United States chemical substances listed on the TSCA Inventory. The Agency's previous experience with TSCA section 8(a) collections has shown that most respondents affected by this collection activity are from the following North American Industrial Classification System (NAICS) code categories:
• NAICS 325—Chemical Manufacturing; and
• NAICS 324—Petroleum and Coal Product Manufacturing.
In addition to the anticipated respondents from the NAICS listed previously, the regulated community consists of manufacturers of byproducts that are required to report under certain TSCA section 8(a) rules, including CDR
owing North American Industrial Classification System (NAICS) code categories:
• NAICS 325—Chemical Manufacturing; and
• NAICS 324—Petroleum and Coal Product Manufacturing.
In addition to the anticipated respondents from the NAICS listed previously, the regulated community consists of manufacturers of byproducts that are required to report under certain TSCA section 8(a) rules, including CDR. Byproduct manufacturers may be listed under a different primary activity for a site, such as NAICS codes 22, 322, 327310, 331, and 3344 representing, utilities, paper manufacturing, cement manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing, respectively.
The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicable provisions at 40 CFR 711.8. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT .
B. What is the Agency's authority for taking this action?
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 (15 U.S.C. 2607). TSCA section 8(a) generally excludes small manufacturers and processors of chemical substances from the reporting requirements established in TSCA section 8(a)
CA 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 (15 U.S.C. 2607). TSCA section 8(a) 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; that is the subject of an order in effect under TSCA sections 4 or 5(e); that is subject to a consent agreement under TSCA section 4; or that is the subject of relief granted pursuant to a civil action under TSCA section 5 or 7.
TSCA section 8(a)(3)(B) authorizes the EPA Administrator, after consultation with the Administrator of the Small Business Administration (SBA), to prescribe by rule the standards for determining the manufacturers and processors which qualify as small manufacturers and processors. Pursuant
TSCA section 8(a)(5) requires the EPA Administrator, to the extent feasible, to not require unnecessary or duplicative reporting and minimize the cost of compliance for small manufacturers.
TSCA section 14 imposes requirements for the assertion, substantiation and review of confidential business information (CBI) claims.
C. What action is the Agency taking?
In this action, EPA is proposing several amendments to the current CDR rule requirements
o the extent feasible, to not require unnecessary or duplicative reporting and minimize the cost of compliance for small manufacturers.
TSCA section 14 imposes requirements for the assertion, substantiation and review of confidential business information (CBI) claims.
C. What action is the Agency taking?
In this action, EPA is proposing several amendments to the current CDR rule requirements. These amendments, described in more detail in Unit III., include:
• Changing requirements for making confidentiality claims, including to identify when upfront substantiation is required, update the substantiation questions, and identify data elements that cannot be claimed as confidential to align with the Lautenberg Chemical Safety for the 21st Century Act (2016 Amendments);
• Replacing certain processing and use codes (industrial function and commercial/consumer product use) with codes based on the Organisation for Economic Co-operation and Development's (OECD) functional use and product and article use codes, including adding reporting of the OECD-based functional use codes for consumer and commercial use information;
• Adding the requirement to report the NAICS code(s) for the site of manufacture;
• Modifying the requirement to indicate whether a chemical is removed from the waste stream and recycled, remanufactured, reprocessed, or reused with the requirement to indicate whether a chemical is removed from the waste stream and recycled;
• Adding a requirement to identify the percent total production volume of a chemical substance that is a byproduct;
• Requiring that the secondary submitter of a joint submission report the chemical specific function along with the percentage of the chemical in the imported product;
• Adding a voluntary data element to provide a public contact;
• Modifying the definition of “parent company” to clarify the definition, add the requirement to report a foreign parent company, when applicable, and codify reporting scenarios;
• Simplifying the reporting process for co-m
on report the chemical specific function along with the percentage of the chemical in the imported product;
• Adding a voluntary data element to provide a public contact;
• Modifying the definition of “parent company” to clarify the definition, add the requirement to report a foreign parent company, when applicable, and codify reporting scenarios;
• Simplifying the reporting process for co-manufacturers by enabling a multi-reporter process for reporters to separately report directly to EPA within the e-CDRweb reporting tool;
• Allowing reporting in specified metal categories for inorganic byproducts;
• Adding exemptions for specifically identified byproducts that are recycled in a site-limited, enclosed system and for byproducts that are manufactured as part of non-integral pollution control and boiler equipment; and
• Clarifying regulatory text by removing outdated text, consolidating exemptions, and making other improvements.
Additionally, EPA is proposing an amendment to update the size standards definition for small manufacturers for reporting and recordkeeping requirements under TSCA section 8(a). Further details of this amendment are in Unit IV.
EPA is also giving notice of some aspects of the amendments to TSCA from the Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016 Amendments) that may impact, more broadly, TSCA submitters. For example, under TSCA section 14(e)(1)(B), the Agency is charged with implementing a ten year “sunset” provision for confidentiality claims.
Because the small manufacturer size standard under TSCA section 8(a) impacts the CDR rule more than other TSCA section 8(a) reporting rules at this time, EPA included these two actions as one proposed rule. However, EPA recognizes that the changes made to the small business definition will impact current and future TSCA section 8(a) reporting rules and intends to finalize these amendments as two separate actions
ll manufacturer size standard under TSCA section 8(a) impacts the CDR rule more than other TSCA section 8(a) reporting rules at this time, EPA included these two actions as one proposed rule. However, EPA recognizes that the changes made to the small business definition will impact current and future TSCA section 8(a) reporting rules and intends to finalize these amendments as two separate actions.
EPA is taking other, non-regulatory steps to minimize the burden on all reporters, including small entities, by improving the reporting application and database to be user-friendly and dynamic, consisting of straightforward questions that include fill-in-the-blank (number) fields, check boxes, and drop-down menus. In addition, EPA is replacing the current pre-formatted Form U with a customized report based on the actual information submitted by a site through e-CDRweb, the electronic reporting tool. Although these changes are not discussed further in this proposal, they are an important component of the effort to reduce burden and modernize the data collection system. EPA is adding an addendum to the current CDR rule ICR (OMB Control Number 2070-0162) for the regulatory changes proposed in this document. In addition to the changes outlined in this proposed rule, if needed, EPA will provide a second addendum to this ICR to address non-regulatory changes. As was done for previous CDR collections, EPA will provide industry with the opportunity to test and comment on the updated e-CDRweb prior to the 2020 CDR submission period. EPA anticipates holding a webinar to introduce the revised e-CDRweb to the regulated community directly following the finalization of the CDR Revisions rule. During the webinar, EPA will issue a general invitation to interested parties to participate in a short testing period of the revised e-CDRweb. EPA will open the testing period within 4 months after this proposal is finalized, and currently anticipates that testing will occur in the February to March 2020 timeframe
regulated community directly following the finalization of the CDR Revisions rule. During the webinar, EPA will issue a general invitation to interested parties to participate in a short testing period of the revised e-CDRweb. EPA will open the testing period within 4 months after this proposal is finalized, and currently anticipates that testing will occur in the February to March 2020 timeframe. Because of resource constraints, the testing period will be limited to 25 participants. For additional information, contact the person under FOR FURTHER INFORMATION CONTACT . Also, information will be posted on the CDR website ( https://www.epa.gov/chemical-data-reporting ).
D. Why is the Agency taking this action?
EPA is proposing revisions to the CDR rule for three primary reasons: Align with amendments to TSCA from the Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016 Amendments), improve the CDR data collected as necessary to support the implementation of TSCA, and reduce burden for CDR reporters pursuant to TSCA section 8(a)(5).
The 2016 Amendments to TSCA changed requirements associated with confidentiality claims, including identifying the data elements eligible for confidentiality claims and when substantiation of claims is required. EPA is proposing revisions to the CDR rule to address these changes.
EPA is proposing to modify the definition for small manufacturers, as a result of the 2016 Amendments revision of TSCA section 8(a)(3)(C), which requires EPA, after consultation with the Administrator of the SBA, to review the adequacy of the standards for determining which manufacturers and processors qualify as small manufacturers and processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). EPA published a determination that revision of the TSCA section 8(a) size standards for small manufacturers as warranted in a Federal Register Notice published November 30, 2017 (82 FR 56824)
istrator of the SBA, to review the adequacy of the standards for determining which manufacturers and processors qualify as small manufacturers and processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). EPA published a determination that revision of the TSCA section 8(a) size standards for small manufacturers as warranted in a Federal Register Notice published November 30, 2017 (82 FR 56824). EPA's determination, supporting documents, and comments received can be found at regulations.gov under docket number EPA-HQ-OPPT-2016-0675. This proposed change may reduce burden for some manufacturers
EPA is also proposing to make some changes to the CDR data reporting so the information collected is tailored to better meet the Agency's overall information needs and aligned with specific needs for prioritization and risk evaluation under TSCA section 6. TSCA section 2 specifies that “adequate information should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such information should be the responsibility of those who manufacture and those who process such chemical substances and mixtures” (TSCA section 2(b)(1)). These proposed changes include the addition of data elements, such as a site-specific NAICS code and how much of a chemical is a byproduct; modification to multi-reporter submission requirements, including adding a process for jointly reporting co-manufactured chemicals; and changes to current data elements, such as codes used for reporting processing and use information. In addition, proposed changes to the parent company reporting requirements would increase EPA's ability to protect confidential information while better enabling EPA to make information publicly available and the addition of a voluntary public contact would direct inquiries from the public to a designated individual rather than to the technical contact
for reporting processing and use information. In addition, proposed changes to the parent company reporting requirements would increase EPA's ability to protect confidential information while better enabling EPA to make information publicly available and the addition of a voluntary public contact would direct inquiries from the public to a designated individual rather than to the technical contact. These changes would help to meet the Agency's requirement under TSCA section 26(h), in carrying out TSCA sections 4, 5, and 6, to make scientific decisions consistent with the best available science, improve the CDR data collected as necessary to support the implementation of TSCA, and improve EPA's ability to effectively provide public access to the information. Furthermore, these changes would meet the Agency's objective to obtain new and updated information relating to potential exposures to a major subset of chemical substances listed on the TSCA Inventory.
