2556-01_ss_2017-01-19
2556-01_ss_2017-01-19.docx
Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses under TSCA §6(a) (Proposed Rule; RIN 2070-AK07)
OMB: 2070-0204
January 19, 2017
Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
Title: Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses under TSCA §6(a) (Proposed Rule; RIN 2070-AK07)
ICR Numbers: EPA ICR No.: 2556.01; OMB Control No.: 2070-NEW.
EPA Form Numbers: No required forms for ICR activities
Docket ID Number: EPA-HQ-OPPT-2016-0231.
The information collection request (ICR) that explains the information collection activities and related burden and cost estimates, as well as other supporting documents related to the ICR, are available in the docket established for the rulemaking. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave., N.W., Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA’s public docket, visit http://www.epa.gov/dockets.
This is a new ICR that addresses the information collection activities that are contained in a proposed rule. Under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid control number issued by the Office of Management and Budget (OMB). The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.
Before submitting an ICR to OMB for review and approval under the PRA, an agency must solicit comments pursuant to PRA §3506(c)(2)(A) and 5 CFR 1320.8(d)(1). After considering comments received on the draft ICR, the agency must submit the ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. In announcing the submission of the final ICR to OMB for review and approval, the agency must provide another opportunity for public review and comments on the revised ICR pursuant to 5 CFR 1320.12(c).
The Environmental Protection Agency (EPA) is developing a proposed rule under section 6 of the Toxic Substances Control Act (TSCA) concerning the prohibition of methylene chloride and N-methylpyrrolidone (NMP) in paint and coating removal for certain uses. For methylene chloride, the proposed rule requires each person who manufactures, processes, or distributes in commerce methylene chloride for non-prohibited uses to notify companies to whom methylene chloride was shipped of the prohibitions under the rules. The proposed rule also requires each person who manufactures, processes, or distributes in commerce any methylene chloride to retain in one location at the headquarters of the company documentation of information showing: (i) the name, address, contact, and telephone number of companies to whom methylene chloride was shipped; and (ii) the amount of methylene chloride shipped. This information must be retained for 3 years from the date of shipment.
For NMP, EPA is co-proposing two approaches. Under both co-proposed approaches, the proposed rule requires each person who manufactures, processes, or distributes in commerce NMP for non-prohibited uses to notify companies to whom NMP was shipped of the prohibitions under the rules. The proposed rule also requires each person who manufactures, processes, or distributes in commerce any NMP to retain in one location at the headquarters of the company documentation of information showing: (i) the name, address, contact, and telephone number of companies to whom methylene chloride was shipped; and (ii) the amount of methylene chloride shipped. This information must be retained for 3 years from the date of shipment. Under the second co-proposed approach, the proposed rule requires each person who formulates paint and coating removal products containing NMP to identify, through testing, gloves that are protective against each specific product formulation using defined testing and reporting protocols, and provide information about those gloves as well as additional instructions and warnings for consumers on product labels.
EPA is proposing this rule under section 6(a) of TSCA in response to a determination that methylene chloride and NMP present an unreasonable risk to human health in paint and coating removal. The portions of the proposed rule that trigger this Information Collection Request (ICR) consist of a downstream notification of the prohibitions in the rules, a recordkeeping requirement, and, for the second co-proposal for NMP, a testing and labeling requirement.
Legal authority: The Toxic Substances Control Act (TSCA), 15 U.S.C. § 2605(a).
Respondents/affected entities: Entities potentially affected by this ICR include persons that manufacture, process, or distributes in commerce methylene chloride and NMP for any use.
Respondent’s obligation to respond: Respondents are not obligated to respond or report to EPA (under the proposed approach for methylene chloride and both co-proposed approaches for NMP).
Confidentiality of responses: Not applicable (under the proposed approach for methylene chloride and both co-proposed approaches for NMP).
Estimated total number of potential respondents for the proposed approach for methylene chloride and the first co-proposed approach for NMP: 327
Estimated total number of potential respondents for the proposed approach for methylene chloride and the second co-proposed approach for NMP: 327
Frequency of response: On occasion to third parties as needed (under the proposed approach for methylene chloride and both co-proposed approaches for NMP).
Estimated total annual burden for the proposed approach for methylene chloride and the first co-proposed approach for NMP: 163.5 hours. Burden is defined at 5 CFR 1320.3(b).
Estimated total annual burden for the proposed approach for methylene chloride and the second co-proposed approach for NMP: 1,084 hours. Burden is defined at 5 CFR 1320.3(b).
Estimated total annual costs for the proposed approach for methylene chloride and the first co-proposed approach for NMP: $7,904
Estimated total annual costs for the proposed approach for methylene chloride and the second co-proposed approach for NMP: $924,890
Changes in the estimates: Not applicable. This is a request for a new OMB Control Number (under the proposed approach for methylene chloride and both co-proposed approaches for NMP).
TSCA – Under section 6(a) of TSCA (15 U.S.C. § 2605(a)), if EPA determines after risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation, under the conditions of use, EPA must by rule apply one or more requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk. Section 6(a) authorizes EPA to:
Prohibit or restrict manufacture, processing, or distribution in commerce;
Prohibit or restrict the manufacture, processing, or distribution in commerce of the chemical substance above a specified concentration;
Require minimum warnings or instructions with respect to use, distribution, or disposal;
Require manufacturers or processors to make and retain records;
Prohibit or regulate any manner of commercial use;
Prohibit or regulate any manner of disposal; and/or
Require manufacturers or processors to give notice of the unreasonable risk of injury, and to recall products if required.
For methylene chloride, this proposed rule:
Prohibits all persons from manufacturing, processing, and distributing in commerce, and from commercial use of methylene chloride in paint and coating removal for all industries except for commercial furniture refinishing and except for uses proposed to be critical to national security;
Requires any methylene chloride for paint and coating removal to be packaged in volumes no less than 55-gallon drums, except formulations specifically manufactured for the Department of Defense;
Requires downstream notification of these prohibitions and limited recordkeeping.
