82 FR 4805 - Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 10 (January 17, 2017)
Federal Register Volume 82, Issue 10 (January 17, 2017)
| Page Range | 4805-4825 | |
| FR Document | 2017-00743 |
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)] [Proposed Rules] [Pages 4805-4825] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00743] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 141 and 143 [EPA-HQ-OW-2015-0680; FRL-9958-23-OW] RIN 2040-AF55 Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Environmental Protection Agency (EPA) proposes to make conforming changes to existing drinking water regulations based on the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA). Section 1417 of the Safe Drinking Water Act (SDWA) prohibits the use and introduction into commerce of certain plumbing products that are not lead free. The RLDWA revised the definition of lead free to lower the allowable maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of plumbing products and established a statutory method for calculating lead content. In addition, the RLDWA created exemptions from the lead free requirements for plumbing products that are used exclusively for nonpotable services as well as for other specified products. The CFSA further amended section 1417 to exempt fire hydrants from these requirements. EPA proposes to establish new requirements to assure that individuals purchasing, installing or inspecting potable water systems can identify lead free plumbing materials. Specifically, EPA proposes to establish labeling requirements to differentiate plumbing products that meet the lead free requirements from those that are exempt from the lead free requirements and to require manufacturers to certify compliance with the lead free requirements. These proposed requirements would reduce inadvertent use of non-lead free plumbing products in potable use applications and, consequently, reduce exposure to lead in drinking water and associated adverse health effects. DATES: Comments must be received on or before April 17, 2017. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW- 2015-0680, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets. FOR FURTHER INFORMATION CONTACT: Russ Perkinson, telephone number: 202-564-4901; email address: [email protected], Office of Ground Water and Drinking Water, Standards and Risk [[Page 4806]] Management Division (4607), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460. SUPPLEMENTARY INFORMATION: Abbreviations and Acronyms AFS--American Foundries Society ANSI--American National Standards Institute CFSA--Community Fire Safety Act of 2013 CFR--Code of Federal Regulations FAQs--Frequently Asked Questions O&M--Operations and Maintenance NAICS--North American Industry Classification System NSF--NSF International PMI--Plumbing Manufacturers International RFA--Regulatory Flexibility Act RLDWA--Reduction of Lead in Drinking Water Act of 2011 SDWA--Safe Drinking Water Act SIC--Standard Industrial Classification UL--Underwriters Laboratories Table of Contents I. General Information A. Does this action apply to me? B. What action is EPA taking? C. What is EPA's authority for taking this action? D. What are the costs and benefits of this action? II. Background III. Summary of Data Used A. Characterization of the Affected Industry B. Determining Baseline Industry Practices and Potential Costs of Compliance IV. Proposed Regulatory Provisions A. Scope/Applicability of Proposed Rule B. Labeling of Potable Use Products C. Exempt Products D. Product Certification E. Other Regulatory Requirements and Clarifications F. Implementation V. Costs A. Initial Administrative and Initial Implementation Costs B. Labeling Potable Use Products C. Labeling Products Eligible for the ``Used Exclusively'' Exemption D. Product Certification E. Response to EPA Data Request Costs F. Other Regulatory Requirements and Clarifications VI. Economic Impacts Analysis A. Annualized Social Costs Estimates B. Economic Impacts--Cost-to-Revenue Analysis VII. Benefits VIII. Statutory and Executive Orders Reviews IX. References I. General Information A. Does this action apply to me? The statutory prohibitions on use and introduction into commerce of certain products that are not lead free codified by this rule apply to ``any person'' as defined in the Safe Drinking Water Act (SDWA). This rule implementing those provisions applies to any person who would introduce plumbing products into commerce, such as manufacturers, importers, wholesalers, distributors, re-sellers, retailers, and to any person who would use plumbing products in a public water system or in a residential or non-residential facility providing water for human consumption. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section. B. What action is EPA taking? EPA is proposing this regulation to codify revisions to the SDWA prohibition on use and introduction into commerce of certain products that are not lead free (hereafter termed the SDWA lead prohibitions) as enacted in the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA). EPA is also proposing requirements to certify and label plumbing products introduced into commerce to assure they are lead free. SDWA 1417(a)(1) prohibits the ``use of any pipe, any pipe or plumbing fitting or fixture, any solder, or any flux in the installation or repair of any public water system; or any plumbing in a residential or non-residential facility providing water for human consumption, that is not lead free'' as defined in section 1417(d). Section 1417(a)(3) provides that ``it shall be unlawful (A) for any person to introduce into commerce any pipe, or any pipe or plumbing fitting or fixture, that is not lead free, except for a pipe that is used in manufacturing or industrial processing; (B) for any person engaged in the business of selling plumbing supplies, except manufacturers, to sell solder or flux that is not lead free; or (C) for any person to introduce into commerce any solder or flux that is not lead free unless the solder or flux bears a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing providing water for human consumption.'' The 2011 RLDWA revised section 1417 to redefine lead free in SDWA section 1417(d) to lower the maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of plumbing products; established a statutory method for the calculation of lead content; and eliminated the requirement that lead free products be in compliance with voluntary standards established in accordance with SDWA 1417(e) for leaching of lead from new plumbing fittings and fixtures. In addition, the RLDWA created exemptions in SDWA section 1417(a)(4) from the prohibitions on the use or introduction into commerce for ``pipes, pipe fittings, plumbing fittings, or fixtures, including backflow preventers, that are used exclusively for nonpotable services such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption'' (SDWA 1417(a)(4)(A)), as well as for ``toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, service saddles, or water distribution main gate valves that are 2 inches in diameter or larger.'' (SDWA 1417(a)(4)(B)). The CFSA further amended section 1417 to exempt fire hydrants. In addition to codifying the revised requirements under RLDWA and CFSA, EPA is proposing product certification requirements and data gathering authorities to ensure consistent implementation and enforcement of the SDWA lead prohibition, as well as new labeling requirements to assure that individuals purchasing, installing or inspecting potable water systems can identify lead free plumbing materials. Specifically, EPA proposes to establish labeling requirements to differentiate plumbing products that meet the lead free requirements from those that are exempt from the lead free requirements and to require manufacturers to certify compliance with the lead free requirements. These proposed requirements would reduce inadvertent use of non-lead free plumbing products in potable use applications and, consequently, reduce exposure to lead in drinking water and associated adverse health effects. The goals of these proposed regulatory provisions are to limit accidental lead exposure by clearly identifying those products to be used or not used for potable services; and to ensure that plumbing products that are identified as lead free for use in potable services meet the requirements of the SDWA lead prohibition. C. What is EPA's authority for taking this action? EPA's authority for this proposed rule is sections 1417, 1445 and 1450 of the SDWA, 42 U.S.C. 300j-6, 300j-4, and 300j-9. SDWA section 1417 authorizes the EPA Administrator to ``prescribe such regulations as are necessary or appropriate to carry out his/her functions under this subchapter.'' EPA's current regulations (40 CFR 141.43) codify parts of section 1417 of the SDWA, but they do not reflect the current version of section 1417, as [[Page 4807]] amended by the RLDWA and the CFSA. This proposed rule would amend those regulations to reflect the current law. In addition, because the RLDWA created exemptions from the use prohibition in section 1417(a)(1) and the introduction into commerce prohibition in section 1417(a)(3), EPA proposes additional regulations to aid in the implementation and enforcement of these prohibitions. D. What are the costs and benefits of this action? EPA conducted an incremental compliance cost analysis of this proposed rule. For detail on the cost analysis see sections V and VI of this notice. The Technical Support Document (USEPA, 2016) prepared for this proposed rule and available in the docket for this proposed rule contains the detailed description of the cost assessment. EPA did not conduct a quantified and monetized benefits analysis, but a qualitative discussion of the benefits attributable to this rule can be found in section VII and in the Technical Support Document. Total annualized costs for the proposed rule range from $12 million discounted at three percent to $18 million discounted at seven percent. These costs include administrative requirement costs, the cost to potable use product manufacturers for both labeling on the product and on the product's packaging, the cost to manufacturers employing the ``used exclusively'' exemption for package labeling indicating non- potable uses, third party and self-certification costs and the costs of responding to EPA data requests. The proposed rule would reduce inadvertent use of non-lead free plumbing products in potable use applications and, as a result, would reduce exposure to lead in drinking water. The benefits of this proposed rule would be the resulting incremental reduction in the adverse health effects of low doses of lead, which include adverse neurological, cardiovascular, renal, reproductive, developmental, immunological and carcinogenic effects. II. Background Lead can be introduced into drinking water by corrosion of plumbing products (pipes, pipe and plumbing fittings and fixtures, solder, and flux). Lead exposure causes damage to the brain and kidneys, and can interfere with the production of red blood cells that carry oxygen to all parts of the body. The greatest risk associated with lead exposure is to infants, young children and pregnant women. Scientists have linked the effects of lead on the brain with lowered IQ in children. In 1986, Congress amended the SDWA to prohibit the use of pipes, solder or flux that are not ``lead free'' in public water systems or plumbing in facilities providing water for human consumption. At the time, lead free was defined as solder and flux with no more than 0.2 percent lead and pipes with no more than 8.0 percent lead. In 1996, Congress further amended the SDWA to prohibit the use of pipe and plumbing fittings and fixtures that are not lead free in the installation and repair of any public water system or plumbing in a facility providing water for human consumption. The 1996 amendments also required lead free plumbing fittings and fixtures (endpoint devices) to be in compliance with a lead leaching standard established in accordance with section 1417(e). The 1996 amendments also made it unlawful for any person to introduce into commerce any pipe, pipe or plumbing fitting, or fixture that is not lead free, except for a pipe that is used in manufacturing or industrial processing. As amended in 1996, SDWA section 1417(a)(3)(B) prohibits ``any person engaged in the business of selling plumbing supplies, except manufacturers, to sell solder or flux that is not lead free,'' and SDWA section 1417(a)(3)(C) makes it unlawful ``for any person to introduce into commerce any solder or flux that is not lead free unless the solder or flux bears a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing of water for human consumption.'' In 2011, Congress enacted the RLDWA. It revised the definition of lead free by lowering the allowable maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of plumbing products. It also revised the definition of lead free to include a statutory method for the calculation of lead content, and eliminated the requirement that lead free products be in compliance with standards established in accordance with SDWA section 1417(e) for leaching of lead from new plumbing fittings and fixtures. The 2011 RLDWA also established two types of exemptions from the section 1417 prohibitions on the use or introduction into commerce of pipes, pipe fittings, plumbing fittings or fixtures, solder or flux not meeting the statutory definition of lead free. One exemption is for pipes, pipe fittings, plumbing fittings or fixtures, including backflow preventers, that are used exclusively for non-potable services, such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption (SDWA 1417(a)(4)(A)). A second exemption was established for toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, service saddles, or water distribution main gate valves that are 2 inches in diameter or larger (SDWA 1417(a)(4)(B)). The RLDWA established a prospective effective date of January 4, 2014, which provided a three-year timeframe for affected parties to transition to the new requirements. The CFSA further amended SDWA section 1417 to exempt fire hydrants from the prohibitions otherwise applicable under that section. In anticipation of these changes taking effect, EPA provided a summary of the requirements of the lead ban provisions in SDWA section 1417 and answers to frequently asked questions (FAQs) related to the amendments to assist manufacturers, retailers, plumbers and consumers in understanding the changes to the law (USEPA, 2013a). In this FAQ document, EPA stated its intention to further evaluate and refine the issues raised in the FAQ in a future rulemaking. III. Summary of Data Used A. Characterization of the Affected Industry A number of data sources were used in the characterization of the plumbing manufacturing industry. GMP Research, Inc., provided a report to EPA in 2014, which included data on the total number of both potable and non-potable plumbing products sold in 2013, distributed across 40 product subcategories, and the market share of the leading suppliers by each product subcategory that may be subject to EPA's proposed rule. These data were supplemented with information from a number of additional sources. Dun & Bradstreet data were obtained for those firms that were identified by North American Industry Classification System (NAICS) and Standard Industrial Classification (SIC) code classifications as potentially producing plumbing products that would be affected by the proposed rule. Additional data for plumbing manufacturers and fabricators were obtained from ThomasNet, a comprehensive online database that provides information on manufacturing firms in the United States. EPA also used NSF International's Certified Drinking Water System Components database, which provides a list of manufacturers who use NSF to certify [[Page 4808]] their products to NSF/ANSI Standard 61, including the subset of products that are certified to Annex G of that standard. Additional information was gathered from the Plumbing Manufacturers International (PMI) Web site, a plumbing industry trade association. EPA used data on the number of employees and annual receipts for firms from the U.S. Census Bureau's Statistics of U.S. Businesses. Information used in the development of industry production growth was obtained from both the GMP Research, Inc., report and projections on United States housing growth from IHS Global Insight. The Technical Support Document (USEPA, 2016) contains more information and data sources used and is available in the docket. B. Determining Baseline Industry Practices and Potential Costs of Compliance EPA conducted calls with representatives of both the PMI and the American Foundries Society (AFS) industry associations and held a stakeholder webinar in 2015 in order to obtain information on current practice within the plumbing parts manufacturing industry, in regard to labeling of product packages, marking of the plumbing products themselves, and the technical feasibility and costs associated with making changes to product labeling and marking. Additionally, the two industry associations provided information to EPA on product identification methods, including the estimated percentage of products that currently include lead free identification and general cost information for modifications to package labeling and product marking. Information on the feasibility and time requirements for changing production molds in response to potential regulatory requirements was also discussed, along with plumbing product inventory turnover rates. The trade associations also provided information on the use and costs of third party certification in the industry. In addition, data were obtained from a number of independent geographically diverse tool and dye firms on the cost of mold modifications. EPA also contacted suppliers to obtain capital equipment and operations and maintenance (O&M) costs to allow the Agency to estimate the economic impact of potential new labeling requirements under the proposed rule. EPA also contacted the eight firms currently accredited to certify plumbing components for compliance with NSF/ANSI Standard 372, for information on the cost of certification and the technical process for testing and certifying products as meeting the standard. IV. Proposed Regulatory Provisions A. Scope/Applicability of Proposed Rule The statutory prohibition on the use or introduction into commerce of pipes, pipe and plumbing fittings, fixtures, solder and flux that are not lead free, and the corresponding requirements described in this proposal would apply to any person. ``Person'' is defined under the SDWA to include individuals; corporations; companies; associations; partnerships; municipalities; or state, federal or tribal agencies. The statutory ban on selling solder and flux that is not lead free applies only to ``any person engaged in the business of selling plumbing supplies.'' The use prohibition applies only to use in the ``installation or repair'' of any public water system or any plumbing in a residential or nonresidential facility or location that provides water for human consumption. EPA solicits comments on all aspects of the proposed approach set forth in this notice. EPA specifically solicits comments, information and data on the following topics: 1. In order to clarify the requirements, set forth in the RLDWA and this proposal, EPA defined terms, such as ``pipes,'' ``fittings,'' ``fixtures,'' ``solder,'' ``flux'' and several subcategories of these components, which are terms used in the statute, but are not defined within section 1417 of the SDWA. EPA included these and other definitions to provide clarity to provisions of the proposed rule. EPA requests comment concerning the appropriateness of these definitions and any additional terms that should be defined, specifically terms describing exempt products included in section 1417(a)(4)(B) of the SDWA (e.g., water distribution main gate valve). 2. Section 1461 of the SDWA defines lead free with respect to drinking water coolers to mean that ``each part or component of the cooler which may come into contact with drinking water contains no more than 8 percent lead'' except that any solder, flux or storage tank interior surface may not contain more than 0.2 percent lead. SDWA section 1461(2) also authorizes the Administrator to establish more stringent requirements for treating any part or component of a drinking water cooler as lead free ``whenever he determines that any such part may constitute an important source of lead in drinking water.'' A drinking water cooler is also a ``fixture'' under section 1417 of the SDWA; and, therefore, subject to the definition of lead free in section 1417. To give effect to both provisions, in practice, drinking water coolers would need to comply with the most restrictive of the requirements in sections 1417 and 1461 of the SDWA. For clarity, EPA could consider addressing the requirements of section 1461 in the final rule by inserting language such as: ``In addition to the definitions of ``lead-free'' in Sec. 143.12(a)(1) and (2), no drinking water cooler which contains any solder, flux, or storage tank interior surface which may come into contact with drinking water is lead free if the solder, flux, or storage tank interior surface contains more than 0.2 percent lead. Drinking water coolers must be manufactured such that each individual part or component that may come in contact with drinking water shall not contain more than 8 percent lead while still meeting the maximum 0.25 percent weighted average lead content of the wetted surfaces of the entire product.'' Should EPA consider adding such a provision to the rule? 3. The regulatory modifications in this proposal are designed, in part, to make the requirements set forth in section 1417 of the SDWA clearer and easier to implement and enforce in a consistent manner. Are additional clarifications needed to improve the regulation? If so, what specific clarifications are needed? B. Labeling Potable Use Products EPA evaluated several options concerning labeling of products that comply with the definition of lead free, including a requirement to label a product's packaging, physically marking a product, or a combination of both. EPA found that many manufacturers already utilize a combination of package and product labeling to inform product users that the products comply with the RLDWA and several similar state laws. In an effort to reduce consumer confusion and establish a consistent labeling scheme for these products, EPA proposes to require that all lead free products be labeled on the package, container or tag, as well as marked directly on the product, unless the product is too small for a legible marking (in a type approximately 8 point to 14 point depending on the method of marking and roughness of product surface). Direct product marking to indicate lead free status will assist building inspectors in verifying that installations are in compliance with plumbing codes and allow for identification of products if they become separated from packaging prior to installation. Separation from [[Page 4809]] packaging is likely to occur when used products are salvaged and sold or reused. After a product has been installed, a marking on the product itself will aid inspectors in identifying products that are lead free. In the long term, product marking to indicate lead free status will help the metals recycling industry segregate scrap materials that may be used to produce future products with low lead content. This proposal provides that products that are too small to be marked on the product would be exempt from product marking, but would still need to comply with package, container or tag labeling. Also, when marking a product directly, the manufacturer should, to the extent practical, locate the marking in an area where it would be visible after installation. For those products where visual aesthetics is a factor in marketing and selling the product, the manufacturer may locate the marking in a manner that will not negatively impact the design. EPA is not proposing a specific phrase be required on products or packages, but rather a performance standard that the phrase clearly conveys to users that the product is in compliance with the lead free requirements of the SDWA. The proposed regulation would include these examples of acceptable phrases for packaging: ``This product conforms to the lead free requirements of the SDWA,'' or ``Lead Free.'' Examples of acceptable product markings include: ``Lead Free,'' ``LF,'' or appropriate third party certification markings such as NSF/ANSI 372. The requirements EPA proposes for lead free products will ensure that purchasers of plumbing products do not inadvertently use products that are not lead free, or re-introduce them into commerce for potable applications (e.g., in the case of a distributor, wholesale supplier, retailer). In addition to the package and product labeling requirement set forth in this proposal, EPA also considered requiring that either the product be marked or the package be labeled, but not both. While this option would decrease the costs and burden on the manufacturer responsible for labeling and marking, EPA is concerned that this option may not provide consumers and others (such as building inspectors) with the information needed to determine that a product is lead free after its initial purchase and installation. If a product is removed from its packaging and stored prior to installation, or if a regulatory body is looking for confirmation after installation that the product meets the lead free requirements, the package labeling would likely be insufficient. Similarly, labeling of a product that is sold in an unlabeled package could also lead to the inadvertent installation of products that did not meet the new definition of lead free for potable purposes. For those reasons, labels on both the package and product are more appropriate (unless the product is too small for a label). EPA solicits comments on all aspects of the proposed approach set forth above. In addition, EPA specifically solicits comments, information and data on the following topics: 1. Whether the rule should require the specific phrase ``lead free'' on package labeling and product markings rather than allowing some discretion in the use of phrases. 