At the same time, EPA is interested in reducing burden on industry while maintaining the Agency's ability to receive the information it needs to understand exposure to these chemicals (TSCA section 8(a)(5)). EPA used experiences from the 2016 CDR submission period, concerns identified by users of CDR information, and burden-reduction suggestions made as part of public comment opportunities, including public comments solicited in conjunction with Executive Order 13777, Enforcing the Regulatory Reform Agenda (EPA-HQ-OA-2017-0190 and 82 FR 17793, April 13, 2017) and as part of the renewal of the Information Collection Request (ICR) (EPA-HQ-OPPT-2017-0648 and 83 FR 36928, July 31, 2018). In addition, EPA identified ways to reduce burden specifically for manufacturers of inorganic byproducts as part of an extensive negotiated rulemaking effort, which included participation by all stakeholder groups, and subsequent public comment period in 2017 (EPA-HQ-OPPT-2016-0597 and 82 FR 47423, October 12, 2017)
n Collection Request (ICR) (EPA-HQ-OPPT-2017-0648 and 83 FR 36928, July 31, 2018). In addition, EPA identified ways to reduce burden specifically for manufacturers of inorganic byproducts as part of an extensive negotiated rulemaking effort, which included participation by all stakeholder groups, and subsequent public comment period in 2017 (EPA-HQ-OPPT-2016-0597 and 82 FR 47423, October 12, 2017). Taking into account these experiences and stakeholder input, EPA is proposing the following changes to reduce burden: The new ability to alternatively report inorganic byproducts within defined metal categories, the introduction of two new exemptions related to byproducts, a revised approach to reporting for co-manufactured chemicals, and the harmonization of function and product codes with those used by other countries.
Additionally, EPA has received comments that modernizing the CDR data collection and public access to the database would reduce reporting burden and facilitate ease of use by reporters and the public (81 FR 90843; EPA-HQ-OPPT-2016-0597 and Refs. 1, 2, and 3). These comments were used to develop this proposal and to inform other, non-regulatory changes that EPA plans to make to the reporting process.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs and benefits of revising CDR reporting requirements and modifying standards for small manufacturers in CDR and other TSCA section 8(a) reporting. Some aspects of the proposal increase burden and cost while other aspects decrease burden and result in cost savings. Overall, EPA estimates that the combined impact of all the proposed amendments would decrease the total burden and result in a cost savings to industry and government reporters. These analyses, which are available in the docket (Refs. 4 and 5), are discussed in Units III. and IV. and are briefly summarized here.
1. CDR revisions economic impacts summary
ecrease burden and result in cost savings. Overall, EPA estimates that the combined impact of all the proposed amendments would decrease the total burden and result in a cost savings to industry and government reporters. These analyses, which are available in the docket (Refs. 4 and 5), are discussed in Units III. and IV. and are briefly summarized here.
1. CDR revisions economic impacts summary. The proposed amendments are estimated to result in an overall net decrease in burden with associated cost savings. The estimated changes include increases in rule familiarization, compliance determination, and form completion. The future cycle burden and costs or cost savings are listed by type of change:
• For changes to modify or add reportable data elements ( e.g., processing and use codes, NAICS codes, byproduct percentage, chemical function, public contact, and parent company—discussed in Units III.B. and III.C.), the incremental burden is expected to increase by 45,000 hours with an associated cost increase of $3.5 million.
• For changes to claiming confidentiality (discussed in Unit III.A.), the incremental burden is expected to decrease by 340 hours with an associated cost savings of $0.03 million.
• For changes to add byproducts exemptions (discussed in Unit III.D.), the incremental burden is expected to decrease by 68,000 hours with an associated cost savings of $5.2 million.
• For changes to implement consolidated category reporting for certain inorganic metals (discussed in Unit III.D.), the incremental burden is expected to decrease by 13,000 hours with an associated cost savings of $1.0 million.
• For changes that affect CDR reporting eligibility (targeted to certain sites with varying reductions to the number of chemicals reported per site), the incremental burden is expected to result in a net decrease by 81,000 hours with associated cost savings at $6.3 million
nit III.D.), the incremental burden is expected to decrease by 13,000 hours with an associated cost savings of $1.0 million.
• For changes that affect CDR reporting eligibility (targeted to certain sites with varying reductions to the number of chemicals reported per site), the incremental burden is expected to result in a net decrease by 81,000 hours with associated cost savings at $6.3 million. There are increases in burden and costs for several requirements, such as the need to assess whether exemptions apply (compliance determination) and the need to familiarize oneself with modifications to the rule (rule familiarization), estimated at 3,000 hours with an associated cost of $0.24 million. However, the changes to form completion in the aggregate are estimated to result in an overall net decrease in burden and cost savings due to decreases in the number of sites reporting and or the number of chemical reports from a site. These decreases are due to the proposed byproduct exemptions (discussed in Units III.D.2. and III.D.3.) and consolidated category reporting (discussed in Unit III.D.1.).
In sum, the overall incremental impacts to industry and government reporters result in a net decrease in burden and cost savings. Estimates include rule familiarization, compliance determination, and CDR form completion (Ref. 4). Note that estimated changes to recordkeeping burden and cost are negligible and estimated at zero. An estimated 5,660 sites are expected to report during the next CDR submission period in 2020. The total incremental burden reduction and cost savings are estimated at a 36,000 hour reduction and $2.79 million cost savings. On an annualized basis using a 3 percent and
2. TSCA section 8(a) small manufacturer definition economic impacts summary. The proposed modified standards for small manufacturers would affect TSCA section 8(a) rules, including CDR
the next CDR submission period in 2020. The total incremental burden reduction and cost savings are estimated at a 36,000 hour reduction and $2.79 million cost savings. On an annualized basis using a 3 percent and
2. TSCA section 8(a) small manufacturer definition economic impacts summary. The proposed modified standards for small manufacturers would affect TSCA section 8(a) rules, including CDR. These rules use the TSCA section 8(a) small manufacturer definition to identify the entities exempted from reporting or for other reduced reporting requirements. The impact from the proposal is focused on the CDR rule and may impact whether a site is required to report or the number of chemicals a site would report. There is no measurable impact to other TSCA section 8(a) rules either because EPA has not received any chemical reports for the rule for an extended period of time or because the rule uses a different definition that is not being changed by this proposal (see Unit IV.A. for a more detailed discussion). The proposed definition, discussed in detail in Unit IV., results in a cost savings.
a. Impact of proposed small manufacturer definition. The proposal is estimated to eliminate reporting entirely for 93 industry sites and reduce reporting by eliminating the need to report at least one chemical for additional 129 industry sites (Ref. 5). This reduction in reporting is in addition to the sites already not reporting because they meet the current small manufacturer definition.
Under this proposed definition, incremental future cycle burden reductions and cost savings are estimated at 64,000 hours and $5.0 million, respectively, over a four-year CDR reporting cycle (Ref. 5). On an annualized basis, using a 3 percent and 7 percent discount rate over a 10-year period yields net annualized incremental cost savings of $1.2 million and $1.2 million per year, respectively (Ref. 5). This proposal also includes a small government exemption (described in this unit).
b. Impact of proposed small government definition
respectively, over a four-year CDR reporting cycle (Ref. 5). On an annualized basis, using a 3 percent and 7 percent discount rate over a 10-year period yields net annualized incremental cost savings of $1.2 million and $1.2 million per year, respectively (Ref. 5). This proposal also includes a small government exemption (described in this unit).
b. Impact of proposed small government definition. The following government entities report under CDR: Seven municipalities, one county-level public utility district, and one tribal entity. Under the proposed small government definition, four government entities would be exempted from the need to report. The burden and cost savings associated with the exempted entities, in future reporting cycles, are included in the estimates for the proposed definition with incremental future cycle burden reduction and cost savings estimated at 500 hours and $39,000 respectively, over a four-year CDR reporting cycle (Ref. 5).
3. Total economic impacts summary for proposal. The amendments in this proposal may affect the number of reports submitted during a submission period and the burden to prepare a report. EPA estimates that the combined impact of all the proposed amendments would decrease the total burden and cost to industry associated with CDR reporting. Tables 1A and 1B present the summaries of burden and cost impacts, respectively, for the proposed CDR revisions and TSCA section 8(a) small manufacturer definition update. In the tables, estimates are presented for the CDR four-year first cycle and in the future cycle. In the first cycle, higher burdens and costs are incurred, because all reporters need to familiarize themselves with the changes and may take longer to complete reporting activities. After the first cycle, and for future cycles, experienced reporters (85%) are familiar with the changed requirements. In addition to estimates that cover the four-year CDR cycle, Tables 1A and 1B present annual estimates
the first cycle, higher burdens and costs are incurred, because all reporters need to familiarize themselves with the changes and may take longer to complete reporting activities. After the first cycle, and for future cycles, experienced reporters (85%) are familiar with the changed requirements. In addition to estimates that cover the four-year CDR cycle, Tables 1A and 1B present annual estimates. These annual estimates are the four-year estimates divided by four. EPA acknowledges that activities may be spread unevenly across the four years. On an annualized basis, using a 3 percent and 7 percent discount rate over a 10-year period yields a net annualized incremental cost savings of $1.85 million and $1.83 million per year, respectively, for the overall proposed rule.
Table 1A—Summary of Economic Impacts, Burden Reductions Number of affected sites First cycle Four-year cycle Burden reduction (hours) Annual Burden reduction (hours) Future cycles Four-year cycle Burden reduction (hours) Annual Burden reduction (hours) CDR Revisions 5,660 31,306 7,827 36,005 9,001 8(a) Small Manufacturer Exemption 1 5,627 56,162 14,040 64,295 16,074 Small Government Exemption 2 33 454 113 504 126 Net Incremental Change 5,660 87,922 21,980 100,804 25,201 General Note: Annual estimates are based on changes applied evenly across the four-year cycle. However, due to rounding issues, results may not be readily derived using this table. Footnotes: 1 Under the proposed exemptions, incremental changes represent the net change due to the proposed rule and therefore include sites and chemical reports that are exempted. Note that sites and reports can be entirely affected or undergo a split effect, with a portion of the site's chemical reports exempted. 2 Four small governments are identified to qualify for the small government exemption under the proposed small government exemption
mental changes represent the net change due to the proposed rule and therefore include sites and chemical reports that are exempted. Note that sites and reports can be entirely affected or undergo a split effect, with a portion of the site's chemical reports exempted. 2 Four small governments are identified to qualify for the small government exemption under the proposed small government exemption.
