Holding US Back: Regulation of the U.S. Sector

Report to the National Association of Manufacturers Prepared by Pareto Policy Solutions, LLC

Table of Contents

Prologue 3

Introduction 8

Methodology 9

Federal Regulation of the U.S. Manufacturing Sector 13

Summary and Conclusion 40

Appendix A: Interview Instrument 44

Appendix B: Survey Results 49

Appendix C: List of Federal Regulations 67

2 Prologue

Smith Custom Manufacturing (Smith) is a hypothetical family-owned manufacturer located in the American Midwest. Smith’s story is similar, oftentimes identical, to the plight of many small firms in the . The founder’s daughter, Mary Smith, has worked for the for more than 25 years and has served as president and CEO since 2010. Smith cuts, bends, welds and forms metal parts and structures used by other manufacturers in industrial sectors like , automotive and , and exports its products to customers in , Mexico, Europe and Asia. The company employs more than 100 full-time individuals, including shop floor workers, engineers, attorneys, accountants, human resources managers and information personnel. It provides competitive pay, a retirement plan and various forms of . The account that follows is based on actual regulations.

The Regulatory Journey Begins

The first shift at Smith begins at 6:00 a.m., but Mary Smith arrives an hour earlier every morning to meet with the supervisors she oversees and to run through a daily checklist of operational and safety items. Depending on the task, employees are required to wear personal protective equipment, including helmets, eye and ear protection, steel-toed boots and appropriate clothing. Every activity within the manufacturing process requires awareness of and compliance with worker safety requirements.

By the time Mary arrives at 5:00 a.m., Smith already has all the materials it needs for the day’s runs thanks to a special crew who worked from midnight to 4:00 a.m. to off-load raw materials from a group of delivery trucks. These raw materials and the processes that create them are governed by a raft of federal, state and local requirements, leading to higher for Smith’s suppliers and higher prices for Smith. For example, the foundries that supply Smith’s metal will be impacted by the Occupational Safety and Health Administration’s (OSHA) final rule on occupational exposure to crystalline silica, which is a basic component of soil, sand, and other . The local utility, which supplies Smith with gas and electricity, has been directly affected by Environmental Protection Agency (EPA) regulations on and , including the Clean Power Plan and Utility MATS, increasing costs for Smith and other energy- intensive manufacturers. And many of the chemicals that Smith purchases are governed by additional regulations, from required safety data sheets, to rules about personal protective equipment and specialized training, to regulations by the Securities and Exchange Commission (SEC), that mandate the company and its suppliers must determine the origin of its materials and file this information annually with the agency.

The Manufacturing Process: A Long and Winding Regulatory

A large has hired Smith to produce steel parts that will be used in commercial . To create the finished product, the steel must be cut, stamped and bent, and the unit must be finish-coated to prevent corrosion. Smith will ship the product to two of its customer’s facilities—one in the southern United States and one in Europe.

Federal and state requirements establish mandates for every element of the manufacturing process: the employees, machinery, methods, inputs and waste. For example, Smith must comply with OSHA requirements for the control of hazardous energy, including by training each worker to ensure that he or she knows and

3 understands the procedures for dealing with an unexpected startup or release of stored energy during the servicing and of machines and equipment. Smith is also required to let machines sit idle after completion of an activity for one product before they can be used for another job. These requirements must be met even if the machine is controlled by a computer and an employee is not involved. And because the finished product will be used in the production of aircraft, Smith needs the Federal Administration (FAA) to certify that the of the part is satisfactory and that the production process meets the FAA’s safety standards. If the certification processes are stalled, the new product must wait to be sold—sometimes delaying a larger project or preventing Smith from meeting its customers’ needs.

Once the product meets its required specifications, it is heat-treated twice using natural gas to strengthen it and tested to ensure it meets the strength requirements for aircraft use. The product is cleaned to prepare for cadmium plating through a process that involves suspending it above heated solvents while vapors dissolve any foreign material. To comply with federal requirements to provide workers with a safe workplace, Smith utilizes a ventilation system that captures all vapors, and employees are required to wear personal protective equipment to ensure their safety.

Next, the pieces are sandblasted with aluminum oxide to improve the adherence of the cadmium plating. Smith already has a space dedicated to its sandblasting operations as well as a specialized ventilation system, and employees wear head-to-toe protection with full-face respirators. But OSHA’s new rule says that personal protective equipment will no longer be suitable as the primary form of protection, so Smith must look at purchasing and installing additional controls to reduce airborne crystalline silica.

To complete the electroplating, wiring and copper frames are used to suspend the parts within a chemical solution that dissolves the cadmium, which is transferred to the manufactured pieces using an electrical current. The pieces are then rinsed in water and given several chemical baths and a hot water rinse.

Packaged and Shipped: New Worlds of Regulation

The finished product is now packaged by hand into crates, with each piece separated and protected by closed-cell polyethylene foam, which is regulated by the EPA and comes with its own safety data sheet. If a shipment is damaged and rejected by the customer, then Smith’s contract could be voided if Smith is found to be at all responsible.

The crates are loaded onto trucks supplied by a local trucking company—standard tractor-trailers for the products to be shipped domestically and tractors pulling an intermodal container for those that are bound for Europe. The trucks must meet increasingly strict air emission standards and fuel requirements issued by the EPA. The Federal Highway Administration establishes truck weight requirements that apply for shipments traveling on the Interstate Highway System, meaning that Smith keep extensive records on how it loads materials onto its trailers.

Since Smith is shipping products to an overseas facility, it must comply with regulations issued by the Department of Commerce and U.S. Customs and Border Protection. The part must be classified correctly, which is doubly challenging if it could be used in . Smith must know whether a license is required for the export of a product. And Smith has to check the regulations that would be applied by the destination country,

4 including any specific standards that the product has to meet, any testing or certification requirements and any labeling requirements for the product shipments.

A Finished Product, but Regulatory Compliance Doesn’t End

Regardless of the product Smith manufactures, its operations are heavily influenced by a maze of EPA regulations. When Smith decided 15 years ago to move into its current facility, the company had to acquire permits under the Clean Air Act to ensure its emissions didn’t exceed permissible levels. The permit requires the facility and its machinery to use state-of-the-art -control technology—and depending on the machine, Smith has to acquire additional permits. As a metal fabricator, Smith is subject to EPA regulations pertaining to processes like dry blasting, dry grinding and polishing, dry machining, spray painting and welding and must periodically monitor these processes using EPA test methods. Of course, the EPA’s standards are subject to change; a few years ago, Smith spent nearly $20 million to retrofit its gas-fired boiler to comply with new Boiler MACT regulations, and the EPA’s recent decision to begin including emissions during startup, shutdown and mechanical malfunctions in monitoring that can occur hourly will require Smith to make significant additional investments or risk penalties.

Air standards are only one part of the environmental regulations that Smith must follow. The water Smith uses throughout the day is subject to regulations issued by federal, state and local authorities to ensure it meets clean water standards before it can be discharged. Smith’s is regulated through strict procedures that dictate how the company manages and captures its waste before transferring it to a third-party facility for , treatment and disposal. And its workspace is governed by standards developed by OSHA, including those pertaining to safe equipment use, electrical procedures and materials handling. Smith ensures that its employees are appropriately certified to engage in the facility’s activities, often requiring classes, licensing and additional safety trainings. The state in which Smith’s facility is located, for example, requires floor supervisors to have CPR certification.

Even if Smith complies with dozens of relevant OSHA regulations (in addition to state and local requirements), inspectors and enforcement officials still decide whether the company is in violation of the law. Every two or three years, an OSHA inspector arrives unannounced at Smith to observe areas and watch employees in action. The visit might take half a day or several days. The inspector may take issue with the color of the that highlights emergency exits or with the location of the equipment. Different OSHA inspectors may have different interpretations of a particular standard, and it’s not unusual for OSHA to change its interpretation of a standard over time.

Beyond the Shopfloor

Human Resources

At Smith, the human resources department is responsible for any policy that involves the relationship between the company and its employees and must ensure compliance with no fewer than a dozen federal laws enforced by a range of federal agencies. These agencies include the Department of Health and Human Services (health care); the Department of Labor’s Wage and Hour Division (minimum wage, overtime, family and medical leave); Department of Labor’s Employment and Training Administration (unemployment insurance); Equal Employment Opportunity Commission (a range of

5 employee protections); National Labor Relations Board (NLRB) (employee rights and representation); Department of Labor’s Veterans’ Employment and Training (job for military personnel); and the Department of Homeland Security’s Citizenship and Immigration Services (issues involving immigration status). Smith’s human resources paperwork requirements have quadrupled in recent years due to new federal regulations including new health care reporting requirements. Since Smith serves customers who are federal contractors, it is subject to the Federal Acquisition Regulation and other actions impacting federal contractors and subcontractors. Under a final rule issued in August 2016, Smith is required to report any allegations that it violated a federal labor law—and even if an allegation is proven false and Smith is cleared of any wrongdoing, the company could become ineligible for work with federal contractors.

Legal Department

Smith has one attorney who serves as general counsel. While Smith is not a union shop, it is subject to decisions and interpretations by the NLRB, which safeguards employees’ rights to organize. The NLRB also acts to prevent and remedy unfair labor practices committed by private-sector employers and unions. A single employee complaint can trigger an NLRB investigation of Smith—and in certain circumstances, NLRB regulations dictate how and when Smith can communicate with its employees as well as the type of information the company can share. In fact, Smith has found it challenging to obtain legal advice on how the company should react to potential union activity, due to a 2016 final rule from the Department of Labor that requires attorneys who provide labor law advice to extensively disclose their activities, including what information they are providing, who they are providing it to and how much they are collecting in fees.

Recently, the NLRB redefined the 30-year-old joint-employer standard, calling into question what type of relationship one employer has with another. The previous standard considered joint employers only when they share direct and immediate control over essential terms and conditions of employment like hiring, firing, discipline, supervision and direction. Now, Smith is concerned that it could find itself in a joint-employer relationship, triggering responsibility for collective-bargaining agreements and other parts of the National Labor Relations Act. As a result, Smith has had to reexamine its relationships with its contractors and to determine if it must follow additional regulatory requirements.

