Code of Federal Regulations · Section
§ 705.15 — What Information To Report
40 C.F.R. § 705.15
For the one-time submission, persons identified in § 705.10 must report to EPA, for each site of each of the chemical substances identified in § 705.5, the following information to the extent known to or reasonably ascertainable by them, except as allowed under § 705.18. In the event that actual data is not known to or reasonably ascertainable by the submitter, then reasonable estimates may be submitted:
(a) Company and plant site information. The following currently correct company and plant site information must be reported for each site at which a reportable chemical substance is manufactured (see 40 CFR 711.3 for the “site” for importers):
(1) The highest-level U.S. parent company name, address, and Dun and Bradstreet D-U-N-S® (D&B) number, if one exists.
(2) The name of a person who will serve as Authorized Official for the submitter company, and who will be able to sign the certification statement as described in § 705.30(d), the Authorized Official's full mailing address, telephone number, and email address.
(3) The name of a person who will serve as technical contact for the submitter company, and who will be able to answer questions about the information submitted by the company to EPA, the contact person's full mailing address, telephone number, and email address.
(4) The name, full street address, and six-digit North American Industry Classification System (NAICS) code(s) of the site. A submitter under this part must include the appropriate D&B number for each plant site reported, and the county or parish (or other jurisdictional indicator) in which the plant site is located. A submitter under this part must obtain a D&B number for the site reported if none exists. A submitter under this part must also provide other site identification numbers, including the Facility Registry Service (FRS) identification number, if they exist.
(b) Chemical-specific information. The following chemical-specific information must be reported for each chemical substance that is a PFAS manufactured for each year since January 1, 2011, except as allowed under § 705.18. This includes each chemical substance that is a PFAS and incorporated into mixtures:
(1) The common or trade name, the chemical identity, and, except for chemical substances that are Class 1 substances on the TSCA Inventory, the representative molecular structure of each PFAS for which such a report is required.
(i) The specific, currently correct Chemical Abstracts (CA) Index name as used to list the chemical substance on the TSCA Inventory and the correct corresponding Chemical Abstracts Service Registry Number (CASRN) for each reportable PFAS at each site. Submitters who wish to report chemical substances listed on the confidential portion of the TSCA Inventory will need to report the chemical substance using a TSCA Accession Number. If a submitter has a low-volume exemption (LVE) case number for the chemical substance, that number may also be used if a CASRN is not known to or reasonably ascertainable by the submitter.
(ii) In addition to reporting the number itself, submitters must specify the type of number they are reporting by selecting from among the codes in table 1 to this paragraph (b)(1)(ii).
Table 1 to Paragraph (b)(1)(ii)—Codes To Specify Type of Chemical Identifying Number
(iii) If the CASRN or specific identifier (i.e., Accession Number or LVE number) of the PFAS is not known to or reasonably ascertainable (NKRA) to the submitter (e.g., if the chemical identity is claimed as confidential business information by the submitter's supplier, or if the submitter knows they have a PFAS but are unable to ascertain its specific identifier and/or specific chemical identity), the submitter may provide a generic name or description of the PFAS and also initiate a joint submission if the secondary submitter is known. The submitter may only initiate a joint submission if the CASRN or the specific identifier (i.e., Accession Number or LVE number) is not known or reasonably ascertainable, and a secondary submitter (who would provide such information) is known. The manufacturer (including importer) must use the reporting tool described under § 705.35 to ask the supplier or other entity to provide the chemical identity directly to EPA in a joint submission. Such request must include instructions for submitting chemical identity information electronically, using e-CDRweb and CDX (see 40 CFR 711.35), and for clearly referencing the manufacturer's (including importer) submission. Contact information for the supplier or other entity, a trade name or other designation for the chemical substance, and a copy of the request to the supplier or other entity must be included with the manufacturer's (including importer) submission. If, after conducting due diligence and reviewing known or reasonably ascertainable information, a secondary submitter to complete the joint submission is not known, the reporter may indicate that the secondary submitter is NKRA. However, the PFAS manufacturer would be required to provide as much identifying detail as they have regarding the PFAS identity, and would be able to report to EPA without initiating a joint submission even if they do not know the underlying identity of the chemical substance.