Table 1B—Summary of Economic Impacts, Cost Savings Number of affected sites First cycle Four-year cycle Cost savings (2017$) Annual Cost savings (2017$) Future cycles Four-year cycle Cost savings (2017$) Annual Cost savings (2017$) CDR Revisions 5,660 $2,428,630 $607,157 $2,792,871 $698,218 8(a) Small Manufacturer Exemption 1 5,627 4,357,362 1,089,341 4,988,270 1,247,068 Small Government Exemption 2 33 35,132 8,783 39,025 9,756 Net Incremental Change 5,660 6,821,124 1,705,281 7,820,166 1,955,042 General Note: Annual estimates are based on changes applied evenly across the four-year cycle. However, due to rounding issues, results may not be readily derived using this table. Footnotes: 1 Under the proposed exemptions, incremental changes represent the net change due to the proposed rule and therefore include sites and chemical reports that are exempted. Note that sites and reports can be entirely affected or undergo a split effect, with a portion of the site's chemical reports exempted. 2 Four small governments are identified to qualify for the small government exemption under the proposed small government exemption. F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI
I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.
II. Background
A. What is the Chemical Data Reporting (CDR) rule?
The CDR rule requires U.S. manufacturers of certain chemicals listed on the TSCA Inventory to report to EPA every four years the identity of chemical substances manufactured for all years since the last principal reporting year. For example, for the 2020 submission period, the principal reporting year is 2019 and the last principal reporting year for the 2016 submission period was 2015. Reporting during the 2020 submission period covers the manufacture of chemicals in 2016, 2017, 2018, and 2019. To help minimize reporting burden, detailed information is required only for the principal reporting year ( i.e., 2019), including a breakout of the production volume to provide separate volumes for domestically manufactured and imported amounts. Generally, reporting is required for substances whose production volumes are 25,000 pounds or more at any single site during any of the calendar years since the last principal reporting year. However, a lower threshold applies for chemical substances that are the subject of certain TSCA actions (see 40 CFR 711.8(b))
me to provide separate volumes for domestically manufactured and imported amounts. Generally, reporting is required for substances whose production volumes are 25,000 pounds or more at any single site during any of the calendar years since the last principal reporting year. However, a lower threshold applies for chemical substances that are the subject of certain TSCA actions (see 40 CFR 711.8(b)). The CDR regulation generally excludes several groups of chemical substances from its reporting requirements, e.g., polymers, microorganisms, naturally occurring chemical substances, certain forms of natural gas, and water (see 40 CFR 711.5 and 711.6). For the 2016 CDR, EPA received Form U's from 5,660 sites with an associated 42,464 chemical reports, providing information on 8,717 unique chemicals.
Persons domestically manufacturing or importing chemical substances are 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, including the physical form and maximum concentration of the chemical substance, the number of potentially exposed workers at the reporting site and certain processing and use information (40 CFR 711.15). The processing and use information that is currently required includes: Process or use category; NAICS code; industrial function category; percent production volume associated with each process or use category; number of sites; number of potentially exposed industrial or commercial workers; and consumer/commercial information such as use category, use in or on products intended for use by children, and maximum concentration
rmation that is currently required includes: Process or use category; NAICS code; industrial function category; percent production volume associated with each process or use category; number of sites; number of potentially exposed industrial or commercial workers; and consumer/commercial information such as use category, use in or on products intended for use by children, and maximum concentration. Under CDR, submitters report information to the extent that it is “known to or reasonably ascertainable” (40 CFR 711.15), which 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” (40 CFR 711.3, referencing 40 CFR 704.3). Reported information can be claimed as confidential (40 CFR 711.30).
B. How are the CDR data used by EPA?
EPA uses the data reported pursuant to the CDR rule to support health, safety, and environmental protection activities related to chemical manufacturing and use. Manufacturing, processing and use information about chemicals in commerce helps EPA understand exposure to these chemicals and screen and prioritize chemicals to identify potential human health and environmental effects. EPA uses the data reported under the CDR rule to support many activities under TSCA and to provide overall support for EPA and other federal, state, local, and tribal health, safety, and environmental protection activities (Ref. 6 and 83 FR 36928, July 31, 2018 (EPA-HQ-OPPT-2017-0648)).
CDR provides basic exposure-related data which EPA uses in a wide variety of its activities, from choosing the chemicals EPA will focus on for prioritization and assessment activities to informing response actions, such as to hurricanes and other disasters
e, local, and tribal health, safety, and environmental protection activities (Ref. 6 and 83 FR 36928, July 31, 2018 (EPA-HQ-OPPT-2017-0648)).
CDR provides basic exposure-related data which EPA uses in a wide variety of its activities, from choosing the chemicals EPA will focus on for prioritization and assessment activities to informing response actions, such as to hurricanes and other disasters. For example, in accordance with TSCA section 6(b)(1)(A), EPA is required to consider “the conditions of use or significant changes in conditions of use of the chemical substance, and the Problem Formulation of the Risk Evaluation for Perchloroethylene (Ethene, 1,1,2,2-Tertrachloro), EPA used CDR data to identify conditions of use for Perchloroethylene (Ref. 7). CDR data will continue to inform future prioritization, risk evaluation, and risk management work under TSCA.
For another example, to help prepare EPA and others to respond to hurricane disasters that occurred in 2018, EPA prepared information about chemicals expected to be in the affected areas from data sources such as CDR.
In 2012, EPA published its TSCA Work Plan for Chemical Assessments. CDR data were used extensively in the development of this Work Plan. Using CDR data collected during the 2012 CDR submission period, EPA updated the exposure rankings for the chemicals initially screened as part of the original Work Plan and, in 2014, published a revised Work Plan (2014 Work Plan). TSCA requires that at least 50 percent of all chemical substances undergoing risk evaluation (High-Priority designations) come from the 2014 Work Plan, until the Work Plan chemical list is exhausted.
The Interagency Testing Committee (ITC), an independent advisory committee to the EPA Administrator, uses CDR data when updating the Priority Testing List (PTL). The ITC designates or recommends chemicals to the PTL that the Agency may prioritize when requiring testing under TSCA section 4 or collecting information under TSCA sections 8(a) or 8(d)
until the Work Plan chemical list is exhausted.
The Interagency Testing Committee (ITC), an independent advisory committee to the EPA Administrator, uses CDR data when updating the Priority Testing List (PTL). The ITC designates or recommends chemicals to the PTL that the Agency may prioritize when requiring testing under TSCA section 4 or collecting information under TSCA sections 8(a) or 8(d). In making those determinations, production volumes reported to CDR are used to identify the opportunity for exposure to a particular chemical.
OECD member countries develop Emission Scenario Documents (ESD). EPA is an active participant of the OECD Task Force and regularly works on the development of ESDs that are reviewed by the Task Force and added to the published series of ESDs. ESDs developed by EPA cover both occupational exposures and environmental releases due to EPA's review responsibilities under TSCA. In a separate and related effort, EPA has regularly developed industry-specific generic scenarios which are similar to an OECD ESD, as tools to assist in the assessment of the many types of uses for new chemicals reviewed under TSCA. CDR data are used to identify the chemicals commonly used in specific industries, estimate the number of potentially exposed workers, and develop estimates of exposure and releases that support the development of these documents and scenarios.
Additional examples of how EPA uses CDR data include use by the Office of Research and Development to characterize the life cycle of chemicals for life cycle inventories, to develop conceptual models, and to develop standardized emission and release estimates from chemical production. The Office of Water uses CDR data to identify facilities in specific industry sectors while developing effluent guidelines and to identify chemicals of interest and their associated processing and use activities for Effluent Guidelines Annual Review Reports.
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ife cycle inventories, to develop conceptual models, and to develop standardized emission and release estimates from chemical production. The Office of Water uses CDR data to identify facilities in specific industry sectors while developing effluent guidelines and to identify chemicals of interest and their associated processing and use activities for Effluent Guidelines Annual Review Reports.
C. What are the current standards for small manufacturers and processors?
In 1988, EPA established the general TSCA section 8(a) small manufacturer definition for use in other rules issued under TSCA section 8(a), which are codified at 40 CFR 704.3. These are the current standards that apply to CDR:
Small manufacturer or importer means a manufacturer or importer that meets either of the following standards:
1. First standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $40 million. However, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer or importer is greater than 45,400 kilograms (100,000 pounds), the manufacturer or importer shall not qualify as small for purposes of reporting on the production or importation of that substance at that site, unless the manufacturer or importer qualifies as small under standard (2) of this definition.
2. Second standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of substances produced or imported by that manufacturer or importer.
3. Inflation index. EPA must use the Producer Price Index for Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor Statistics, for purposes of determining the need to adjust the total annual sales values and for determining new sales values when adjustments are made
than $4 million, regardless of the quantity of substances produced or imported by that manufacturer or importer.
3. Inflation index. EPA must use the Producer Price Index for Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor Statistics, for purposes of determining the need to adjust the total annual sales values and for determining new sales values when adjustments are made. EPA may adjust the total annual sales values whenever the Agency deems it necessary to do so, provided that the Producer Price Index for Chemicals and Allied Products has changed more than 20 percent since either the most recent previous change in sales values or the date of promulgation of the rule ( i.e., 40 CFR 704), whichever is later. EPA shall provide Federal Register notification when changing the total annual sales values.
Pursuant to authority under TSCA section 8(a)(3)(B), certain TSCA section 8(a) rules codify slight variations of the general TSCA section 8(a) small manufacturer definition at 40 CFR 704.3 (see, e.g., 40 CFR 704.45). There is no general small processor standard, and EPA is not proposing one in this action. However, other rules issued under TSCA section 8(a) establish analogous standards for small processors in those particular rules. See Unit IV.A. for additional discussion.
III. Detailed Discussion of the Proposed Modifications to CDR
A. Changes to Claiming Confidentiality
EPA is proposing changes to requirements related to claiming CDR data as confidential to be consistent with the new statutory requirements in TSCA section 14. TSCA requires the Agency to review and make determinations regarding the validity of confidential claims for information submitted to EPA. EPA estimates that this proposed change would result in a decrease in burden, which is explained in detail in Table 4-14 in the Economic Analysis (Ref. 4)
claiming CDR data as confidential to be consistent with the new statutory requirements in TSCA section 14. TSCA requires the Agency to review and make determinations regarding the validity of confidential claims for information submitted to EPA. EPA estimates that this proposed change would result in a decrease in burden, which is explained in detail in Table 4-14 in the Economic Analysis (Ref. 4).