Executive Officers

Smith’s top officers are by no means immune to the reach of federal regulators. For example, a capital-intensive company like Smith must constantly upgrade its equipment and improve its efficiency to keep up with its competitors, and executive officers are responsible for deciding which capital projects get funded and which do not. This difficult choice is made even more difficult by federal regulations, which often require additional capital investment. The more costly the regulatory mandates, the less discretion Smith has over its capital improvement budget and the fewer worthy projects Smith can fund. According to Smith’s director of corporate compliance, one of the projects that had to be cut this year was a plan to rework a production process to eliminate hazardous waste generation, which is costly to manage because of EPA regulation.

If Smith is successful enough for the CEO to consider expanding its operations, the company faces additional regulatory hurdles, such as obtaining the necessary governmental permits. If the desired new location has levels of air pollution that exceed

6 the EPA’s national safety standard, Smith must install more stringent air-pollution controls and purchase “offsets”—reductions in air pollution made by existing businesses in the area to allow for potential new emissions from Smith.

Accounting and Tax Compliance

Because the tax code is so complex, Smith must employ an accounting firm to help with its federal income taxes. Like two-thirds of all manufacturers in the United States, Smith is considered a “pass-through” entity, meaning that the owner (i.e., the CEO) is taxed individually on the company’s income, taking into account her share of the profits and losses. The resulting tax return averages 65 pages every year. And because of the amount of income reported and the large deductions for capital (depreciation, capital improvements, etc.), Mary can always expect questions from the IRS and an occasional audit.

Navigating Unfamiliar Waters

To ensure compliance with every new regulation, Smith follows a five-step process: (1) identify proposed regulations under development that might be applicable to Smith; (2) analyze the final regulation to understand it and determine the applicable portions; (3) develop a compliance plan, including standard operating procedures and employee training materials; (4) disseminate these materials and educate/train employees prior to the compliance date(s); and (5) periodically self-audit to ensure continued compliance.

This process is not simple. For Smith, the biggest challenge is becoming aware of new regulations. After a recent open house featuring a new welding area, the local air- pollution control authority said Smith needed a permit to comply with a brand-new regulation. Smith had to apply for a permit and then show why the new regulation didn’t apply to its situation.

Regulatory compliance is also extremely complex, which can be daunting to small businesses that don’t have the dedicated compliance staff found in the largest corporations. Smith uses outside help to ensure compliance with some federal regulations like those governing hazardous waste disposal, income tax filings and employee health care.

The Bottom Line

Each of these regulations, considered in isolation, serves a public purpose. They provide environmental protections, employee safeguards and public safety benefits. The cumulative effect on Smith, however, poses a real and serious challenge. To comply with these regulations, Smith has to divert resources that otherwise would go toward that can yield increased business and provide value to its customers like improving its efficiency and developing new solutions. This market —itself a public benefit—is an opportunity lost. Collectively, regulation at the federal, state and local level doesn’t just hold Smith back but it also holds our country back in a competitive fight to be the best place in the world to manufacture and create jobs.

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7 Introduction

Federal regulation is associated with some big numbers:

• An average of 3,300 new regulations are issued each year.1 • Between 66 and 99 of these regulations are major,2 meaning each has an estimated impact of at least $100 million or more in a single year. A few have an estimated impact of more than $1 billion in a single year. • Together, old and new federal regulations impose annual costs in the hundreds of billions of dollars,3 plus or minus an order of magnitude because of uncertainty. Even greater is the uncertainty over estimates of aggregate annual benefits.

Public debates over the value of regulation tend to focus on these figures in stark, pro- versus-con terms. Buried within these numbers are two often overlooked facts: (1) regulations pose significant compliance challenges; and (2) resources spent complying with a mandatory requirement cannot be spent on valuable discretionary activities. As one compliance official interviewed for this report noted, “We will dedicate the resources even if the resources could be better used for risk reduction elsewhere.” It is these missed opportunities that represent the true of regulation and hold the United States back in a competitive global economy.

This report represents an attempt to convey the opportunity cost of regulation from the perspective of manufacturers in the United States. Unlike other studies that quantify regulatory impact using macroeconomic modeling (a “top-down” approach), this study identifies specific regulatory requirements and elicits the perspective of compliance officials at regulated firms (a “bottom-up” approach). Our goal is to paint a broad picture of the compliance challenges facing a business. The picture that emerges is a constantly changing one; layer upon layer of new regulatory mandates create a burden on manufacturers that is significant, growing and impactful, diverting resources away from important discretionary activities like market innovation.

1 Source: U.S. GAO Federal Rules Database; the average annual number of regulations issued from 2000 to 2014. 2 Source: U.S. GAO Federal Rules Database; the average annual number of major regulations issued from 2000 to 2014 ranges between 2 percent and 3 percent of the total number of regulations. 3 In testimony before Congress, Michael Greenstone, an MIT professor and former economist with the President’s Council of Economic Advisers, said, “Consequently, it seems safe to conclude that the total costs of regulations can be measured in the hundreds of billions of dollars annually.” See Michael Greenstone. “Improving Regulatory Performance: Lessons from the .” Committee on Budget. U.S. Senate. November 16, 2011.

8 Methodology The research employed for this study consists of three exercises: structured interviews with corporate compliance officials, a survey of the NAM membership, and identification and analysis of hundreds of specific federal regulations affecting US manufacturing.

Structured interviews were held with 19 compliance officials from six chosen to span the full range of size and subsectors within the NAM membership. An interview instrument was developed and used to facilitate each of the interviews. For some companies, the interviews included multiple compliance officials, while in others the interviewee was a single individual responsible for some aspect or all aspects of regulatory compliance (including one CEO). The interview instrument (Appendix A) served two purposes: (1) to elucidate information on regulatory burden, compliance challenges, and opportunity cost; and (2) to assist in development of an email survey of NAM members. Interview subjects were promised confidentiality; no citing of their name or company would be revealed in any final report unless they gave explicit permission. This report honors that commitment: Appendix A provides the survey instrument but not the written summary of their responses.

As a result of the interviews, the number of questions was pared down and simplified to ease respondent burden during the next phase—the email survey of NAM members, which was conducted in the second half of June 2016. The questions and the aggregate responses (from 486 respondents) are shown in Appendix B. The respondents were representative of the various manufacturing subsectors within the NAM membership.

A search of the Code of Federal Regulations (the electronic version, or eCFR) was conducted (in the Spring of 2016) to identify specific federal regulations affecting US manufacturers. The CFR is organized into 50 titles, and each title is further divided into chapters, subchapters, parts, subparts, and sections. The unit of analysis (i.e., the “regulation”) chosen for this exercise was the part. The part was chosen to ease the task of identifying and compiling requirements applicable to manufacturers and to enable comparisons across regulatory requirements.

To identify CFR parts applicable to US manufacturers, the following multi-step process was used:

First, a search of the eCFR4 was conducted to identify parts containing the following specific words in the heading: “manufacturing”, “manufacturer”, “manufacturers”, “sourcing”, “processing”, “production”, “assembly”, “quality control”, “testing”, “labeling”, “packaging”, “”, and “sale”. Any CFR parts specific to , oil and gas extraction or to electric utilities were excluded as being not relevant for manufacturing. Regulations pertaining to federal benefit programs (subsidies, grants, etc.) were removed from the list to

4 The eCFR can be accessed via the GPO : http://www.ecfr.gov/cgi- bin/ECFR?page=browse

9 focus solely on requirements that restrict operational freedom. A search of regulations.gov5 was conducted to identify NAM public comments on proposed regulations over a five-year time period (2010-2015) and identify the associated CFR citation for these regulations. This list of citations was crosschecked against the table to ensure completeness; citations were added if they were not already included. Similarly, additional crosschecking was done against the regulatory programs identified in a 2012 MAPI-sponsored study6 on the macroeconomic impact of regulation on manufacturers and against the SBA.gov tools7 identifying major regulations affecting small business. A final completeness check was done by reviewing adjacent CFR parts to those already identified and adding those adjacent parts that impose similar restrictions on manufacturers.

As a result of this exercise, 715 CFR parts applicable to manufacturers (see Appendix C) were identified.

Not all CFR parts are equal in terms of burden. A CFR part can span in range from very (e.g., under one page) to very long (e.g., multiple -lengths), it is necessary to standardize this information in some . To “normalize” the info to make it more comparable, a count of “restrictions” per CFR part was employed. This information comes from the George Mason Mercatus Center database of the CFR (RegData version 2.2, metadata file, 2014 CFR). The number of restrictions is a simple count of the number of occurrences of certain words or phrases in each CFR part (“shall”, “must”, “may not”, “prohibited”, and “required”).8 This count allows comparisons across parts. For example, the number of restrictions in the identified list of CFR citations ranges from zero (e.g., 21 CFR 579, FDA radiation of animal feed) to 44,959 (26 CFR 1, IRS income tax), suggesting that the latter is much more voluminous and/or more prescriptive than the former.

There are several reasons to believe that the number of CFR parts identified as a result of this exercise is likely to significantly undercount the actual number of regulations (and “restrictions”) imposed on US manufacturers. First, the methodology is designed to ascertain with a high degree of certainty those CFR parts that impact manufacturing. The absence of inclusion on the resulting list does not imply a lack of impact on the manufacturing sector; it simply reflects a preference to avoid false positives over false negatives. Second, the RegData 2.2 database does not include a count of restrictions for 22 of the CFR parts identified in Appendix C. Third, the CFR does not contain all federal mandates that restrict the freedom of manufacturers. Many statutory provisions enacted to limit business behavior are “self-executing;” requiring no new regulations to be

5 https://www.regulations.gov 6 NERA Economic Consulting. 2012. Macroeconomic Impacts of Federal Regulation of the Manufacturing Sector. Manufacturers Alliance for Productivity and Innovation. 7 https://www.sba.gov/about-sba/sba-performance/policy-regulations/laws-regulations 8 For more information on RegData, see Al-Ubaydli, O. and McLaughlin, P.A. (2015) “RegData: A numerical database on -specific regulations for all United States industries and federal regulations, 1997-2012.” Regulation & Governance, doi: 10.1111/rego.12107.

10 issued. Regulatory agencies are not required to insert these statutory provisions into the CFR, although they sometimes do.9 Guidance documents that pertain to specific regulatory programs, and sometimes have the effect of a regulation, were excluded. Finally, manufacturers are regulated outside the federal government. State laws and regulations,10 local/municipal laws and regulations, or a combination of federal, state, and local regulations11 restrict the behavior of U.S. manufacturers. Furthermore, regulations issued by other countries affect U.S. manufacturers.12

To categorize each CFR part with respect to its impact on manufacturing, a typology of a typical manufacturing firm was developed. This typology consists of six sequential process steps used in most if not all manufacturing operations (sourcing raw materials and energy; preliminary processing, production, and assembly; quality control; labeling and packaging; distribution and shipping; and post-sale follow-up) and six common “shared services” to support these operations (human resources, tax/accounting; and ; environment, health, and safety; R&D/new product development; and governance/executive level decisions). This typology reflects information gleaned from the structured interviews regarding how companies organize for compliance purposes.