(2) The physical form(s) of the PFAS as it is sent off-site from each site. If the PFAS is site-limited, you must report the physical form(s) of the PFAS at the time it is reacted on-site to produce a different chemical substance. For each PFAS at each site, the submitter must report as many physical forms as applicable from among the physical forms listed in this unit:
(i) Dry powder.
(ii) Pellets or large crystals.
(iii) Water- or solvent-wet solid.
(iv) Other solid.
(v) Gas or vapor.
(vi) Liquid.
(c) Categories of use. For each year since January 1, 2011, report the following information on categories of use of each chemical substance that is a PFAS manufactured for commercial purposes.
(1) Industrial processing and use information. A designation indicating the type of industrial processing or use operation(s) at each site that receives a PFAS from the submitter site directly or indirectly (whether the recipient site(s) are controlled by the submitter site or not). For each PFAS, report the letters which correspond to the appropriate processing or use operation(s) listed in table 2 to this paragraph (c)(1). A particular designation may need to be reported more than once, to the extent that a submitter reports more than one sector that applies to a given designation under this paragraph (c)(1).
Table 2 to Paragraph (c)(1)—Codes for Reporting Type of Industrial Processing or Use Operation
(2) Corresponding sector code. A code indicating the sector(s) that best describes the industrial activities associated with each industrial processing or use operation reported under this section. For each chemical substance, report the code that corresponds to the appropriate sector(s) listed in table 3 to this paragraph (c)(2). A particular sector code may need to be reported more than once, to the extent that a submitter reports more than one function code that applies to a given sector code under this paragraph (c)(2).
Table 3 to Paragraph (c)(2)—Codes for Reporting Industrial Sectors
(3) Corresponding function category. For each sector reported under paragraph (c)(2) of this section, the applicable code(s) from table 4 to this paragraph (c)(3) must be selected to designate the function category(ies) that best represents the specific manner in which the PFAS is used.
Table 4 to Paragraph (c)(3)—Codes for Reporting Function Categories
(4) Consumer and commercial use information. Using the applicable codes listed in table 5 to this paragraph (c)(4), submitters must designate the consumer and commercial product category(ies) that best describe the consumer and commercial products in which each PFAS is used (whether the recipient site(s) are controlled by the submitter site or not). If more than 10 codes apply to a PFAS, submitters need only report the 10 codes for PFAS that cumulatively represent the largest percentage of the submitter's production volume for that chemical, measured by weight. If none of the listed consumer and commercial product categories accurately describes the consumer and commercial products in which each PFAS is used, the category “Other” may be used, and must include a description of the use.
Table 5 to Paragraph (c)(4)—Codes for Reporting Consumer and Commercial Product Categories
(5) Applicable codes for each commercial and consumer products. For each consumer and commercial product category reported under paragraph (c)(4) of this section, the applicable code(s) described in table 4 to paragraph (c)(3) of this section must be selected to designate the function category(ies) that best represents the specific manner in which the PFAS is used.
(6) Commercial and consumer products. Submitters must indicate, for each consumer and commercial product category reported under paragraph (c)(4) of this section, whether the use is a consumer or a commercial use, or both.
(7) Consumer product category. Submitters must determine, within each consumer and commercial product category reported under paragraph (c)(4) of this section, whether any amount of each reportable chemical substance manufactured (including imported) by the submitter is present in (for example, a plasticizer chemical substance used to make pacifiers) or on (for example, as a component in the paint on a toy) any consumer products intended for use by children age 14 or younger, regardless of the concentration of the chemical substance remaining in or on the product. Submitters must select from the following options: The chemical substance is used in or on any consumer products intended for use by children; the chemical substance is not used in or on any consumer products intended for use by children; or information as to whether the chemical substance is used in or on any consumer products intended for use by children is not known to or reasonably ascertainable by the submitter.