New statutory provisions that are pertinent to reporting under CDR include the following:
• Under TSCA section 14(c)(3), all claims of confidentiality must be substantiated at the time the information is submitted to EPA, except for those types of information exempt under TSCA section 14(c)(2).
• The submitter must provide a statement supporting the claim, as described in TSCA section 14(c)(1)(B) and must certify that the statement is true and correct, as described in TSCA section 14(c)(5).
• TSCA section 14(b)(3)(B) limits confidentiality claims for reported use information that customarily would be shared with the general public or within an industry or industry sector.
• Under TSCA section 14(e)(1)(B), confidentiality claims on information not described in TSCA section 14(c)(2) expire after ten years, unless a request for extension is submitted and granted.
The proposed amendments to the CDR rule address these new provisions, with the exception of the TSCA section 14(e)(1)(B) CBI expiration provision which while it will impact all TSCA submissions filed after June 22, 2016 does not distinctively impact the CDR data collections.
This preamble discussion also includes information about other provisions of TSCA relating to actions EPA must take, but that do not impact the regulatory text or require specific submitter actions.
1. Substantiations. EPA interprets TSCA section 14(c)(3) as requiring substantiations of non-exempt CBI claims at the time the information claimed as CBI is submitted to EPA (82 FR 6522, January 19, 2017)
preamble discussion also includes information about other provisions of TSCA relating to actions EPA must take, but that do not impact the regulatory text or require specific submitter actions.
1. Substantiations. EPA interprets TSCA section 14(c)(3) as requiring substantiations of non-exempt CBI claims at the time the information claimed as CBI is submitted to EPA (82 FR 6522, January 19, 2017). The Agency is proposing to amend the CDR substantiation provisions to require substantiation for all confidentiality claims except for those types of information exempt from substantiation under TSCA section 14(c)(2), which are described later in this unit. Submission of substantiations at the time of assertion of confidentiality enables EPA to fulfill its obligation under TSCA section 14(g) to review all confidentiality claims for specific chemical identity, plus a representative subset (comprising at least 25 percent) of all other non-exempt confidentiality claims.
EPA is proposing revisions to the current substantiation questions in 40 CFR 711.30 and the addition of new substantiation questions to address data elements which, prior to amended TSCA, did not require substantiation at the time of submission. The questions are in the proposed regulatory text at the end of this notice. In addition, Appendix B of the CDR Revisions EA (Ref. 4) provides a summary of the questions prior to the 2016 TSCA Amendments and those that are being proposed in this action (Ref. 4). These questions would facilitate the Agency's implementation of TSCA section 14 and the requirement to review and approve, approve in part, deny in part, or fully deny requests for confidentiality
d of this notice. In addition, Appendix B of the CDR Revisions EA (Ref. 4) provides a summary of the questions prior to the 2016 TSCA Amendments and those that are being proposed in this action (Ref. 4). These questions would facilitate the Agency's implementation of TSCA section 14 and the requirement to review and approve, approve in part, deny in part, or fully deny requests for confidentiality. These CDR-specific questions are designed to encourage thoughtful consideration of the need for confidential treatment, improve the consistency of EPA's review of the responses, and reduce the need for multiple discussions between EPA and the submitter regarding the substantiations that may otherwise hinder the Agency's ability to timely fulfill its review obligations under TSCA.
The questions have been carefully drafted to elicit the required information to allow for a CBI review and determination, without imposing an unnecessary burden. A set of standard questions, set forth in proposed 40 CFR 711.30(b), would apply to all non-exempt CBI claims. These questions generally ask about the impact of disclosure on the submitter's competitive position, whether the information has been made available to others, and the controls used to protect the confidential information. These are similar in concept to questions under the current CDR at 40 CFR 711.30. Additional questions are targeted to specific data elements. For chemical substance identity confidentiality claims, the additional substantiation questions, set forth in proposed 40 CFR 711.30(c), are substantively the same as exist under the current CDR at 40 CFR 711.30(b). An additional question for company, site, and technical contact identity is set forth in proposed 40 CFR 711.30(d). Although substantively the same as exists for site identity substantiations in the current CDR at 40 CFR 711.30(c), it is newly applied to company name and technical contact confidentiality claims
1.30(c), are substantively the same as exist under the current CDR at 40 CFR 711.30(b). An additional question for company, site, and technical contact identity is set forth in proposed 40 CFR 711.30(d). Although substantively the same as exists for site identity substantiations in the current CDR at 40 CFR 711.30(c), it is newly applied to company name and technical contact confidentiality claims. Additional questions for processing and use information are set forth in proposed 40 CFR 711.30(e) and are substantively the same as exist in the current CDR at 40 CFR 711.30(d).
a. Exceptions to the substantiation requirements. TSCA section 14(c)(2) identifies certain information that shall not be subject to substantiation requirements under this rule. This includes:
• Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article;
• Marketing and sales information;
• Information identifying a supplier or customer;
• In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents;
• Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article;
• Specific production or import volumes of the manufacturer or processor; and
• Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA section 5
ical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA section 5.
EPA believes that the only data elements collected under CDR that may be subject to the TSCA section 14(c)(2) limit on substantiation requirements are: (1) Production volume and (2) supplier information associated with joint submissions, such as supplier identity and details of the full composition of a mixture. However, these two data elements may still be subject to substantiation and CBI review under the circumstances described in TSCA section 14(f).
i. Regarding production volume. EPA is proposing to not require substantiation at the time the claim of confidentiality is made for five production volume data elements ( e.g., the volume domestically manufactured in 2019, the volume imported in 2019, and the total production volume for each of the three years 2016 through 2018). For each reported chemical, total production volume is reported for each of the years since the last principal reporting year, except for the current principal reporting year when the production volume is reported as domestically manufactured and imported volumes. As an example, for the 2020 CDR submission period, production volume is collected for the calendar years 2016, 2017, and 2018. For calendar year 2019, the production volume is reported as domestically manufactured and imported volumes. EPA believes that these five data elements are exactly the kinds of specific production or import volumes identified in TSCA section 14(c)(2)(F).
ii. Regarding information associated with a joint submission. Joint
A joint submission is a submission started by a primary submitter, typically an importer
ar 2019, the production volume is reported as domestically manufactured and imported volumes. EPA believes that these five data elements are exactly the kinds of specific production or import volumes identified in TSCA section 14(c)(2)(F).
ii. Regarding information associated with a joint submission. Joint
A joint submission is a submission started by a primary submitter, typically an importer. The primary submitter provides the trade name of the subject chemical substance or mixture, the name and address of the supplier, and other information as appropriate. Given the requirements of amended TSCA, EPA proposes to require that the primary submitter identify whether the supplier information, including the supplier identity and chemical substance name (trade name) is confidential. Substantiation of the confidentiality claims for this information is not required at the time of submission under the proposed rule because EPA believes it is exempt from substantiation as “[i]nformation identifying a supplier” under TSCA section 14(c)(2)(C).
The secondary submitter of the joint submission provides their company name and location, a technical contact, trade name, and chemical identity(ies) and percentage of each chemical substance in the composition of the substance or mixture represented by the trade name. In addition, as explained in Unit III.B.5., EPA proposes to collect the function of each chemical in the mixture. Given the requirements of amended TSCA, EPA is proposing to provide the ability for the secondary submitter to specifically identify whether this information is claimed as confidential. Except for the percentage composition information, which is generally exempt from substantiation pursuant to TSCA section 14(c)(2)(D), all other reported data elements are subject to substantiation at the time the information is submitted.
b. Chemical identity. Only chemical substances listed on the confidential portion of the TSCA Inventory (the Inventory) can be claimed as confidential
ential. Except for the percentage composition information, which is generally exempt from substantiation pursuant to TSCA section 14(c)(2)(D), all other reported data elements are subject to substantiation at the time the information is submitted.
b. Chemical identity. Only chemical substances listed on the confidential portion of the TSCA Inventory (the Inventory) can be claimed as confidential. This provision is not new and is reflected in the current CDR rule at 40 CFR 711.30(b). Such a confidentiality claim applies to the specific identity of the chemical substance as it is listed on the confidential portion of the Inventory. CDR reported chemical identities, including generic chemical names, that are listed on the public portion of the Inventory cannot be claimed as confidential and would be made publicly available. EPA included this discussion for clarification purposes only and is not proposing any changes to this approach.
c. Connection between company, site, or technical contact identity and chemical-specific information. EPA is proposing to require assertion and substantiation of a claim of confidentiality at the time of submission, on a chemical-specific basis, for the linkage between company or technical contact identity and chemical substance information. This is the same as is currently required under 40 CFR 711.30(c) for site identity, when on a chemical-specific basis, one must claim the linkage between the site identity and the chemical substance information as confidential by asserting and substantiating the claim at the time of submission. There would likely be instances where a confidentiality claim for a company name would not be appropriate, but one for site identity or technical contact might be appropriate.
d. Benefits of proposed changes to CBI substantiation
claim the linkage between the site identity and the chemical substance information as confidential by asserting and substantiating the claim at the time of submission. There would likely be instances where a confidentiality claim for a company name would not be appropriate, but one for site identity or technical contact might be appropriate.
d. Benefits of proposed changes to CBI substantiation. The reduced amount of information subject to confidentiality limitations will facilitate greater interagency and public sharing of data and will decrease the number of inappropriate or unnecessary claims of confidentiality, which will increase the transparency and public accessibility of the CDR. Clarification of which data elements can be claimed as confidential will improve the consistency of EPA's review of CBI substantiation information and will decrease the need for multiple conversations between EPA and reporters about substantiation responses, thus reducing burden for the Agency and for reporters.
2. Certification. The authorized official submitting confidentiality claims must certify all claims for confidentiality are true and correct, and all information submitted to substantiate such claims is true and correct. As required by TSCA sections 14(c)(1)(B) and 14(c)(5). EPA combined these requirements into a single certification statement, which was implemented in the CDR electronic reporting tool in June 2016. EPA is proposing to codify the language of the certification statement in the CDR rule (see the proposed regulatory text for 40 CFR 711.30(h)).
3. Processing and use data not protected from disclosure
s required by TSCA sections 14(c)(1)(B) and 14(c)(5). EPA combined these requirements into a single certification statement, which was implemented in the CDR electronic reporting tool in June 2016. EPA is proposing to codify the language of the certification statement in the CDR rule (see the proposed regulatory text for 40 CFR 711.30(h)).