2. Whether an alternative specific phrase should be required for product and package labeling and, if so, what phrase. 3. If a specific phrase such as ``lead free'' were required, what period of time should be allowed for a transition period to enable manufacturers to modify their product and packaging to incorporate such phrase? 4. If products were required to use a specific phrase such as ``lead free,'' whether that specific phrase should be required on both the package label and product marking or whether an abbreviated message should instead be allowed on the product. 5. Whether the rule should allow for either package labeling or product marking rather than package labeling and product marking. 6. Whether the rule should require any package labeling or product marking. C. Exempt Products As a result of the exemptions created by the RLDWA, there will be plumbing products in the marketplace that are not required to meet the definition of lead free in section 1417(d) of the SDWA. Therefore, without appropriate labeling, there is a risk that non-lead free products will be inadvertently used in potable water applications or re-introduced into commerce for potable applications. There are several points along the distribution chain where EPA anticipates a non-lead free product could be mistakenly identified as a lead free product, including the initial sale of the product and at the time of installation. Prior to the RLDWA, all plumbing devices were required to contain less than 8.0 percent lead, and certain endpoint devices (e.g., faucets) were required to meet additional standards for lead leaching. The exemptions created in the RLDWA allow for certain pipes, fittings and fixtures to be sold with no limit to the amount of lead they contain. One of the exemptions allows the use and introduction into commerce of pipes, fittings and fixtures that are used exclusively for nonpotable services. EPA has determined that a plumbing product that is physically incompatible with potable drinking water systems, rendering it impossible to be used for potable service, qualifies for this exemption. In addition, EPA also proposes a second option for manufacturers to demonstrate that their product is ``used exclusively'' for nonpotable services and therefore eligible for this exemption (hereafter referred to in this notice as the ``used exclusively'' exemption). As EPA explained in the RLDWA FAQs, EPA would generally consider pipes, fittings or fixtures to be used exclusively for nonpotable services if they are marketed and sold for use in nonpotable services, and prominently and clearly labeled as illegal for use in potable services and not anticipated for use with water for human consumption. This proposal would codify that interpretation of this exemption by allowing the use of a package label (or the product marking for those products sold without an external package) clearly identifying the product as not for use with water for human consumption. A package label, combined with the labeling requirements for products that must meet the lead free requirements (i.e., package labeling and product marking described in section VI.B of this document and described in Sec. 143.17 of this proposed rule), should provide consumers with sufficient information to determine which plumbing products are designed for use with potable water systems; thus significantly reducing the likelihood of improperly installing a non-lead free product. The products specifically listed as exempt in SDWA section 1417(a)(4)(B) would not be subject to these labeling requirements or any of the other requirements of this proposal. These products are exempt from the requirements of this proposal: Toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, fire hydrants, shower valves, service saddles or water distribution main gate valves that are 2 inches in diameter or larger. In addition to the specific plumbing devices excluded in the SDWA, EPA is also proposing to exclude clothes washing machines, fire suppression sprinklers, eyewash devices, sump pumps and emergency drench showers, because EPA is not aware of any potable use for these specific products. [[Page 4810]] EPA solicits comments on all aspects of the proposed approach set forth above. EPA specifically solicits comments, information and data on the following topics: 1. This proposal includes two methods of qualifying for the ``used exclusively for non-potable exemption:'' (a) the product is physically incompatible with potable water systems, or (b) the packaging is clearly labeled that it is not for use for water for human consumption. Are the criteria listed above appropriate for qualifying for the ``used exclusively'' exemption or are there different or additional criteria that EPA should consider? 2. Is there any reason EPA should not extend the used exclusively for non-potable services exemption to plumbing products that are physically compatible with drinking water systems? 3. Will labeling the packaging of pipes, fittings or fixtures as not for use for water for human consumption be sufficient to inform consumers of the appropriate use of the product? 4. In addition to the specific plumbing devices excluded in the SDWA, EPA is also proposing to exclude clothes washing machines, fire suppression sprinklers, eyewash devices, sump pumps and emergency drench showers. EPA is not aware of a potable use for these devices, or of a potable use product that they could be confused with; and as such, requiring a label to qualify for the ``used exclusively'' exemption could be redundant and unnecessary for those devices. Is EPA's assumption about the lack of a potable use for these specific plumbing devices appropriate? 5. Are there other specific plumbing devices for which there are no potable uses, nor a potable use product they could be confused with that should be added to the list of excluded products? 6. EPA is proposing to retain the exemption for leaded joints used in the repair of cast iron pipes. EPA interprets the introduction into commerce provision as not prohibiting the sale or distribution of lead which may be used to form leaded joints used in the repair of cast iron pipes. Congress did not remove the statutory exemption for these types of repairs in section 1417(a)(1)(B) in either the 1996 or the 2011 amendments to section 1417 of the SDWA. Therefore, EPA believes that Congress intended to continue to allow the use of leaded joints necessary for the repair of cast iron pipes. EPA is seeking comment on this interpretation of section 1417(a)(1)(B). D. Product Certification EPA is proposing certification requirements for manufacturers and importers to demonstrate the maximum lead content of the wetted surfaces of their plumbing products do not exceed a weighted average of 0.25 percent using the method for the calculation of lead content established in the statute by either third party certification bodies or self-certification. For products that are required to meet Section 1417's lead free requirements, EPA proposes to require manufacturers with 100 or more employees or importers representing foreign manufacturers with 100 or more employees to demonstrate compliance with the lead free definition by obtaining third party certification by an American National Standards Institute (ANSI) accredited third party certification body. EPA proposes to require manufacturers with fewer than 100 employees or importers representing foreign manufacturers with fewer than 100 employees to demonstrate compliance either through third party certification by an ANSI accredited certification body or through self-certification as described below. Third party certification is currently required for certain products in widely adopted model plumbing codes. The most recent version of the single most widely adopted model plumbing code requires pipe, pipe fittings, joints, values, faucets and fixture fittings used to supply water for drinking or cooking purposes to comply with the NSF/ANSI 372 standard for lead content. To meet the NSF/ANSI 372 standard, a product must be evaluated by an ANSI accredited third party certification body. These are independent organizations that test a product, review a product's manufacturing process and determine that the product complies with specific standards for safety, quality, sustainability or performance (i.e., NSF/ANSI 372 standard for lead content). ANSI accredited third party certification bodies currently include NSF International, CSA Group, ICC Evaluation Services, International Association of Plumbing and Mechanical Officials Research & Testing (IAPMO R&T), Intertek Testing Services, Truesdail Laboratories, Underwriters Laboratories and Water Quality Association. For manufacturers with fewer than 100 employees and importers sourcing products from or representing foreign manufacturers with fewer than 100 employees, the proposed rule provides the flexibility of allowing these entities to demonstrate product compliance by either using an ANSI accredited third party certification body or by self- certification of the products. EPA estimated that manufacturers of covered products having fewer than 100 employees account for 72 percent of the total number of such manufacturers, but only produce 5 to 18 percent of the total volume of products. Small manufacturers that opt for the self-certification option would be required to develop a ``certificate of conformity,'' also known as a declaration of conformity, to attest that products meet the lead free requirements. A similar concept is currently in use for certain products regulated by the Federal Communications Commission and the Consumer Products Safety Commission. For manufacturers or importers electing to self-certify products, the proposed rule would require the manufacturer to post the certificate of conformity on a Web page with continuing public access in the United States. As proposed, the certificate of conformity would be required to include: Contact information for the manufacturer and any importer, a listing of products, statements attesting that the products meet the lead free requirements and that the manufacturer's or importer's eligibility to self-certify the product is consistent with the regulation (i.e., manufacturer has fewer than 100 employees), a statement indicating how the manufacturer or importer verified conformance, and signatory information. The statement indicating how the manufacturer or importer verified conformance could be a brief overview of the general methodology employed, such as: Laboratory testing using X-Ray Fluorescence, other specific technologies, or that all source materials used in manufacture were confirmed to be less than 0.25 percent lead. This proposal would require manufacturers or importers using self-certification to maintain sufficient documentation to confirm that products meet the lead free requirements. The proposed certification requirements will further reduce the likelihood that non-lead free products will either intentionally or inadvertently be placed into commerce or used in the repair or installation of any public water system or any plumbing in a facility providing water for human consumption. In addition, the labeling and the certification requirements will assist in the enforcement of the SDWA section 1417(a)(3) prohibition of the introduction into commerce of pipes, pipe or plumbing fittings or fixtures that are not lead free. A third party certification requirement leverages the [[Page 4811]] resources of the third party certifiers as well as the supply chain to help the market meet the requirements of RDLWA. The self-certification requirement, which is applicable to manufacturers with fewer than 100 employees, while not as rigorous as a requirement to obtain third party certification, nonetheless provides an additional assurance that products sold by those smaller manufacturers are lead free. As an alternative to the proposed product certification requirements previously described, EPA considered requiring all manufacturers to obtain third party certification for products required to meet the lead free requirements. A uniform third party certification requirement would result in a level playing field for all manufacturers and would also make the marketplace consistent when a consumer is shopping for pipes, fittings or fixtures. EPA is not proposing this option because we are concerned about the economic impacts of a mandatory third-party certification requirement on manufacturers with fewer than 100 employees. Some of these manufacturers likely produce or fabricate small quantities of products that may be custom-made for a single specific use with a customer. A requirement for third party certification in these instances may be impractical and costly per unit produced. For those reasons, EPA chose the approach described in this proposal. EPA also considered the option of allowing all manufacturers the option of electing third party certification or self-certification for their various products. This option would allow maximum flexibility for manufacturers and would likely limit financial impacts to firms that currently do not get their products independently certified. EPA opted not to propose this approach because we found that (currently) the most widely used model plumbing codes require many products to be third party certified, and that there already exists a high level of adoption of third party standards in the plumbing industry. Additionally, requiring all but the smallest firms to certify their products using third party certification bodies would ensure that the vast majority of products sold in the marketplace are independently verified as lead free. EPA solicits comments on this aspect of the proposed rule, including EPA's rationale as described in this preamble. In addition, EPA specifically solicits comments, information and data on the following topics: 1. Should third party certification be required of U.S. manufacturers regardless of the number of employees? 2. Should U.S. manufacturers have the option of conducting either third party certification or self-certification for products they produce? 3. Is there a need for some manufacturers to have a self- certification option? 4. Should third party certification be required of importers of foreign manufactured plumbing materials regardless of the number of employees at the foreign manufacturer? 5. Is there a more appropriate break point (e.g., fewer than 20 employees, fewer than 500 employees based on other categories of Census Bureau's Statistics of U.S. Businesses) for allowing self- certification? 6. Conversely, should all importers of foreign manufactured plumbing products be eligible for self-certification? 7. Is the definition of importer in Sec. 143.11 of this proposed rule adequate to ensure compliance with the proposed requirements? 8. Are there more appropriate criteria for requiring third party certification for manufacturers based on classes of products that EPA should evaluate, such as more complicated multi-component devices (for example, valves, faucets, pumps, water coolers, etc.), but allowing an option of self-certification for simple single component plumbing pieces (for example, elbow joint, gasket, pipe, etc.); or alternatively, based on whether a product is mass produced or custom fabricated? 9. Should self-certification be allowed for all products made by any manufacturer if the product is composed of a single material such as pure copper? 10. For self-certification, is the requirement for a ``certificate of conformity'' and its proposed content appropriate, or should there be another process for self-certification or is there other content for the ``certificate of conformity'' that would be more appropriate? 11. Should any product certification be required? E. Other Regulatory Requirements and Clarifications 1. Compliance Information Authority In order to effectively enforce the lead free requirements of the SDWA and the proposed implementing regulations, EPA needs the ability to obtain, if necessary on a case-by-case basis, certain compliance related information from manufacturers, importers, wholesalers and retailers and others subject to SDWA section 1417, such as information related to the calculation of the weighted average of wetted surfaces, schematics of fittings/fixtures, certification documentation, purchases/sales dates, and examples of lead free product and/or package messaging. This proposed rule contains a provision providing the EPA Administrator with explicit authority to request such information on a case-by-case basis and a requirement for entities to provide the information requested to the Administrator. This provision is based on statutory authority contained in section 1445 of the SDWA. 2. State Enforcement of Use Prohibitions EPA is proposing language in Sec. 143.14 to codify in regulation that the SDWA 1417(b) requirement for states to enforce the use prohibition on pipe, pipe fittings or fixtures, any solder, or any flux that are not lead free is a condition of receiving a full Public Water System Supervision grant allocation. Under SDWA 1417(b)(1), the state enforcement provision only applies to the use prohibition in section 1417(a)(1); it does not apply to the introduction into commerce prohibition in section 1417(a)(3) of the SDWA, nor would it apply to the proposed requirements for labeling and certification. F. Implementation The revised definition of lead free has been in effect since January 4, 2014, as per the RLDWA and the CFSA. EPA is proposing that labeling and the product certification requirements contained within this proposal will be in effect three years from the date the final regulation is published, consistent with the three-year time period provided under the RLDWA and CFSA. EPA is also proposing that all other provisions are effective 30 days after the date the final regulation is published, because those provisions merely codify statutory provisions already in effect. EPA solicits comments on all aspects of the proposed implementation period for this proposed rule. EPA specifically requests comments, information and data on whether three years is an appropriate timeframe to achieve compliance with the proposed labeling and certification requirements, or is a different timeframe more appropriate? Is there a need for a different effective date for any other provisions of the rule? V. Costs EPA collected data from public sources and private data vendors to develop the estimated rule costs to plumbing manufacturing firms. Annual [[Page 4812]] production of potable use products and products eligible for the ``used exclusively'' exemption is 1.3 billion units and 500 million units, respectively. There are 2,193 firms producing plumbing products impacted by this proposed rule, which are spread across 14 NAICS codes. Table V.1 summarizes information for the segment of the industry that produces potable use products. Table V.2 summarizes the data for the segment of the industry that produces products eligible for the ``used exclusively'' exemption. Both tables break production into product subcategories and provide EPA's estimated annual production values, the NAICS code assigned and the number of manufacturers in the subcategory. Table V.1--Product Subcategories, Production, NAICS and Number of Manufacturers EPA Identified for Potable Use Products ---------------------------------------------------------------------------------------------------------------- Number of Product category Product name Units produced NAICS for manufacturers annually (2013) product for product ---------------------------------------------------------------------------------------------------------------- Pipe and Fittings............... Copper Tube (<4'' in 233,049,645 332996 213 diameter). PEX Pipe (<4'' in 348,583,587 326122 27 diameter). CPVC Pipe (<4'' in 148,219,048 326122 48 diameter). Copper Fittings (<4'' in 93,219,858 332913 119 diameter). Brass Fittings (<4'' in 80,026,241 332913 523 diameter). PEX Fittings (<4'' in 99,620,061 332913 47 diameter). CPVC Pipe Fittings (<4'' 59,287,619 332913 63 in diameter). Small and Mid-Diameter 58,257,345 326122 143 PVC Pipe. PVC Pipe Fittings....... 14,927,862 332913 103 Faucets and Mixers.............. Kitchen and Bar Faucet 8,531,915 332913 74 Market. Lavatory Faucet......... 18,635,258 332913 74 Kitchen Sinks and Accessories... Kitchen Sink............ 4,730,496 332999 24 Sink Strainer........... 11,036,332 332999 24 Residential Water Filtration Point-of-entry 1,236,699 333318 713 Products. Residential Water Filtration Market. Point-of-use Counter Top 72,857 333318 694 Water Filtration Market. Point-of-use Under the 261,702 333318 704 Sink Water Filtration Market. Point-of-use Faucet 1,707,194 333318 694 Mount Water Filtration Market. Stop Valves, Stainless Steel Stop Valve Market....... 9,455,319 332911 23 Braided Hoses, Inline Valves. ........................ ................ ................ ................ Stainless Steel Braided 9,424,559 333999 204 Hose Market. Residential Inline Valve 30,597,771 332919 204 Market. Water Heaters and Boilers....... Combi Boiler Market..... 55,527 333999 15 Residential Gas Tankless 410,831 335228 20 Water Heater Market. Residential Gas Storage 4,338,506 335228 11 Water Heaters. Residential Electric 4,061,277 335228 11 Storage Water Heaters. Residential Indirect 133,647 335228 10 Fired Water Heater Market. Residential Electric 276,398 335228 19 Tankless Water Heater Market. Residential Solar 21,819 335228 42 Storage Water Heater Market. Residential Oil Water 31,692 335228 1 Heaters. Commercial Gas Storage 89,706 335228 11 Water Heater Market. Commercial Electric 70,071 335228 15 Storage Water Heater Market. Water Coolers/Drinking Fountains/ Water Cooler/Drinking 557,244 333415 5 Bubblers. Fountain/Bubbler Market. Household Appliances............ Refrigerators with Water 4,540,527 335222 7 Dispenser/Ice Making Machinery. Dishwasher Market....... 5,537,416 335228 5 Water Softener Market... 3,444,782 333318 98 Household & Commercial Coffee Makers........... 234,247 333318 40 Appliances. Other........................... Aerator................. 27,167,173 332913 3 Backflow preventers/ 32,202 332913 11 Vacuum Breakers. Gaskets/O-rings......... 5,433,435 339991 13 Pumps................... 1,808,369 333911 19 Water Meters/End Point 7,053,100 334514 68 Meters. ---------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibits 3-3 and 3-11 (USEPA, 2016). Table V.2--Product Subcategories, Production, NAICS and Number of Manufacturers EPA Identified for Products Eligible for the ``Used Exclusively'' Exemption ---------------------------------------------------------------------------------------------------------------- Number of Product category Product name Units produced NAICS for manufacturers annually (2013) product for product ---------------------------------------------------------------------------------------------------------------- Pipe and Fittings............... Copper Tube (<4'' in 81,033,435 332996 213 diameter). Pipe and Fittings Faucets and PEX Pipe (<4'' in 59,116,515 326122 27 Mixers. diameter). [[Page 4813]] CPVC Pipe (<4'' in 39,876,190 326122 48 diameter). Copper Fittings (<4'' in 32,413,374 332913 119 diameter). Brass Fittings (<4'' in 27,825,836 332913 523 diameter). PEX Fittings (<4'' in 16,894,630 332913 47 diameter). CPVC Pipe Fittings (<4'' 15,950,476 332913 63 in diameter). Small and Mid-Diameter 68,389,058 326122 143 PVC Pipe. PVC Pipe Fittings....... 35,048,024 332913 103 Laundry Faucet.......... 1,122,594 332913 72 Stop Valves, Stainless Steel Stop Valve Market....... 62,175,887 332911 23 Braided Hoses, Inline Valves. Stop Valves, Stainless Steel Stainless Steel Braided 106,928,024 333999 204 Braided Hoses, Inline Valves, Hose Market. 1,122,594 332913 3 Other. Aerator................. Other........................... Backflow preventers/ 79,265 332913 11 Vacuum Breakers. Gaskets/O-rings......... 224,519 339991 13 Pumps................... 21,914 333911 19 ---------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibits 3-6 and 3-12 (USEPA, 2016). EPA developed cost estimates for this proposed rule along with two additional regulatory alternatives EPA considered in the development of the proposal. All three regulatory options contain estimates for initial administrative and implementation costs, costs to modify their product and/or package messaging, third party or self-certification costs, and response to data request costs. The three options are presented in Table V.3. Option B is the regulatory option selected for this proposal. The Technical Support Document (USEPA, 2016) provides more detailed information on the costing methodology and a discussion of the uncertainties and limitations of this assessment. Table V.3--Regulatory Options ------------------------------------------------------------------------ Option Option description ------------------------------------------------------------------------ A..................................Product labels and package marking for potable use products. Third party certification required for all firms. B.................................. Product labels and package marking for potable use products. Self-certification or third party certification for <100 Employees; Third party certification only for >=100 Employees. C.................................. Product labels or package marking for potable use products. Third party certification or self-certification for all firms. ------------------------------------------------------------------------ A. Initial Administrative and Initial Implementation Costs The analysis for initial administrative and implementation costs was conducted at the level of the manufacturing firm. These costs do not vary by regulatory option. EPA estimated that it would take each firm an average of 8 hours to read and understand the rule once promulgated. This time estimate when multiplied by an average labor rate of $71.72 and the number of firms affected by the rule, 2,193, gives a total cost of $1.26 million. EPA also estimated the cost to manufacturing firms that would have to redesign their product and/or package messaging to include lead- related information. To calculate the cost of package and product messaging redesign, EPA first estimated the total number of product types across 46 product subcategories. A total of 5,705 product types were identified. EPA estimated a percent range of firms that would be required to redesign their product and package in order to comply with this proposed rule. Firms with greater than 500 employees are estimated to redesign 10 percent of product and package messaging. Manufacturers with fewer than 500 employees are assumed to redesign between 25 and 50 percent of their product and package messaging. Redesign was estimated to require 5 hours of labor multiplied by the number of products, giving a total costs range between $0.24 and $0.47 million. Table V.4 summarizes, by size category, the initial rule implementation annualized cost ranges. The values were discounted at both the 3 and 7 percent rates over the 25-year period of analysis. Annual total initial implementation costs range from $0.08 to $0.14 million. [[Page 4814]] Table V.4--Rule Initial Administrative and Initial Implementation Annualized Costs, in Millions [2014$] -------------------------------------------------------------------------------------------------------------------------------------------------------- Read and understand the rule Messaging design change Initial rule implementation ---------------------------------------------------------------- cost Discount rate Discount rate ------------------------------- Manufacturer size (no. of employees) ---------------------------------------------------------------- Discount rate ------------------------------- 3% 7% 3% 7% 3% 7% -------------------------------------------------------------------------------------------------------------------------------------------------------- <100.................................................... $0.051 $0.073 $0.011-0.021 $0.015-0.03 $0.061-0.072 $0.088-0.103 100-499................................................. 0.001 0.016 0.002-0.005 0.003-0.007 0.014-0.016 0.020-0.023 >=500................................................... 0.008 0.012 0.001-0.001 0.001-0.001 0.009-0.009 0.013-0.013 All Sizes............................................... 0.07 0.101 0.014-0.027 0.02-0.038 0.084-0.097 0.121-0.139 -------------------------------------------------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibits 4-7a and 4-7b (USEPA, 2016). B. Labeling Potable Use Products In order to estimate the potential cost of this proposed rule and the two alternative regulatory scenarios presented in this proposed rule preamble, EPA collected information on current labeling practices to set the regulatory baseline. EPA developed three baseline scenarios characterizing the proportion of firms by size category that either currently have lead free labeling (meeting the requirements of this proposed rule), have product messaging not related to lead free requirements, or have no product messaging. These three scenarios capture the uncertainty surrounding EPA's understanding of current industry labeling practices. Table V.5 presents preexisting labeling assumptions that represent the lower bound for regulatory cost estimates. Table V.6 shows a possible lower level baseline of product labeling. This table represents the upper bound for rule cost estimate. Across both lower and upper bound scenarios, EPA has made the conservative assumption that 5 percent of all firms have no messaging on product or package. Also common across the scenarios, is the concept that firms with greater numbers of employees have larger production totals and serve larger market areas and, therefore, will have a higher probability of selling in markets that already require lead content labeling on product and package. The upper bound scenario assumes manufacturers with fewer than 500 employees mark products with lead content messaging 50 percent of the time, while in the lower bound scenario, those same firms label 75 percent of products with lead content messaging. Also, firms in the upper bound scenario with less than 100 employees mark 50 percent of their packaging with lead content labeling. The lower bound assumes that firms with fewer than 100 employees label 75 percent of packaging with lead content information. Table V.5--Estimated Percentage of Potable Use Products With and Without Existing Messaging [Lower bound] -------------------------------------------------------------------------------------------------------------------------------------------------------- Percent with lead-content Percent with existing Percent with no messaging messaging messaging but not lead-related (incur total messaging costs) -------------------------------- (incur partial messaging ------------------------------- Manufacturer size (number of employees) costs) Product Package -------------------------------- Product Package Product Package -------------------------------------------------------------------------------------------------------------------------------------------------------- <100.................................................... 75 75 20 20 5 5 100-499................................................. 75 90 20 5 5 5 >=500................................................... 90 90 5 5 5 5 -------------------------------------------------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibit 4-8a (USEPA, 2016). Table V.6--Estimated Percentage of Potable Use Products With and Without Existing Messaging [Upper bound] -------------------------------------------------------------------------------------------------------------------------------------------------------- Percent with lead-content Percent with existing Percent with no messaging messaging messaging but not lead-related (incur total messaging costs) -------------------------------- (incur partial messaging ------------------------------- Manufacturer size (number of employees) costs) Product Package -------------------------------- Product Package Product Package -------------------------------------------------------------------------------------------------------------------------------------------------------- <100.................................................... 50 50 45 45 5 5 100-499................................................. 50 90 45 5 5 5 >=500................................................... 90 90 5 5 5 5 -------------------------------------------------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibit 4-8b (USEPA, 2016). Using the assumptions on current industry messaging practices detailed in Tables V.5 and V.6, EPA applied its unit compliance technology costs for both product and package labeling in the following way: (1) Firms that currently have lead content messaging on both product and package are assumed to have no labeling costs in this regulatory analysis; (2) manufacturers that currently mark their product and/or package with some messaging (e.g., company name and marketing materials, a description of how the product is used, installation instructions or other certification and identification information) were assigned a partial cost to implement the requirements of this proposed rule; and (3) firms assumed to have no product labeling on package or product received full capital and O&M [[Page 4815]] costs as part of the regulatory assessment of costs. Under regulatory options requiring lead free marking on potable use products, EPA assigned to each of the 40 identified product subcategories one of three compliance technologies: Printing on product (e.g., copper or plastic pipe), modification of production molds and patterns through the use of electric diode machining (e.g., brass fittings), or attaching a tag with wire or another non adhesive method (e.g., water heaters).\1\ --------------------------------------------------------------------------- \1\ Small products like gaskets and o-rings are assumed to be bagged with lead free messaging. --------------------------------------------------------------------------- For regulatory costing scenarios that required lead free labeling on product packages, EPA (again) assigned one of three compliance technologies to each of the 40 potable use product categories. The compliance technologies are printing on product box (e.g., faucets), printing on product bag (e.g., copper and brass fittings), or adhesive label (e.g., braided steel hose).\2\ --------------------------------------------------------------------------- \2\ Products that are not sold with packaging like pipe are assumed to comply by printing on product. --------------------------------------------------------------------------- Unit capital and O&M costs for each of the six compliance technologies were derived with information collected from both the PMI and AFS trade associations and information from tool and die firms, product packaging vendors, and printing equipment suppliers. Table V.7 provides EPA's estimated total annual cost ranges for potable use product lead free messaging on product and/or package for the three options considered as part of the regulatory analysis. For Options A and B, costs include labeling on both the product and package and range from $8.69 to $13.60 million (2014$) dollars annually. For Option C, which gives producers the choice to label the product or package, EPA assumed that impacted firms would choose the lower cost package labeling alternative; therefore, annual costs range from $1.14 to $1.28 million dollars. Table V.7--Total Annualized Present Value Costs for Lead Free Labeling of Potable Use Products on Product and Package, Millions [2014$] ------------------------------------------------------------------------ 3% Discount rate 7% Discount rate Option in millions in millions (2014$) (2014$) ------------------------------------------------------------------------ A: Product and package messaging $8.69-10.34 $11.32-13.60 B: Product and package messaging 8.69-10.34 11.32-13.60 C: Product or package messaging. 1.17-1.28 1.14-1.26 ------------------------------------------------------------------------ Source: Technical Support Document, Exhibits 4-13a and 4-13b (USEPA, 2016). C. Labeling of Products Eligible for the ``Used Exclusively'' Exemption As discussed in section IV.C, EPA has included an additional means of qualifying for the ``used exclusively'' exemption. The proposed provision to label products to establish that the products are ``used exclusively'' in nonpotable services provides a less costly option to persons introducing the product into commerce. If the proposed regulations limited the availability of the ``used exclusively'' exemption to products that are physically incompatible with potable water systems, then persons introducing non-potable water plumbing products into commerce that are physically compatible and capable of being connected to systems providing water for human consumption would be required to assure that these products meet the lead free requirements. Alternatively, they could or redesign their products to make them physical incompatible with potable water systems. EPA anticipates that the costs associated with designing and applying a label are likely to be less than the costs associated with reformulating the alloy and overhauling the manufacturing processes associated with meeting the ``lead free'' requirements. Therefore, this optional compliance alternative will not result in increased costs or burden, and will result in a cost savings for those manufacturers who elect to take advantage of this proposed optional exemption mechanism. There are six product subcategories that are both physically compatible with potable use applications and would meet the lead content limit of 0.25 percent of wetted surfaces to be considered lead free. In order to develop costs for this requirement EPA first determined the baseline current industry practices when it comes to labeling products eligible for the ``used exclusively'' exemption and their packaging. Table V.8 shows the lower bound percentage of products by firm size category that currently use lead content messaging, messaging of some kind (e.g., marks, serial numbers, installation instructions), and have no labeling on product or packaging. Table V.9 details the upper bound baseline assumed percentages for labeling by firm size for products eligible for the ``used exclusively'' exemption. Table V.8--Estimated Percentage of Products Eligible for ``Used Exclusively'' Exemption With and Without Existing Messaging [Lower bound] -------------------------------------------------------------------------------------------------------------------------------------------------------- Percent with lead-related Percent with existing Percent with no messaging messaging messaging but not lead-related (incur total messaging costs) -------------------------------- (incur partial messaging ------------------------------- Manufacturer size (number of employees) costs) Product (%) Package (%) -------------------------------- Product (%) Package (%) Product (%) Package (%) -------------------------------------------------------------------------------------------------------------------------------------------------------- <100.................................................... 50 50 45 45 5 5 100-499................................................. 75 75 20 20 5 5 [[Page 4816]] >=500................................................... 75 75 20 20 5 5 -------------------------------------------------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibit 4-14a (USEPA, 2016). Table V.9--Estimated Percentage of Products Eligible for ``Used Exclusively'' Exemption With and Without Existing Messaging [Upper bound] -------------------------------------------------------------------------------------------------------------------------------------------------------- Percent with lead-related Percent with existing Percent with no messaging messaging messaging but not lead-related (incur total messaging costs) -------------------------------- (incur partial messaging ------------------------------- Manufacturer size (number of employees) costs) Product (%) Package (%) -------------------------------- Product (%) Package (%) Product (%) Package (%) -------------------------------------------------------------------------------------------------------------------------------------------------------- <100.................................................... 25 25 70 70 5 5 100-499................................................. 50 50 45 45 5 5 >=500................................................... 50 50 45 45 5 5 -------------------------------------------------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibit 4-14b (USEPA, 2016). EPA assumed manufacturers of products eligible for the ``used exclusively'' exemption that currently do not have lead-related information on their product would use the same compliance technologies that would be used for the labeling of potable use products and packages. For labeling on the product, EPA assigned each of the subcategories as either the printing on product or the mold modification compliance technology.\3\ Also, for package compliance, EPA assigned the print on bag compliance technology. Under the ``used exclusively'' exempt package marking requirements, piping products are required to be printed directly on the product since they are generally not packaged. --------------------------------------------------------------------------- \3\ Small products like gaskets and o-rings are assumed to be bagged with lead free messaging. --------------------------------------------------------------------------- EPA used the same unit cost information that was developed for the potable use labeling requirements. Table V.10 details, by size category, the regulatory annual total cost ranges for labeling those products eligible for the ``used exclusively'' exemption not for potable use applications. This cost component does not vary by regulatory option. Annual total cost for labeling products that are not for potable use range from $0.14 to $0.22 million. Exhibit V.10--Total Annualized Present Value Costs for Lead-Related Messaging on Products Eligible for the ``Used Exclusively'' Exemption on Package or Product, Millions [2014$] ------------------------------------------------------------------------ 3% Discount rate 7% Discount rate Manufacturer size (number of in millions in millions employees) (2014$) (2014$) ------------------------------------------------------------------------ <100............................ $0.03-$0.03 $0.02-$0.03 100-499......................... 0.01-0.01 0.01-0.01 >=500........................... 0.11-0.17 0.10-0.16 --------------------------------------- Total Cost.................. 0.15-0.22 0.14-0.20 ------------------------------------------------------------------------ Source: Technical Support Document, Exhibit 4-17 (USEPA, 2016), Rule Component All Sizes worksheet. D. Product Certification In order to develop total compliance costs for third party certification, EPA had to determine the regulatory baseline. This baseline represents the current industry practice with regard to third party certification. EPA collected information on use of third party certification by plumbing manufacturers by reviewing current state laws requiring certification for NSF Standard 61 and 372; reviewing the International and Uniform Plumbing Codes; contacting the two primary industry trade groups, PMI and AFS; and acquiring information from industry third party certifiers (e.g., NSF International, CSA Group, UL, etc.). Based on the collected information, EPA assumed that 90 percent of manufacturers with 100 or greater employees already use an accredited third party agency to certify that their products are lead free. As with potable use product labeling, third party certification costs are a major driver of [[Page 4817]] overall cost to manufacturers; therefore, EPA chose to develop lower and upper bound cost scenarios based on baseline compliance assumptions for firms having less than 100 employees. Fifty to 75 percent of plumbing manufacturers having fewer than 100 employees are assumed to use third party certifiers. Table V.11 summarizes the third party certification baseline assumptions EPA used in the development of regulatory costs. Under all regulatory options, certification costs would only be attributable to those manufacturers that do not already use these third party certification bodies. Table V.11--Estimated Percentage of Manufacturers That Do Not Already Use Third Party Certification Bodies ------------------------------------------------------------------------ Percentage of manufacturers that currently do not use third party Manufacturer size (number of certifying bodies and to which employees) certification costs would apply --------------------------------------- Lower bound (%) Upper bound (%) ------------------------------------------------------------------------ <100............................ 25 50 100-499......................... 10 10 >=500........................... 