For NMP, this proposed rule co-proposes two options. Under the first co-proposed approach, this proposed rule:
Prohibits all persons from manufacturing, processing, and distributing in commerce, and from commercial use of NMP in paint and coating removal for all industries except for uses proposed to be critical to national security;
Requires any NMP for paint and coating removal to be packaged in containers with a volume no less than 5 gallons;
Requires downstream notification of these prohibitions and limited recordkeeping.
Under the second co-proposed approach for NMP, this proposed rule:
Requires formulators of paint and coating removal products containing NMP to limit concentration of NMP in the products to 35%
Requires that formulators of paint and coating removal products containing NMP identify, through testing, gloves providing protection against specific product formulations and provide that information as well as warnings and consumer instructions on product labels
Requires that commercial users of NMP for paint and coating removal implement and carry out worker protection programs for dermal and respiratory protection;
Requires downstream notification of these requirements and limited recordkeeping.
As there are currently no prohibitions under section 6 of TSCA regarding paint and coating removal uses of these chemicals, there are currently no requirements for downstream notification in the methylene chloride or NMP supply chains related to such prohibition. Likewise, there is currently no requirement for the specific recordkeeping mandated under the proposed approach for methylene chloride and both co-proposed approaches for NMP. There are no current requirements for glove testing or product labeling as would be mandated under the second co-proposed approach for NMP.
The downstream notification requirement under the proposed rule mandates that each person, excluding retailers of products to consumers, who manufactures, processes, or distributes in commerce methylene chloride or NMP for any use must notify companies to whom methylene chloride or NMP was shipped of the prohibitions under this rule, under the proposed approach for methylene chloride and both co-proposed approaches for NMP.
The recordkeeping requirement under the proposed approach for methylene chloride and both co-proposed approaches for NMP mandates that each person, excluding retailers of products to consumers, who manufactures, processes, or distributes in commerce any methylene chloride or NMP must retain in one location at the headquarters of the company documentation of the information showing: the name, address, contact, and telephone number of companies to whom methylene chloride, NMP, or products containing methylene chloride or NMP was shipped and the amount of methylene chloride or NMP shipped. This information must be retained for 3 years from the date of shipment.
The testing requirements for glove permeability and the labeling requirements mandate that processors paint removers containing perform glove permeability testing on each paint remover product containing NMP, conduct relevant recordkeeping, and update their current product labels to contain warnings and instructions for consumers on how to reduce exposures to NMP.
EPA is not proposing at this time to regulate the use of methylene chloride in commercial furniture refinishing, or furniture stripping or refinishing conducted by professionals or commercial workers. EPA intends to issue a separate proposal on methylene chloride in paint and coating removal in commercial furniture refinishing, and plans to issue one final rule covering both this proposal and the future proposed rule on methylene chloride in paint and coating removal in commercial furniture refinishing.
The information collection activities covered by this ICR are necessary in order to enhance the mitigation of unreasonable risks identified in certain uses of methylene chloride and NMP in paint and coating removal. EPA is proposing a rule that involves information collection activities that mitigate the health risks identified and do not present unreasonable burdens to the regulated entities.
Without the downstream notification requirement, there is a greater likelihood that non-prohibited uses of methylene chloride or NMP could be diverted to the prohibited use and that users would be buying or using materials that they do not realize contain methylene chloride or NMP because they would not be aware of the prohibitions. This would result in continuation of the risks that EPA has identified and proposes are unreasonable. Some companies may manufacture and process methylene chloride or NMP for uses that are not prohibited by this proposed rule or some companies may only be engaged in the distribution of methylene chloride or NMP to customers for uses that are not regulated by the proposed rule. In order to ensure awareness of the prohibitions and improve the likelihood methylene chloride or NMP products are not used in applications where their use is prohibited under the proposed rule, the manufacturers, importers, processors, and distributors (not including consumer retailers) of products that contain methylene chloride or NMP designed for uses that are not prohibited will be required to notify downstream purchasers about the uses that are prohibited. Downstream notification will also be necessary for effective enforcement of the rule as it provides a record of notification on use restrictions down the supply chain via Safety Data Sheet. The Occupational Safety and Health Administration (OSHA) already requires safety Data Sheets. Therefore, this additional information should not substantially increase the burden on these companies.
EPA also has authority under section 6 of TSCA to require recordkeeping related to the regulatory requirements imposed by EPA. This is important where, as here, such records and reports are necessary for effective enforcement of the section 6 rule and would apply to persons who are not covered by section 8(a) of TSCA, i.e., those who are not manufacturers or processors.
Without the glove testing and recordkeeping requirements, it would not be possible to identify which specific gloves could provide protection to dermal exposure to NMP through paint and coating removal. One type of gloves may not be appropriate for all NMP paint remover formulations because the permeability of the product will vary based on the other solvents and chemicals used in the formulation. Without the reporting requirements, processors of these products might not provide information about the specific types of protective gloves to users. Requiring that labels of paint and coating removal products containing NMP include information about which specific types of gloves provide dermal protection from the specific product formulation provides information that is essential for knowing how to reduce exposures while carrying out paint and coating removal with NMP. Requiring additional warnings and instructions to consumers provides information about the risks presented by the product and how those risks can be reduced.
EPA. This information collection will provide EPA with information only upon inspection of such materials. There are no reporting requirements to submit information to EPA under the information collection activities.
Downstream Companies. Under the proposed approach for methylene chloride and both co-proposed approaches for NMP, manufacturers, processors, and distributors in commerce of methylene chloride or NMP must notify companies downstream upon shipment of methylene chloride or NMP about the prohibitions or requirements under the proposed rule. Under the proposed rule, retailers are specifically excluded from the definition of distribute in commerce. The information submitted to downstream companies would provide knowledge and awareness of the prohibited use to these companies.