3. Processing and use data not protected from disclosure. TSCA section 14(b)(3)(B), as amended by the 2016 Amendments, prohibits confidentiality claims for the following submitted information: “a general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector.”
This statutory provision directly impacts and limits confidentiality claims for certain CDR processing and use data. Thus, EPA proposes to codify in the regulatory text that the following data elements cannot be claimed as confidential because they constitute general descriptions of processes and uses that customarily would be shared with the general public or within an industry or industry sector:
• Certain Industrial processing and use data elements. The data elements which directly relate to how the chemical is used or processed, i.e., the type of process or use; the industrial sector; and the industrial function (40 CFR 711.15(b)(4)(i)(A), (B), and (C)).
• Certain Consumer and Commercial use data elements
uld be shared with the general public or within an industry or industry sector:
• Certain Industrial processing and use data elements. The data elements which directly relate to how the chemical is used or processed, i.e., the type of process or use; the industrial sector; and the industrial function (40 CFR 711.15(b)(4)(i)(A), (B), and (C)).
• Certain Consumer and Commercial use data elements. The data elements which directly relate to how the chemical is used, i.e., the product category (§ 711.15(b)(4)(ii)(A)); whether the chemical is used in commercial or consumer products (§ 711.15(b)(4)(ii)(B)); whether the chemical is likely to be used in children's products (§ 711.15(b)(4)(ii)(C)); and the function of the chemical in the consumer or commercial product (the function is a proposed data element—see Unit III.B.5. for additional information).
For the purposes of this proposal, EPA believes that other CDR processing and use data elements do not offer a “general description” and therefore do not fall within the limits of TSCA section 14(b)(3)(B). Under this proposal, submitters may continue to assert claims of confidentiality for the following processing and use data elements:
• Certain Industrial Processing and use data elements. Percent production volume, number of sites, and number of workers (§ 711.15(b)(4)(i)(D), (E), and (F)).
• Certain Consumer and Commercial use data elements. Percent production volume, maximum concentration, and number of commercial workers (§ 711.15(b)(4)(ii)(D), (E), and (F)).
4. Time duration of confidentiality claims. In accordance with TSCA section 14(e)(1)(B), non-exempt confidentiality claims are initially protected from disclosure for a period of 10 years from the date of submission and confidentiality assertion, assuming all other relevant requirements of the statute are met. Information on confidential business information under TSCA is available on EPA's website at https://www.epa.gov/tsca-cbi
ty claims. In accordance with TSCA section 14(e)(1)(B), non-exempt confidentiality claims are initially protected from disclosure for a period of 10 years from the date of submission and confidentiality assertion, assuming all other relevant requirements of the statute are met. Information on confidential business information under TSCA is available on EPA's website at https://www.epa.gov/tsca-cbi. One of the proposed new substantiation questions asks whether the submitter anticipates that the claim's duration would last less than the 10-year statutory time frame. Respondents would indicate when the claim would no longer be needed, and EPA would incorporate the release date into its data system, enabling the information to be made publicly available at that time.
B. Modifications to Reportable Data Elements
1. Processing and use codes. The CDR rule requires manufacturers to report industrial, consumer, and commercial processing and use information for chemical substances manufactured during the principal reporting year. EPA is proposing multiple changes to the data elements comprising this processing and use information. Specifically, EPA is proposing to replace the CDR industrial function and commercial/consumer product use codes with OECD function, product, and article use categories and to add OECD function categories for commercial/consumer products. EPA is listing these codes in the CDR instructions, rather than codifying them in the CFR, which would enable EPA to limit the codes to just those considered relevant for CDR reporting, with a catch-all “non-TSCA” code for the OECD codes that do not fit under TSCA. EPA would then be able to update the Instructions prior to each CDR submission period to align with any changes to the OECD codes.
EPA did not develop burden estimates associated with replacing the current CDR codes with ones based on the OECD codes because such an estimate heavily relies on the e-CDRweb user interface which will feature burden-reducing guided data entry
t do not fit under TSCA. EPA would then be able to update the Instructions prior to each CDR submission period to align with any changes to the OECD codes.
EPA did not develop burden estimates associated with replacing the current CDR codes with ones based on the OECD codes because such an estimate heavily relies on the e-CDRweb user interface which will feature burden-reducing guided data entry. The addition of the function categories for commercial/consumer products is a new data element whose addition could potentially result in an increase in burden (not estimated at this time). For additional information, see section 4.1.3.2 in the Economic Analysis (Ref. 4).
The OECD Internationally Harmonized Functional, Product, and Article Use Categories were developed through the OECD Working Party on Exposure Assessment (Task Force on Exposure Assessment) under the leadership of the EPA, based on a review of current functional use and product categories from the United States, Canada, and the European Union; bilateral discussions with the European Chemicals Agency (ECHA); and multiple reviews from task force members. The OECD categories are described in the document “Internationally Harmonised Functional, Product and Article Use Categories” (referred to herein as the OECD Category Document) (Ref. 8).
Harmonizing CDR use codes with the OECD codes would expand the utilization of applicable use and exposure-related information from international sources to support EPA risk evaluation and risk assessment activities for new and existing chemicals. Additionally, this harmonization would provide industry with international uniformity in use and exposure information reporting, enabling industry to better streamline their different country-specific reporting requirements.
EPA has received requests to harmonize CDR data categories and descriptions with other countries to the extent possible
assessment activities for new and existing chemicals. Additionally, this harmonization would provide industry with international uniformity in use and exposure information reporting, enabling industry to better streamline their different country-specific reporting requirements.
EPA has received requests to harmonize CDR data categories and descriptions with other countries to the extent possible. In particular, industry stakeholder groups such as the American Chemistry Council have expressed a desire to harmonize with Canadian and OECD data collections in order to provide common global terminology and preciseness in risk evaluation (Ref. 9). EPA worked closely with Canada in the development of the current CDR processing and use codes, and both EPA and Canada were involved in the development of the OECD Harmonized codes.
Under CDR, there are two main categories of use codes: Function use codes and product use codes. The function of a chemical combined with the type of product that the chemical is used in provides an exposure scenario with unique characteristics. These exposure scenarios are necessary for implementation of TSCA for the prioritization of the chemical and for further consideration for the development of exposure and risk evaluations.
a. Function codes (industrial and consumer/commercial). EPA currently requires the reporting of function categories for chemical substances used in industrial products but does not require the reporting of a chemical substance's function for commercial/consumer products. EPA is proposing to require reporting of function use categories for both industrial and commercial/consumer products and to adopt the OECD functional use categories.
Function codes are based on the intended physical or chemical characteristic for when a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, or article; repackaged; or used ( e.g., as an abrasive, a catalyst, or an elasticizer)
ries for both industrial and commercial/consumer products and to adopt the OECD functional use categories.
Function codes are based on the intended physical or chemical characteristic for when a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, or article; repackaged; or used ( e.g., as an abrasive, a catalyst, or an elasticizer). EPA uses information regarding the function of a chemical substance in combination with the industrial sector and processing or use operation to identify an exposure scenario or the type of application in which a chemical would be used (such as solvents for cleaning and degreasing). Understanding the exposure scenarios or the type of application of the chemical would inform assessment of the potential route, duration, frequency and magnitude of exposure.
During screening and risk evaluation activities, EPA evaluates how the chemical substance is manufactured, processed, distributed in commerce, used, and disposed of. Currently, CDR requires the reporting of consumer and commercial product categories but does not require the reporting of chemical function within the product category. The lack of functional use information for consumer and commercial applications has restricted EPA's ability to provide more complete evaluations or more realistic characterizations of exposure for consumer and commercial applications; instead, EPA relies in many cases on scenarios using potentially conservative assumptions. (Ref. 10) The addition of information on the function of the chemical in combination with the consumer or commercial product category would improve EPA's ability to consider exposures to consumers and in commercial applications, providing a more accurate and real-world understanding of the uses of chemical substances throughout their life cycle
scenarios using potentially conservative assumptions. (Ref. 10) The addition of information on the function of the chemical in combination with the consumer or commercial product category would improve EPA's ability to consider exposures to consumers and in commercial applications, providing a more accurate and real-world understanding of the uses of chemical substances throughout their life cycle.
As explained in the OECD Category Document, the OECD product and article use categories are intended to focus on the end-use application of chemicals within products and articles, rather than upstream manufacturing and processing. However, the functional use categories cover the life cycle and describe the specific function that a chemical provides when used in the formulation of a product or article, or when used within an industrial process. While the function of a chemical may be the same across its life cycle, certain functions may only be appropriate for consideration in an industrial setting,
Adopting the OECD functional use codes would provide greater detail by expanding the function categories from the 35 codes currently used by CDR to 117 codes. For example, the broad current CDR category Adhesives and Sealants corresponds to four categories under the OECD harmonized codes in this proposal: Adhesion/Cohesion Promoters, Binders, Flux Agents, and Sealants (Barrier). In this proposed rule, not all of the OECD harmonized codes would be adopted to CDR because some are for uses not covered by TSCA ( e.g., in the circumstances where, because of a chemical's particular use, it is not a “chemical substance” under TSCA section 3(2)(B)(vi)). The current CDR codes contain a catch-all “non-TSCA code” for uses that are not covered under TSCA
ents, and Sealants (Barrier). In this proposed rule, not all of the OECD harmonized codes would be adopted to CDR because some are for uses not covered by TSCA ( e.g., in the circumstances where, because of a chemical's particular use, it is not a “chemical substance” under TSCA section 3(2)(B)(vi)). The current CDR codes contain a catch-all “non-TSCA code” for uses that are not covered under TSCA. Under this proposed rule, EPA would continue to provide the same non-TSCA code as a blanket code for these applications, such as for a food or cosmetic (other than soap), when the chemical is reportable to CDR because the chemical is also used in a way that falls under the jurisdiction of TSCA. EPA is interested in receiving comments on whether all of the OECD harmonized codes should be listed so that the codes are an exact match, even if the uses are not covered by TSCA. Would the exact match make it easier for submitters to report information under CDR and other reporting requirements using the OECD harmonized codes?