10 10 ------------------------------------------------------------------------ Source: Technical Support Document, Exhibit 4-18 (USEPA, 2016). Third party certifying firms usually conduct the certification process according to product families. For NSF/ANSI Standard 372, products of the same material formulation and similar configuration are considered one product family. Thus, certifying costs were developed on a product family basis. EPA estimated that each firm produces an average of three product families, based on an assessment of firm Web site data for manufacturers across all potable use product subcategories. Certification costs can be broken into initial assessment and testing costs and annual renewal costs. Most of the accredited third party certification bodies offer an annual renewal based on an audit process for a set number of years after the initial certification year. In order to derive initial and renewal certification unit costs, EPA contacted the eight ANSI accredited third party certification bodies to obtain estimated costs for certifying products to ANSI/NSF Standard 372. The certifiers were asked to provide estimates for four representative product categories (faucets, fittings, valves and pipes), which are intended to represent the range in complexity of plumbing products. Four certification bodies provided quotes of sufficient specificity or comparable scope to be used in estimating initial certification costs. None of the firms provided quotes for all four product lines. Costs varied based on the product type and certifying body. EPA used the average of these quotes across firms and product types to derive a composite estimated cost of $6,000 for an initial certification of a single product family. Five of the eight certification bodies provided estimates for annually renewing the third party certification to Standard 372. Costs varied based on the product type and certification body. One of the responding certifiers requires re-certification annually. The other four certification bodies require renewal on a less frequent basis, the longest being every five years. EPA determined a five-year cost stream for each of the third party certifiers and computed a per product family average annual renewal cost of $3,200. In addition to the certifiers' fees, EPA assumed a $224 annualized cost for recordkeeping on the part of the plumbing manufacturing firms. Both the preferred proposed rule Option B and Option C allow for some firms to self-certify compliance with lead free requirements. EPA estimated that each manufacturer would require 40 hours of labor to initially develop the certificate of conformity (the requirement of the certificate of conformity can be found in section IV.D of this preamble) which certifies a product family as being compliant with the lead free requirements. The unit cost per product family is $1,122. The labor burden for the annual renewal of the self-certification per product family is estimated to be 16 hours. These hours are used to update the certificate of conformity and perform recordkeeping activities. This means the unit cost of annual self-recertification is $449 per product family. Table V.12 provides EPA's estimated total annual cost ranges for potable use product certification requirements of this proposed rule and other options that were considered. Unit certification costs were multiplied by the number of firms and average number of product families. Option A's cost range of $11.20 to $21.58 million reflects a third party certification requirement for all regulated firms. Option B, the proposed option, requires third party certification for firms with 100 or more employees and gives the option of self-certification to firms with fewer than 100 employees. Annual costs for Option B range from $2.82 to $4.31 million. The analysis of Option C assumes that all firms, when given the less costly self-certification choice, will opt for that compliance path. Therefore, the annual costs that range from $1.52 to $2.98 million reported here are for all firms conducting self- certifications. EPA did not assess any cost savings to firms that would no longer choose to have products third party certified. [[Page 4818]] Table V.12--Total Annualized Present Value Costs for Demonstration of Compliance Requirements, Millions [2014$] ------------------------------------------------------------------------ 3% Discount rate 7% Discount rate Option in millions in millions (2014$) (2014$) ------------------------------------------------------------------------ A: Third party certification $11.20-$20.90 $11.56-$21.58 only........................... B: Third party for >=100; Choice 2.82-4.14 2.93-4.31 of self-certification for <100 (Proposed Rule)................ C: Third party certification or 1.52-2.84 1.59-2.98 self-certification............. ------------------------------------------------------------------------ Source: Technical Support Document, Exhibits 4-23a and 4-23b (USEPA, 2016). Note: Under Option C, all manufacturers are assumed to select the less costly choice of self-certification. E. Response to EPA Data Request Costs Under all three of the proposed regulatory options, plumbing manufacturers will be required to respond to EPA's requests for product information (See section IV.E.1.a for a detailed description of the data request provision). EPA assumed that firms would spend an average of 20 hours responding to each data request, resulting in a unit cost of $1,434. As part of the cost assessment, EPA multiplied the per unit cost by 10 unique data requests per year, starting in the fourth year after promulgation of the final rule and continuing over the 25-year period of analysis. Seventy percent of requests would be to firms with 500 or more employees, 20 percent of requests would be to firms with 100 to 499 employees, and firms with fewer than 100 employees would receive the remaining 10 percent. This breakdown of requests between firm size categories roughly corresponds to the proportion of total products produced by firms in each of the size categories. Table V.13 shows the total annualized cost of EPA data request response by firm size category. Total data request costs range from approximately $12,400 a year discounted at 3 percent to about $11,900 a year when discounted at 7 percent. Table V.13--Total Annualized Present Value Costs for Responding to Data Requests, in Millions [2014$] ------------------------------------------------------------------------ Manufacturer size (number of employees) 3% Discount rate 7% Discount rate ------------------------------------------------------------------------ <100............................ $0.0012 $0.0012 100-499......................... 0.0025 0.0024 >=500........................... 0.0087 0.0083 All Sizes....................... 0.0124 0.0119 ------------------------------------------------------------------------ Source: Technical Support Document, Exhibit 4-25 (USEPA, 2016). VI. Economic Impacts Analysis EPA assessed the social costs and the projected economic impacts of the three regulatory options described in this proposal. This section provides an overview of the methodology EPA used to assess the social costs and the economic impacts of this proposed rule and summarizes the results of these analyses. The Technical Support Document (USEPA, 2016), which is available in the docket, provides more details on these analyses, including discussions of uncertainties and limitations. A. Annualized Social Costs Estimates EPA estimated the total annualized social costs to plumbing manufacturers by summing the rule's component costs, which include administrative requirement costs, the cost to potable use product manufacturers for both labeling on the product and on the product's packaging, the cost to manufacturers of products eligible for the ``used exclusively'' exemption for package labeling indicating non- compliance with lead free requirements, third party- and self- certification costs, and the costs of responding to EPA data requests. EPA annualized the stream of future costs using both the 3 percent (the social discount rate) and 7 percent (opportunity cost of capital) discount rates. EPA annualized one-time costs over the period of analysis, 25 years. Capital and O&M costs recurring on other than an annual basis were annualized over a specific useful life, implementation, and/or event recurrence period (i.e., 10 years for mold modifications), using rates of 3 and 7 percent. EPA added the annualized capital, initial one-time costs, and the non-annual portion of O&M costs to annual O&M costs to derive total annualized compliance costs, where all costs are expressed on an equivalent constantly recurring annual cost basis. Table VI.1 presents the total annualized compliance costs of the regulatory options. As shown in the table, total annualized compliance costs range between $3 million and $36 million for Options C and A, respectively, with the proposed option (Option B) estimated to have annualized costs of $12 million to $18 million. Table VI.1--Total Annualized Social Costs [Millions, 2014$] ------------------------------------------------------------------------ Regulatory option \1\ 3% Discount rate 7% Discount rate ------------------------------------------------------------------------ A: Label product and packaging/ $20.1-$31.6 $23.1-$35.5 third party certification...... B: (Proposed Rule): Label 11.8-14.8 14.5-18.3 product and packaging/third party certification for manufacturers >=100 employees and third party or self- certification for others....... [[Page 4819]] C: Label product or packaging/ 2.9-4.5 3.0-4.6 third party or self- certification.................. ------------------------------------------------------------------------ Source: Technical Support Document, Exhibit 4-27 (USEPA, 2016). \1\ Table includes annualized costs for rule implementation, certification of potable use products, lead-related messaging for potable use products and products eligible for the ``used exclusively'' exemption, and EPA requests for data. B. Economic Impacts--Cost-to-Revenue Analysis To provide an assessment of the impact of the rule on plumbing manufacturing firms, EPA used a cost-to-revenue analysis. The cost-to- revenue analysis compares the total annualized compliance cost of each regulatory option with the revenue of the impacted entities. This same analysis is also used under the Regulatory Flexibility Act (RFA) to determine if a rule has the potential to have a significant impact on a substantial number of small entities. In order to conduct the cost-to-revenue test, EPA developed a list of 2,193 manufacturers that participate in the production of specific types of plumbing products for both potable use and those eligible for the ``used exclusively'' exemption. These firms were assigned to a NAICS code, based on the type of plumbing product they manufacture. Firm size distributional information, based on number of employees, available from the U.S. Census Bureau's Statistics of U.S. Businesses for the year 2012 was then used to parse the number of entities in each NAICS code into a number of small business and large firm categories. In this way, the number of firms in each of the 14 NAICS codes having seven employee size categories each (e.g., 0-4, 5-9, 10-19, 20-99, 100- 499, 500+ to the Small Business Administration (SBA) small business threshold, and large firms above the SBA threshold) was derived. Computation of total average firm cost under each of the NAICS/employee entity size categories was developed by applying the estimated unit fixed and variable costs to each regulatory option. In order to calculate total average variable costs for each size category, unit variable costs must be adjusted by the units produced and firms producing in each of the NAICS/employee size categories. To determine the number of units produced per NAICS/employee size category, EPA used information from the U.S. Census Bureau's Statistics of U.S. Businesses. The Census Bureau does not provide units produced for each of the NAICS employee size categories, so EPA used the percent of firm receipts by size category as a proxy. The approximated units per size category were then divided by the estimated number of entities in the category (derivation of the number of entities per NAICS/employee size category was previously described) giving average units produced per firm. Average units per firm for each size category was multiplied by unit variable cost to get total variable cost for each NAICS/employees size category. The Census does not provide revenue values by NAICS and employee sizes, so EPA used data on total annual receipts (assuming receipts is an unbiased estimator) by NAICS/employee size categories as a close (although more conservative) approximation of revenue. The total receipts information was divided by the number of firms per category to approximate average revenue. EPA then compared the computed average annual costs to the average revenue for each of the NAICS/employee size categories. If average cost exceeded revenue by 1 percent, all firms assigned to that category were assumed to incur impacts. Likewise, if average annual cost exceeded revenue by 3 percent in a NAICS/employee size category, all entities in that category are assumed to be impacted at the 3 percent level. Impacted firms are summed across NAICS codes and employee size categories to assess the total impact to the industry. Table VI.2 summarizes the cost-to-revenue analysis results for the three main regulatory options. The table only shows the largest impact scenarios analyzed, based on upper bound compliance cost estimates, and using a 7 percent discount rate. For the lower bound cost and 3 percent discounted impact results see the Technical Support Document (USEPA, 2016). Under Option B, which represents this proposed rule (which includes costs for rule implementation, potable use labeling costs for both package and product, labeling of products eligible for the ``used exclusively'' exemption that do not meet lead free requirements, third party certification cost for firms with 100 or more employees and third party or self-certification costs for firm with fewer than 100 employees, and data request costs), EPA estimates that the vast majority of plumbing manufacturing firms subject to the regulations will incur annualized costs amounting to less than 1 percent of revenue (2163 firms, or 98.6 percent of the total 2,193 manufacturers). A total of 29 firms (2 percent of small firms) had impacts between 1 and 3 percent of revenue, and no small manufacturers had impacts above 3 percent, given the costs estimated for Option B. The analysis of Option B also found that 1 large entity (0.5 percent of large firms) had impacts between 1 and 3 percent of revenue, and no large firms were impacted at the 3 percent revenue threshold. [[Page 4820]] Table VI.2--Summary of Cost-to-Revenue Economic Impact Analysis [Upper bound scenario, small entities 7% discount rate, large entities 3% discount rate] ---------------------------------------------------------------------------------------------------------------- Small entities (7% discount rate) Large entities (3% discount rate) ------------------------------------------------------------------------------- Option Option description Count \2\ Percentage Count \2\ Percentage \1\ ------------------------------------------------------------------------------- Total >=1% >=3% >=1% >=3% Total >=1% >=3% >=1% >=3% ---------------------------------------------------------------------------------------------------------------- A........... Product and 1,976 783 27 40 1 217 1 0 0.5 0.0 Package Costs for Potable Product or Package Costs for ``Used Exclusively'' Exempt Product, 3rd Party Cert for all manufacturers. B........... Product and 1,976 29 0 2 0 217 1 0 0.5 0.0 Package Costs for Potable Product or Package Costs for ``Used Exclusively'' Exempt Product, 3rd Party Cert for >=100 employees, Self or 3rd Party Cert for <100 employees. C........... Product or Package 1,976 0 0 0.0 0.0 217 0 0 0.0 0.0 Costs for Potable Product or Package Costs for ``Used Exclusively'' Exempt Product, Self or 3rd Party Cert for all manufacturers. ---------------------------------------------------------------------------------------------------------------- Source: Technical Support Document, Exhibit 6-7 (USEPA, 2016). \1\ All options also include implementation and data request costs. For Option B, EPA assumes that manufacturers <100 employees choose the least cost option of self-certification. For Option C, EPA assumes all manufacturers pick the least cost option of self-certification. In addition, for Option C, EPA assumes manufacturers choose the least cost option for labeling, which is usually package labeling except when the products do not have packaging. \2\ Counts of impacted entities are rounded up to 1 if they fall between 0 and 1. EPA solicits comments on the economic analysis for this proposed rule, including EPA's cost analysis and benefits assessment as described in this preamble and the Technical Support Document (USEPA, 2016) for this proposed rule. Comments are most helpful when accompanied by specific examples or supporting data. VII. Benefits EPA did not quantify the expected change in health endpoints for this proposed regulation. EPA assessed the health effects associated with reductions in lead ingestion qualitatively using two main sources: (1) The EPA ``Integrated Science Assessment for Lead'' (USEPA, 2013b); and (2) the National Toxicity Program's Monograph on Health Effects of Low-level Lead (USHHS, 2012). A wealth of information exists on the adverse health effects associated with lead exposure. When ingested, lead is distributed throughout the body and can affect many organ systems. Lead is a highly toxic contaminant that can cause adverse neurological, cardiovascular, renal, reproductive, developmental, immunological and carcinogenic effects. The neurological effects are particularly pronounced in children; however, recent studies in the public health literature have found that a wide spectrum of adverse health outcomes can occur in people of all ages. In 2013, the U.S. Burden of Diseases Collaborators identified lead as one of the top 15 mortality risk factors (and top 10 cardiovascular risk factors) in the country. In addition, a level of lead exposure below which adverse effects do not occur has not been identified. This suggests that further declines in lead exposure below current-day levels could still yield meaningful benefits in the U.S. population, and the reduction in lead exposures from this proposed rule would result in fewer adverse health outcomes and, in turn, decrease societal costs of treatment. Chapter 5 of the Technical Support Document (USEPA, 2016) for this proposed rule contains additional detailed information on the potential health impacts of lead on both children and adults. VIII. Statutory and Executive Orders Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review. B. Paperwork Reduction Act (PRA) The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2563.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The PRA requires EPA to estimate the burden on manufacturers and primacy agencies of complying with the proposed rule. The information collected as a result of this proposed rule should allow EPA to determine appropriate requirements for specific manufacturers and evaluate compliance with the proposed rule. For the first three years after publication of the final rule in the Federal Register, manufacturers will incur burden to conduct the following rule compliance activities: Obtaining certification of products from an accredited third party certification body to document compliance with the lead free requirements as set forth in the SDWA. Maintaining record costs associated with the initial certification (conducted by an accredited third party certification body) that potable use products meet the requirements of NSF/ANSI Standard 372. Preparing the initial certificate of conformity and maintaining records for potable use products that are self-certified by the manufacturer as being lead free. Respondents/affected entities: The respondents include manufacturers of plumbing products intended for potable use and manufacturers of some plumbing products eligible for the ``used exclusively'' exemption that are physically compatible with potable use products. States and local governments are not impacted by the rule. For the first three years after publication of the [[Page 4821]] final rule, EPA is not anticipated to incur any reporting or recordkeeping burden for implementation activities and ensuring compliance. Respondent's obligation to respond: Compliance with the final rulemaking regulatory requirements would be mandatory. The authority for these requirements comes from EPA's authority for this proposed rule is section 1450 of the SDWA, 42 U.S.C. 300j-9. It authorizes the EPA Administrator to ``prescribe such regulations as are necessary or appropriate to carry out his/her functions under this subchapter.'' Estimated number of respondents: EPA estimates that 2,193 firms will be affected by the proposed requirements of this regulation. Frequency of response: The requirements of this proposed rule that occur once during the three year ICR period include: Obtaining initial third-party certification or self-certify activities to indicate that a product meets the lead free requirements. Ongoing costs include the third party annual renewal fees, and for all firms annual recordkeeping costs for third party or self-certification. The rule requirement to respond to EPA requests for information is on an ad hoc basis (however, this information collection is not anticipated to occur during the three-year period covered by this ICR). Total estimated burden: Total three-year burden to manufacturers is estimated to be 162,582 to 318,276 hours, therefore the average annual burden number ranges from 54,194 to 106,092 hours. EPA estimated a range of burden (and costs) based on a lower and upper bound estimate of manufacturers that already include product and/or package lead free messaging that comply with the proposed rule requirements, as well as manufacturers that currently use a third party certifying agency. Burden is defined at 5 CFR 1320.3(b). Total estimated cost: The total costs over the three-year period are between $8.5 and $12.9 million, or an average of $2.8 to $4.3 million per year. 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 OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. Submit your comments on EPA's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than February 16, 2017. EPA will respond to any ICR-related comments in the final rule. C. Regulatory Flexibility Act (RFA) I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are the manufacturing firms involved in the production of pipe, pipe or plumbing fitting or fixture, flux or solder, which are utilized in public water system or any plumbing in a residential or nonresidential facility or location that provides water for human consumption that meet the SBA's size standards for small businesses. Firms providing these types of plumbing products span fourteen different North American Industrial Classification System (NAICS) categories. The SBA small business definitions used in the analysis of this proposed rule vary across NAICS categories and range from firms with fewer than 500 employees to firm's with fewer than 1,250 employees (See Table XII.1). Table VIII.1--SBA Small Entity Size Standards by NAICS Code ------------------------------------------------------------------------ SBA size NAICS code standard ------------------------------------------------------------------------ 326122....................................................... 750 332911....................................................... 750 332913....................................................... 1000 332919....................................................... 750 332996....................................................... 500 332999....................................................... 750 333318....................................................... 1000 333415....................................................... 1250 333911....................................................... 750 333999....................................................... 500 334514....................................................... 750 335222....................................................... 1250 335228....................................................... 1000 339991....................................................... 