The regulated entities will compile and retain records that are necessary as a reference for EPA or authorized entities. These records demonstrate that the entities throughout the methylene chloride or NMP supply chain are aware of the prohibitions of certain uses of methylene chloride or NMP and that companies upstream can show what entities they supply to and therefore what entities they would need to notify of the prohibitions. These recordkeeping requirements are also necessary to permit EPA to conduct its enforcement activities and to ensure compliance within the regulated community.
Processors of NMP for paint and coating removal. Under the second co-proposed approach for NMP, processors of paint and coating removal products containing NMP must test gloves for permeability for each formulation they process, and keep records relevant to this testing. One type of gloves may not be appropriate for all NMP paint remover formulations because the permeability of the product will vary based on the other solvents and chemicals used in the formulation. The testing requirements for glove permeability and the labeling requirements mandate that processors paint removers containing perform glove permeability testing on each paint remover product containing NMP and update their current product labels to contain warnings and instructions for consumers on how to reduce exposures to NMP.
The EPA’s collection pursuant to the TSCA section 6(a) regulations do not duplicate any other collection. There is no other Federal program that requires the information collection activities related to the prohibitions under the proposed rule.
The notice of proposed rulemaking serves as the public notice for this ICR. Interested parties should submit comments referencing Docket ID No. EPA-HQ-OPPT-2016-0231 to the address listed at the end of this document. Responses will be taken into account in developing the final rulemaking.
3(c). Consultations
EPA consulted with state and local officials early in the process of developing the proposed action to permit them to have meaningful and timely input into its development. EPA invited the following national organizations representing state and local elected officials to a meeting on May 13, 2015, in Washington DC: National Governors Association; National Conference of State Legislatures, Council of State Governments, National League of Cities, U.S. Conference of Mayors, National Association of Counties, International City/County Management Association, National Association of Towns and Townships, County Executives of America, and Environmental Council of States. A summary of the meeting with these organizations, including the views that they expressed, is available in the docket. Although EPA provided these organizations an opportunity to provide follow-up comments in writing, no written follow-up was received by the Agency.
EPA met with tribal officials in a national informational webinar held on May 12, 2015 concerning the prospective regulation of methylene chloride and NMP under TSCA section 6, and in another teleconference with tribal officials on May 27, 2015. EPA also met with the National Tribal Toxics Council (NTTC) in Washington, D.C. and via teleconference on April 22, 2015. In those meetings, EPA provided background information on the proposed rule and a summary of issues being explored by the Agency. These officials expressed concern for methylene chloride and NMP contamination on tribal lands and supported additional regulation of methylene chloride and NMP.
On May 27, 2015, EPA held an Environmental Justice public consultation webinar to gather stakeholder input about reducing risks from use of methylene chloride and NMP. The webinar shared information about the proposed methylene chloride and NMP rulemaking and focused on discussing concerns of environmental justice communities.
3(d). Effects of Less Frequent Collection
Due to the nature of the triggering events that initiate information collection activities under the proposed rule, less frequent collection is not feasible. The proposed rule only includes reporting information to third parties and does not require reporting information to EPA.
3(e). Small Entity Flexibility
EPA believes that the downstream notification and recordkeeping requirements do not unduly burden small businesses. EPA concludes that the proposed information collection request has no significant impacts on any of the entities subject to downstream notification as firms subject to this requirement have a cost-revenue impact of less than 1 percent.
3(f). General PRA Related Guidelines
This ICR is consistent with OMB’s general guidelines. Companies that ship methylene chloride and NMP are required to maintain records for three years. Therefore, this ICR does not exceed the Paperwork Reduction Act guidelines at 5 CFR 1320.5.
3(g). Confidentiality
EPA will not be collecting any information. Therefore, confidential information will not be submitted to EPA.
3(h). Sensitive Questions
The information collection activities do not include questions of a sensitive nature.
There will be no agency collection activities under the proposed rule. There will only be third party notification and recordkeeping requirements.
This collection requires third party notification and recordkeeping. EPA will not receive or process any information as a result of the collection. Therefore, EPA estimates that it costs the EPA approximately $0 to carry out the activities associated with the information collection activities covered by this ICR.
There is no collection of information by EPA included under the proposed rule. Therefore, collections occur only by third parties and will occur as needed via Safety Data Sheet or product label.
There will be no information collection by EPA. Therefore, there is no need for any technology facilitation under the proposed rule related to information collection activities. The recordkeeping requirement does not specify a particular technology or method of retaining the required information. The collection of information by third parties will occur via Safety Data Sheet or product label.
For each respondent category, this section of the ICR describes the respondents, the information collection activities and related estimates for burden and costs associated with those activities.