With this typology in pace, each identified CFR part was placed into one and only one of these 12 categories based on the perceived primary purpose of the regulatory language. For example, if a CFR part focused primarily on labeling, it was placed in the labeling/packaging process step. For the vast majority of CFR parts identified, placement into a category was relatively straightforward. In some cases, two or more categories might be appropriate. In these cases, a decisional criterion was developed to facilitate the choice. For example, some CFR parts specify design standards for a product (e.g., CPSC product standards). Should these CFR parts be placed under the R&D shared service (because it affects the design of a manufactured product) or the production process step (because it limits what products can be made)? In this case, the decisional criterion was to place only CFR parts related to truly “new” products (e.g., regulations requiring pre-market governmental approval) under the R&D category and to place all other product specification standards under the production process step. Consistency in application was the goal in this exercise.

9 For example, according to the CPSC, the Consumer Product Safety Improvement Act of 2008 added statutory requirements for specific children’s products, some of which may not have corresponding regulations in the CFR. The Children’s Burn Prevention Act places specific requirements on manufacturers and importers of portable gas cans that are not delineated in the CFR. 10 For example, according to the FTC, “implied warranties” are created by state law, and all states have them. 11 One company interviewed indicated one of their facilities is subject to separate storm water regulations from EPA, state regulators, and municipal regulators. 12 One global manufacturer interviewed revealed that product regulations affecting chemicals have grown 12% annually over the past decade, largely driven by new laws and regulations in other countries.

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The resulting list of CFR parts per manufacturing step or shared service was examined to select regulatory programs that could be used to illustrate the compliance challenges identified in the interviews and survey. When describing the underlying regulatory program, care was taken to utilize source material from the regulatory agency itself to most accurately characterize regulatory obligations.

12 Federal Regulation of the U.S. Manufacturing Sector A manufacturing operation involves several steps: sourcing of raw materials; preliminary processing, production, and assembly; quality control and testing; labeling and packaging; distribution/transportation, and post-sale follow-up. To enable this manufacturing process requires several support functions: research & development (R&D) and product design; human resources; tax; environment, health & safety (EH&S); marketing & sales; and governance/executive leadership.

Each step of the manufacturing process and each support function is subject to regulation at the federal, state, and/or local/municipal level of government and is also impacted (directly or indirectly) by regulations and regulatory decisions imposed by governments of other countries.

The remainder this section conveys the breadth and depth of U.S. federal regulations13 applicable to U.S. manufacturers across these six process steps and six support functions. Examples were drawn from in-depth interviews with compliance officials from both large and small manufacturers across various subsectors (see Appendix A), a survey of NAM members (see Appendix B), and a list of federal regulations affecting US manufacturing (see Appendix C).

Steps in the Manufacturing Process

Sourcing of Raw Materials

Sourcing of raw materials involves the acquisition of raw materials, including energy, to a manufacturing site.

When it comes to sourcing raw materials, regulators impose an array of restrictions and obligations on manufacturers. Such mandates include import limitations; obtaining a license or permit; avoiding, limiting, and/or reporting uses of certain materials; segregating and tracking of materials through the chain of commerce; reporting on the origin/history of raw materials; adhering to quality standards; and recordkeeping.

The CFR includes at least 43 parts that impose 4,168 restrictions on US manufacturers for sourcing raw materials. Federal regulatory programs span a range of regulatory agencies, including the US Department of (USDA) Agricultural Marketing Service (AMS) country of origin labeling (COOL), USDA Animal, Plant Health, and Information Service (APHIS) permits for imported biological products, Federal Trade Commission (FTC) products, Securities Exchange Commission (SEC) conflict minerals, Department of Health and Human Services (HHS) Food and Drug Administration (FDA) food additives,

13 A recent survey of NAM members identified federal regulation as imposing greater burden and challenges compared to the other levels of government. Accordingly, this report focuses on federal regulation of the manufacturing sector. Appendix E contains a list of citations in the Code of Federal Regulation (CFR) applicable to U.S. manufacturing.

13 Environmental Protection Agency (EPA) metalworking fluids, Department of the Interior (Interior) sale of Alaskan lands for manufacturing, and Department of Transportation (DOT) National Highway Transportation Safety Administration (NHTSA) importation of motor and equipment.

Aside from regulating manufacturers directly, regulation can have an indirect impact, too. When it sources raw materials and energy, manufacturers don’t realize the higher price that is passed down the supply chain from “upstream” regulation. For example, manufacturers pay higher prices for electricity due to Environmental Protection Agency (EPA) regulation of coal-fired power in recent years, which forced many electric utilities to switch their fuel source from coal to higher priced natural gas. A chemical formulator must ensure that its suppliers have first registered their products with EPA in accordance with new chemical regulations lest their formulated product be found in noncompliance. And manufacturers that purchase helium (e.g., for welding purposes) may have noticed a price jump in recent years due to a shortage associated with the federal government’s near- as a supplier of this inert gas.

Two illustrative examples of federal regulatory programs that require manufacturers to raw materials through the chain of commerce include AMS Country of Origin Labeling (COOL) and SEC conflict minerals.

USDA requires certain food products to be labeled for country of origin. Retailers, such as full-line grocery stores, supermarkets and club stores, must notify their customers with information regarding the source of certain foods. Food products covered by the law include muscle cut and ground meats: lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng.

To comply with this regulation, affected companies in the food manufacturing sector must know the country of origin of covered raw materials, segregate and track these products throughout the manufacturing process, convey the country of origin to its customers, and maintain records for a period of time to ensure compliance in case of a USDA compliance audit.

For certain businesses, federal regulations mandate burdensome tracking and reporting requirements for the annual disclosure on the use of designated minerals. Depending on the conclusion of an inquiry into a ’s source, the company may have to undertake due diligence (that includes an independent private sector audit) on its source and chain of custody and file a detailed report with the government. The SEC estimates that it will take the average manufacturer 480 hours annually to comply with this regulation.

As these two examples demonstrate, segregating and tracking raw materials is not costless to manufacturers. Requirements may vary for different products, even if the inputs are identical. As such, the regulations influence a company’s decisions on where raw materials are sourced. Importing tomatoes from another country may make sense for making tomato soup but perhaps not for tomato

14 paste, which is subject to COOL, even though the location where the tomato was harvested makes no difference in terms of product safety. But in many cases, substituting unregulated raw materials for regulated raw materials is simply not an option, and the resources used for compliance cannot be used for other purposes, such as increasing productivity.

Many different laws and regulations pertain to imports of raw materials from abroad. The US Customs and Border Protection agency (part of the Department of Homeland Security) is responsible for ensuring that all entering and exiting the US do so in accordance with all applicable regulations. Importers must file entry documents for good s at the port of entry. Imported goods are not legally entered until after the shipment arrives at the port of entry, delivery of merchandise has been authorized by CBP, and all duties have been paid.

The import of certain classes of merchandize may be prohibited or limited under various laws and regulations from other agencies, and CBP cooperates with these agencies on enforcement. These other regulations may prohibit entry; limit entry into certain ports; restrict routing, storage, or use; or require treatment, labeling, or processing as a condition of release. CBP clearance is given only if these conditions are met.

For example, APHIS, issues regulations to ensure that all imported products shipped to the US meet the Agency’s entry requirements to exclude pests and agricultural diseases. In 2015, APHIS raised its fees on importers for conducting agricultural quarantine inspections at US ports of entry.

Preliminary Processing, Production, and Assembly

Preliminary processing, production, and assembly involve preparing raw materials for production and transformation of prepared materials into a saleable product.

Regulatory agencies impose a litany of requirements when it comes to processing and transforming raw materials into a saleable product. Such mandates include manufacturer registration, ingredient restrictions, specific processing and production standards, product standards, product bans, registration and/or licensing of products and byproducts, certification of compliance, rep0rting, and recordkeeping.

The CFR includes at least 239 parts that impose 44,268 restrictions on US manufacturers during the production process itself. Several federal regulatory agencies impose requirements, including the AMS “organic” program, DOT Federal Aviation Administration (FAA) certification for products and articles, Consumer Product Safety Commission (CPSC) product standards, FDA licensing of biologics, DOT registration of distilled spirits plants, Department of Energy (DOE) energy conservation standards, EPA volatile organic compounds (VOC) standards for consumer and commercial products, EPA fuel economy standards for motor vehicles, and the DOT bumper standard.

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For example, makers of recreational boats, consumer products, and appliances must adhere to specific production standards.

Recreational boat manufacturers have to meet requirements from the U.S. Coast Guard (USCG) and EPA. USCG requirements cover hull ID numbers, labels, horsepower, loading, flotation, fuel systems, electrical systems, ventilation, recalls, and navigable lighting.14 EPA requirements cover exhaust emissions and evaporative emissions from fuel lines.15

Regulations issued by the CPSC cover hundreds of manufactured products (e.g., charcoal briquettes, automatic garage door openers, matchbooks, and swimming pool slides).16 Manufacturers and importers are responsible for ensuring that their products meet any mandatory standards or regulations. Every manufacturer subject to a consumer product safety rule, ban, standard, or regulation must issue a certificate of compliance to accompany the applicable product or shipment of products, and a copy of the certificate must be furnished to each distributor or retailer of the product.

DOE establishes energy efficiency standards for covered consumer products and covered commercial and industrial equipment. To date, DOE has published regulations17 for more than 50 categories of appliance and equipment types, including consumer products (refrigerators, air conditioners, furnaces, clothes washers, water heaters, etc.), (flush toilets, showerheads, faucets, urinals, etc.) and lighting (fluorescent lamps, incandescent lamps, LED lamps, ceiling fans, etc.). For example, the maximum water usage allowed for a gravity- tank-type flush toilet is 1.6 gallons per flush. ( has set an even lower standard.) To ensure compliance, manufacturers must test their product using a methodology prescribed by DOE. However, test procedures may not accurately reflect actual energy use because new products change over time to incorporate new features and . In such cases, DOE has issued regulations that provide a petition process for waivers from test procedures for consumer products18 and commercial and industrial equipment19.