500 ------------------------------------------------------------------------ EPA has determined that 1,976 plumbing product manufacturers out of 2,193 plumbing product manufacturers potentially subject to this proposal meet the small business definitions. EPA's analysis of projected impacts on small entities is described in detail in section VII (Economic Impacts). EPA projects less than 2 percent of the 1,976 affected small entities may experience an impact of costs exceeding 1 percent of revenue and no small entities would incur compliance costs exceeding 3 percent of revenue. Details of this analysis are presented in Chapter 6 of the Technical Support Document, available in the docket, for the proposed rule. D. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The proposed rule places no federal mandates on state, local, or tribal governments. The mandated annual cost to the private sector is estimated to be between $11.8 and $18.3 million and the highest single year nominal cost is $53.4 million which is below the $100 million UMRA threshold. E. Executive Order 13132: Federalism This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175. It would not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian Tribes, or on the distribution of power and responsibilities between the federal government and Indian Tribes. This proposed rule contains no federal mandates for tribal governments and does not impose any enforceable duties on tribal governments. Thus, Executive Order 13175 does not apply to this action. G. Executive Order 13045: Protection of Children From Environmental Health & Safety Risks The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of ``covered regulatory action'' in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it implements specific standards established by Congress in statute. While the executive order does not apply, EPA does anticipate that the labeling requirements associated with [[Page 4822]] this proposal will limit the inadvertent use of leaded plumbing products, thereby reducing exposure of children to lead in drinking water. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) This action involves technical standards. The EPA is proposing a requirement that can be satisfied by, depending on the size of the regulated entity, either self-certifying compliance with the SDWA lead prohibition or by achieving a voluntary standard that mirrors the SDWA requirements, such as the NSF/ANSI 372 standard. While EPA is not specifying a technical standard under this proposed rule, EPA is proposing the use of technical standards that will meet the new definition of lead free as a means of demonstrating compliance with this proposal. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, or indigenous peoples as described in Executive Order 12898 (59 FR 7629, February 16, 1994), because this action does not establish any specific regulatory requirements that would affect these communities. Instead, it is a proposed rule that codifies existing requirements set forth by Congress regarding the allowable levels of lead in plumbing products, and also includes additional provisions intended to aid in the implementation of those requirements. IX. References USHHS, 2012. National Toxicity Program Monograph on Health Effects of Low-level Lead. U.S. Department of Health and Human Services. June 2012. Available on the Internet at: https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf. USEPA, 2013a. Summary of the Reduction of Lead in Drinking Water Act and Frequently Asked Questions. December 2013. Available on the Internet at: https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100M5DB.txt. USEPA, 2013b. Final Report: Integrated Science Assessment for Lead. EPA 600-R-10-075F. June 2013. Available on the Internet at: https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=255721. USEPA, 2016. Technical Support Document for the Proposed Rule: Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water. EPA 815-R-16-009. December 2016. List of Subjects 40 CFR Part 141 Environmental protection, Chemicals, Indian--lands, Intergovernmental relations, Radiation protection, Reporting and recordkeeping requirements, Water supply. 40 CFR Part 143 Environmental protection, Chemicals, Indian--lands, Water supply. Dated: January 4, 2017. Gina McCarthy, Administrator. For the reasons set forth in the preamble, EPA proposes to amend title 40 chapter I of the Code of Federal Regulations parts 141 and 143 as follows: PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS 0 1. The authority citation for part 141 continues to read as follows: Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11. 0 2. Revise the subpart heading for subpart E to read as follows: Subpart E--Special Regulations, Including Monitoring Sec. 141.43 [Removed] 0 3. Remove Sec. 141.43. PART 143--NATIONAL SECONDARY DRINKING WATER REGULATIONS 0 4. The authority citation for part 143 continues to read as follows: Authority: 42 U.S.C. 300f et seq. 0 5. Revise the part heading for part 143 to read as follows: PART 143--OTHER SAFE DRINKING WATER ACT REGULATIONS 0 6. Add subpart A to read as follows: Subpart A--National Secondary Drinking Water Regulations 0 7. Redesignate Sec. Sec. 143.1 through 143.4 as subpart A. Sec. Sec. 143.5-143.10 [Reserved] 0 8. Reserve Sec. Sec. 143.5 through 143.10. 0 9. Add subpart B to read as follows: Subpart B--Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water Sec. 143.11 Definitions. 143.12 Definition of lead free and calculation methodology. 143.13 Use prohibitions. 143.14 State enforcement of use prohibitions. 143.15 Introduction into commerce prohibitions. 143.16 Exempt uses and labeling of certain exempt use products. 143.17 Required labeling of products that must meet lead free requirements. 143.18 Required labeling of solder and flux that is not lead free. 143.19 Required certification of products. 143.20 Compliance provisions. Subpart B--Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water Sec. 143.11 Definitions. The following definitions apply to this subpart: Accredited third party certification body means those bodies that are accredited by the American National Standards Institute (ANSI) to provide product certification to meet the lead free requirements of not more than a weighted average of 0.25 percent lead content when used with respect to the wetted surfaces, consistent with section 1417 of the Safe Drinking Water Act and Sec. 143.12, such as certification to the NSF/ANSI 372 standard. Administrator means the Administrator of the U.S. Environmental Protection Agency or his or her authorized representative. Affiliated means a person or entity that directly or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with, the person or entity specified. Affiliated persons or entities include, but are not limited to: A parent company and all wholly or partially owned subsidiaries of a parent company, or two or more corporations or family partnerships that have overlap in ownership or control. Alloy means a substance composed of two or more metals or of a metal and a nonmetal. Coating means a thin layer of material such as paint, epoxy, zinc galvanization, or other material usually applied by spraying or in liquid form to coat internal surfaces of pipes, fittings or fixtures. Drinking water cooler means any mechanical device affixed to drinking water supply plumbing which actively cools water for human consumption. [[Page 4823]] Fitting means a pipe fitting or plumbing fitting. Fixture means a receptacle or device that is connected to a water supply system or discharges to a drainage system or both. Fixtures used for potable uses shall include, but are not limited to: (1) Drinking water coolers, drinking water fountains, drinking water bottle fillers, dishwashers; (2) plumbed in devices such as point-of-use water treatment devices, coffee makers, and refrigerator ice and water dispensers; and (3) water heaters, water pumps, and water tanks, unless such fixtures are not used for potable uses. Flux means a substance used for helping to melt or join metals such as by removal of oxides and other coatings or residues from the metals before joining by using solder or other means. Importer means any person who introduces into commerce any pipe, any pipe or plumbing fitting or fixture, or any solder or flux that is manufactured by a firm located outside of the United States. Introduce into commerce or introduction into commerce means the sale or distribution of products, or offering products for sale or distribution in the United States. Liner means a rigid lining such as a plastic or copper sleeve that is: (1) Sealed with a permanent barrier to exclude lead-bearing surfaces from water contact; and (2) of sufficient thickness and having physical properties necessary to prevent erosion and cracking for the expected useful life of the product. Manufacturer means a person or entity who: (1) Processes or makes a product; or (2) has products processed or made under a contractual arrangement for distribution using their brand name or trademark. Nonpotable services means all uses of water that are not potable uses. Person means an individual; corporation; company; association; partnership; municipality; or state, federal, or tribal agency (including officers, employees, and agents of any corporation, company, association, municipality, state, tribal, or federal agency). Pipe means a conduit or conductor, tubing or hose. Pipe fitting means any piece (such as a coupling, elbow, washer, or gasket) used for connecting pipe lengths together or to connect other plumbing pieces together or to change direction. Plumbing fitting means a plumbing component that controls the volume and/or directional flow of water, such as kitchen faucets, bathroom lavatory faucets, and valves. Potable uses means services or applications that provide water for human ingestion such as for drinking, cooking, food preparation, dishwashing, teeth brushing, or maintaining oral hygiene. Product means a pipe, fitting, fixture. Solder means a type of metal that is used to join metal parts such as sections of pipe, without melting the existing metal in the parts to be joined. Solder is usually sold or distributed in the form of wire rolls or bars. United States includes its commonwealths, districts, states, tribes, and territories. Water distribution main means a pipe, typically found under or adjacent to a roadway that supplies water to buildings via service lines. Sec. 143.12 Definition of lead free and calculation methodology. (a) ``Lead free'' for the purposes of this subpart means: (1) Not containing more than 0.2 percent lead when used with respect to solder and flux; and (2) Not more than a weighted average of 0.25 percent lead when used with respect to the wetted surfaces of pipes, pipe fittings, plumbing fittings, and fixtures. (b) The weighted average lead content of a pipe, pipe fitting, plumbing fitting, or fixture is calculated by using the following formula: For each wetted component, the percentage of lead in the component is multiplied by the ratio of the wetted surface area of that component to the total wetted surface area of the entire product to arrive at the weighted percentage of lead of the component. The weighted percentage of lead of each wetted component is added together, and the sum of these weighted percentages constitutes the weighted average lead content of the product. The lead content of the material used to produce wetted components is used to determine compliance with paragraph (a)(2) of this section. For lead content of materials that are provided as a range, the maximum content of the range must be used. (c) If a coating, as defined in Sec. 143.11, is applied to the internal surfaces of a pipe, fitting or fixture component, the maximum lead content of both the coating and the alloy must be used to calculate the lead content of the component. (d) If a liner, as defined in Sec. 143.11, is manufactured into a pipe, fitting or fixture, the maximum lead content of the liner must be used to calculate the lead content of the component. Sec. 143.13 Use prohibitions. (a) No person may use any pipe, any pipe or plumbing fitting or fixture, any solder or any flux that is not lead free as defined in Sec. 143.12 in the installation or repair of: (1) Any public water system; or (2) Any plumbing in a residential or nonresidential facility providing water for human consumption. (b) Paragraph (a) of this section shall not apply to leaded joints necessary for the repair of cast iron pipes. Sec. 143.14 State enforcement of use prohibitions. As a condition of receiving a full allotment of Public Water System Supervision grants under section 1443(a) of the Safe Drinking Water Act, states must enforce the requirements of section 1417(a)(1) of Safe Drinking Water Act and Sec. 143.13 through state or local plumbing codes, or such other means of enforcement as the state may determine to be appropriate. Sec. 143.15 Introduction into commerce prohibitions. It shall be unlawful: (a) For any person to introduce into commerce any pipe, or any pipe or plumbing fitting or fixture, that is not lead free, except for a pipe that is used in manufacturing or industrial processing; (b) For any person engaged in the business of selling plumbing supplies in the United States, except manufacturers, to sell solder or flux that is not lead free; and (c) For any person to introduce into commerce any solder or flux that is not lead free unless the solder or flux bears a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing providing water for human consumption. Sec. 143.16 Exempt uses and labeling of certain exempt use products. The prohibitions in Sec. Sec. 143.13 and 143.15 shall not apply to the products listed in paragraphs (a) through (c) of this section: (a) Pipes, pipe fittings, plumbing fittings, or fixtures, including backflow preventers, that are used exclusively for nonpotable services such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption. For the purposes of this subpart, ``used exclusively for nonpotable services'' means: (1) The product is incapable of use in potable services (e.g., physically [[Page 4824]] incompatible with other products that would be needed to convey water for potable uses); or (2) The product is clearly labeled, on the product, package, container, or tag with a phrase such as: ``Not for use with water for human consumption'' or another phrase that conveys the same meaning in plain language. (b) Toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, fire hydrants, service saddles, water distribution main gate valves that are 2 inches in diameter or larger. (c) Clothes washing machines, fire suppression sprinklers, eyewash devices, sump pumps, and emergency drench showers. Sec. 143.17 Required labeling of products that must meet lead free requirements. (a) Persons that introduce into commerce products that must meet the lead free requirements of section 1417(a)(3)(A) of the Safe Drinking Water Act and Sec. 143.12 must label such products to indicate that it is in compliance with those requirements. Such labeling must occur by [DATE 3 YEARS AFTER PUBLICATION OF FINAL RULE IN THE Federal Register] or prior to introduction into commerce, whichever occurs later. (b) Labeling or marking as specified in paragraph (a) of this section must be in accordance with paragraphs (b)(1), (b)(2), and (c) of this section: (1) Packaged, containerized or tagged products must be labeled or marked on the package, container, or tag with a phrase such as: ``Conforms with the lead free requirements of the federal Safe Drinking Water Act,'' ``Lead Free,'' or similar terms that clearly convey to users that the product is in compliance with the applicable requirements. Products that are not packaged, containerized or tagged are only required to be marked consistent with requirements in paragraph (b)(2) of this section. Shrink wrapping of bulk products solely for the purpose of shipping or storage does not constitute being packaged, containerized, or tagged. (2) Products must be directly marked by physically stamping, forging, or printing with indelible ink, except as provided in (b)(2)(i) or (b)(2)(ii) of this section. The marking must clearly convey to consumers that the product is lead free, such as ``Lead Free,'' ``LF,'' or certification marks. If the marking is ``LF'' or another abbreviation, symbol or acronym, the product package, container, or tag must associate that marking with a phrase such as ``lead free'' or ``meets lead free requirements.'' Product markings should be located where they are visible after product installation when practical. (i) If the product is too small for a legible marking in a type face ranging from approximately 8 point to 14 point depending on the method of marking and roughness of product surface, only a product package, container or tag must be labeled or marked. (ii) If the visible marking on installed products will adversely impact the visual appeal to consumers of the finished product, the product may be marked in a location not visible after installation. (c) For products certified by accredited third party certification bodies, labeling or marking on the product, package, container, tag or some combination of these locations must include: (1) The logo or name of the certification body as specified by the specific certification body; and (2) The specific certification body's required identifier text to convey lead free or low lead content. Sec. 143.18 Required labeling of solder and flux that is not lead- free. Solder and flux that is not ``lead free'' as defined in Sec. 143.12(a)(1) must bear a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing providing water for human consumption. Sec. 143.19 Required certification of products. (a) Manufacturers or importers that introduce into commerce products that must meet the lead free requirements of section 1417 of the Safe Drinking Water Act and Sec. 143.12 must ensure that the products are certified to be in compliance as specified in paragraphs (b) and (c) of this section by [DATE 3 YEARS AFTER PUBLICATION OF FINAL RULE IN THE Federal Register] or prior to product introduction into commerce, whichever occurs later. Such manufacturers or importers must maintain documentation to substantiate the certification. (b) Certification of products must be obtained by manufacturers or importers from an accredited third party certification body, except as provided in paragraph (c) of this section. (1) Products certified by an accredited third party certification body must be labeled or marked as specified in Sec. 143.17(c). (2) The manufacturer or importers must keep records for all products certified by an accredited third party certification body that include at a minimum: Documentation of certification, dates of certification and expiration. This documentation must be provided upon request to the Administrator as specified in Sec. 143.20(b). (c) Manufacturers having fewer than 100 employees or importers sourcing products from or representing manufacturers having fewer than 100 employees may elect to self-certify products in lieu of obtaining certification from an accredited third party certification body. The number of employees includes any persons employed by the manufacturer and any of its affiliated entities. The number of employees must be calculated by averaging the number of persons employed, regardless of part-time, full-time or temporary status by an entity and all of its affiliated entities for each pay period over the entity's latest 12 calendar months, or averaged over the number of months in existence if less than 12 months. Such manufacturers or importers electing to self- certify products must comply with paragraphs (d) through (g) of this section. (d) In order for eligible manufacturers or importers to self- certify products, such manufacturers or importers must attest that products are in compliance by developing and maintaining a ``certificate of conformity.'' The certificate of conformity must be: (1) Signed by a responsible corporate officer, a general partner or proprietor, or an authorized representative of a responsible corporate officer, general partner or proprietor; and (2) Posted to a Web page with continuing public access in the United States. (e) The certificate of conformity must be in English and include: (1) Contact information for the manufacturer or importer to include: (i) The entity or proprietor name, (ii) Street and mailing addresses, (iii) Phone number, and (iv) Email address. For products imported into the United States, the contact information must also be included for the manufacturer; (2) A brief listing of the products to include, when applicable, unique identifying information such as model names and numbers; (3) A statement attesting that the products meet the lead free requirements of the Safe Drinking Water Act and 40 CFR part 143, subpart B and also that the manufacturer or importer is eligible to self-certify the product consistent with this regulation; (4) A statement indicating how the manufacturer or importer verified conformance with the Safe Drinking [[Page 4825]] Water Act and 40 CFR part 143, subpart B; and (5) The signature, date, name and position of the signatory; and if the signatory is an authorized representative of a responsible corporate officer, a general partner or proprietor, the name and position of the responsible corporate officer, a general partner or proprietor. (f) Manufacturers or importers that self-certify products must maintain, at a primary place of business within the United States, certificates of conformity and sufficient documentation to confirm that products meet the lead free requirements of this subpart. Sufficient documentation may include: Detailed schematic drawings of the products indicating dimensions, calculations of the weighted average lead content of the product, lead content of materials used in manufacture and other documentation used in verifying the lead content of a plumbing device. This documentation and certificates of conformity must be provided upon request to the Administrator as specified in Sec. 143.20(b). (g) The certificate of conformity and documentation must be completed prior to a product's introduction into commerce. Sec. 143.20 Compliance provisions. (a) Noncompliance with the Safe Drinking Water Act or this subpart may be subject to enforcement. Enforcement actions may include seeking injunctive relief, civil or criminal penalties. (b) The Administrator may, on a case-by-case basis, request any information deemed necessary to determine whether a person has acted or is acting in compliance with section 1417 of the Safe Drinking Water Act and this subpart. Such information requested must be provided to the Administrator at a time and in a format as may be reasonably determined by the Administrator. [FR Doc. 2017-00743 Filed 1-13-17; 8:45 am] BILLING CODE 6560-50-P
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the nature of the preventive control and IV. References percent of the wetted surfaces of
its role in the facility’s food safety The following references are on plumbing products and established a
system, the facility must conduct display at the Division of Dockets statutory method for calculating lead
activities that include environmental Management (see ADDRESSES) and are content. In addition, the RLDWA
monitoring, for an environmental available for viewing by interested created exemptions from the lead free
pathogen or for an appropriate indicator persons between 9 a.m. and 4 p.m., requirements for plumbing products
organism, if contamination of an RTE Monday through Friday; they are also that are used exclusively for nonpotable
food with an environmental pathogen is available electronically at https:// services as well as for other specified
a hazard requiring a preventive control, www.regulations.gov. FDA has verified products. The CFSA further amended
by collecting and testing environmental the Web site addresses, as of the date section 1417 to exempt fire hydrants
samples (§ 117.165(a)(3)). The revised this document publishes in the Federal from these requirements.