EPA is listing these codes in the CDR instructions discussed in Unit III.B.1. Additional details about the proposed function categories, how they are related to the OECD functional use categories, and a crosswalk with the current CDR function codes are in the supplemental document Technical Support Document: Harmonizing CDR Functional and Product codes with OECD Functional, Product, and Article Codes (Ref. 11).
b. Commercial/consumer product codes. CDR currently requires the reporting of product category codes for manufactured chemical substances that have consumer or commercial uses. The current product codes consist of both article and other non-article products; they correlate to the OECD Product and Article Use Categories described in the OECD Category document (Ref. 8)
and Article Codes (Ref. 11).
b. Commercial/consumer product codes. CDR currently requires the reporting of product category codes for manufactured chemical substances that have consumer or commercial uses. The current product codes consist of both article and other non-article products; they correlate to the OECD Product and Article Use Categories described in the OECD Category document (Ref. 8). The OECD Category document uses the term “product” to mean consumable liquids, aerosols, semi-solids, or solids that are used a given number of times before they are depleted and the term “articles” to generally mean solids, polymers, foams, metals, and woods, all of which are always present within indoor environments for the duration of their useful life, which may be several years (Ref. 8). These terms were developed for the OECD Category document because, for the purposes of exposure assessment, products and articles are treated differently. Formulations, anticipated use patterns, and available approaches to estimate exposure are different, and certain chemicals may only be added to articles, others only used to formulate products, and others could be used for both. Because of these differences, OECD provides separate lists of product and article use categories. EPA is proposing to adopt the OECD codes and to consolidate the separate OECD lists into one list to be consistent with the current CDR approach of listing the article and other non-article products in one list of CDR Product Categories.
CDR product categories are broader than the OECD categories. Using the OECD categories would provide a specificity that would be more helpful to EPA in carrying out its responsibilities under TSCA. For example, a broad CDR category is Fuels and Related Products, which, under the OECD product codes, is divided into three categories: Cooking and Heating Fuels, Fuel Additives, and Vehicular or Appliance Fuels (Ref. 11)
ies are broader than the OECD categories. Using the OECD categories would provide a specificity that would be more helpful to EPA in carrying out its responsibilities under TSCA. For example, a broad CDR category is Fuels and Related Products, which, under the OECD product codes, is divided into three categories: Cooking and Heating Fuels, Fuel Additives, and Vehicular or Appliance Fuels (Ref. 11). Under this proposal, the current 33 consumer/commercial product categories would be replaced by 98 categories. For a listing of the proposed product categories, see Appendix D of the Instructions for Reporting (Ref. 12). Under TSCA, the definition of “chemical substance” excludes certain uses such as pesticide, tobacco, food, and other specifically listed uses. Some of the OECD harmonized product categories cover the TSCA-excluded uses; those particular codes were not adopted in CDR. The current CDR codes contain a catch-all “non-TSCA code” for uses that are not covered under TSCA. Under this proposed rule, EPA would continue to provide the same “non-TSCA” code as a blanket code for these applications. EPA is interested in receiving comments on whether all of the OECD harmonized codes should be listed, even if the uses are not covered by TSCA, to make it easier for submitters to report information under CDR and in response to other reporting requirements using the OECD harmonized codes. Additional details about the proposed product categories, how they are related to the OECD product and article categories, and a crosswalk with the current CDR product codes are in the supplemental document Technical Support Document: Harmonizing CDR Functional and Product codes with OECD Functional, Product, and Article Codes (Ref. 11).
2. NAICS codes for manufacturers. EPA is proposing to require submitters to report the 6-digit NAICS code that best describes the manufacturing activities conducted at the reporting site
crosswalk with the current CDR product codes are in the supplemental document Technical Support Document: Harmonizing CDR Functional and Product codes with OECD Functional, Product, and Article Codes (Ref. 11).
2. NAICS codes for manufacturers. EPA is proposing to require submitters to report the 6-digit NAICS code that best describes the manufacturing activities conducted at the reporting site. The NAICS was developed under the direction and guidance of the Office of Management and Budget (OMB) as the standard for use by Federal statistical agencies in classifying business establishments for the collection, tabulation, presentation, and analysis of statistical data. NAICS is based on a production-oriented concept, meaning that it groups establishments into industries according to similarity in the processes used to produce goods or services (62 FR 17288). Use of the standard provides uniformity and comparability in the presentation and understanding of data. EPA estimates that this proposed change would result in a slight increase in burden, which is explained in detail in Table 4-11 in the Economic Analysis (Ref. 4).
EPA would use the NAICS code information in its analysis of the reported manufacturing-related information to better analyze the data by industry sector. EPA's insight into particular industry sectors has been limited without this particular data element. For example, during the 2017 negotiated rulemaking, participants asked EPA to analyze specific industries to determine if there was overlap in reporting among different Agency programs and to determine if EPA could trace the life cycle of some chemical substances from their manufacture through their use and to their disposal (Refs. 13 and 14). NAICS codes would have better enabled EPA to fulfill the requests because many other EPA programs, such as the Toxics Release Inventory (TRI), require the reporting of NAICS codes
re was overlap in reporting among different Agency programs and to determine if EPA could trace the life cycle of some chemical substances from their manufacture through their use and to their disposal (Refs. 13 and 14). NAICS codes would have better enabled EPA to fulfill the requests because many other EPA programs, such as the Toxics Release Inventory (TRI), require the reporting of NAICS codes. By adding the site's NAICS code as a required data element for CDR, EPA would be better able to use information from CDR in conjunction with TRI data to support implementation of TSCA.
Because reporting under CDR is done by the site that is conducting the manufacturing activity, the site is expected to be sufficiently knowledgeable to be able to determine the appropriate NAICS code. EPA believes sites would be able to identify a single NAICS code per site; however, the Agency is interested in comments on whether the CDR reporting tool should enable the reporting of multiple NAICS codes based on each chemical substance, similar to how the technical contact is reported.
a. Relationship to processing and use industrial sector codes. For processing and use information, often conducted at sites other than the manufacturing site, submitters currently report an industrial sector (IS) code instead of the NAICS codes. The IS codes divide the entire range of NAICS codes into sectors such that there is a sector corresponding to any NAICS code. Initially, submitters reported NAICS codes when describing the industrial processing and use of their reported chemicals. In the 2011 Inventory Update Reporting (IUR) Modifications final rule, EPA replaced the NAICS codes with the industrial sector codes. (76 FR 50816, August 16, 2011; EPA-HQ-OPPT-2009-0187-0393). Respondents to the 2006 IUR, the predecessor to the CDR, submitted 342 unique 5-digit NAICS codes. So many codes made it difficult for EPA to group chemical substances based on industrial processing and use scenarios
1 Inventory Update Reporting (IUR) Modifications final rule, EPA replaced the NAICS codes with the industrial sector codes. (76 FR 50816, August 16, 2011; EPA-HQ-OPPT-2009-0187-0393). Respondents to the 2006 IUR, the predecessor to the CDR, submitted 342 unique 5-digit NAICS codes. So many codes made it difficult for EPA to group chemical substances based on industrial processing and use scenarios. In all, the 2006 IUR database has 2,330 unique combinations of processing or use codes, NAICS codes, and industrial function categories. This large number of unique combinations increased the difficulty and time required by EPA to sort and classify chemical substances because EPA either would need to develop exposure scenarios for each unique combination or determine the three-code combinations that have similar exposure scenarios and can be grouped. The use of the IS codes for the 2012 and subsequent CDR reporting cycles has reduced the number of unique combinations, thereby increasing the usability of the data and reducing the associated reporting burden.
EPA believes that the manufacturing of chemicals incorporates a narrower range of NAICS codes than the processing and use of chemicals. Therefore, identifying the more specific NAICS code for the manufacturing site is not expected to result in the large number of combinations experienced in 2006 for the processing and use information.
b. Improving outreach and reporting assistance. EPA would also use the NAICS codes to improve outreach and reporting assistance for manufacturers in specific industry sectors. For the 2016 submission period, EPA developed industry sector-specific Fact Sheets for the printed circuit board, metal mining, and electricity-generating sectors (Refs. 15, 16, and 17). Each Fact Sheet addressed reporting requirements specific to that industry, including the use of specific and unique examples designed to better illustrate the sector's reporting requirements
fic industry sectors. For the 2016 submission period, EPA developed industry sector-specific Fact Sheets for the printed circuit board, metal mining, and electricity-generating sectors (Refs. 15, 16, and 17). Each Fact Sheet addressed reporting requirements specific to that industry, including the use of specific and unique examples designed to better illustrate the sector's reporting requirements. EPA expects to continue this practice for other industries, and having NAICS codes available in the CDR dataset would facilitate expansion of this outreach.
3. Modifying recycled information. Currently, CDR submitters identify whether their reportable chemical substance is 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. EPA is proposing to modify this data element by removing the terms “remanufactured, reprocessed, reused” as this may be interpreted and applied too broadly to obtain the information of interest for this collection. These terms are also not necessarily synonymous with “recycle” in all scenarios. It is EPA's intention that this data element identify the chemical substances that would otherwise be disposed of as a waste, and EPA believes the revised phrase “recycled or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream” best describes this intention. This proposed change is also intended to reduce confusion, and thus burden, and provide greater specificity as to what this data element requires. For example, the term “reused” might cause the site to consider the need to report other chemical substances that it simply purchased and used if the site found a way to reuse that substance. Such reporting would be erroneous, because a site is only required to report a substance that it manufactures, not that it has merely purchased
ovide greater specificity as to what this data element requires. For example, the term “reused” might cause the site to consider the need to report other chemical substances that it simply purchased and used if the site found a way to reuse that substance. Such reporting would be erroneous, because a site is only required to report a substance that it manufactures, not that it has merely purchased. However, if a manufactured (including imported) substance is reused instead of being disposed of as a waste, then that would be reported. EPA does not anticipate a change in burden associated with this proposed change. See section 4.1.3 of the Economic Analysis for additional information (Ref. 4). EPA is soliciting public comments on modifying this data element to better capture recycling in CDR.
EPA is soliciting comment on whether submitters should identify the percentage of total production volume of their chemical substance that is recycled instead of only designating whether recycling occurred, the burden associated with providing such an estimate, and any difficulties industry might encounter in estimating such a percentage (either to the nearest 10 percent or more accurately). EPA believes that the percent production volume for a chemical substance that is being recycled or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream would be information relevant to the exposure profile of a chemical substance and indicates efficiencies within the chemical manufacturing industry. EPA is interested in the exposures from these activities. In addition, information about whether certain types of industries recycle or whether certain types of chemicals are recycled and if such recycling is increasing or decreasing provides information about changes in the manufacturing environment that inform EPA's TSCA activities
dicates efficiencies within the chemical manufacturing industry. EPA is interested in the exposures from these activities. In addition, information about whether certain types of industries recycle or whether certain types of chemicals are recycled and if such recycling is increasing or decreasing provides information about changes in the manufacturing environment that inform EPA's TSCA activities. Collecting specific percentages about recycling could give EPA a better understanding of the recycling reporting universe and provide EPA the opportunity to grant more targeted reporting exemptions and burden reduction activities in future reporting cycles.