DOE and FTC share responsibility for labeling of such appliances. Generally, the Federal Trade Commission (FTC) prescribes labeling rules for residential

14 See 33 CFR 179, 181, and 183. Also, see the following chart: http://newboatbuilders.com/pages/index2.html 15 See 40 CFR 91, 1045, 1060, 1065, and 1068. Also, see the following chart: http://newboatbuilders.com/pages/index2.html 16 CPSC regulations can be found in 16 CFR 1000-1799. For an alphabetical list of products regulated by the CPSC along with CFR citations, go to the CPSC website: https://www.cpsc.gov/en/Regulations-Laws--Standards/Regulations-Mandatory-Standards- Bans/#R 17 See 10 CFR 430 and 10 CFR 431. 18 10 CFR 430.27 19 10 CFR 431.401

16 products and DOE prescribes labeling rules for commercial and industrial equipment.20

As these examples illustrate, it is not uncommon for multiple federal agencies regulate the content of a particular manufactured product. Other examples abound: Food manufacturers can be subject to both USDA and FDA inspection of their manufacturing facilities, makers of biocides are subject to both EPA and FDA requirements, engine manufacturers have to comply with EPA and DOT requirements, and many chemical manufacturers are subject to process safety regulations from both EPA and the Occupational Safety and Health Administration (OSHA). Answering to multiple regulators makes compliance more complex than it otherwise would be. One compliance director interviewed for this report has a facility subject to different and overlapping storm water regulations from federal, state, and municipal regulators. In his opinion, this “layering” effect represents the most challenging part of compliance.

From our interviews, we discern that manufacturers follow the same five-step process to ensure compliance with new regulations: (1) identify new requirements; (2) understand these requirements and determine if and how they impact the company; (3) develop new or modify existing standard operating procedures (SOPs) to ensure compliance; (4) implement a compliance plan through dissemination of SOPs, capital improvements, training employees, creation of systems, etc.; and (5) periodically self-audit to ensure compliance over the long-term. The entire compliance process—applicable to any regulatory requirement—is not simple, nor is it easy.

The NAM survey shows that the most challenging steps are steps 1 and 2— awareness of new regulations and determining their applicability—especially for smaller manufacturers. Interviews of compliance officials conducted align with these survey results. Said one compliance director, “The hardest part of my job is becoming aware of new regulations, especially local regulations.” Said another when describing his company’s compliance approach: “I just have to identify all the changes that are applicable. Each company must do this and determine what it means to them.” One compliance director summarized her experience: “The first year is always a struggle. It takes a great deal of time. It won’t be as difficult in future years.”

Quality Control Quality control involves ensuring product quality, including testing, to meet customer expectations.

Regulatory agencies impose a wide range of requirements to ensure manufactured products meet quality standards. Such requirements cover inspection of both products and establishments that manufacture products, product testing, component part testing, testing for product registration, good

20 See the DOE website: http://energy.gov/eere/buildings/regulatory-processes

17 manufacturing practice (GMP) standards, good laboratory practice (GLP) standards, specification of quality control procedures, handling and disposal of waste materials, reporting, and recordkeeping.

The CFR includes at least 83 parts that impose 23,951 restrictions on US manufacturers pertaining to quality control. Federal regulations include USDA perishable food carriage equipment testing, CPSC testing for product certification, CPSC component part testing, FDA current good manufacturing practice (CGMP), FDA and EPA good laboratory practices (GLPs), EPA emissions testing of motor vehicles, NHTSA anthropomorphic test devices (crash test dummies used for motor vehicles), and NHTSA bus testing.

Two examples illustrate the depth of these requirements. Current Good Manufacturing Processes (CGMP), also known as Good Manufacturing Processes (GMP) are FDA regulations pertaining to manufacturing, testing, and quality assurance to ensure that a product is safe for use. Manufacturers are required to comply with GMPs with respect to pharmaceuticals,21 human food,22 animal food,23 medical devices,24 dietary supplements,25 infant formula,26 and certain biological products.27 The Food Safety Modernization Act, with its focus on preventing hazards, has led FDA to issue additional quality control regulations known as Hazard Analysis and Risk-Based Preventive Controls (HARPC). Manufacturers of animal28 or human food29 must also comply with these more recent regulations. HARPC is similar in concept to hazard analysis and critical control points (HACCP), a management system that is required for seafood,30 juices,31 and USDA-regulated meat and poultry.32

Good Laboratory Practices (GLPs) are procedures followed in non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals). GLP regulations ensure the quality and integrity of non-clinical safety data used for a regulatory purpose. Some regulatory agencies require GLP studies to meet regulatory requirements: FDA for FDA-regulated products33 and

21 See 21 CFR 210 and 21 CFR 211. 22 21 CFR 110 23 21 CFR 507 24 21 CFR 820 25 21 CFR 111 26 21 CFR 106 27 21 CFR 606 28 21 CFR 507 29 21 CFR 117 30 21 CFR 123 31 21 CFR 120 32 9 CFR 417 33 21 CFR 58

18 EPA for the testing of fuels and fuel additives,34 pesticides,35 and chemical substances.36

Despite these and many other requirements imposed to ensure quality control, manufacturers frequently go beyond compliance to ensure customer satisfaction. For example, manufacturers in a particular industry segment may join together to develop voluntary consensus standards for quality assurance purposes. Adherence to such quality standards is one way that markets serve customers without the need for regulation.

The 1995 National Technology Transfer and Advancement Act37 requires government agencies to first consider available consensus standards before developing a government-unique standard. Since 1995, thousands of such standards have been adopted by regulatory agencies. This approach helps regulators (by conserving their resources to develop a unique standard), regulated entities (by ensuring the regulation is developed with their extensive involvement), and the public (by delivering the social benefits of the rule faster).

When given a list of common reasons why a regulation might be a compliance headache (Congress writes a bad law, overzealous enforcement, etc.), respondents to the NAM survey most often chose the following answer: “regulatory agencies writing a final rule absent an adequate understanding of my business and my compliance challenges.” As one company compliance official noted, “The single biggest problem is that people who write the rules have never spent time in the field implementing them.” When regulators choose to adopt a consensus standard, they can be better assured that it was developed with an understanding of the underlying business.

Packaging and Labeling

The manufacturing process includes the packaging and labeling of the finished product for sale.

Regulations often require the labeling of manufactured products and address many aspects of the labeling and packaging of such goods, including the content of the label (e.g., quantity, manufacturer’s and/or distributor’s name), the truthfulness of the label, the origin of the manufactured product and/or component parts, the ability of a consumer to understand and/or make comparisons using the label, a wide variety of product attributes (e.g., noise, energy efficiency, health effects, etc.), the content of the packaging material, and the security of the packaging.

34 See 40 CFR 79 and 40 CFR 80. 35 See 40 CFR 152 and 40 CFR 158. 36 40 CFR 792 37 Public Law 104-113

19 The CFR includes at least 47 parts that impose 7,477 restrictions on US manufacturers pertaining to labeling and packaging. Federal regulations include USDA Food Safety and Inspection Service (FSIS) quantity of contents procedures; Nuclear Regulatory Commission (NRC) packaging standards for radioactive materials; FTC energy and water use labeling; CPSC poison prevention labeling; FDA labeling of food, food additives, , and medical devices; FDA cigarettes packaging; and NHTSA automobile parts content labeling.

According to the FTC,38 the Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the Food and Drug Administration to issue regulations requiring that all "consumer " be labeled to disclose net contents, identity of , and name and place of business of the product's manufacturer, packer, or distributor. The Act authorizes additional regulations where necessary to prevent consumer deception (or to facilitate value comparisons). The Food and Drug Administration (FDA) administers the FPLA with respect to foods, drugs, cosmetics, and medical devices. The FTC administers the FPLA with respect to other consumer commodities. Specific FTC regulations apply to particular products categories (e.g., automotive fuel ratings, textile wearing apparel, and home insulation). Many products that are exempt from the FPLA fall within the purview of the weights and measures laws of the individual states.

Other statutes provide authority for other regulatory agencies to regulate the labeling and/or packaging of products of manufacturing, such as USDA (for labeling of meat and poultry,39 fish,40 and “organic” produce41) the Nuclear Regulatory Commission (for packaging of radioactive materials42), DOE (for labeling the energy efficiency of certain products43), the US Treasury (for labeling wine,44 distilled spirits,45 and malt beverages46) and EPA (for pesticides).

As part of the licensing/registration process for pesticides, EPA reviews the product label. According to the EPA regulations,47 every pesticide product shall bear a label containing the information specified by the Act and the regulations. The contents of a label must show clearly and prominently the following: the name, brand, or trademark under which the product is sold; the name and

38 https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/fair- packaging-labeling-act 39 9 CFR 317 40 9 CFR 541 41 7 CFR 205 42 10 CFR 71 43 See 10 CFR 430 and 10 CFR 431. 44 27 CFR 4 45 27 CFR 5 46 27 CFR 7 47 40 CFR 156

20 address of the producer, registrant, or person for whom produced; the net contents; the product registration number; the producing establishment number; an ingredient statement; hazard and precautionary statements; the directions for use; and the use classification(s). There are prescribed requirements for each of these elements of the label. Other general requirements pertain to prominence and legibility, language to be used, placement of the label, tank cars and other bulk containers, storage, false and misleading statements, and final printed labeling.

According to the FTC,48 several federal regulations pertain to label claims relating to domestic content. U.S. content must be disclosed on automobiles and textile, wool, and fur products. Manufacturers who choose to make claims about the amount of U.S. content in their products must comply with the FTC’s Made in USA policy. The policy applies to all products advertised or sold in the U.S., except for those specifically subject to country-of-origin labeling by other laws.

Compliance officials from multiple companies interviewed for this report brought up the specific challenges posed by a state issuing its own labeling requirements for a manufactured product. It is not unusual for a manufacturer to employ a global IT system to ensure labels adhere to all national and international requirements. When a state mandates a new approach to labeling, it creates a significant compliance headache. Recently, President Obama signed into law two bills49 authorizing federal preemption of state labeling laws under certain circumstances. These new laws are a reflection of manufacturers’ concern about state regulation and its impact on interstate commerce.

Distribution/Shipping

Distribution/Shipping includes transporting raw materials to a manufacturing site, transporting finished product to point of sale and/or customers, and transporting wastes or byproducts from manufacturing operations.