The collection specifies third party notification and recordkeeping requirements on persons who manufacturer, process, or distribute methylene chloride or NMP. The North American Industrial Classification System (NAICS) codes associated with industries most likely affected by the paperwork requirements are described below:
213112 314999 |
Support Activities for Oil and Gas Operations All Other Miscellaneous Textile Product Mills |
324110 |
Petroleum Refineries |
324191 |
Petroleum Lubricating Oil and Grease Manufacturing |
325110 |
Petrochemical Manufacturing |
325120 |
Industrial Gas Manufacturing |
325180 |
Other Basic Inorganic Chemical Manufacturing |
325199 |
All Other Basic Organic Chemical Manufacturing |
325211 |
Plastics Material and Resin Manufacturing |
325212 |
Synthetic Rubber Manufacturing |
325510 |
Paint and Coating Manufacturing |
325520 |
Adhesive Manufacturing |
325611 |
Soap and Other Detergent Manufacturing |
325612 325613 |
Polish and Other Sanitation Good Manufacturing Surface Active Agent Manufacturing |
325998 |
All Other Miscellaneous Chemical Product and Preparation Manufacturing |
326113 |
Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing |
326199 |
All Other Plastics Product Manufacturing |
326220 |
Rubber and Plastics Hoses and Belting Manufacturing |
326299 |
All Other Rubber Product Manufacturing |
327310 |
Cement Manufacturing |
327992 |
Ground or Treated Mineral and Earth Manufacturing |
332117 |
Powder Metallurgy Part Manufacturing |
332119 |
Metal Crown, Closure, and Other Metal Stamping (except Automotive) |
332216 |
Saw Blade and Hand Tool Manufacturing |
332321 |
Metal Window and Door Manufacturing |
332410 |
Power Boiler and Heat Exchanger Manufacturing |
332618 |
Other Fabricated Wire Product Manufacturing |
332710 |
Machine Shops |
332721 |
Precision Turned Product Manufacturing |
332722 |
Bolt, Nut, Screw, Rivet, and Washer Manufacturing |
332811 |
Metal Heat Treating |
332812 |
Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers |
333132 |
Oil and Gas Field Machinery and Equipment Manufacturing |
333515 |
Cutting Tool and Machine Tool Accessory Manufacturing |
332994 |
Small Arms, Ordnance, and Ordnance Accessories Manufacturing |
333996 |
Fluid Power Pump and Motor Manufacturing |
332999 |
All Other Miscellaneous Fabricated Metal Product Manufacturing |
333515 |
Cutting Tool and Machine Tool Accessory Manufacturing |
333911 |
Pump and Pumping Equipment Manufacturing |
333996 |
Fluid Power Pump and Motor Manufacturing |
334511 |
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing |
334512
334516 |
Automatic Environmental Control Manufacturing for Residential, Commercial, and Appliance Use Analytical Laboratory Instrument Manufacturing |
335312 335911 |
Motor and Generator Manufacturing Storage Battery Manufacturing |
335912 335921 |
Primary Battery Manufacturing Fiber Optic Cable Manufacturing |
335991 |
Carbon and Graphite Product Manufacturing |
336340 |
Motor Vehicle Brake System Manufacturing |
336411 |
Aircraft Manufacturing |
336413 |
Other Aircraft Parts and Auxiliary Equipment Manufacturing |
336414 |
Guided Missile and Space Vehicle Manufacturing |
336611 |
Ship Building and Repairing |
339114 424310 |
Dental Equipment and Supplies Manufacturing Piece Goods, Notions, and Other Dry Goods Merchant Wholesalers |
424690 |
Other Chemical and Allied Products Merchant Wholesalers |
424710 |
Petroleum Bulk Stations and Terminals |
562211 |
Hazardous Waste Treatment and Disposal |
562213 |
Solid Waste Combustors and Incinerators |
|
|
Under the proposed approach for methylene chloride and the first co-proposed approach for NMP, the rule would require that each person who manufactures methylene chloride or NMP for any use must notify companies to whom methylene chloride or NMP is shipped of the following prohibitions: (1) All persons are prohibited from manufacturing, processing, and distributing in commerce methylene chloride or NMP for consumer paint and coating removal; (2) All persons are prohibited from manufacturing, processing, and distributing in commerce methylene chloride for commercial paint and coating removal except when for use in furniture refinishing or for specific uses critical for national security; (3) All persons are prohibited from manufacturing, processing, and distributing in commerce NMP for commercial paint and coating removal, except for specific uses critical for national security; (4) All persons are prohibited from commercial use of methylene chloride in paint and coating removal except for commercial furniture refinishing or for specific uses critical for national security; and (5) All persons are prohibited from commercial use of NMP in paint and coating removal except for specific uses critical for national security. Additionally, each person who manufactures, processes, or distributes methylene chloride or NMP for any use would be required to retain records for 3 years showing: (1) The name, address, contact, and telephone number of companies to whom methylene chloride, NMP, or products containing methylene chloride or NMP was shipped, and (2) the chemicals included in the shipment and the amount of each chemical shipped.
Under the second co-proposed approach for NMP, the rule would require that each person who manufactures NMP for any use must notify companies to whom NMP is shipped of the following restriction: Formulations of NMP for commercial or consumer paint and coating removal must not contain more than 35 percent by weight of NMP. Additionally, each person who manufactures, processes, or distributes NMP for any use would be required to retain records for 3 years showing: (1) The name, address, contact, and telephone number of companies to whom NMP, or products NMP was shipped, and (2) the chemicals included in the shipment and the amount of each chemical shipped.
Also under the second co-proposed approach for NMP, the rule would require that each processor of paint and coating removal products containing NMP 1) perform glove permeability testing on each paint remover product containing NMP using methods similar to the Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact (ASTM-F739); 2) label products to identify which gloves provide dermal protection against the product formulation; 3) label products with specific information about risks presented by the chemical and how to reduce those risks through increasing ventilation, wearing the specified gloves; respiratory protection; and other work practices; 4) retain relevant records for this glove permeability testing.
Number of Entities Affected
EPA developed estimates for number of manufacturers, processors, and distributors affected. Based on EPA’s (EPA 2014) Public 2012 Chemical Data Reporting (CDR) data. There are an estimated 29 sites manufacturing or importing methylene chloride or NMP and 16 sites processing or using the chemical for a total of 45 manufacturers and processors.
To estimate the number of wholesaler firms distributing products containing methylene chloride or NMP, the ratio of the number of Chemical and Allied Products Merchant Wholesaler firms (NAICS 4246) to Basic Chemical Manufacturing firms (NAICS 3251) is applied to the number of manufacturers and processors of methylene chloride or NMP:
The number of Chemical and Allied Products Merchant Wholesaler firms and the number of Basic Chemical Manufacturing firms are from the 2012 Statistics of U.S. Businesses (SUSB) data series for employer firms (U.S. Census Bureau 2012a,b). This estimate is conservative in that it includes all wholesalers of products containing methylene chloride or NMP. Wholesalers that only distribute paint removers would no longer be permitted to distribute products containing methylene chloride or NMP, and thus would not have recordkeeping costs under the proposed rule.