4. Percent byproduct. EPA is proposing to add the requirement to report the percent total production volume for a chemical substance that is a byproduct. EPA believes this data element would provide information to better understand the manufacturing of byproduct chemical substances and the impact of current or potential future exemptions to reporting. EPA is interested in this change in order to increase transparency by identifying important submitter subpopulations and their representations in CDR with respect to production volume. EPA estimates that this proposed change would result in an increase in burden, which is explained in detail in Table 4-11 in the Economic Analysis (Ref. 4).
Information about byproduct reporting has been of particular interest due to requirements of the 2016 amendments to TSCA to conduct a negotiated rulemaking for manufacturers of inorganic byproducts. During the deliberations of the negotiated rulemaking committee, EPA was unable to specifically identify, from the CDR data, chemical substances manufactured as byproducts or byproduct manufacturers who would be impacted by changes to the reporting requirements. With the addition of this data element, EPA will be able to identify those manufacturers that recycle portions of their substances or only report to CDR due to their byproduct production
king committee, EPA was unable to specifically identify, from the CDR data, chemical substances manufactured as byproducts or byproduct manufacturers who would be impacted by changes to the reporting requirements. With the addition of this data element, EPA will be able to identify those manufacturers that recycle portions of their substances or only report to CDR due to their byproduct production. EPA would consequently be better able to understand a larger spectrum of potential exposure scenarios, by improving understanding of the connection between manufacturing and downstream activities for the purposes of substance life cycle assessments and risk evaluation. In addition, EPA would use this information to inform future decisions about potential changes to CDR requirements.
There are situations where the same chemical substance is manufactured both as a primary chemical substance and a byproduct. While this is rare, it is a known occurrence. For example, when commercial stearic acid is manufactured, it is known to contain significant amounts of palmitic acid and oleic acid as byproducts. Such a producer would also be likely to separately manufacture palmitic acid and/or oleic acid as primary chemical products. In this situation, if the palmitic acid that is manufactured as a byproduct is used for a reportable commercial purpose, its volume would be reported along with the volume of palmitic acid that is separately manufactured at the same site and its volume would be counted as the byproduct portion when calculating the percent manufactured as a byproduct. It is important to recognize that an overproduction of the primary manufactured substance does not meet the regulatory definition of a byproduct, and thus is not considered a byproduct for the purposes of CDR, and should not be counted as such when calculating the percent manufactured for this data element.
Reporting in percentages
ortion when calculating the percent manufactured as a byproduct. It is important to recognize that an overproduction of the primary manufactured substance does not meet the regulatory definition of a byproduct, and thus is not considered a byproduct for the purposes of CDR, and should not be counted as such when calculating the percent manufactured for this data element.
Reporting in percentages. As with other percentage production volume reporting requirements in the CDR regulation, EPA is proposing to require that the percentages for the percent byproduct be rounded to the nearest 10 percent, unless the percentage is less than 5 percent. EPA would allow the reporting of more specific percent production volumes. In situations where the percentages account for less than 5 percent of the submitter's total production volume for the reportable chemical substance, the submitter would not round off to zero if the production volume attributable to that amount is greater than or equal to 25,000 lbs. (or in an amount of 2,500 lbs. or more for chemical substances subject to the rules, orders, or actions described in § 711.8(b)). In such cases, submitters would report the percentage of production volume attributable to that portion to the nearest 1 percent of production volume. This exception to the general rounding off rule is being proposed to differentiate situations where no portion or a very low portion of the chemical substance is a byproduct, to ensure that adequate manufacturing information would be reported for the larger production volume chemical substances. The 25,000 lbs. (or 2,500 lbs.) level was selected for consistency with the current threshold for reporting under CDR. EPA is interested in receiving comment on whether reporting the percent production volume to the nearest 10 percent or 1 percent for 5 percent or below is a lower burden than simply reporting to the nearest 1 percent for any percentage
larger production volume chemical substances. The 25,000 lbs. (or 2,500 lbs.) level was selected for consistency with the current threshold for reporting under CDR. EPA is interested in receiving comment on whether reporting the percent production volume to the nearest 10 percent or 1 percent for 5 percent or below is a lower burden than simply reporting to the nearest 1 percent for any percentage. EPA is interested in the difficulty that industry might encounter in estimating a percentage rounded to the nearest ten percent or a more accurate percentage of byproduct that is produced in the manufacturing process and what challenges industry may encounter in calculating this estimate. EPA is also interested in the burden estimate associated with calculating this data element. EPA is also interested in receiving general comment on the reporting requirements in this proposed rule, including on the effort required by a submitter to provide the percent production volume that is a byproduct.
5. Chemical specific function for imported mixtures. EPA is proposing to require the secondary submitter of a joint submission to report the chemical-specific function along with information on chemical composition of the imported product or mixture. A joint submission is most typically used when a substance or a mixture is imported and the supplier does not provide to the importer the specific chemical identity of the substance or substances that comprise the mixture. See Unit III.A. for additional information about joint submissions. Currently, the importer identifies the function of the imported product. In some circumstances, the function of the imported product can be correctly applied to the specific chemical substance. However, in the circumstance where the imported product is a multi-component mixture, applying the function of the imported product to each component of the mixture can result in identifying a function for an individual chemical substance that is not appropriate
mported product. In some circumstances, the function of the imported product can be correctly applied to the specific chemical substance. However, in the circumstance where the imported product is a multi-component mixture, applying the function of the imported product to each component of the mixture can result in identifying a function for an individual chemical substance that is not appropriate. For example, a dye or a fragrance that is part of a cleaning mixture should not be identified as a cleaner, but rather as a dye or a fragrance. Providing the appropriate function for the component of the mixture would inform the assessment process by improving the understanding of the conditions of use for a chemical ( e.g., formulation, use rate, etc.). EPA does not anticipate a change in burden associated with this proposed change because the burden associated with reporting the function of the chemical for the secondary submitter is already captured in the baseline burden. See section 4.1.3 of the Economic Analysis for additional information (Ref. 4).
6. Public contact. EPA is proposing to enable the reporting of a public contact for each CDR submission as a voluntary data element. Currently, a technical contact familiar with the information provided in the form is required to be reported. The public contact would be in addition to the technical contact and would be an individual who may be contacted by the general public with questions related to the publicly available information reported by the company under CDR. This person has been designated by the site or company to handle public inquiries. The addition of a public contact to handle public inquiries is modeled after TRI's approach to the public contact, albeit on a voluntary basis, and would include the contact's name, phone number, and email address. Because the public contact is intended to be made available to the public, this voluntary data element would not be able to be claimed as confidential
ompany to handle public inquiries. The addition of a public contact to handle public inquiries is modeled after TRI's approach to the public contact, albeit on a voluntary basis, and would include the contact's name, phone number, and email address. Because the public contact is intended to be made available to the public, this voluntary data element would not be able to be claimed as confidential. EPA is interested in receiving comment on whether it would be helpful to have a public contact available. EPA estimates that this proposed change would result in a slight increase in burden, which is explained in detail in Table 4-11 in the Economic Analysis (Ref. 4).
Difference between public contact and technical contact. Submitters to CDR are already required to supply, and may claim as confidential, a technical contact(s) who should be a person able to answer technical questions about the reported chemical substance(s). Typically, a person located at the manufacturing site is best able to answer such questions. The public contact, which would be voluntarily reported, is intended to be a more general, public-facing company representative who would be available to answer questions the public might ask the company.
7. Parent company identity. EPA is proposing three changes associated with reporting the parent company under CDR: (1) To add the requirement to report a foreign parent company in addition to reporting the highest-level U.S. parent company when the ultimate parent company is located outside of the United States; (2) to remove the definition of U.S. parent company from 40 CFR 711.3 and replace it with a new definition for parent company; and (3) to add a requirement for reporters to report legal name(s) and to follow a naming convention for providing the parent company name(s), the details of which would be provided in the CDR Instructions (see 40 CFR 711.35)
ompany is located outside of the United States; (2) to remove the definition of U.S. parent company from 40 CFR 711.3 and replace it with a new definition for parent company; and (3) to add a requirement for reporters to report legal name(s) and to follow a naming convention for providing the parent company name(s), the details of which would be provided in the CDR Instructions (see 40 CFR 711.35). As a whole, EPA believes these changes would increase the usefulness of the CDR data by improving consistency in reporting, better enabling EPA to protect information claimed as confidential, and reducing the after-reporting quality control effort for both EPA and
Currently, sites required to report to CDR must report their U.S. parent company, which is defined to mean the highest-level company located in the United States that directly owns at least 50 percent of the voting stock of the manufacturer (see 40 CFR 711.3). The site must report its U.S. parent company name, address, and Dun and Bradstreet D-U-N-S® (D&B) number (see 40 CFR 711.15(b)(2)(i)).
Proposed change to definition of U.S. parent company. EPA is proposing to replace the definition of U.S. parent company from 40 CFR 711.3 with a new definition for parent company that includes both U.S. and foreign parent companies and provides guidelines for different company structures. In developing this definition, EPA considered solely using the definition of “parent company” already found in 40 CFR 704.3, but decided to propose the specifically listed guidelines in the regulatory text for clarity and consistency with other programs. Please review the proposals in the following paragraphs. EPA is requesting comment on this approach.
Proposed reporting of foreign parent company. In some situations, the highest-level parent company is outside of the United States
pany” already found in 40 CFR 704.3, but decided to propose the specifically listed guidelines in the regulatory text for clarity and consistency with other programs. Please review the proposals in the following paragraphs. EPA is requesting comment on this approach.
Proposed reporting of foreign parent company. In some situations, the highest-level parent company is outside of the United States. EPA is proposing that sites also identify the highest-level worldwide parent company, when applicable, and therefore is also adding the requirement to report the foreign parent company under 40 CFR 711.15. Under this proposal, reporters would continue to report their U.S. parent company, but also report their foreign parent company if the situation applies.