Depending on the mode of and the , manufacturers must comply with a multitude of regulations, including export controls (including restrictions and bans), licenses, and reporting; tracking of products; commercial driver license standards; drug testing of transportation operators; differentiated safety standards for operators, for vehicles, and for transported materials; registration and licensing of transportation vehicles (e.g., ships, trucks); and extensive documentation of transported materials, including retention of records.

48 See the FTC website: https://www.ftc.gov/tips-advice/business-center/guidance/complying- made-usa-standard 49 On June 22, 2016, President Obama signed into law (Public Law No. 114-182) reform of the Toxic Substances Control Act, which allows for federal preemption of state chemical labeling laws under certain circumstances. On July 29, President Obama signed into law a bill (S.764) that would allow for preemption of state labeling of genetically modified foods.

21 The CFR includes at least 64 parts that impose 21,057 restrictions on manufacturers relating to distribution/shipping. Federal regulations include Department of Commerce (DOC) Export Administration (EA) Commerce Control List (CCL) and CCL controls; FTC regulation of shipping date disclosure; Alcohol and Tobacco Tax and Trade Bureau (ATTTB) requirements for distribution of denatured alcohol and rum; EPA transportation of hazardous waste; USGC documentation of vessels; DOT Pipeline and Hazardous Materials Safety Administration (PHMSA) hazardous materials regulations; DOT Federal Railroad Administration (FRA) noise emission standards; DOT Federal Motor Carrier Safety Administration (FMCSA) noise emission standards; USGC testing and approval of shipping containers; and NHTSA standards for multistage automobile carriers.

Several federal regulatory agencies are involved in distribution/shipping of manufactured goods. For example, FMCSA regulates commercial motor vehicles,50 FRA regulates the railroad system,51 and FAA regulates .52 Intermodal transportation (i.e., the transfer of products involving multiple modes of transportation such as truck, railroad, and/or ocean carrier) is also regulated specifically (e.g., regulation of intermodal containers).

For example, the FMCSA “hours of service” regulation imposes time limits for on- duty and off-duty for commercial truck drivers, a requirement that each truck install an electronic device for monitoring driving time, and extensive recordkeeping requirements. Here is an excerpt from the regulations on recordkeeping:

§395.11 Supporting documents. (a) Effective date. This section takes effect December 18, 2017. (b) Submission of supporting documents to motor carrier. Except drivers for a private motor carrier of passengers (nonbusiness), a driver must submit to the driver's employer the driver's supporting documents within 13 days of either the 24-hour period to which the documents pertain or the day the document comes into the driver's possession, whichever is later. (c) Supporting document retention. (1) Subject to paragraph (d) of this section, a motor carrier must retain each supporting document generated or received in the normal course of business in the following categories for each of its drivers for every 24-hour period to verify on-duty not driving time in accordance with §395.8(k): (i) Each bill of lading, itinerary, schedule, or equivalent document that indicates the origin and destination of each trip; (ii) Each dispatch record, trip record, or equivalent document; (iii) Each expense receipt related to any on-duty not driving time;

50 49 CFR 300-399 51 49 CFR 200-299 52 14 CFR 1-199

22 (iv) Each electronic mobile communication record, reflecting communications transmitted through a fleet management system; and (v) Each payroll record, settlement sheet, or equivalent document that indicates payment to a driver. (2)(i) A supporting document must include each of the following data elements: (A) On the document or on another document that enables the carrier to link the document to the driver, the driver's name or personal identification number (PIN) or a unit () number if the unit number can be associated with the driver operating the unit; (B) The date, which must be the date at the location where the date is recorded; (C) The location, which must include the name of the nearest city, town, or village to enable Federal, State, or local enforcement personnel to quickly determine a vehicle's location on a standard map or road atlas; and (D) Subject to paragraph (c)(2)(ii) of this section, the time, which must be convertible to the local time at the location where it is recorded. (ii) If a driver has fewer than eight supporting documents containing the four data elements under paragraph (c)(2)(i) of this section for a 24-hour period, a document containing the data elements under paragraphs (c)(2)(i)(A) through (C) of this section is considered a supporting document for purposes of paragraph (d) of this section.

Multiple federal agencies impose export controls (i.e., bans or restrictions) on particular kinds of products. DOE restricts the import and export of nuclear equipment and material.53 The Department of State has developed regulations pertaining to international traffic in arms.54 The Department of Treasury Office of Foreign Assets Controls administers economic sanction programs with multiple countries, and some of these programs restrict the movement of goods. Treasury also maintains a list of individuals and companies blocked from U.S. trade.

Export regulations imposed by the Department of Commerce55 cover “dual use” items—goods, such as computers, designed for a commercial purpose but could have military application. The list of regulated items (Commerce Control List, or CCL) includes many items listed under ten broad categories such as computers; electronics; lasers and sensors; chemicals; and navigation and electronics. Restrictions (including embargoes) depend on the destination country, the recipient, and the end use. A license is often required to export items listed on the CCL.

53 10 CFR 110 and 10 CFR 810 54 22 CFR 120-130 55 15 CFR 730-774

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US Customs and Border Protection (CBP) is responsible for ensuring that all goods entering or exiting the US do so in accordance with all applicable laws and regulations. CBP enforces export regulations for other US agencies.

Exports of manufactured goods are not just impacted by US regulation. Regulations from other countries affect US trade. Differential regulations across countries serve as a non-tariff trade barrier. Efforts to harmonize regulatory requirements across trading partners ought to be encouraged, according to compliance officials interviewed for this report. Despite the implementation of several new free trade agreements in recent decades, a substantial number of non-tariff trade barriers remain.

Post-Sale Follow-up

Post-Sale Follow-up includes recalls, post-market surveillance, recordkeeping, and public reporting.

Regulatory requirements continue to apply to some manufacturers after sale of a manufactured product. Such requirements include procedures for recalls, post- market safety surveillance, and public reporting of certain product defects.

The CFR includes at least 9 parts that impose 1,644 restrictions on manufacturers related to customer service and follow-up. Federal regulations include CPSC reports of harm, FDA medical device reporting, EPA emissions defect reporting, and NHTSA defect and noncompliance notification.

Medical devices are subject to several post-sale federal regulations.56 For covered devices, manufacturers must report deaths and serious injuries a covered device may have caused or contributed to along with device malfunctions, and manufacturers must create and maintain adverse effect files.57 Manufacturers are also responsible for tracking Class II or Class III medical devices that meet certain criteria to facilitate potential patient notifications or recalls.58 Manufacturers are also responsible for post-market surveillance of Class II and III medical devices that meet certain criteria.59 In such cases, FDA will issue an order for post-market surveillance for up to 26 months, which can be an outgrowth of its product approval process for the medical device. Manufacturers subject to such an order must develop a post-market surveillance plan per FDA regulations and guidance and submit it to FDA within 30 days of receiving the order.

Manufacturers of motor vehicles and replacement equipment (automobiles, buses, motorcycles, etc.) must adhere to NHTSA regulations relating to defect

56 See 21 CFR 803, 821, and 822. 57 21 CFR 803 58 21 CFR 821 59 21 CFR 822

24 and noncompliance notification60 and reporting and communications about potential defects.61 Notification of motor vehicle owners must occur in a prescribed period of time and using language and a format specified in the regulations, including the labeling of the mailing envelope sent to an owner (e.g., the font size of the print on the envelope). The reporting regulation specifies information and documents that a manufacturer of motor vehicles and motor vehicle equipment must provide to NHTSA with respect to possible safety-related defects and non-compliance with product regulations.

Support Functions Common to Manufacturers

Aside from the manufacturing process steps, regulation is also directed toward corporate services common to all types of businesses, such as human resources and tax/accounting.

The top three areas of regulatory burden, according to NAM survey respondents, are each a support function: EH&S, tax/trade, and labor (human resources). This result is consistent with the relative number of CFR restrictions imposed on manufacturers. EH&S and tax impose the highest number of restrictions, and human resources places sixth out of twelve.

Interviews with compliance officials confirm that their is such that regulatory compliance costs are borne mostly at the corporate level. So what would happen if regulatory compliance costs were permanently reduced? According to one compliance official, “We’d cut corporate and give our business units more money to better serve customers.”

R&D and Product Design

R&D and product design include the creative work that supports the development of new or improved products.

Certain manufactured products are regulated at the design and/or R&D stage. Federal requirements pertain to the use of human subjects for research; the preparation and use of experimental products; design standards for new products, and registration, licensing, and/or pre-market approval of new products and product labels.

The CFR includes at least 22 parts that impose 12,833 restrictions on US manufacturers directly related to R&D and product design. Federal regulations include EPA Significant New Alternatives Policy (SNAP), EPA new chemicals, EPA pesticide registration, NRC approvals for new power plants, APHIS experimental production of biological products, USDA pre-market approval of labels for meat and poultry, FAA airworthiness standards, FDA animal drugs, FDA pre-market approval of drugs, FDA pre-market approval of medical devices,

60 49 CFR 577 61 49 CFR 579

25 FDA pre-market approval of tobacco products, and HHS protection of human subjects in research.

Several types of new products require government approval before they can enter commerce. Examples include chemicals, pesticides, pharmaceuticals, animal drugs, food additives, dietary supplements, new tobacco products, and new aircraft. When pre-market review is simple and relatively quick, the opportunity cost is low. But when pre-market review is lengthy or uncertain, the opportunity cost can be significant, and represents a barrier to market entry.

The time it takes a regulatory agency for pre-market review/approval varies considerably by class of product and even within a class of product. Consider the following examples:

• For new chemicals, EPA is required to review them within 90 days, though the Agency can take an additional 90 days and can take longer if it needs more information for review.62

• The average time to bring a new chemical pesticide to market in 2005- 2008 was 9.8 years (up from 8.3 years in 1995), at a cost of $256 million (versus $152 in 1995). This increase over time is likely due at least partially to the growing complexity and volume of data required by regulatory bodies and the commensurate time needed to develop the data.63

• The time needed to bring a new genetically engineered crop to market was approximately 5.5 years in 2012 (versus 4 years in 2002). Approximately one-third of this time is attributable to pre-market approval by regulatory agencies.64

• For food additives, FDA approval takes an average of 24 months.65

• For some types of new products—genetically engineered crops, pesticides, medicines, tobacco products—regulatory review can take years, if not decades.66

62 See the newly amended Toxic Substances Control Act, Public Law 114-182. 63 Phillips McDougall. 2010. The Cost of Product Discovery, Development and Registration, and . CropLife America. 64 Phillips McDougall. 2011. The cost and time involved in the discovery, development, and authorization of a new plant biotechnology derived trait. CropLife America. 65 See FDA Q&A about the process for approving food additives: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Ing redientsAdditivesGRASPackaging/ucm253328.htm#answerS 66 In 2015, the federal government approved the first genetically engineered animal—a — after twenty years of review. For genetically engineered products, trends are difficult to verify because, with few exceptions, regulatory agencies do not disclose their average pre-market review time by product class.