The total number of entities affected by the recordkeeping and reporting requirements of the rule under the proposed approach for methylene chloride and the first co-proposed approach for NMP, therefore, is estimated to be 327 (45 manufacturers and processors and 282 distributors). EPA was unable to estimate the potential for new firms to enter the market which could affect this estimate over the time period of the ICR.
Under the second co-proposed approach for NMP, EPA estimates the same total number of affected entities (327) as with the first co-proposed approach. However, 7 NMP processors will have additional requirements under the second co-proposed option. EPA was unable to estimate the potential for new firms to enter the market which could affect this estimate of the time period of the ICR.
Rule Familiarization Burden
EPA assumes that each manufacturer (including importers), processor, and distributor of products that contain methylene chloride or NMP is assumed to spend a half an hour (0.5 hours) becoming familiar with the requirements of the rule and developing an understanding of what actions are necessary to comply with the downstream notification and recordkeeping requirements. This is estimated as a one-time burden. The burden is estimated to occur during the first year of the ICR only. To develop an estimate of average annual burden across the time period of the ICR, EPA divided the burden per response equally across the three years. Therefore, average burden per respondent for each year is calculated as 0.5 hour/3 years = 0.167 hours/year.
Downstream Notification Burden
Downstream notification is considered a third-party notification. EPA estimates that downstream notification is accomplished through an annotation to already existing chemical SDSs that each manufacturer, distributor, or importer provides to downstream users under the Hazard Communication Standard (HCS) (29 CFR 1910.1200). EPA estimates that it will require 1 hour of technical labor for each affected manufacturer, importer, and processor of methylene chloride or NMP and methylene chloride or NMP-containing products to make the necessary annotations to the SDSs. Once an SDS is annotated, the action would not need to be repeated, therefore, EPA estimates this as a one-time burden. However, this is a continuing requirement of the rule. Therefore, should new manufacturers, processors, or distributors of methylene chloride or NMP or methylene chloride or NMP-containing products or new methylene chloride or NMP- containing products enter the market, respondents may realize future burden. EPA has no information to estimate the potential for new methylene chloride or NMP-containing products or new respondents subject to the rule to enter the market over the time period of the ICR so the estimate is limited to a one-time burden for manufacturers, importers, and processors.
The burden is estimated to occur during the first year of the ICR only. To develop an estimate of average annual burden across the time period of the ICR, EPA divided the burden per response equally across the three years. Therefore, average burden per respondent for each year is calculated as 1 hour/3 years = 0.33 hours/year.
Glove Testing Burden
Processors of paint removers containing NMP are required to perform glove permeability testing on each paint remover product containing NMP and to keep relevant records. One type of gloves may not be appropriate for all NMP paint remover formulations because the permeability of the product will vary based on the other solvents and chemicals used in the formulation. EPA is requiring processors to conduct the Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact (ASTM-F739) which has an estimated cost of $15,786 based on standard costs for testing required by the Agency. EPA assumes the test takes one week of labor time (40 hours) for one staff person to perform the test and appropriately document the results (40 hours x $72.22 wage rate = $2,889). Under this assumption, the material cost of performing the glove test is an estimated $12,897 ($15,786 - $2,889).
Label Changing Burden
Processors of paint removers containing NMP are required to update their current product labels to contain warnings and instructions for consumers on how to reduce exposures to NMP. The material costs of relabeling are estimated at $600 to cover the cost for the plate change and a minimal labor cost of $200 (approximately 2.5 hours) per product based on a survey of product blenders. This relabeling cost will be a one time and not a recurring cost.
EPA has identified 64 paint removing products that contain NMP and there are 7 processors of NMP paint removers. Based on these numbers EPA assumes processors have to relabel and perform glove testing for an average of 9 products per firm. These are a onetime cost.
Recordkeeping Burden
Manufactures, importers, processors, and distributors (not including consumer retailers) of products that contain methylene chloride or NMP designed for uses that are not prohibited will also be required to retain for three years company documentation of information showing: (i) The name, address, contact, and telephone number of companies to whom methylene chloride or NMP was shipped; and (ii) The amount of methylene chloride or NMP shipped. Entities shipping either methylene chloride or NMP itself (i.e., methylene chloride or NMP manufacturers) or entities that added methylene chloride or NMP to a product that they manufactured are expected to already be retaining the required records. EPA expects that this information would already be included in invoices that already are retained for tax purposes (IRS, 2016a, IRS 2016b). However, distributors of products containing methylene chloride or NMP may not know how much methylene chloride or NMP is in each product they ship and may incur some additional time burden associated with determining this. While only certain of these distributors are expected to have incremental recordkeeping costs under the proposed rule, EPA makes the simplifying assumption that each wholesaler firm will spend one hour researching and recording the methylene chloride or NMP concentration of the products they distribute.
Once a wholesaler becomes familiar with the amount of methylene chloride or NMP in each product shipped, the action would not need to be repeated; therefore, EPA estimates this as a one-time burden. However, this is a continuing requirement of the rule. Therefore, should new distributors of methylene chloride or NMP-containing products or new methylene chloride or NMP-containing products enter the market, respondents may realize future burden. EPA has no information to estimate the potential for new methylene chloride or NMP-containing products or new respondents subject to the rule to enter the market over the time period of the ICR so the estimate is limited to a one-time burden for distributors.
The burden is estimated to occur during the first year of the ICR only. To develop an estimate of average annual burden across the time period of the ICR, EPA divided the burden per response equally across the three years. Therefore, average burden per respondent for each year is calculated as 1 hour/3 years = 0.33 hours/year.