draft guidance includes Register, but Web sites are subject to EPA proposes to establish new
recommendations for controls to change over time. requirements to assure that individuals
significantly minimize or prevent L. purchasing, installing or inspecting
1. FDA. 2015. Food Advisory Committee potable water systems can identify lead
monocytogenes in RTE foods, for Meeting, Charge and Questions. Topic:
sanitation controls to eliminate L. free plumbing materials. Specifically,
Addressing Listeria monocytogenes in
monocytogenes from the food Ready-To-Eat Foods, December 7–8, EPA proposes to establish labeling
production environment, and for 2015. Available at http://www.fda.gov/ requirements to differentiate plumbing
environmental monitoring as downloads/AdvisoryCommittees/ products that meet the lead free
verification of sanitation controls. CommitteesMeetingMaterials/ requirements from those that are exempt
FoodAdvisoryCommittee/ from the lead free requirements and to
II. Paperwork Reduction Act of 1995 UCM472842.pdf. require manufacturers to certify
2. FDA. 2015. Food Advisory Committee compliance with the lead free
The revised draft guidance refers to (FAC) Recommendations. Topic:
requirements. These proposed
previously approved collections of Addressing Listeria monocytogenes in
Ready-To-Eat Foods, December 7–8, requirements would reduce inadvertent
information found in FDA regulations. use of non-lead free plumbing products
These collections of information are 2015. Available at http://www.fda.gov/
downloads/AdvisoryCommittees/ in potable use applications and,
subject to review by the Office of CommitteesMeetingMaterials/ consequently, reduce exposure to lead
Management and Budget (OMB) under FoodAdvisoryCommittee/ in drinking water and associated
the Paperwork Reduction Act of 1995 UCM476521.pdf. adverse health effects.
(the PRA) (44 U.S.C. 3501–3520). The
Dated: January 11, 2017. DATES: Comments must be received on
collections of information in part 117
Leslie Kux, or before April 17, 2017.
have been approved under OMB Control
Associate Commissioner for Policy. ADDRESSES: Submit your comments,
No. 0910–0751.
[FR Doc. 2017–00819 Filed 1–13–17; 8:45 am] identified by Docket ID No. EPA–HQ–
FDA tentatively concludes that the OW–2015–0680, to the Federal
BILLING CODE 4164–01–P
revised draft guidance also contains eRulemaking Portal: http://
proposed information collection www.regulations.gov. Follow the online
provisions that are subject to review by instructions for submitting comments.
OMB under the PRA but are not ENVIRONMENTAL PROTECTION
AGENCY Once submitted, comments cannot be
included in the information collection edited or withdrawn. EPA may publish
approved under OMB Control No. 0910– 40 CFR Parts 141 and 143 any comment received to its public
0751. ‘‘Collection of information’’ is docket. Do not submit electronically any
defined in 44 U.S.C. 3502(3) and 5 CFR [EPA–HQ–OW–2015–0680; FRL–9958–23– information you consider to be
1320.3(c) and includes Agency requests OW]
Confidential Business Information (CBI)
or requirements that members of the RIN 2040–AF55 or other information whose disclosure is
public submit reports, keep records, or restricted by statute. Multimedia
provide information to a third party. Use of Lead Free Pipes, Fittings, submissions (audio, video, etc.) must be
Section 3506(c)(2)(A) of the PRA (44 Fixtures, Solder and Flux for Drinking accompanied by a written comment.
U.S.C. 3506(c)(2)(A)) requires Federal Water The written comment is considered the
Agencies to provide a 60-day notice in official comment and should include
AGENCY: Environmental Protection
the Federal Register for each proposed discussion of all points you wish to
Agency (EPA).
collection of information before make. EPA will generally not consider
submitting the collection to OMB for ACTION: Proposed rule.
comments or comment contents located
approval. To comply with this SUMMARY: The Environmental Protection outside of the primary submission (i.e.,
requirement, we will publish a 60-day Agency (EPA) proposes to make on the web, cloud, or other file sharing
notice on the proposed collection of conforming changes to existing drinking system).
information in a future issue of the water regulations based on the For additional submission methods,
Federal Register. Reduction of Lead in Drinking Water the full EPA public comment policy,
III. Electronic Access Act of 2011 (RLDWA) and the information about CBI or multimedia
Community Fire Safety Act of 2013 submissions, and general guidance on
sradovich on DSK3GMQ082PROD with PROPOSALS
Persons with access to the Internet (CFSA). Section 1417 of the Safe making effective comments, please visit
may obtain the revised draft guidance at Drinking Water Act (SDWA) prohibits http://www2.epa.gov/dockets/
either http://www.fda.gov/ the use and introduction into commerce commenting-epa-dockets.
FoodGuidances or https:// of certain plumbing products that are FOR FURTHER INFORMATION CONTACT: Russ
www.regulations.gov. Use the FDA Web not lead free. The RLDWA revised the Perkinson, telephone number: 202–564–
site listed in the previous sentence to definition of lead free to lower the 4901; email address: perkinson.russ@
find the most current version of the allowable maximum lead content from epa.gov, Office of Ground Water and
guidance. 8.0 percent to a weighted average of 0.25 Drinking Water, Standards and Risk
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TABLE V.4—RULE INITIAL ADMINISTRATIVE AND INITIAL IMPLEMENTATION ANNUALIZED COSTS, IN MILLIONS
[2014$]
Read and understand the rule Messaging design change Initial rule implementation cost
Manufacturer size (no. of employees) Discount rate Discount rate Discount rate
3% 7% 3% 7% 3% 7%
<100 ......................................................... $0.051 $0.073 $0.011–0.021 $0.015–0.03 $0.061–0.072 $0.088–0.103
100–499 ................................................... 0.001 0.016 0.002–0.005 0.003–0.007 0.014–0.016 0.020–0.023
≥500 ......................................................... 0.008 0.012 0.001–0.001 0.001–0.001 0.009–0.009 0.013–0.013
All Sizes ................................................... 0.07 0.101 0.014–0.027 0.02–0.038 0.084–0.097 0.121–0.139
Source: Technical Support Document, Exhibits 4–7a and 4–7b (USEPA, 2016).
B. Labeling Potable Use Products EPA’s understanding of current industry higher probability of selling in markets
In order to estimate the potential cost labeling practices. Table V.5 presents that already require lead content
of this proposed rule and the two preexisting labeling assumptions that labeling on product and package. The
alternative regulatory scenarios represent the lower bound for regulatory upper bound scenario assumes
presented in this proposed rule cost estimates. Table V.6 shows a manufacturers with fewer than 500
preamble, EPA collected information on possible lower level baseline of product employees mark products with lead
current labeling practices to set the labeling. This table represents the upper content messaging 50 percent of the
regulatory baseline. EPA developed bound for rule cost estimate. Across time, while in the lower bound scenario,
three baseline scenarios characterizing both lower and upper bound scenarios, those same firms label 75 percent of
the proportion of firms by size category EPA has made the conservative products with lead content messaging.
that either currently have lead free assumption that 5 percent of all firms Also, firms in the upper bound scenario
labeling (meeting the requirements of have no messaging on product or with less than 100 employees mark 50
this proposed rule), have product package. Also common across the percent of their packaging with lead
messaging not related to lead free scenarios, is the concept that firms with content labeling. The lower bound
requirements, or have no product greater numbers of employees have assumes that firms with fewer than 100
messaging. These three scenarios larger production totals and serve larger employees label 75 percent of packaging
capture the uncertainty surrounding market areas and, therefore, will have a with lead content information.
TABLE V.5—ESTIMATED PERCENTAGE OF POTABLE USE PRODUCTS WITH AND WITHOUT EXISTING MESSAGING
[Lower bound]
Percent with existing messaging
Percent with lead-content but not lead-related Percent with no messaging
Manufacturer size messaging (incur partial messaging costs) (incur total messaging costs)
(number of employees)
Product Package Product Package Product Package
<100 ......................................................... 75 75 20 20 5 5
100–499 ................................................... 75 90 20 5 5 5
≥500 ......................................................... 90 90 5 5 5 5
Source: Technical Support Document, Exhibit 4–8a (USEPA, 2016).
TABLE V.6—ESTIMATED PERCENTAGE OF POTABLE USE PRODUCTS WITH AND WITHOUT EXISTING MESSAGING
[Upper bound]
Percent with existing messaging
Percent with lead-content but not lead-related Percent with no messaging
Manufacturer size messaging (incur partial messaging costs) (incur total messaging costs)
(number of employees)
Product Package Product Package Product Package
<100 ......................................................... 50 50 45 45 5 5
100–499 ................................................... 50 90 45 5 5 5
≥500 ......................................................... 90 90 5 5 5 5
Source: Technical Support Document, Exhibit 4–8b (USEPA, 2016).
sradovich on DSK3GMQ082PROD with PROPOSALS
Using the assumptions on current product and package are assumed to used, installation instructions or other
industry messaging practices detailed in have no labeling costs in this regulatory certification and identification
Tables V.5 and V.6, EPA applied its unit analysis; (2) manufacturers that information) were assigned a partial cost
compliance technology costs for both currently mark their product and/or to implement the requirements of this
product and package labeling in the package with some messaging (e.g., proposed rule; and (3) firms assumed to
following way: (1) Firms that currently company name and marketing materials, have no product labeling on package or
have lead content messaging on both a description of how the product is product received full capital and O&M
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![Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules 4815
costs as part of the regulatory three compliance technologies to each product lead free messaging on product
assessment of costs. of the 40 potable use product categories. and/or package for the three options
Under regulatory options requiring The compliance technologies are considered as part of the regulatory
lead free marking on potable use printing on product box (e.g., faucets), analysis. For Options A and B, costs
products, EPA assigned to each of the 40 printing on product bag (e.g., copper include labeling on both the product
identified product subcategories one of and brass fittings), or adhesive label and package and range from $8.69 to
three compliance technologies: Printing (e.g., braided steel hose).2 $13.60 million (2014$) dollars annually.
on product (e.g., copper or plastic pipe), Unit capital and O&M costs for each For Option C, which gives producers the
modification of production molds and of the six compliance technologies were choice to label the product or package,
patterns through the use of electric derived with information collected from
EPA assumed that impacted firms
diode machining (e.g., brass fittings), or both the PMI and AFS trade associations
would choose the lower cost package
attaching a tag with wire or another non and information from tool and die firms,
adhesive method (e.g., water heaters).1 product packaging vendors, and labeling alternative; therefore, annual
For regulatory costing scenarios that printing equipment suppliers. costs range from $1.14 to $1.28 million
required lead free labeling on product Table V.7 provides EPA’s estimated dollars.
packages, EPA (again) assigned one of total annual cost ranges for potable use
TABLE V.7—TOTAL ANNUALIZED PRESENT VALUE COSTS FOR LEAD FREE LABELING OF POTABLE USE PRODUCTS ON
PRODUCT AND PACKAGE, MILLIONS
[2014$]
3% Discount rate 7% Discount rate
Option in millions in millions
(2014$) (2014$)
A: Product and package messaging ....................................................................................................... $8.69–10.34 $11.32–13.60
B: Product and package messaging ....................................................................................................... 8.69–10.34 11.32–13.60
C: Product or package messaging .......................................................................................................... 1.17–1.28 1.14–1.26
Source: Technical Support Document, Exhibits 4–13a and 4–13b (USEPA, 2016).
C. Labeling of Products Eligible for the water for human consumption would be potable use applications and would
‘‘Used Exclusively’’ Exemption required to assure that these products meet the lead content limit of 0.25
meet the lead free requirements. percent of wetted surfaces to be
As discussed in section IV.C, EPA has Alternatively, they could or redesign considered lead free. In order to develop
included an additional means of their products to make them physical
qualifying for the ‘‘used exclusively’’ costs for this requirement EPA first
incompatible with potable water determined the baseline current
exemption. systems. EPA anticipates that the costs industry practices when it comes to
The proposed provision to label associated with designing and applying labeling products eligible for the ‘‘used
products to establish that the products a label are likely to be less than the costs exclusively’’ exemption and their
are ‘‘used exclusively’’ in nonpotable associated with reformulating the alloy
services provides a less costly option to packaging. Table V.8 shows the lower
and overhauling the manufacturing
persons introducing the product into bound percentage of products by firm
processes associated with meeting the
commerce. If the proposed regulations ‘‘lead free’’ requirements. Therefore, this size category that currently use lead
limited the availability of the ‘‘used optional compliance alternative will not content messaging, messaging of some
exclusively’’ exemption to products that result in increased costs or burden, and kind (e.g., marks, serial numbers,
are physically incompatible with will result in a cost savings for those installation instructions), and have no
potable water systems, then persons manufacturers who elect to take labeling on product or packaging. Table
introducing non-potable water advantage of this proposed optional V.9 details the upper bound baseline
plumbing products into commerce that exemption mechanism. assumed percentages for labeling by
are physically compatible and capable There are six product subcategories firm size for products eligible for the
of being connected to systems providing that are both physically compatible with ‘‘used exclusively’’ exemption.
TABLE V.8—ESTIMATED PERCENTAGE OF PRODUCTS ELIGIBLE FOR ‘‘USED EXCLUSIVELY’’ EXEMPTION WITH AND WITHOUT
EXISTING MESSAGING
[Lower bound]
Percent with lead-related Percent with existing messaging Percent with no messaging
messaging but not lead-related (incur total messaging costs)
Manufacturer size (incur partial messaging costs)
(number of employees) Product Package Product Package
Product Package
sradovich on DSK3GMQ082PROD with PROPOSALS
(%) (%) (%) (%)
(%) (%)
<100 ......................................................... 50 50 45 45 5 5
100–499 ................................................... 75 75 20 20 5 5
1 Small products like gaskets and o-rings are 2 Products that are not sold with packaging like
assumed to be bagged with lead free messaging. pipe are assumed to comply by printing on product.
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TABLE V.8—ESTIMATED PERCENTAGE OF PRODUCTS ELIGIBLE FOR ‘‘USED EXCLUSIVELY’’ EXEMPTION WITH AND WITHOUT
EXISTING MESSAGING—Continued
[Lower bound]
Percent with lead-related Percent with existing messaging Percent with no messaging
messaging but not lead-related (incur total messaging costs)
Manufacturer size (incur partial messaging costs)
(number of employees) Product Package Product Package
Product Package
(%) (%) (%) (%)
(%) (%)
≥500 ......................................................... 75 75 20 20 5 5
Source: Technical Support Document, Exhibit 4–14a (USEPA, 2016).