26 Whereas many federal regulations are not intended to limit or suppress technological innovation, the cost and prescriptiveness of regulation creates a barrier to entry. Resources devoted to a mandatory activity like regulation cannot be used for discretionary activities such as innovation that reduces operating costs or better serves customer needs. Several manufacturing companies interviewed for this report identified innovation as the biggest opportunity cost of regulation. The survey of NAM members confirmed this perception among compliance officials. When asked how their company would re-direct resources if regulatory compliance costs were suddenly reduced significantly and permanently, nearly two-thirds said increase investment in capital equipment or in R&D/new products. This finding should be particularly concerning to policy makers and regulators alike; market innovation raises the standard of living and increases quality of life.

Even regulators acknowledge that overly prescriptive regulation sometimes gets in the way of market innovation. Two current examples include self-driving vehicles and modern products of biotechnology.

Many companies, including automotive manufacturers, are in the process of developing for self-driving vehicles (SDVs). In its February 16, 2016 response to a November 15, 2015 request from Google, NHTSA acknowledged that its current regulations67 create barriers to entry for this new technology. For example, 49 CFR 571.3 defines “driver” as “the occupant of a motor vehicle seated immediately behind the steering control system.” Other regulatory requirements presume the presence of a driver (e.g., location of steering wheels).

Products of biotechnology (and transgenic products in particular) are subject to the Coordinated Framework for the Regulation of Products of Biotechnology, last revised in 1992.68 In July 2015, the White House admitted that “navigating the regulatory process for these products can be unduly challenging, especially for small companies” because of scientific advances since 1992.69

Human Resources

Human resources includes the acquisition, compensation, and treatment of employees, including wages and benefit programs.

Federal regulations impose obligations on employers, including requirements related to the hiring and treatment of employees and contractors (including nondiscrimination, leave, worker adjustment and retraining, etc.), compensation and benefits (including wages, working hours, , pensions, thrift savings plans, profit-sharing plans, etc.), and drug and alcohol testing.

67 49 CFR 571 68 See 57 Federal Register 39, February 27, 1992. 69 See the White House announcement on revisiting the Coordinated Framework: https://www.whitehouse.gov/blog/2015/07/02/improving-transparency-and-ensuring- continued-safety-biotechnology

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The CFR includes at least 54 parts that impose 7,042 restrictions on US manufacturers directly related to human resources. Federal regulations include Department of Homeland Security (DHS) immigration forms; Department of Labor (DOL) worker adjustment and retraining notification; wage payments, exempt employees, hours worked, overtime, thrift or savings plans, and Americans with Disability Act (ADA) requirements, fiduciary regulations under ERISA, and group health plan requirements; Equal Employment Opportunity Commission (EEOC) affirmative action obligations of federal contractors; HHS Affordable Care Act (ACA) health insurance issuer standards; DOT FMCSA controlled substance and alcohol use testing of commercial drivers; PHMSA drug and alcohol testing of pipeline operators; and Federal Acquisition Regulatory System (FARS) contractor qualifications.

For example, Affordable Care Act (ACA) reporting requirements impose a paperwork burden on covered employers, including manufacturers. The paperwork burden associated with these reporting requirements is extremely large and requires companies to expend capital on accounting systems to generate the required information.

According to the Treasury’s Internal Revenue Service (IRS),70 every provider of minimum essential coverage must report coverage information by filing an information return with the IRS and furnishing a statement to individuals. The information is used by the IRS to administer – and individuals to show compliance with – the individual shared responsibility provision in section 5000A of the ACA.

According to the regulation,71 the following information is required:

the name, address, and employer identification number (EIN) of the reporting entity required to file the return; the name, address, and TIN, or date of birth if a TIN is not available, of the responsible individual, except that reporting entities may but are not required to report the TIN of a responsible individual not enrolled in the coverage; the name and TIN, or date of birth if a TIN is not available, of each individual who is covered under the policy or program; for each covered individual, the months for which, for at least one day, the individual was enrolled in coverage and entitled to receive benefits; and any other information specified in forms, instructions, or published guidance, see §§601.601(d) and 601.602 of this chapter. In addition, information returns reporting minimum essential coverage provided to an individual that has coverage provided by a health insurance issuer through a group health plan must report the name, address, and EIN of the

70 See the IRS website: https://www.irs.gov/affordable-care-act/questions-and-answers-on- information-reporting-by-health-coverage-providers-section-6055 71 26 CFR 1.6055-1

28 employer sponsoring the plan; whether the coverage is a qualified health plan enrolled in through the Small Business Health Options Program (SHOP) and the SHOP's unique identifier; and other information specified in forms, instructions, or published guidance.

Applicable large employers (ALE) must also file information returns with the IRS and provide statements to their full-time employees about the health insurance coverage the employer offered. The IRS uses this information to administer the employer shared responsibility provisions of section 4980H of the ACA. The IRS and the employees of an ALE member use the information provided as part of the determination of whether an employee is eligible for the premium tax under section 36B of the ACA. The Internal Revenue Code prescribes the information that ALE must report.

Compliance officials interviewed for this report indicate that paperwork burden associated with providing health care to their employees has increased dramatically (quadrupled for some companies) due to regulations issued under the ACA. They also point to new regulations issued by the DOL as a significant driver of regulatory burden.

Human resources must pay attention to decisions by the National Labor Relations Board (NLRB), a federal agency vested with the power to safeguard employees' rights to organize. The Board also acts to prevent and remedy unfair labor practices committed by private sector employers and unions. A single employee complaint can trigger an NLRB investigation of manufacturing company.

Tax/Accounting

Accounting for financial flows, including taxes, is subject to extensive regulation.

The Internal Revenue Code contains numerous and complex provisions affecting manufacturers, including corporate income taxes (including the treatment of foreign income), business deductions, various corporate transactions, employment taxes, excise taxes, etc. Other federal regulations address taxes on specific products (e.g., tobacco, alcohol, firearms, and ammunition).

The CFR includes at least 26 parts that impose 51,760 restrictions on US manufacturers pertaining to tax and trade. Federal regulations include Commodity Futures Trading Commission (CFTC) clearing requirements, US Customs and Border Protection (CBP) drawback, IRS income taxes, IRS taxes on corporations, IRS employment taxes, IRS excise taxes, IRS health insurers providers fee, Treasury exportation of alcohol, and Treasury exportation of tobacco products.

According to the NAM survey, one of the most difficult tasks associated with compliance is analyzing regulations to determine which parts are applicable and

29 how to comply. This task is extremely difficult with respect to the tax code and the accompanying regulations, which are dizzyingly complicated.

According to the Tax Foundation72, these regulations are growing at an alarming rate. The tax code itself is about six times its length in 1955 and the accompanying regulations are 2.5 times as long. Together, these documents have grown an average of 144,500 words per year, from 1.4 million words in 1955 to more than 10 million words as of 2015. Roughly 75% of the total paperwork burden imposed by the federal government is attributable to the IRS.73

Uncertainty about tax policy hinders business decision-making and investment. According to a NAM-sponsored study, “A permanent, stable, and in many cases, simpler tax code would reduce the cost of administration and compliance.”

The US tax code puts manufacturers at a competitive disadvantage.74 The United States has one of the highest statutory corporate tax rates in the world. And the US is the only country in the G-7 that taxes the active foreign earnings of it companies. The rest have a territorial system in which business income earned abroad by foreign subsidiaries is wholly or partially exempt from home country tax. As of 2014, 29 out of 34 OECD countries had a territorial system.

Corporate tax reform is needed to improve the competitive position of US companies, and it should be done carefully to benefit all manufacturers. About two-thirds of U.S. manufacturers are “pass-through” entities (e.g., S corporations, , sole proprietorships), meaning they file taxes through the individual tax system, unlike C corporations subject to the corporate income tax. Being a pass-through entity does not make filing taxes simple. The tax return of one small-business manufacturer interviewed for this study averages 60-pages per year.

The Internal Revenue Code changes over time, growing in length and complexity, all of which makes it difficult for businesses to comply. External expertise is nearly always employed to ensure compliance. But the tax code is not the only area where manufacturers rely on outside expertise. According to the survey of NAM members, 70% sought and used outside expertise to assist with regulatory compliance over the past 12 months. Only the largest of US corporations have the internal expertise to comply with all relevant regulations.

Marketing and Sales

Marketing, advertising, pricing, and sales are subject to regulatory requirements.

72 http://taxfoundation.org/blog/federal-tax-laws-and-regulations-are-now-over-10-million- words-long 73 Office of Management and Budget. 2014. Information Collection Budget of the United States Government. 74 NERA Economic Consulting. 2012. Macroeconomic Impacts of Federal Regulation of the Manufacturing Sector. Manufacturers Alliance for Productivity and Innovation.

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Numerous federal regulatory requirements pertain to type of marketing (by email, by telephone, etc.), marketing claims (e.g., environmental claims), advertising (e.g., use of testimonials and endorsements), pricing (including use of the word “free”), sales (e.g., warranties and guarantees), and/or other business practices (e.g., credit practices, negative option plans, etc.) in general or to particular products (e.g., used cars, eyeglasses, contact lenses, goods, precious metals, energy products, etc.).

The CFR includes at least 35 parts that impose 1,518 restrictions on US manufacturers with respect to marketing and sales. Federal regulations include FTC deceptive pricing, FTC endorsements and testimonials in advertising, FTC telemarketing sales rule, FTC written warranties, FTC environmental marketing claims, FTC use of the word “free”, CFTC commodity option transactions, FDA prescription drug advertising, FARS improper business practices, and NHTSA odometer disclosure.