(8) Concentrations of PFAS. For each year where the PFAS is used in consumer or commercial products, the estimated typical maximum concentration, measured by weight, of the chemical substance in each consumer and commercial product category reported under paragraph (c)(4) of this section. For each PFAS in each commercial and consumer product category reported under paragraph (c)(4) of this section, submitters must select from among the ranges of concentrations listed in table 6 to this paragraph (c)(8) and report the corresponding code (i.e., M1 through M5):
Table 6 to Paragraph (c)(8)—Codes for Reporting Maximum Concentration of Chemical Substance
(d) Manufactured amounts. For each year since January 1, 2011, the total amounts manufactured of each PFAS, including the amounts manufactured in each calendar year for each category of use as described in paragraph (c) of this section.
(1) Total volume. For each year the PFAS was manufactured, the total annual volume (in pounds) of each PFAS domestically manufactured or imported at each site. The total annual domestically manufactured volume (not including imported volume) and the total annual imported volume must be separately reported. These amounts must be reported to two significant figures of accuracy.
(2) Site designation. A designation indicating, for each PFAS at each site, whether the imported PFAS is physically present at the reporting site.
(3) Volume imported. The volume directly exported of each PFAS domestically manufactured or imported at each site. These amounts must be reported to two significant figures of accuracy.
(4) Production volume. The estimated percentage, rounded off to the closest 10 percent, of total production volume of the reportable chemical substance associated with each combination of industrial processing or use operation, sector, and function category as reported in paragraph (c) of this section. Where a particular combination of industrial processing or use operation, sector, and function category accounts for less than 5 percent of the submitter's site's total production volume of a reportable chemical substance, the percentage must not be rounded off to 0 percent. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1 percent, of the submitter's site's total production volume of the reportable chemical substance associated with the particular combination of industrial processing or use operation, sector, and function category.
(5) Site production volume. The estimated percentage, rounded off to the closest 10 percent, of the submitter's site's total production volume of the PFAS associated with each consumer and commercial product category as reported in paragraph (c)(4) of this section. Where a particular consumer and commercial product category accounts for less than 5 percent of the total production volume of a reportable chemical substance, the percentage must not be rounded off to 0 percent. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1 percent, of the submitter's site's total production volume of the reportable chemical substance associated with the particular consumer and commercial product category.
(6) Site-limited. An indication of whether the PFAS was site-limited.
(7) Volume recycled. The total volume (in pounds) of each PFAS recycled on-site.
(e) Byproduct reporting. A description of the byproducts resulting from the manufacture, processing, use, or disposal of each PFAS.
(1) Byproduct identification. For each byproduct produced from the manufacture, processing, use, or disposal of a PFAS, the submitter will identify the byproduct by its specific, currently correct CA Index name as used to list the chemical substance on the TSCA Inventory and the correct corresponding CASRN. A submitter under this part may use a known EPA-designated TSCA Accession Number for a chemical substance in lieu of a CASRN when a CASRN is not known to or reasonably ascertainable by the submitter. Submitters who wish to report chemical substances listed on the confidential portion of the TSCA Inventory will need to report the chemical substance using a TSCA Accession Number.
(i) In addition to reporting the number itself, submitters must specify the type of number they are reporting by selecting from among the codes in table 1 to paragraph (b)(1)(ii) of this section.
(ii) If the specific chemical identity of the byproduct is unknown to the submitter, the submitter may provide a description of the chemical substance.
(iii) An indication of which specific PFAS activity(ies) (i.e., manufacture, process, use, or disposal) manufactured the byproduct.
(2) Releases. An indication of whether the byproduct is released to the environment, and if so, the environmental medium to which it is released (i.e., air, water, land).
(3) Volume. For each year, the byproduct volume (in pounds) released to the environment.
(f) Environmental and health effects. All existing information concerning the environmental and health effects of such substance or mixture containing a chemical substance in the manufacturer's possession or control. The scope of this information shall not be limited to studies conducted or published since 2011.
(1) Organization for Economic Cooperation and Development (OECD) Harmonized Templates. For each unpublished study report, the submitter shall complete an OECD Harmonized Templates for Reporting Chemical Test Summaries and submit the accompanying study reports and supporting information. This can be accomplished by using the freely available IUCLID software.