TABLE V.9—ESTIMATED PERCENTAGE OF PRODUCTS ELIGIBLE FOR ‘‘USED EXCLUSIVELY’’ EXEMPTION WITH AND WITHOUT
EXISTING MESSAGING
[Upper bound]
Percent with lead-related Percent with existing messaging Percent with no messaging
messaging but not lead-related (incur total messaging costs)
Manufacturer size (incur partial messaging costs)
(number of employees) Product Package Product Package
Product Package
(%) (%) (%) (%)
(%) (%)
<100 ......................................................... 25 25 70 70 5 5
100–499 ................................................... 50 50 45 45 5 5
≥500 ......................................................... 50 50 45 45 5 5
Source: Technical Support Document, Exhibit 4–14b (USEPA, 2016).
EPA assumed manufacturers of compliance technology.3 Also, for V.10 details, by size category, the
products eligible for the ‘‘used package compliance, EPA assigned the regulatory annual total cost ranges for
exclusively’’ exemption that currently print on bag compliance technology. labeling those products eligible for the
do not have lead-related information on Under the ‘‘used exclusively’’ exempt ‘‘used exclusively’’ exemption not for
their product would use the same package marking requirements, piping potable use applications. This cost
compliance technologies that would be products are required to be printed component does not vary by regulatory
used for the labeling of potable use directly on the product since they are option. Annual total cost for labeling
products and packages. For labeling on generally not packaged. products that are not for potable use
the product, EPA assigned each of the EPA used the same unit cost range from $0.14 to $0.22 million.
subcategories as either the printing on information that was developed for the
product or the mold modification potable use labeling requirements. Table
EXHIBIT V.10—TOTAL ANNUALIZED PRESENT VALUE COSTS FOR LEAD-RELATED MESSAGING ON PRODUCTS ELIGIBLE FOR
THE ‘‘USED EXCLUSIVELY’’ EXEMPTION ON PACKAGE OR PRODUCT, MILLIONS
[2014$]
3% Discount rate 7% Discount rate
Manufacturer size in millions in millions
(number of employees) (2014$) (2014$)
<100 ......................................................................................................................................................... $0.03–$0.03 $0.02–$0.03
100–499 ................................................................................................................................................... 0.01–0.01 0.01–0.01
≥500 ......................................................................................................................................................... 0.11–0.17 0.10–0.16
Total Cost ......................................................................................................................................... 0.15–0.22 0.14–0.20
Source: Technical Support Document, Exhibit 4–17 (USEPA, 2016), Rule Component All Sizes worksheet.
D. Product Certification certification by plumbing manufacturers International, CSA Group, UL, etc.).
by reviewing current state laws Based on the collected information, EPA
In order to develop total compliance requiring certification for NSF Standard assumed that 90 percent of
costs for third party certification, EPA
sradovich on DSK3GMQ082PROD with PROPOSALS
61 and 372; reviewing the International manufacturers with 100 or greater
had to determine the regulatory and Uniform Plumbing Codes; employees already use an accredited
baseline. This baseline represents the contacting the two primary industry third party agency to certify that their
current industry practice with regard to trade groups, PMI and AFS; and products are lead free. As with potable
third party certification. EPA collected acquiring information from industry use product labeling, third party
information on use of third party third party certifiers (e.g., NSF certification costs are a major driver of
3 Small products like gaskets and o-rings are
assumed to be bagged with lead free messaging.
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TABLE V.12—TOTAL ANNUALIZED PRESENT VALUE COSTS FOR DEMONSTRATION OF COMPLIANCE REQUIREMENTS,
MILLIONS
[2014$]
3% Discount rate 7% Discount rate
Option in millions in millions
(2014$) (2014$)
A: Third party certification only ................................................................................................................ $11.20–$20.90 $11.56–$21.58
B: Third party for ≥100; Choice of self-certification for <100 (Proposed Rule) ...................................... 2.82–4.14 2.93–4.31
C: Third party certification or self-certification ......................................................................................... 1.52–2.84 1.59–2.98
Source: Technical Support Document, Exhibits 4–23a and 4–23b (USEPA, 2016).
Note: Under Option C, all manufacturers are assumed to select the less costly choice of self-certification.
E. Response to EPA Data Request Costs part of the cost assessment, EPA remaining 10 percent. This breakdown
Under all three of the proposed multiplied the per unit cost by 10 of requests between firm size categories
regulatory options, plumbing unique data requests per year, starting roughly corresponds to the proportion
manufacturers will be required to in the fourth year after promulgation of of total products produced by firms in
respond to EPA’s requests for product the final rule and continuing over the each of the size categories. Table V.13
information (See section IV.E.1.a for a 25-year period of analysis. Seventy shows the total annualized cost of EPA
detailed description of the data request percent of requests would be to firms data request response by firm size
provision). EPA assumed that firms with 500 or more employees, 20 percent category. Total data request costs range
would spend an average of 20 hours of requests would be to firms with 100 from approximately $12,400 a year
responding to each data request, to 499 employees, and firms with fewer discounted at 3 percent to about $11,900
resulting in a unit cost of $1,434. As than 100 employees would receive the a year when discounted at 7 percent.
TABLE V.13—TOTAL ANNUALIZED PRESENT VALUE COSTS FOR RESPONDING TO DATA REQUESTS, IN MILLIONS
[2014$]
Manufacturer size 3% Discount rate 7% Discount rate
(number of employees)
<100 ......................................................................................................................................................... $0.0012 $0.0012
100–499 ................................................................................................................................................... 0.0025 0.0024
≥500 ......................................................................................................................................................... 0.0087 0.0083
All Sizes ................................................................................................................................................... 0.0124 0.0119
Source: Technical Support Document, Exhibit 4–25 (USEPA, 2016).
VI. Economic Impacts Analysis which include administrative implementation, and/or event
EPA assessed the social costs and the requirement costs, the cost to potable recurrence period (i.e., 10 years for
projected economic impacts of the three use product manufacturers for both mold modifications), using rates of 3
regulatory options described in this labeling on the product and on the and 7 percent. EPA added the
proposal. This section provides an product’s packaging, the cost to annualized capital, initial one-time
overview of the methodology EPA used manufacturers of products eligible for costs, and the non-annual portion of
to assess the social costs and the the ‘‘used exclusively’’ exemption for O&M costs to annual O&M costs to
economic impacts of this proposed rule package labeling indicating non- derive total annualized compliance
and summarizes the results of these compliance with lead free requirements, costs, where all costs are expressed on
analyses. The Technical Support third party- and self-certification costs, an equivalent constantly recurring
Document (USEPA, 2016), which is and the costs of responding to EPA data annual cost basis.
available in the docket, provides more requests. EPA annualized the stream of Table VI.1 presents the total
details on these analyses, including future costs using both the 3 percent annualized compliance costs of the
discussions of uncertainties and (the social discount rate) and 7 percent regulatory options. As shown in the
limitations. (opportunity cost of capital) discount table, total annualized compliance costs
rates. EPA annualized one-time costs range between $3 million and $36
A. Annualized Social Costs Estimates over the period of analysis, 25 years. million for Options C and A,
EPA estimated the total annualized Capital and O&M costs recurring on respectively, with the proposed option
social costs to plumbing manufacturers other than an annual basis were (Option B) estimated to have annualized
by summing the rule’s component costs, annualized over a specific useful life, costs of $12 million to $18 million.
sradovich on DSK3GMQ082PROD with PROPOSALS
TABLE VI.1—TOTAL ANNUALIZED SOCIAL COSTS
[Millions, 2014$]
Regulatory option 1 3% Discount rate 7% Discount rate
A: Label product and packaging/third party certification ......................................................................... $20.1–$31.6 $23.1–$35.5
B: (Proposed Rule): Label product and packaging/third party certification for manufacturers ≥100 em-
ployees and third party or self-certification for others ......................................................................... 11.8–14.8 14.5–18.3
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![Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules 4819
TABLE VI.1—TOTAL ANNUALIZED SOCIAL COSTS—Continued
[Millions, 2014$]
Regulatory option 1 3% Discount rate 7% Discount rate
C: Label product or packaging/third party or self-certification ................................................................ 2.9–4.5 3.0–4.6
Source: Technical Support Document, Exhibit 4–27 (USEPA, 2016).
1 Table includes annualized costs for rule implementation, certification of potable use products, lead-related messaging for potable use prod-
ucts and products eligible for the ‘‘used exclusively’’ exemption, and EPA requests for data.
B. Economic Impacts—Cost-to-Revenue total average variable costs for each size assumed to be impacted at the 3 percent
Analysis category, unit variable costs must be level. Impacted firms are summed
adjusted by the units produced and across NAICS codes and employee size
To provide an assessment of the
firms producing in each of the NAICS/ categories to assess the total impact to
impact of the rule on plumbing
employee size categories. To determine the industry.
manufacturing firms, EPA used a cost-
the number of units produced per Table VI.2 summarizes the cost-to-
to-revenue analysis. The cost-to-revenue
NAICS/employee size category, EPA revenue analysis results for the three
analysis compares the total annualized used information from the U.S. Census
compliance cost of each regulatory main regulatory options. The table only
Bureau’s Statistics of U.S. Businesses.
option with the revenue of the impacted shows the largest impact scenarios
The Census Bureau does not provide
entities. This same analysis is also used analyzed, based on upper bound
units produced for each of the NAICS
under the Regulatory Flexibility Act compliance cost estimates, and using a
employee size categories, so EPA used
(RFA) to determine if a rule has the 7 percent discount rate. For the lower
the percent of firm receipts by size
potential to have a significant impact on category as a proxy. The approximated bound cost and 3 percent discounted
a substantial number of small entities. units per size category were then impact results see the Technical
In order to conduct the cost-to- divided by the estimated number of Support Document (USEPA, 2016).
revenue test, EPA developed a list of entities in the category (derivation of the Under Option B, which represents this
2,193 manufacturers that participate in number of entities per NAICS/employee proposed rule (which includes costs for
the production of specific types of size category was previously described) rule implementation, potable use
plumbing products for both potable use giving average units produced per firm. labeling costs for both package and
and those eligible for the ‘‘used Average units per firm for each size product, labeling of products eligible for
exclusively’’ exemption. These firms category was multiplied by unit variable the ‘‘used exclusively’’ exemption that
were assigned to a NAICS code, based cost to get total variable cost for each do not meet lead free requirements,
on the type of plumbing product they NAICS/employees size category. The third party certification cost for firms
manufacture. Firm size distributional Census does not provide revenue values with 100 or more employees and third
information, based on number of by NAICS and employee sizes, so EPA party or self-certification costs for firm
employees, available from the U.S. used data on total annual receipts with fewer than 100 employees, and
Census Bureau’s Statistics of U.S. (assuming receipts is an unbiased data request costs), EPA estimates that
Businesses for the year 2012 was then estimator) by NAICS/employee size the vast majority of plumbing
used to parse the number of entities in categories as a close (although more manufacturing firms subject to the
each NAICS code into a number of small conservative) approximation of revenue. regulations will incur annualized costs
business and large firm categories. In The total receipts information was amounting to less than 1 percent of
this way, the number of firms in each of divided by the number of firms per revenue (2163 firms, or 98.6 percent of
the 14 NAICS codes having seven category to approximate average the total 2,193 manufacturers). A total of
employee size categories each (e.g., 0–4, revenue. 29 firms (2 percent of small firms) had
5–9, 10–19, 20–99, 100–499, 500+ to the EPA then compared the computed impacts between 1 and 3 percent of
Small Business Administration (SBA) average annual costs to the average revenue, and no small manufacturers
small business threshold, and large revenue for each of the NAICS/ had impacts above 3 percent, given the
firms above the SBA threshold) was employee size categories. If average cost costs estimated for Option B. The
derived. Computation of total average exceeded revenue by 1 percent, all firms analysis of Option B also found that 1
firm cost under each of the NAICS/ assigned to that category were assumed large entity (0.5 percent of large firms)
employee entity size categories was to incur impacts. Likewise, if average had impacts between 1 and 3 percent of
developed by applying the estimated annual cost exceeded revenue by 3 revenue, and no large firms were
unit fixed and variable costs to each percent in a NAICS/employee size impacted at the 3 percent revenue
regulatory option. In order to calculate category, all entities in that category are threshold.
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![4820 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
TABLE VI.2—SUMMARY OF COST-TO-REVENUE ECONOMIC IMPACT ANALYSIS
[Upper bound scenario, small entities 7% discount rate, large entities 3% discount rate]
Small entities Large entities
(7% discount rate) (3% discount rate)
Option Option description 1 Count 2 Percentage Count 2 Percentage
Total ≥1% ≥3% ≥1% ≥3% Total ≥1% ≥3% ≥1% ≥3%
A ........ Product and Package Costs for Potable Product 1,976 783 27 40 1 217 1 0 0.5 0.0
or Package Costs for ‘‘Used Exclusively’’ Ex-
empt Product, 3rd Party Cert for all manufac-
turers.
B ........ Product and Package Costs for Potable Product 1,976 29 0 2 0 217 1 0 0.5 0.0
or Package Costs for ‘‘Used Exclusively’’ Ex-
empt Product, 3rd Party Cert for ≥100 employ-
ees, Self or 3rd Party Cert for <100 employ-
ees.
C ........ Product or Package Costs for Potable Product or 1,976 0 0 0.0 0.0 217 0 0 0.0 0.0
Package Costs for ‘‘Used Exclusively’’ Exempt
Product, Self or 3rd Party Cert for all manufac-
turers.
Source: Technical Support Document, Exhibit 6–7 (USEPA, 2016).
1 All options also include implementation and data request costs. For Option B, EPA assumes that manufacturers <100 employees choose the
least cost option of self-certification. For Option C, EPA assumes all manufacturers pick the least cost option of self-certification. In addition, for
Option C, EPA assumes manufacturers choose the least cost option for labeling, which is usually package labeling except when the products do
not have packaging.
2 Counts of impacted entities are rounded up to 1 if they fall between 0 and 1.
EPA solicits comments on the country. In addition, a level of lead The PRA requires EPA to estimate the
economic analysis for this proposed exposure below which adverse effects burden on manufacturers and primacy
rule, including EPA’s cost analysis and do not occur has not been identified. agencies of complying with the
benefits assessment as described in this This suggests that further declines in proposed rule. The information
preamble and the Technical Support lead exposure below current-day levels collected as a result of this proposed
Document (USEPA, 2016) for this could still yield meaningful benefits in rule should allow EPA to determine
proposed rule. Comments are most the U.S. population, and the reduction appropriate requirements for specific
helpful when accompanied by specific in lead exposures from this proposed manufacturers and evaluate compliance
examples or supporting data. rule would result in fewer adverse with the proposed rule. For the first
health outcomes and, in turn, decrease three years after publication of the final
VII. Benefits
societal costs of treatment. Chapter 5 of rule in the Federal Register,
EPA did not quantify the expected the Technical Support Document manufacturers will incur burden to
change in health endpoints for this (USEPA, 2016) for this proposed rule conduct the following rule compliance
proposed regulation. EPA assessed the contains additional detailed information activities:
health effects associated with reductions on the potential health impacts of lead • Obtaining certification of products
in lead ingestion qualitatively using two on both children and adults. from an accredited third party
main sources: (1) The EPA ‘‘Integrated certification body to document
Science Assessment for Lead’’ (USEPA, VIII. Statutory and Executive Orders compliance with the lead free
2013b); and (2) the National Toxicity Reviews requirements as set forth in the SDWA.
Program’s Monograph on Health Effects A. Executive Order 12866: Regulatory • Maintaining record costs associated
of Low-level Lead (USHHS, 2012). Planning and Review and Executive with the initial certification (conducted
A wealth of information exists on the Order 13563: Improving Regulation and by an accredited third party certification
adverse health effects associated with Regulatory Review body) that potable use products meet
lead exposure. When ingested, lead is the requirements of NSF/ANSI Standard
distributed throughout the body and can This action is not a significant 372.
affect many organ systems. Lead is a regulatory action and was therefore not • Preparing the initial certificate of
highly toxic contaminant that can cause submitted to the Office of Management conformity and maintaining records for
adverse neurological, cardiovascular, and Budget (OMB) for review. potable use products that are self-
renal, reproductive, developmental, B. Paperwork Reduction Act (PRA) certified by the manufacturer as being
immunological and carcinogenic effects. lead free.
The neurological effects are particularly The information collection activities Respondents/affected entities: The
pronounced in children; however, in this proposed rule have been respondents include manufacturers of
sradovich on DSK3GMQ082PROD with PROPOSALS
recent studies in the public health submitted for approval to the Office of plumbing products intended for potable
literature have found that a wide Management and Budget (OMB) under use and manufacturers of some
spectrum of adverse health outcomes the PRA. The Information Collection plumbing products eligible for the
can occur in people of all ages. In 2013, Request (ICR) document that EPA ‘‘used exclusively’’ exemption that are
the U.S. Burden of Diseases prepared has been assigned EPA ICR physically compatible with potable use
Collaborators identified lead as one of No. 2563.01. You can find a copy of the products. States and local governments
the top 15 mortality risk factors (and top ICR in the docket for this rule, and it is are not impacted by the rule. For the
10 cardiovascular risk factors) in the briefly summarized here. first three years after publication of the
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![4822 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
this proposal will limit the inadvertent USEPA, 2013b. Final Report: Integrated ■ 9. Add subpart B to read as follows:
use of leaded plumbing products, Science Assessment for Lead. EPA 600–
R–10–075F. June 2013. Available on the Subpart B—Use of Lead Free Pipes,
thereby reducing exposure of children Fittings, Fixtures, Solder and Flux for
to lead in drinking water. Internet at: https://cfpub.epa.gov/ncea/
risk/recordisplay.cfm?deid=255721. Drinking Water
H. Executive Order 13211: Actions That USEPA, 2016. Technical Support Document Sec.
Significantly Affect Energy Supply, for the Proposed Rule: Use of Lead Free 143.11 Definitions.