Costs
EPA assumes no direct costs are associated with this collection. Labor costs are based on fully loaded wage rates. The estimated wage for manufacturers and processors is $72.22. The estimated wage for distributors is $44.23. More detail on the calculation of wage rates is presented in Appendix 2.
IC #1: Methylene chloride or NMP manufacturer downstream notification and recordkeeping activities
This Information Collection would be required for the proposed approach for methylene chloride and only under the first co-proposed approach for NMP. Respondent NAICS Codes associated with industries most likely affected by the paperwork requirements are listed in section 5(a).
213112 314999 |
Support Activities for Oil and Gas Operations All Other Miscellaneous Textile Product Mills |
324110 |
Petroleum Refineries |
324191 |
Petroleum Lubricating Oil and Grease Manufacturing |
325110 |
Petrochemical Manufacturing |
325120 |
Industrial Gas Manufacturing |
325180 |
Other Basic Inorganic Chemical Manufacturing |
325199 |
All Other Basic Organic Chemical Manufacturing |
325211 |
Plastics Material and Resin Manufacturing |
325212 |
Synthetic Rubber Manufacturing |
325510 |
Paint and Coating Manufacturing |
325520 |
Adhesive Manufacturing |
325611 |
Soap and Other Detergent Manufacturing |
325612 325613 |
Polish and Other Sanitation Good Manufacturing Surface Active Agent Manufacturing |
325998 |
All Other Miscellaneous Chemical Product and Preparation Manufacturing |
326113 |
Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing |
326199 |
All Other Plastics Product Manufacturing |
326220 |
Rubber and Plastics Hoses and Belting Manufacturing |
326299 |
All Other Rubber Product Manufacturing |
327310 |
Cement Manufacturing |
327992 |
Ground or Treated Mineral and Earth Manufacturing |
332117 |
Powder Metallurgy Part Manufacturing |
332119 |
Metal Crown, Closure, and Other Metal Stamping (except Automotive) |
332216 |
Saw Blade and Hand Tool Manufacturing |
332321 |
Metal Window and Door Manufacturing |
332410 |
Power Boiler and Heat Exchanger Manufacturing |
332618 |
Other Fabricated Wire Product Manufacturing |
332710 |
Machine Shops |
332721 |
Precision Turned Product Manufacturing |
332722 |
Bolt, Nut, Screw, Rivet, and Washer Manufacturing |
332811 |
Metal Heat Treating |
332812 |
Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers |
333132 |
Oil and Gas Field Machinery and Equipment Manufacturing |
333515 |
Cutting Tool and Machine Tool Accessory Manufacturing |
332994 |
Small Arms, Ordnance, and Ordnance Accessories Manufacturing |
333996 |
Fluid Power Pump and Motor Manufacturing |
332999 |
All Other Miscellaneous Fabricated Metal Product Manufacturing |
333515 |
Cutting Tool and Machine Tool Accessory Manufacturing |
333911 |
Pump and Pumping Equipment Manufacturing |
333996 |
Fluid Power Pump and Motor Manufacturing |
334511 |
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing |
334512
334516 |
Automatic Environmental Control Manufacturing for Residential, Commercial, and Appliance Use Analytical Laboratory Instrument Manufacturing |
335312 335911 |
Motor and Generator Manufacturing Storage Battery Manufacturing |
335912 335921 |
Primary Battery Manufacturing Fiber Optic Cable Manufacturing |
335991 |
Carbon and Graphite Product Manufacturing |
336340 |
Motor Vehicle Brake System Manufacturing |
336411 |
Aircraft Manufacturing |
336413 |
Other Aircraft Parts and Auxiliary Equipment Manufacturing |
336414 |
Guided Missile and Space Vehicle Manufacturing |
336611 |
Ship Building and Repairing |
339114 424310 |
Dental Equipment and Supplies Manufacturing Piece Goods, Notions, and Other Dry Goods Merchant Wholesalers |
424690 |
Other Chemical and Allied Products Merchant Wholesalers |
424710 |
Petroleum Bulk Stations and Terminals |
562211 |
Hazardous Waste Treatment and Disposal |
562213 |
Solid Waste Combustors and Incinerators |
IC #2: NMP processor reformulation and labeling
This Information Collection would be required only under the second co-proposed approach for NMP. Respondent NAICS Codes associated with industries most likely affected by the paperwork requirements are listed in section 5(a).