(2) Human health data—preliminary studies. Submitters shall also provide any additional human health data not in study reports, including but not limited to any preliminary studies, informal test results in workers, or inhalation studies.
(3) Analytical tests. Submitters shall also provide the names of any analytical or test methods used to detect or otherwise test for the PFAS.
(g) Worker exposure data. The number of individuals exposed to PFAS in their places of employment and the duration of such exposure.
(1) Employment activities. A narrative description of worker activities involving the PFAS at the manufacturing site, such as bag dumping, sampling, cleaning, or unloading drums.
(2) Number of workers. For each worker activity in this paragraph, indicate the number of workers reasonably likely to be exposed. The submitter must select from among the worker ranges listed in table 7 to this paragraph (g)(2) and report the corresponding code (i.e., W1 though W8).
Table 7 to Paragraph (g)(2)—Codes for Reporting Number of Workers Reasonably Likely To Be Exposed
(3) Exposure scenarios. For each worker activity in this paragraph (g), the maximum duration of exposure for any worker at the manufacturing site, for each of the following scenarios:
(i) The daily exposure duration (in hours per day) in the case of the worker with greatest annual exposure frequency (i.e., the worker exposed the most days per year); and
(ii) The annual exposure frequency (in days per year) in the case of the worker with greatest daily exposure duration (i.e., the worker exposed for the most hours per day during the year).
(4) Exposure by category. For each combination of industrial processing or use operation, sector, and function category identified in paragraph (c) of this section, the submitter must estimate the number of workers reasonably likely to be exposed to each PFAS. For each combination associated with each chemical substance, the submitter must select from among the worker ranges listed in table 7 to paragraph (g)(2) of this section and report the corresponding code (i.e., W1 though W8).
(5) Duration of exposure industrial use. For each PFAS, the maximum duration of exposure for any worker for each combination of industrial processing or use operation, sector, and function category, for each of the following scenarios:
(i) The daily exposure duration (in hours per day) in the case of the worker with the greatest annual exposure frequency (i.e., the worker exposed the most days per year); and
(ii) The annual exposure frequency (in days per year) in the case of the worker with the greatest daily exposure duration (i.e., the worker exposed for the most hours per day during the year).
(6) Commercial workers. Where the PFAS is used in a commercial product, the submitter must estimate the number of commercial workers reasonably likely to be exposed to each reportable chemical substance. For each commercial use associated with each substance, the submitter must select from among the worker ranges listed in table 7 to paragraph (g)(2) of this section and report the corresponding code (i.e., W1 though W8).
(7) Duration of exposure commercial use. For each PFAS, the maximum duration of exposure for any worker for each commercial use, for each of the following scenarios:
(i) The daily exposure duration (in hours per day) in the case of the worker with greatest annual exposure frequency (i.e., the worker exposed the most days per year); and
(ii) The annual exposure frequency (in days per year) in the case of the worker with greatest daily exposure duration (i.e., the worker exposed for the most hours per day during the year).
(h) Disposal data. During the years in which the PFAS was manufactured, the manners or methods of its disposal, and any changes to the disposal methods or processes.
(1) Categories of disposal methods. Description of disposal processes or methods, using the appropriate codes in table 8 to this paragraph (h)(1), and additional descriptions as needed.
Table 8 to Paragraph (h)(1)—Codes for Reporting Disposal Methods
(2) Disposal processes. Describe any changes to the disposal process(es) or method(s) indicated in paragraph (h)(1) of this section for any PFAS manufactured since 2011.
(3) Disposal volume. Indicate total volume of the PFAS that was released to each environmental medium in each year since 2011: land, water, and air.
(4) Incineration volume. Indicate total volume of the PFAS that was incinerated on-site in each year since 2011. If incineration occurred, indicate the temperature (in degrees Celsius) at which the PFAS was incinerated. If incineration occurred at multiple temperatures, indicate the minimum temperature (in degrees Celsius) at which the PFAS was incinerated.
Authorizing Statute
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Reporting and retention of information15 U.S.C. § 2607