Including the foreign parent company would increase the ability of EPA to protect information claimed as confidential. Currently, some confidential information may be inadvertently disclosed due to challenges in identifying connections between sites when the parent companies are outside of the United States. EPA takes such relationships into account when aggregating confidential information. By reporting the foreign parent company, EPA would be able to better identify company groupings for data aggregation and, ultimately, protection of information claimed as confidential.
This modification would be responsive to industry concerns expressed during the 2016 CDR submission period with not being able to report their “true” parent company when that company is outside of the United States. In many cases, sites know the foreign corporation's name more readily than the U.S. parent company's name.
As opposed to relying exclusively on the foreign parent company (where applicable), EPA is retaining the U.S. parent company reporting requirement to allow EPA to align future CDR collections with historical data; inclusion of the U.S
mpany when that company is outside of the United States. In many cases, sites know the foreign corporation's name more readily than the U.S. parent company's name.
As opposed to relying exclusively on the foreign parent company (where applicable), EPA is retaining the U.S. parent company reporting requirement to allow EPA to align future CDR collections with historical data; inclusion of the U.S. parent company for 2020 reporting would enable EPA to correlate with past reporting cycles and potentially to increase consistency in reporting among sites associated with the same parent company. Including both the U.S. and the foreign parent companies would provide data users greater flexibility when combining CDR data with data from other sources, some of which are limited to only U.S. information.
Application of parent company definition to different situations. EPA recognizes that there are a variety of ownership situations for manufacturers reporting under CDR. The scenario-specific information listed in this document is based on the guidelines included in the proposed definition and contains additional examples illustrating the application of the proposed parent company definition and reporting requirements. The guidelines include how to populate the U.S. and a foreign parent company data elements. EPA is interested in receiving comments on whether the guidelines and these examples encompass the representative range of scenarios for reporting under CDR, and whether the guidelines included in the proposed definition are sufficient. The examples are as follows:
(1) If the site is entirely owned by a single U.S. company that is not owned by another company, then that single company is the U.S. parent company and there is no foreign parent company.
idelines and these examples encompass the representative range of scenarios for reporting under CDR, and whether the guidelines included in the proposed definition are sufficient. The examples are as follows:
(1) If the site is entirely owned by a single U.S. company that is not owned by another company, then that single company is the U.S. parent company and there is no foreign parent company.
(2) If the site is entirely owned by a single U.S. company that is, itself, owned by another U.S.-based company ( e.g., it is a division or subsidiary of a higher-level company), the highest-level company in the ownership hierarchy is the U.S. parent company. If there is a higher-level parent company that is outside of the United States, the highest-level foreign company in the ownership hierarchy is the foreign parent company.
(3) If the site is owned by more than one company ( e.g., company A owns 40 percent, company B owns 35 percent, and company C owns 25 percent of the site), the highest-level U.S. company with the largest ownership interest in the site is the U.S. parent company. Under this scenario, this would be either company A itself (if it doesn't have a U.S.-based parent company), company A's parent, or, if it exists, a single parent company that owns both company B and company C, in which case that single parent company would have the largest ownership interest. If there is a higher-level foreign company in the site's ownership hierarchy, that company is the foreign parent company. There may be the situation where the highest U.S. company is company A's parent company but a foreign company owns both company B and company C. In this situation, the foreign parent company would be the highest-level parent company that owns companies B and C and the U.S. parent company would be the parent company of company A.
e's ownership hierarchy, that company is the foreign parent company. There may be the situation where the highest U.S. company is company A's parent company but a foreign company owns both company B and company C. In this situation, the foreign parent company would be the highest-level parent company that owns companies B and C and the U.S. parent company would be the parent company of company A.
(4) If the site is ultimately owned by a 50:50 joint venture or a cooperative, the joint venture or cooperative is its own U.S. parent company. If the site is owned by a U.S. joint venture or cooperative, the highest level of the joint venture or cooperative is the U.S. parent company. If the site is owned by a joint venture or cooperative outside the United States, the highest level of the joint venture or cooperative outside the United States is the foreign parent company.
(5) If the site is entirely owned by a foreign company ( i.e., without a U.S.-based subsidiary within the facility's ownership hierarchy), the highest-level foreign parent company is the facility's foreign parent company. In this situation, the U.S. parent company would be the site itself.
(6) If the site is a federally owned, the highest-level federal agency or department is the U.S. parent company.
(7) If the site is owned by a non-federal public entity, that entity (such as a municipality, State, or tribe) is the U.S. parent company.
Proposed use of naming convention. EPA is also proposing to require sites to follow the CDR instructions regarding standardized conventions for the naming of a parent company. These naming conventions address common formatting discrepancies, such as punctuation, capitalization, and abbreviations ( e.g., “Corp” for “Corporation”). The use of these naming conventions would reduce the number of inconsistencies with the Parent Company Name data field, and thereby would increase the reliability and usability of the data and reduce the associated reporting burden due to the
C
ese naming conventions address common formatting discrepancies, such as punctuation, capitalization, and abbreviations ( e.g., “Corp” for “Corporation”). The use of these naming conventions would reduce the number of inconsistencies with the Parent Company Name data field, and thereby would increase the reliability and usability of the data and reduce the associated reporting burden due to the
C. Changes to Reporting Process for Co-Manufactured Chemicals
EPA is proposing to change the method manufacturers use to report co-manufactured chemicals. A co-manufacturing relationship occurs when a chemical substance, manufactured other than by import, is produced exclusively for another person who contracts for such production. To be considered a co-manufacture situation, the producing company produces the chemical substance exclusively for another person (the contracting company) under contract for that production. If the chemical substance is produced for other purposes, then the situation fails this first test of “co-manufacturing.” For example, if a company manufactures a chemical for speculative purposes based on expectations of the market, the company is not operating in a co-manufacturing situation. In addition, the other person contracting the manufacture ( i.e., the contracting company) specifies the identity of the chemical substance, the total amount produced, and the basic technology for the plant process. This is the second test of “co-manufacturing.” To be considered co-manufacturers, both of these tests must be met. See 40 CFR 711.3 (definition of “manufacture”). Although this proposed change reduces co-manufacturer confusion and addresses other industry concerns, EPA estimates that it would have a minimal impact on the burden and therefore did not include an estimate in the analysis. See section 4.1.3.2 in the Economic Analysis for additional information (Ref. 4)
nufacturers, both of these tests must be met. See 40 CFR 711.3 (definition of “manufacture”). Although this proposed change reduces co-manufacturer confusion and addresses other industry concerns, EPA estimates that it would have a minimal impact on the burden and therefore did not include an estimate in the analysis. See section 4.1.3.2 in the Economic Analysis for additional information (Ref. 4).
EPA is avoiding the use of the term toll manufacturer for this proposal and future guidance to add clarity for the co-manufacturing situation. In instructions, guidance, and other communication with submitters, EPA may previously have referred to co-manufacturing as toll manufacturing, and more specifically to the two parties as the contracting manufacturer and the toll manufacturer. Because EPA does not specifically define the term “toll manufacturer,” EPA now believes the use of this term may be open to mis-interpretation and it would be clearer to use terms associated with the CDR definition of manufacturer in 40 CFR 711.3. Additionally, EPA believes the chemical industry often refers to toll manufacturing in a more general manner, where both of the tests included in the CDR definition for manufacture are not met. These tests are: (1) The chemical substance is 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.
Current reporting requirements. Under the current CDR rule, the contracting company and the producing company are jointly responsible for reporting and submitting to CDR. Only one report may be submitted per reportable chemical and per production site. In order to report, the contracting company and the producing company must work together and identify who will submit the report they are both responsible for, to prevent duplicate reporting and ensure both parties have met their reporting obligations
mpany are jointly responsible for reporting and submitting to CDR. Only one report may be submitted per reportable chemical and per production site. In order to report, the contracting company and the producing company must work together and identify who will submit the report they are both responsible for, to prevent duplicate reporting and ensure both parties have met their reporting obligations.
Pursuant to the CDR definition of “site” at 40 CFR 711.3, the site reported is the site of physical manufacture ( i.e., the producing company's site). This is true irrespective of whether it is the producing company or the contracting company who completes the report. If both parties fail to report, both the contracting company and producing company are liable.
The companies must designate a single technical contact for the specified chemical(s), who can be an employee of either the contracting company or the producing company (or a consultant). This technical contact should be knowledgeable about the specific chemical and should be the best equipped to answer questions about the certain chemical.
Submitters have identified multiple concerns with the current reporting process for co-manufacturers. Current issues associated with using this method for reporting include:
• The contracting company and producing company are unsure who should be primarily or solely responsible for CDR reporting and are concerned regarding the shared liability.
• The producing company has information (such as the number of workers likely to be exposed) that the contracting company does not have, and the contracting company has information (such as information about the processing and use of the chemical substance) that the producing company does not have. However, when currently completing the CDR chemical report, one company may not be willing to share information it considers confidential with the other company
of workers likely to be exposed) that the contracting company does not have, and the contracting company has information (such as information about the processing and use of the chemical substance) that the producing company does not have. However, when currently completing the CDR chemical report, one company may not be willing to share information it considers confidential with the other company.
• In situations where the producing company is reporting for additional chemical substances, the current co-reporting requirement may result in the need to submit multiple CDR reports for the producing company's site. This created a complicated situation that required special handling and increased confusion and burden for the submitter.
Proposed reporting methodology. EPA is proposing to change the reporting mechanism for co-manufacturers by developing a multi-submitter process, similar to that used by importers, where the contracting company is the primary submitter and the producing company is the secondary submitter. When evaluating the co-manufacturing reporting process, EPA considered industry's desire for a flexible reporting mechanism and the need to protect the confidential information of both the contracting company and the producing company. These considerations were made apparent through documented correspondence between EPA and reporters to the 2016 CDR who were either a contracting company or a producing company regarding issues with the co-manufacturing mechanism. EPA also met with representatives from reporting companies to discuss the co-manufacturing mechanism and the challenges related to coordinating a dual effort between the contracting companies and producing companies during the 2016 reporting period (Ref. 18).
In response, EPA is proposing a new methodology for the 2020 and future reporting cycles
rding issues with the co-manufacturing mechanism. EPA also met with representatives from reporting companies to discuss the co-manufacturing mechanism and the challenges related to coordinating a dual effort between the contracting compa

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2019-07716. Check the current official text before relying on it. Not legal advice.