213112 314999 |
Support Activities for Oil and Gas Operations All Other Miscellaneous Textile Product Mills |
324110 |
Petroleum Refineries |
324191 |
Petroleum Lubricating Oil and Grease Manufacturing |
325110 |
Petrochemical Manufacturing |
325120 |
Industrial Gas Manufacturing |
325180 |
Other Basic Inorganic Chemical Manufacturing |
325199 |
All Other Basic Organic Chemical Manufacturing |
325211 |
Plastics Material and Resin Manufacturing |
325212 |
Synthetic Rubber Manufacturing |
325510 |
Paint and Coating Manufacturing |
325520 |
Adhesive Manufacturing |
325611 |
Soap and Other Detergent Manufacturing |
325612 325613 |
Polish and Other Sanitation Good Manufacturing Surface Active Agent Manufacturing |
325998 |
All Other Miscellaneous Chemical Product and Preparation Manufacturing |
326113 |
Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing |
326199 |
All Other Plastics Product Manufacturing |
326220 |
Rubber and Plastics Hoses and Belting Manufacturing |
326299 |
All Other Rubber Product Manufacturing |
327310 |
Cement Manufacturing |
327992 |
Ground or Treated Mineral and Earth Manufacturing |
332117 |
Powder Metallurgy Part Manufacturing |
332119 |
Metal Crown, Closure, and Other Metal Stamping (except Automotive) |
332216 |
Saw Blade and Hand Tool Manufacturing |
332321 |
Metal Window and Door Manufacturing |
332410 |
Power Boiler and Heat Exchanger Manufacturing |
332618 |
Other Fabricated Wire Product Manufacturing |
332710 |
Machine Shops |
332721 |
Precision Turned Product Manufacturing |
332722 |
Bolt, Nut, Screw, Rivet, and Washer Manufacturing |
332811 |
Metal Heat Treating |
332812 |
Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers |
333132 |
Oil and Gas Field Machinery and Equipment Manufacturing |
333515 |
Cutting Tool and Machine Tool Accessory Manufacturing |
332994 |
Small Arms, Ordnance, and Ordnance Accessories Manufacturing |
333996 |
Fluid Power Pump and Motor Manufacturing |
332999 |
All Other Miscellaneous Fabricated Metal Product Manufacturing |
333515 |
Cutting Tool and Machine Tool Accessory Manufacturing |
333911 |
Pump and Pumping Equipment Manufacturing |
333996 |
Fluid Power Pump and Motor Manufacturing |
334511 |
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing |
334512
334516 |
Automatic Environmental Control Manufacturing for Residential, Commercial, and Appliance Use Analytical Laboratory Instrument Manufacturing |
335312 335911 |
Motor and Generator Manufacturing Storage Battery Manufacturing |
335912 335921 |
Primary Battery Manufacturing Fiber Optic Cable Manufacturing |
335991 |
Carbon and Graphite Product Manufacturing |
336340 |
Motor Vehicle Brake System Manufacturing |
336411 |
Aircraft Manufacturing |
336413 |
Other Aircraft Parts and Auxiliary Equipment Manufacturing |
336414 |
Guided Missile and Space Vehicle Manufacturing |
336611 |
Ship Building and Repairing |
339114 424310 |
Dental Equipment and Supplies Manufacturing Piece Goods, Notions, and Other Dry Goods Merchant Wholesalers |
424690 |
Other Chemical and Allied Products Merchant Wholesalers |
424710 |
Petroleum Bulk Stations and Terminals |
562211 |
Hazardous Waste Treatment and Disposal |
562213 |
Solid Waste Combustors and Incinerators |
Information Collection Activities
Under the proposed approach for methylene chloride and the first co-proposed approach for NMP, the proposed rule imposes downstream notification requirements and limited recordkeeping requirements on persons who manufacture any methylene chloride or NMP. Each person who manufactures methylene chloride or NMP for any use must notify companies to whom methylene chloride or NMP is shipped of the following prohibitions: (1) All persons are prohibited from manufacturing, processing, and distributing in commerce methylene chloride or NMP for consumer paint and coating removal; (2) All persons are prohibited from manufacturing, processing, and distributing in commerce methylene chloride for commercial paint and coating removal except for uses identified as critical for national security (3) All persons are prohibited from manufacturing, processing, and distributing in commerce NMP for commercial paint and coating removal; (4) All persons are prohibited from commercial use of methylene chloride in paint and coating removal except for uses identified as critical for national security; and (5) All persons are prohibited from commercial use of NMP in paint and coating removal. Additionally, each person who manufactures, processes, or distributes methylene chloride or NMP for any use would be required to retain records for 3 years showing: (1) The name, address, contact, and telephone number of companies to whom methylene chloride, NMP, or products containing methylene chloride or NMP was shipped, and (2) the chemicals included in the shipment and the amount of each chemical shipped.
In addition to the requirements, EPA also expects that each manufacturer (including importers), processor, and distributor of products that contain methylene chloride or NMP will incur burden becoming familiar with the requirements of the rule and developing an understanding of what actions are necessary to comply with the downstream notification and recordkeeping requirements. Details on the burden estimate calculations per activity are presented in section 5(a). The table below presents the estimated average annual burden for each activity and each respondent type. Note: The total number of respondents includes an entity who is counted twice as a processor and distributor.
IC# 1. Methylene chloride or NMP Manufacturers, Processors, Distributors Downstream Notification and Recordkeeping activities1 |
||||||
Activity/Respondent
|
Number of Respondents |
Responses per Respondent |
Total Responses |
Burden per Response (hours) |
Total Burden (hours) |
Cost |
Rule Familiarization |
||||||
Methylene Chloride or NMP manufacturers
|
29 |
1
|
29 |
.167 |
4.8 |
$347 |
Methylene Chloride or NMP processors
|
16 |
1 |
16 |
.167 |
2.7 |
$193 |
Methylene Chloride or NMP distributors |
282 |
1 |
282 |
.167 |
47 |
$2,093 |
Downstream Notification |
||||||
Methylene Chloride or NMP manufacturers |
29 |
1 |
29 |
.33 |
9.6 |
$693 |
Methylene Chloride or NMP processors |
16 |
1 |
16 |
.33 |
5.3 |
$383 |
Recordkeeping |
||||||
Methylene Chloride or NMP distributors |
282 |
1 |
282 |
.33 |
93 |
$4,141 |
Total Burden for all Activities by Respondent |
||||||
Methylene Chloride or NMP Manufacturers |
29 |
1 |
29 |
.5 |
14.5 |
$1,047 |
Methylene Chloride or NMP Processors |
16 |
1 |
16 |
.5 |
8 |
$578 |
Methylene Chloride or NMP Distributors |
282 |
1 |
282 |
.5 |
141 |
$6,279 |
Total |
327 |
|
327 |
|
163.5 |
$7,904 |
Under the proposed approach for methylene chloride and the second co-proposed approach for NMP, the rule would place the same requirements as described above related to methylene chloride, and would require that each person who manufactures NMP for any use must notify companies to whom NMP is shipped of the following restriction: Formulations of NMP for commercial or consumer paint and coating removal must not contain more than 35 percent by weight of NMP. Additionally, each person who manufactures, processes, or distributes NMP for any use would be required to retain records for 3 years showing: (1) The name, address, contact, and telephone number of companies to whom NMP, or products NMP was shipped, and (2) the chemicals included in the shipment and the amount of each chemical shipped.