Distribution, or Use Pipes, Fittings, Fixtures, Solder and Flux 143.12 Definition of lead free and
for Drinking Water. EPA 815–R–16–009. calculation methodology.
This action is not subject to Executive December 2016. 143.13 Use prohibitions.
Order 13211, because it is not a 143.14 State enforcement of use
significant regulatory action under List of Subjects prohibitions.
Executive Order 12866. 40 CFR Part 141 143.15 Introduction into commerce
prohibitions.
I. National Technology Transfer and Environmental protection, Chemicals, 143.16 Exempt uses and labeling of certain
Advancement Act (NTTAA) Indian—lands, Intergovernmental exempt use products.
This action involves technical relations, Radiation protection, 143.17 Required labeling of products that
Reporting and recordkeeping must meet lead free requirements.
standards. The EPA is proposing a 143.18 Required labeling of solder and flux
requirement that can be satisfied by, requirements, Water supply.
that is not lead free.
depending on the size of the regulated 40 CFR Part 143 143.19 Required certification of products.
entity, either self-certifying compliance 143.20 Compliance provisions.
Environmental protection, Chemicals,
with the SDWA lead prohibition or by
Indian—lands, Water supply. Subpart B—Use of Lead Free Pipes,
achieving a voluntary standard that
mirrors the SDWA requirements, such Dated: January 4, 2017. Fittings, Fixtures, Solder and Flux for
as the NSF/ANSI 372 standard. While Gina McCarthy, Drinking Water
EPA is not specifying a technical Administrator.
§ 143.11 Definitions.
standard under this proposed rule, EPA For the reasons set forth in the
is proposing the use of technical The following definitions apply to
preamble, EPA proposes to amend title this subpart:
standards that will meet the new 40 chapter I of the Code of Federal
definition of lead free as a means of Accredited third party certification
Regulations parts 141 and 143 as body means those bodies that are
demonstrating compliance with this follows:
proposal. accredited by the American National
Standards Institute (ANSI) to provide
J. Executive Order 12898: Federal PART 141—NATIONAL PRIMARY
product certification to meet the lead
Actions To Address Environmental DRINKING WATER REGULATIONS
free requirements of not more than a
Justice in Minority Populations and ■ 1. The authority citation for part 141 weighted average of 0.25 percent lead
Low-Income Populations continues to read as follows: content when used with respect to the
EPA has determined that this action wetted surfaces, consistent with section
Authority: 42 U.S.C. 300f, 300g–1, 300g–
will not have disproportionately high 2, 300g–3, 300g–4, 300g–5, 300g–6, 300j–4,
1417 of the Safe Drinking Water Act and
and adverse human health or 300j–9, and 300j–11. § 143.12, such as certification to the
environmental effects on minority NSF/ANSI 372 standard.
■ 2. Revise the subpart heading for Administrator means the
populations, low-income populations,
subpart E to read as follows: Administrator of the U.S.
or indigenous peoples as described in
Executive Order 12898 (59 FR 7629, Environmental Protection Agency or his
Subpart E—Special Regulations,
February 16, 1994), because this action or her authorized representative.
Including Monitoring Affiliated means a person or entity
does not establish any specific
regulatory requirements that would § 141.43 [Removed] that directly or indirectly through one or
affect these communities. Instead, it is ■ 3. Remove § 141.43. more intermediaries, controls or is
a proposed rule that codifies existing controlled by, or is under common
requirements set forth by Congress PART 143—NATIONAL SECONDARY control with, the person or entity
regarding the allowable levels of lead in DRINKING WATER REGULATIONS specified. Affiliated persons or entities
plumbing products, and also includes include, but are not limited to: A parent
■ 4. The authority citation for part 143 company and all wholly or partially
additional provisions intended to aid in continues to read as follows:
the implementation of those owned subsidiaries of a parent
requirements. Authority: 42 U.S.C. 300f et seq. company, or two or more corporations
■ 5. Revise the part heading for part 143 or family partnerships that have overlap
IX. References in ownership or control.
to read as follows:
USHHS, 2012. National Toxicity Program Alloy means a substance composed of
Monograph on Health Effects of Low- PART 143—OTHER SAFE DRINKING two or more metals or of a metal and a
level Lead. U.S. Department of Health WATER ACT REGULATIONS nonmetal.
and Human Services. June 2012. Coating means a thin layer of material
Available on the Internet at: https:// ■ 6. Add subpart A to read as follows: such as paint, epoxy, zinc galvanization,
sradovich on DSK3GMQ082PROD with PROPOSALS
ntp.niehs.nih.gov/ntp/ohat/lead/final/ or other material usually applied by
monographhealtheffectslowlevellead_ Subpart A—National Secondary spraying or in liquid form to coat
newissn_508.pdf. Drinking Water Regulations internal surfaces of pipes, fittings or
USEPA, 2013a. Summary of the Reduction of
Lead in Drinking Water Act and ■ 7. Redesignate §§ 143.1 through 143.4 fixtures.
Frequently Asked Questions. December as subpart A. Drinking water cooler means any
2013. Available on the Internet at: mechanical device affixed to drinking
https://nepis.epa.gov/Exe/ §§ 143.5–143.10 [Reserved] water supply plumbing which actively
ZyPURL.cgi?Dockey=P100M5DB.txt. ■ 8. Reserve §§ 143.5 through 143.10. cools water for human consumption.
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![4824 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
incompatible with other products that where they are visible after product certification, dates of certification and
would be needed to convey water for installation when practical. expiration. This documentation must be
potable uses); or (i) If the product is too small for a provided upon request to the
(2) The product is clearly labeled, on legible marking in a type face ranging Administrator as specified in
the product, package, container, or tag from approximately 8 point to 14 point § 143.20(b).
with a phrase such as: ‘‘Not for use with depending on the method of marking (c) Manufacturers having fewer than
water for human consumption’’ or and roughness of product surface, only 100 employees or importers sourcing
another phrase that conveys the same a product package, container or tag must products from or representing
meaning in plain language. be labeled or marked. manufacturers having fewer than 100
(b) Toilets, bidets, urinals, fill valves, (ii) If the visible marking on installed employees may elect to self-certify
flushometer valves, tub fillers, shower products will adversely impact the products in lieu of obtaining
valves, fire hydrants, service saddles, visual appeal to consumers of the certification from an accredited third
water distribution main gate valves that finished product, the product may be party certification body. The number of
are 2 inches in diameter or larger. marked in a location not visible after employees includes any persons
(c) Clothes washing machines, fire installation. employed by the manufacturer and any
suppression sprinklers, eyewash (c) For products certified by of its affiliated entities. The number of
devices, sump pumps, and emergency accredited third party certification employees must be calculated by
drench showers. bodies, labeling or marking on the averaging the number of persons
§ 143.17 Required labeling of products
product, package, container, tag or some employed, regardless of part-time, full-
that must meet lead free requirements. combination of these locations must time or temporary status by an entity
include: and all of its affiliated entities for each
(a) Persons that introduce into
(1) The logo or name of the pay period over the entity’s latest 12
commerce products that must meet the
certification body as specified by the calendar months, or averaged over the
lead free requirements of section
specific certification body; and number of months in existence if less
1417(a)(3)(A) of the Safe Drinking Water
(2) The specific certification body’s than 12 months. Such manufacturers or
Act and § 143.12 must label such
required identifier text to convey lead importers electing to self-certify
products to indicate that it is in
free or low lead content. products must comply with paragraphs
compliance with those requirements.
Such labeling must occur by [DATE 3 (d) through (g) of this section.
§ 143.18 Required labeling of solder and
YEARS AFTER PUBLICATION OF flux that is not lead-free. (d) In order for eligible manufacturers
FINAL RULE IN THE Federal Register] or importers to self-certify products,
Solder and flux that is not ‘‘lead free’’
or prior to introduction into commerce, such manufacturers or importers must
as defined in § 143.12(a)(1) must bear a
whichever occurs later. attest that products are in compliance
prominent label stating that it is illegal
(b) Labeling or marking as specified in by developing and maintaining a
to use the solder or flux in the
paragraph (a) of this section must be in ‘‘certificate of conformity.’’ The
installation or repair of any plumbing
accordance with paragraphs (b)(1), certificate of conformity must be:
providing water for human
(b)(2), and (c) of this section: (1) Signed by a responsible corporate
consumption.
(1) Packaged, containerized or tagged officer, a general partner or proprietor,
products must be labeled or marked on § 143.19 Required certification of or an authorized representative of a
the package, container, or tag with a products. responsible corporate officer, general
phrase such as: ‘‘Conforms with the lead (a) Manufacturers or importers that partner or proprietor; and
free requirements of the federal Safe introduce into commerce products that (2) Posted to a Web page with
Drinking Water Act,’’ ‘‘Lead Free,’’ or must meet the lead free requirements of continuing public access in the United
similar terms that clearly convey to section 1417 of the Safe Drinking Water States.
users that the product is in compliance Act and § 143.12 must ensure that the (e) The certificate of conformity must
with the applicable requirements. products are certified to be in be in English and include:
Products that are not packaged, compliance as specified in paragraphs (1) Contact information for the
containerized or tagged are only (b) and (c) of this section by [DATE 3 manufacturer or importer to include:
required to be marked consistent with YEARS AFTER PUBLICATION OF (i) The entity or proprietor name,
requirements in paragraph (b)(2) of this FINAL RULE IN THE Federal Register] (ii) Street and mailing addresses,
section. Shrink wrapping of bulk or prior to product introduction into (iii) Phone number, and
products solely for the purpose of commerce, whichever occurs later. Such (iv) Email address.
shipping or storage does not constitute manufacturers or importers must For products imported into the United
being packaged, containerized, or maintain documentation to substantiate States, the contact information must
tagged. the certification. also be included for the manufacturer;
(2) Products must be directly marked (b) Certification of products must be (2) A brief listing of the products to
by physically stamping, forging, or obtained by manufacturers or importers include, when applicable, unique
printing with indelible ink, except as from an accredited third party identifying information such as model
provided in (b)(2)(i) or (b)(2)(ii) of this certification body, except as provided in names and numbers;
section. The marking must clearly paragraph (c) of this section. (3) A statement attesting that the
convey to consumers that the product is (1) Products certified by an accredited products meet the lead free
sradovich on DSK3GMQ082PROD with PROPOSALS
lead free, such as ‘‘Lead Free,’’ ‘‘LF,’’ or third party certification body must be requirements of the Safe Drinking Water
certification marks. If the marking is labeled or marked as specified in Act and 40 CFR part 143, subpart B and
‘‘LF’’ or another abbreviation, symbol or § 143.17(c). also that the manufacturer or importer is
acronym, the product package, (2) The manufacturer or importers eligible to self-certify the product
container, or tag must associate that must keep records for all products consistent with this regulation;
marking with a phrase such as ‘‘lead certified by an accredited third party (4) A statement indicating how the
free’’ or ‘‘meets lead free requirements.’’ certification body that include at a manufacturer or importer verified
Product markings should be located minimum: Documentation of conformance with the Safe Drinking
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![Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules 4825
Water Act and 40 CFR part 143, subpart ACTION: Proposed rule. SUPPLEMENTARY INFORMATION:
B; and
SUMMARY: As required under section I. Executive Summary
(5) The signature, date, name and
position of the signatory; and if the 6(b)(1) of the Toxic Substances Control A. Does this action apply to me?
signatory is an authorized representative Act (TSCA), EPA is proposing to
establish a risk-based screening process This proposed rule does not propose
of a responsible corporate officer, a to establish any requirements on
general partner or proprietor, the name and criteria that EPA will use to identify
chemical substances as either High- persons or entities outside of the
and position of the responsible Agency. This action may, however, be of
corporate officer, a general partner or Priority Substances for risk evaluation,
or Low-Priority Substances for which interest to entities that are or may
proprietor. manufacture or import a chemical
(f) Manufacturers or importers that risk evaluations are not warranted at the
substance regulated under TSCA (e.g.,
self-certify products must maintain, at a time. The proposed rule describes the
entities identified under North
primary place of business within the processes for identifying potential
American Industrial Classification
United States, certificates of conformity candidates for prioritization, selecting a
System (NAICS) codes 325 and 324110).
and sufficient documentation to confirm candidate, screening that candidate
Since other entities may also be
that products meet the lead free against certain criteria, formally
interested, the Agency has not
requirements of this subpart. Sufficient initiating the prioritization process,
attempted to describe all the specific
documentation may include: Detailed providing opportunities for public
entities and corresponding NAICS codes
schematic drawings of the products comment, and proposing and finalizing
for entities that may be interested in or
indicating dimensions, calculations of designations of priority. Prioritization is
affected by this action.
the weighted average lead content of the the initial step in a new process of
product, lead content of materials used existing chemical substance review and B. What action is the agency taking?
in manufacture and other risk management activity established EPA is proposing to establish the
documentation used in verifying the under recent amendments to TSCA. internal processes and criteria by which
lead content of a plumbing device. This DATES: Comments must be received on EPA will identify chemical substances
documentation and certificates of or before March 20, 2017. as either High-Priority Substances for
conformity must be provided upon ADDRESSES: Submit your comments, risk evaluation, or Low-Priority
request to the Administrator as specified identified by docket identification (ID) Substances for which risk evaluations
in § 143.20(b). number EPA–HQ–OPPT–2016–0636, by are not warranted at the time.
(g) The certificate of conformity and one of the following methods:
C. Why is the agency taking this action?
documentation must be completed prior • Federal eRulemaking Portal: http://
to a product’s introduction into www.regulations.gov. Follow the online This rulemaking is required by TSCA
commerce. instructions for submitting comments. section 6(b)(1)(A). Prioritization of
Do not submit electronically any chemical substances for further
§ 143.20 Compliance provisions. information you consider to be evaluation will ensure that the Agency’s
(a) Noncompliance with the Safe Confidential Business Information (CBI) limited resources are conserved for
Drinking Water Act or this subpart may or other information whose disclosure is those chemical substances most likely to
be subject to enforcement. Enforcement restricted by statute. present risks, thereby furthering EPA’s
actions may include seeking injunctive • Mail: Document Control Office overall mission to protect health and the
relief, civil or criminal penalties. (7407M), Office of Pollution Prevention environment.
(b) The Administrator may, on a case- and Toxics (OPPT), Environmental D. What is the agency’s authority for
by-case basis, request any information Protection Agency, 1200 Pennsylvania taking this action?
deemed necessary to determine whether Ave. NW., Washington, DC 20460–0001.
a person has acted or is acting in • Hand Delivery: To make special EPA is proposing this rule pursuant to
compliance with section 1417 of the arrangements for hand delivery or the authority in TSCA section 6(b), 15
Safe Drinking Water Act and this delivery of boxed information, please U.S.C. 2605(b). See also the discussion
subpart. Such information requested follow the instructions at http:// in Units II.A and B.
must be provided to the Administrator www.epa.gov/dockets/contacts.html. E. What are the estimated incremental
at a time and in a format as may be Additional instructions on commenting impacts of this action?
reasonably determined by the or visiting the docket, along with more
Administrator. This is a proposed rule that would
information about dockets generally, is
establish the processes by which EPA
[FR Doc. 2017–00743 Filed 1–13–17; 8:45 am] available at http://www.epa.gov/
intends to designate chemical
BILLING CODE 6560–50–P dockets.
substances as either High or Low-
FOR FURTHER INFORMATION CONTACT: Priority Substances for risk evaluation.
For technical information contact: It would not establish any requirements
ENVIRONMENTAL PROTECTION Ryan Schmit, Immediate Office, Office on persons or entities outside of the
AGENCY of Chemical Safety and Pollution Agency. EPA did not, therefore, estimate
Prevention, Environmental Protection potential incremental impacts from this
40 CFR Part 702
Agency, 1200 Pennsylvania Ave. NW., action.
[EPA–HQ–OPPT–2016–0636; FRL–9957–74] Washington, DC 20460–0001; telephone
sradovich on DSK3GMQ082PROD with PROPOSALS
number: (202) 564–0610; email address: F. What should I consider as I prepare
RIN 2070–AK23
schmit.ryan@epa.gov. my comments for EPA?
Procedures for Prioritization of For general information contact: The 1. Submitting CBI. Do not submit this
Chemicals for Risk Evaluation Under TSCA-Hotline, ABVI-Goodwill, 422 information to EPA through
the Toxic Substances Control Act South Clinton Ave., Rochester, NY regulations.gov or email. Clearly mark
14620; telephone number: (202) 554– the part or all of the information that
AGENCY: Environmental Protection 1404; email address: TSCA-Hotline@ you claim to be CBI. For CBI
Agency (EPA). epa.gov. information in a disk or CD–ROM that
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Document Created: 2017-01-14 01:44:49
Document Modified: 2017-01-14 01:44:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before April 17, 2017. | |
| Contact | Russ Perkinson, telephone number: | |
| FR Citation | 82 FR 4805 | |
| RIN Number | 2040-AF55 | |
| CFR Citation | 40
CFR
141 40 CFR 143 | |
| CFR Associated | Environmental Protection; Chemicals; Indian-Lands; Intergovernmental Relations; Radiation Protection; Reporting and Recordkeeping Requirements and Water Supply |
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