In the Code of Federal Regulations, FTC has issued a guide for businesses marketing products as “free” that includes restrictions on the frequency of such marketing offers:

“So that a ‘Free’ offer will be special and meaningful, a single size of a product or a single kind of service should not be advertised with a “Free” offer in a trade area for more than 6 months in any 12-month period. At least 30 days should elapse before another such offer is promoted in the same trade area. No more than three such offers should be made in the same area in any 12-month period. In such period, the offeror's sale in that area of the product in the size promoted with a “Free” offer should not exceed 50 percent of the total volume of his sales of the product, in the same size, in the area.”75

FTC also regulates environmental marketing claims. FTC regulations describe general principles that apply to all environmental marketing claims; how marketers can substantiate these claims; and how marketers can qualify their claims. For example, FTC regulation (16 CFR 260) states that a marketer claiming that an item is compostable should have competent and reliable scientific evidence that all the materials in the item will break down into, or otherwise become part of, usable compost (e.g., soil-conditioning material, mulch) in a safe and timely manner (i.e., in approximately the same time as the materials with which it is composted) in an appropriate composting facility, or in a home compost pile or device.

Environment, Health, & Safety

75 16 CFR 251

31 EH&S includes standards for worker safety, pollution control (air and water), and waste management.

Few areas of regulation have grown faster than those designed to address risks to the environment, human health, and safety. Manufacturing facilities must report, control, and manage emissions of hundreds of waste materials, including air and water pollution and solid wastes. Safety standards to protect workers also apply. Monitoring, recordkeeping, and recurring reporting requirements are legion. Some requirements apply generally to manufacturers and others to specific subsectors of manufacturing.

The CFR includes at least 85 parts that impose 102,734 restrictions on US manufacturers for EH&S. Federal regulations include NRC land disposal of radioactive waste; OSHA injury and illness reporting; OSHA construction standards; EPA NESHAPs; EPA NPDES permits; EPA water quality standards; EPA identification and listing of hazardous waste; EPA hazardous waste treatment, storage, and disposal (TSD) facilities; and PHMSA hazardous materials transportation.

These parts and restrictions can further be divided into those relating to air quality, water quality, waste management, and worker safety.

Air Quality

Federal air quality regulations include at least 7 CFR parts that impose 58,420 restrictions on manufacturers. These regulations impact manufacturers directly (limiting emissions from their operations) or indirectly (limiting the products they make). Two examples are EPA’s National Emission Standards for Hazardous Air Pollutants (i.e. air pollution control for industry sources) and EPA’s regulation of portable fuel containers (i.e., gas cans).

The Clean Air Act requires the EPA to regulate 187 specific hazardous air pollutants (HAPs) from categories of industrial facilities in two phases: (1) imposition of technology-based standards based on the best controlled and lower emitting sources in an industry category, and (2) additional requirements, if needed, after an assessment of whether the standards protect public health with an ample margin of safety. EPA has issued regulations for more than 100 source categories (e.g., boar manufacturing, lime manufacturing, rubber tire manufacturing). These regulations (also known as national mission standards for hazardous air pollutants) are very prescriptive and give regulated entities little flexibility. For example, EPA has issued regulations76 controlling HAPs from primary copper smelting facilities. Specific emission limits are set for copper concentrate dryers, smelting furnaces, slag cleaning vessels, existing copper converter departments, new copper converter departments, baghouses, Venturi wet scrubbers, and other control devices. For smelting furnaces, below is an excerpt from the regulation:

76 40 CFR 60 Subpart QQQ

32

(b) Smelting furnaces. For each smelting furnace, you must comply with the emission limitations and work practice standards in paragraphs (b)(1) and (2) of this section. (1) For each smelting furnace, you must not cause to be discharged to the atmosphere any process off-gas that contains nonsulfuric acid particulate matter in excess of 6.2 mg/dscm as measured using the test methods specified in §63.1450(b). Process off-gas from a smelting furnace is generated when copper concentrates and fluxes are being smelted to form molten copper matte and slag layers. (2) For each smelting furnace, you must control the process fugitive emissions released when tapping copper matte or slag from the smelting furnace according to paragraphs (b)(2)(i) and (ii) of this section. (i) At all times when copper matte or slag is tapped from the smelting furnace, you must operate a capture system that collects the gases and fumes released from the tapping port in use. The design and placement of this capture system must be such that the tapping port opening, launder, and receiving vessel (e.g., ladle, slag pot) are positioned within the confines or influence of the capture system's ventilation draft during those times when the copper matte or slag is flowing from the tapping port opening. (ii) You must not cause to be discharged to the atmosphere from the capture system used to comply with paragraph (b)(2)(i) of this section any gases that contain total particulate matter in excess of 23 mg/dscm as measured using the test methods specified in §63.1450(a).

EPA has set limits for emissions of hydrocarbons from portable fuel containers (i.e., gas cans) manufactured after January 1, 2009. The regulations (40 CFR 59.600-59.699) require manufacturers to comply with specific testing, certification, and labeling requirements. Here are the requirements for an application for certification of a gas can: (testing is even more prescribed)

This section specifies the information that must be in your application, unless we ask you to include less information under §59.622(c). We may require you to provide additional information to evaluate your application. (a) Describe the emission family's specifications and other basic parameters of the emission controls. List each distinguishable configuration in the emission family. Include descriptions and part numbers for all detachable components such as spouts and caps and describe any devices designed for venting pressure, if applicable. (b) Describe and explain the method of emission control. (c) Describe the products you selected for testing and the reasons for selecting them.

33 (d) Describe the test equipment and procedures that you used, including any special or alternate test procedures you used (see §59.650). (e) List the specifications of the test fuel to show that it falls within the required ranges specified in §59.650. (f) Include the maintenance and use instructions and warranty information you will give to the ultimate purchaser of each new portable fuel container (see §59.613). (g) Describe your emission control information label (see §59.615). (h) State that your product was tested as described in the application (including the test procedures, test parameters, and test fuels) to show you meet the requirements of this subpart. (i) Present emission data to show your products meet the applicable emission standards. Where applicable, §§59.626 and 59.627 may allow you to submit an application in certain cases without new emission data. (j) Report all test results, including those from invalid tests or from any other tests, whether or not they were conducted according to the test procedures of §§59.650 through 59.653. We may ask you to send other information to confirm that your tests were valid under the requirements of this subpart. (k) Unconditionally certify that all the products in the emission family comply with the requirements of this subpart, other referenced parts of the CFR, and the Clean Air Act. (l) Include estimates of U.S.-directed production volumes. (m) Include the information required by other sections of this subpart. (n) Include other relevant information, including any additional information requested by EPA. (o) Name an agent for service located in the United States. Service on this agent constitutes service on you or any of your officers or employees for any action by EPA or otherwise by the United States related to the requirements of this subpart.

One factor affecting the siting of a new manufacturing facility is air quality. EPA sets national ambient air quality standards for a number of ubiquitous pollutants, including ozone, a major component of smog. For areas that EPA designates as being in nonattainment with the standard, new sources must comply with requirements such as stringent emission limitations (known as LAER) and the purchase of emission offsets (emission reductions generally obtained from existing sources located in the vicinity of a proposed new source). Manufacturers that wish to expand operations into new parts of the country must take into account the additional cost associated with non-attainment areas. Academic research77 has shown that such regulatory requirements can negatively impact jobs by shifting production away from nonattainment areas.

77 According to economist Michael Greenstone, in the first 15 years in which the Clean Air Act was in force (1972–87), nonattainment counties (relative to attainment ones) lost approximately

34

Water Quality

Federal water quality regulations include at least 54 CFR parts that impose 6,940 restrictions on manufacturers.

For example, EPA effluent guidelines are national regulatory standards for wastewater discharged to surface waters and municipal plants.78 EPA issues these regulations for industrial categories, based on the performance of treatment and control technologies. These are technology-based regulations, and are intended to represent the greatest pollutant reductions that are economically achievable for an industry. The standards for direct dischargers (e.g., a manufacturer that discharges pollutants to waters of the United States, such as streams, lakes, or oceans) are incorporated into National Pollutant Discharge Elimination System (NPDES) permits issued by states and EPA regional offices, and permits or other control mechanisms for indirect dischargers.

To develop effluent guidelines, EPA first gathers information on industry practices, characteristics of discharges (e.g., pollutants, flow variability, storm water), technologies or practices used to prevent or treat the discharge, and economic characteristics. EPA then identifies the best available technology that is economically achievable for that industry and sets regulatory requirements based on the performance of that technology.

EPA’s has promulgated regulatory requirements for 58 industries under this program, including glass manufacturing,79 iron and steel manufacturing,80 metal finishing,81 pharmaceutical manufacturing,82 and textile mills.83

These EPA requirements employ numeric limitations for specific pollutants at several levels of control: best practicable control technology (BPT), best conventional pollutant control technology (BCT), best available technology economically achievable, (BAT), new source performance standards (NSPS), pretreatment standards for new sources (PSNS), pretreatment standards for existing sources (PSES), and best management practices (BMP). EPA employs a particular methodology to derive each level of control for an industrial category.

590,000 jobs, $37 billion in capital stock, and $75 billion (1987 dollars) of output in pollution intensive industries. Michael Greenstone. “The Impacts of Environmental Regulations on Industrial Activity: Evidence from the 1970 and 1977 Clean Air Act Amendments and the Census of Manufacturers.” Journal of Political Economy, 2002, 110(6). 78 For more information on EPA effluent guidelines, see EPA’s web page: https://www.epa.gov/eg 79 40 CFR 426 80 40 CFR 420 81 40 CFR 433 82 40 CFR 439 83 40 CFR 410

35 To ensure that the resulting numeric limits are enforceable, EPA requires that an analytical testing procedure be used to measure the relevant parameter.84 Regulated entities are required to employ these analytical testing procedures to ensure compliance.

By statute, EPA must annually review and, if appropriate, revise effluent guidelines. EPA publishes a plan every other year, establishing a schedule for annual review and revision. This ensures that these requirements change periodically, requiring renewed compliance strategies.

Waste Management

Federal regulation of waste generation and management includes at least 15 CFR parts that impose 8,780 restrictions on manufacturers.

For example, under the Resource Conservation and Recovery Act, EPA regulates hazardous waste from “cradle to grave” (i.e., from generation through to disposal). A hazardous waste is a solid waste that is not excluded from regulation and meets the criteria as a listed or a characteristic hazardous waste. This definition is rather complex but the end result is that many types of industrial wastes, such as those at a manufacturing operation are considered hazardous waste subject to regulation under RCRA.

Certain manufacturers that treat, store, or dispose of hazardous waste (known as TSD facilities) are required to obtain permission, in the form of an RCRA permit, which establishes the administrative and technical conditions under which waste at the facility must be managed. The facility must obtain the permit before construction begins. A permit is typically granted for a period of ten years, and it must be renewed.