Also under the second co-proposed approach for NMP, the rule would require that each processor of paint and coating removal products containing NMP 1) perform glove permeability testing on each paint remover product containing NMP using methods similar to the Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact (ASTM-F739); 2) label products to identify which gloves provide dermal protection against the product formulation; 3) label products with specific information about risks presented by the chemical and how to reduce those risks through increasing ventilation, wearing the specified gloves; respiratory protection; and other work practices; 4) retain relevant records for this glove permeability testing.
In addition to the requirements, EPA also expects that each manufacturer (including importers), processor, and distributor of products that contain methylene chloride or NMP will incur burden becoming familiar with the requirements of the rule and developing an understanding of what actions are necessary to comply with the downstream notification and recordkeeping requirements. Details on the burden estimate calculations per activity are presented in section 5(a). The table below presents the estimated average annual burden for each activity and each respondent type. Note: The total number of respondents includes entities who may be counted in multiple categories.
IC# 2. Methylene chloride or NMP Manufacturers, Processors, Distributors Downstream Notification, Recordkeeping activities, Glove Testing, Relabeling1 |
|||||||||
Activity/Respondent |
Number of Respondents |
Responses per Respondent |
Total Responses |
Burden per Response (hours) |
Total Burden (hours) |
Total Labor Cost |
Material Cost per response |
Total Material Cost |
Total Cost |
Rule Familiarization |
|||||||||
Methylene Chloride or NMP manufacturers |
29 |
1 |
29 |
0.167 |
4.8 |
$350 |
0 |
0 |
$350 |
Methylene Chloride or NMP processors |
16 |
1 |
16 |
0.167 |
2.7 |
$193 |
0 |
0 |
$193 |
Methylene Chloride or NMP distributors |
282 |
1 |
282 |
0.167 |
47 |
$2,083 |
0 |
0 |
$2,083 |
Downstream Notification |
|||||||||
Methylene Chloride or NMP manufacturers |
29 |
1 |
29 |
0.33 |
9.6 |
$691 |
0 |
0 |
$691 |
Methylene Chloride or NMP processors |
16 |
1 |
16 |
0.33 |
5.3 |
$381 |
0 |
0 |
$381 |
Recordkeeping |
|||||||||
Methylene Chloride or NMP distributors |
282 |
1 |
282 |
0.33 |
93.1 |
$4,116 |
0 |
0 |
$4,116 |
NMP Processors |
7 |
9 |
63 |
0.33 |
20.8 |
$1,605 |
0 |
0 |
$1,605 |
Glove Testing |
|||||||||
NMP Processors |
7 |
9 |
63 |
13.33 |
840.0 |
$60,665 |
$12,897 |
$812,511 |
$873,176 |
Relabeling |
|||||||||
NMP Processors |
7 |
9 |
63 |
0.83 |
52.5 |
$3,792 |
$600 |
$37,800 |
$41,592 |
Total Burden for all Activities by Respondent |
|||||||||
Methylene Chloride or NMP Manufacturers |
29 |
1 |
29 |
0.5 |
14.5 |
$1,047 |
0 |
$ - |
$1,047 |
Methylene Chloride Processors |
10 |
1 |
10 |
0.5 |
5 |
$361 |
0 |
$ - |
$578 |
NMP Processors |
7 |
9 |
63 |
14.66 |
924 |
$66,718 |
$13,497 |
$850,311 |
$917,029 |
Methylene Chloride or NMP Distributors |
282 |
1 |
282 |
0.5 |
141 |
$6,236 |
0 |
$ - |
$ 6,236.43 |
Total |
327 |
|
384 |
|
1,084 |
$74,362 |
|
$ 850,311 |
$ 924,890 |
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PRA Burden Statement
Under the PRA, burden is defined at 5 CFR 1320.3(b).
This is a new, rule-related information collection. Under the proposed approach for methylene chloride and the first co-proposed approach for NMP, the total burden requested for this ICR is 163.5 hours per year. The total annual cost burden requested for this ICR is $7,904. Under the proposed approach for methylene chloride and the second co-proposed approach for NMP, the total burden requested for this ICR is 1,084 hours per year. The total annual cost burden requested for this ICR is $924,890. You may submit comments regarding the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Comments, referencing Docket ID No. EPA-HQ-OPPT-2016-0231 and OMB Control No. 2070-NEW (EPA ICR No. 2556.01), may be submitted to EPA electronically through http://www.regulations.gov and to OMB, addressed to “OMB Desk Officer for EPA” and referencing OMB Control No. 2070-NEW (EPA ICR No. TBD), via email to [email protected].
References
U.S. Census Bureau (2012a). 2012 Statistics of U.S. Businesses- Number of Firms, Number of Establishments, Employment, Annual Payroll, and Estimated Receipts by Enterprise Employment Size for the United States, All Industries: 2012.
U.S. Census Bureau (2012b). Geographic Areas Series: U.S. Nonemployer Statistics 2012.
U.S. Environmental Protection Agency (EPA) (2014a). Downloadable of the Non-Confidential Chemical Data Reporting (CDR) Database. Office of Pollution Prevention and Toxics.
U.S. Internal Revenue Service (IRS) (2016a). https://www.irs.gov/Businesses/Small-Businesses-&-Self-Employed/What-kind-of-records-should-I-keep, accessed April 22, 2016.
U.S. Internal Revenue service (IRS) (2015). Publication 583. Starting a Business and Keeping
Records. January 2015.
Attachments to the ICR supporting statement are available in the public docket established for the rulemaking under docket identification number EPA-HQ-OPPT-2016-0231. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in the following listing.
Attachment 1: |
Calculation of Wage Rates |
|
|
Page
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Angela Hofmann |
| File Modified | 0000-00-00 |
| File Created | 2021-01-23 |
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