The permit includes applicable EPA regulations,85 describes facility design and operation, lays out safety standards, and describes facility performance activities (e.g., monitoring and reporting).

Permits typically require facilities to develop emergency plans, find insurance and financial backing and train employees to handle hazards. Permits can also include specific facility requirements such as controlling the emissions of volatile organic compounds from process vents, closure requirements, corrective action, groundwater monitoring, and land disposal restrictions.

Worker Safety

Federal regulation of worker safety includes at least 9 CFR parts that impose 28,594 restrictions on manufacturers. Most of these restrictions come from

84 40 CFR 136 85 40 CFR 260-270

36 OSHA, which issues regulatory standards applicable to different types of work places.

For example, OSHA's Hazard Communication Standard86 is designed to ensure the dissemination of information about chemical hazards and associated protective measures. According to OSHA,87 this is accomplished by requiring chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import, and to provide information about them through labels on shipped containers and more detailed information sheets called material safety data sheets (MSDSs). All employers with hazardous chemicals in their workplaces must prepare and implement a written hazard communication program, and must ensure that all containers are labeled, employees are provided access to MSDSs, and an effective training program is conducted for all potentially exposed employees. Recent changes to this regulatory program are aimed at bringing the United States into alignment with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). OSHA estimated that more than 5 million workplaces employing approximately 43 million workers are affected by its revised standard, which had a final compliance deadline of June 1, 2016.88

How does an affected manufacturer comply with a major rule such as this change to OSHA’s long-standing regulations? Two companies interviewed for this report explained their compliance approach. According to one: “I had to train our employees on new forms and labels, and explain to them the wording changes (caution, danger, warning). Our chemical suppliers had to change their labeling and we had to make sure they sent us new Safety Data Sheets to replace the old MSDSs. Secondary labeling was up to us—if we poured some mineral spirits from a bucket into a spray bottle, we had to label the spray bottle in accordance with the new regulation.” According to another compliance official with a larger company, “Compliance with the new rule is more complicated for larger companies due to multiple locations and employee turnover. Getting multiple manufacturing sites to be in compliance takes considerable effort.”

Governance/Top-Level Management

The governance of a manufacturing company includes responsibility for financial management and controls, as well as the overall management of the company.

Federal requirements pertain to manufacturers that are also publicly traded companies, including obligations related to internal controls, financing, public

86 29 CFR 1910.1200 87 See OSHA website for more on the hazard communication standard: https://www.osha.gov/dsg/hazcom/whatishazcom.html 88 See OSHA fact sheet: https://www.osha.gov/dsg/hazcom/HCSFactsheet.html

37 filings, the content of required financial statements, and responsibilities under changes in . Certain manufacturers that are not publicly traded companies are also subject to certain requirements, including financial reporting.

The CFR includes at least 8 parts that impose 8,884 restrictions pertaining to the governance of US manufacturers. Federal regulations include SEC rules of practice, SEC financial statements, SEC crowdfunding, and SEC regulations S-K.

Executives at manufacturing operations make many critical decisions that are influenced by regulation. Regulatory compliance through the acquisition of permits is a significant factor affecting decisions throughout the entire business. The siting of a new manufacturing facility can be influenced by the need for construction permits. Capital investments, sourcing decisions and other operational determinations cannot be made without permit acquisition. According to the NAM survey, 35% of respondents say their company was adversely affected through government delay in making a regulatory decision on a permit, license, or product approval within the last 12 months. For those adversely affected, nearly 50% say the result was a delay in or construction.

For example, signing-off on financial reports for investors, determining the location of new facilities, and approving annual capital budgets—each is impacted by regulatory requirements.

Federal securities laws require public companies to disclose certain information on an ongoing basis. For example, domestic companies must submit annual reports on Form 10-K, which provides a comprehensive overview of the company's business and financial condition and includes audited financial statements. According to a Wall Street journal report,89 the length of the average 10-K report is increasing, doubling from 1996 levels and longer than the 2002 Sarbanes-Oxley law. The largest companies spend weeks every quarter updating filings required under various regulations. Recently, researchers at Columbia Law School90 conducted a study to determine the cause of this doubling in length since 1996. Of the more than 150 topics in 10-K reports they examined, the largest drivers of 10-K length were due to new disclosure requirements, specifically those relating to internal controls, risk factors, and fair value accounting. These disclosure requirements largely explain increases in the quantity, complexity, and redundancy of 10-K reports.

Manufacturing companies commonly develop an internal capital budget to improve the efficiency and operation of their facilities, which are capital intensive. Typically, company executives determine the size of the capital budget and choose the projects that will be funded out of the limited funds. Regulatory requirements, which are mandatory, impact these choices by siphoning off

89 http://www.wsj.com/articles/the-109-894-word-annual-report-1433203762 90 http://clsbluesky.law.columbia.edu/2016/05/05/the-ever-expanding-10-k-why-are-10-ks- getting-so-much-longer-and-does-it-matter/

38 resources that would otherwise go toward “discretionary” capital projects. When regulation imposes substantial capital investment, which is not infrequent, the opportunity cost is readily apparent—capital projects that otherwise would have been given the green light are put on hold. According to the NAM survey, the greatest opportunity cost associated with regulation is reduced capital spending on otherwise worthwhile projects.

When asked how her company would spend extra money if compliance costs were permanently reduced, one compliance officer said, “From my perspective, we would use it to make improvements to processes or procedures. Fixed costs you can’t save on. Labor costs are fixed. Material parts are fixed costs. So we have to make things more efficient.”

The cumulative burden of regulation is a growing concern of US manufacturers. A 2012 study by NERA,91 an economic , employed a macroeconomic model to look at regulation of the manufacturing sector. It found that the cumulative cost of regulation is greater than the sum of individual regulations in isolation. The NERA explanation is that regulations interact with each other to create distortions in the economy leading to higher costs and negative impacts. The impact of regulations already in place, concluded NERA, is as important as the future growth of regulation. The perspective of manufacturers aligns with this macroeconomic perspective.

When asked to choose between reform that reduces the cost of major new regulations or cumulative cost of regulations, 75% of respondents to the NAM survey preferred reducing the cumulative cost of regulation compared to 17% preferring reform of major new regulations.

The compliance officials interviewed for this report confirm the need for regulatory certainty. According to one, “Regulatory stability is a good thing. Change is always challenging. Change can come in many forms—interpretation of old regs--lockout/tagout with OSHA--or new rules that are labor intensive, especially at first.”

91 NERA Economic Consulting. 2012. Macroeconomic Impacts of Federal Regulation of the Manufacturing Sector. Manufacturers Alliance for Productivity and Innovation.

39 Summary and Conclusion Manufacturers in the United States are subject to regulatory restrictions at each step of the manufacturing process and also at the corporate level. Searching the voluminous Code of Federal Regulations (CFR), we found 715 parts that contain nearly 300,000 restrictions on domestic manufacturing (see Table ES-1). It is important to note that the CFR is not a complete listing of mandates that restrict the activities of manufacturers: federal statutes that are self-executing, federal “guidance” documents that are sometimes the subject of enforcement actions, state regulations, local/municipal regulatory requirements and the regulations imposed by other countries on manufactured goods significantly add to these numbers.

Table ES-1. Federal Regulations Across the Manufacturing Process

Manufacturing # CFR Parts # Restrictions # Restrictions Process Step per CFR Part

Sourcing 43 4,168 96 Production 239 44,628 187 Quality Control 83 23,951 289 Labeling and 47 7,477 159 Packaging Distribution and 64 21,057 329 Shipping Post-Sale 9 1,644 183 Follow-Up Human Resources 54 17,042 316 Tax 26 51,760 1,991 Governance 8 8,884 1,111 Marketing and 35 1,518 43 Sales R&D and New 22 12,833 583 Products EH&S 85 102,734 1,209 Totals 715 297,696 416

We delved into the challenges of regulatory compliance with a survey of compliance officials of NAM members; 486 responses were received. The U.S. regulatory burden is seen as greater than that of other developed countries. Among the cost pressures facing business over the next 6 to 12 months, regulatory cost ranks relatively high—among the top three (along with health care and labor). Driving this trend is regulation at the federal level, particularly in the areas of EH&S, tax and labor. Compliance officials say that regulatory burden has

40 increased within the past five years; 72 percent of respondents believe it has increased significantly, and less than 1 percent believe it has declined.

From our interviews, we discern that manufacturers follow the same five-step process to ensure compliance with new regulations: (1) identify new requirements; (2) understand these requirements and determine if and how they impact the company; (3) develop new or modify existing standard operating procedures (SOPs) to ensure compliance; (4) implement a compliance plan through dissemination of SOPs, capital improvements, training employees, creation of management systems, etc.; and (5) periodically self-audit to ensure compliance over the long term.

This generic compliance process is not simple, nor is it easy. Our survey shows that the most challenging steps are the very first ones, especially for smaller manufacturers. When asked to choose among various explanations often given for onerous regulation, 42 percent of compliance officials chose the following answer: “regulatory agencies writing a rule absent an adequate understanding of my business and my compliance challenges.” Said one compliance director, “Translating a legal rule into something an engineer can understand is a real challenge.” Another common criticism of regulators is their selection of a compliance date. “Regulatory agencies consistently underestimate the time needed to comply,” said one compliance official.

Compliance with regulation is mandatory; a dollar diverted to compliance cannot be used for discretionary activities. What exactly are these discretionary activities? We explored this question in our interviews and survey. The opportunity cost of regulation is primarily reduced market innovation, such as foregone capital investment opportunities that would either improve operational efficiency and/or improve the products offered to customers. When asked how their company would redirect resources if regulatory compliance costs were suddenly reduced significantly and permanently, nearly two-thirds said increase investment in capital equipment or in R&D/new products. This finding should be particularly concerning to policymakers and regulators alike; market innovation raises the standard of living and increases the quality of life. When asked how their company would redirect resources if regulatory compliance costs were suddenly and permanently increased significantly, more than one-third of respondents said they would decrease hiring.

When asked to identify a specific example of a regulation that negatively impacted hiring or capital replacement within the past five years, 134 respondents identified a wide range of federal regulations. The most frequently mentioned included those related to health care, labor or EH&S.

To explore regulatory reform, respondents prefer reducing the cumulative burden of existing regulations (75 percent) to reducing the cost of new major regulations (17 percent). When asked to indicate a preference over faster (speedier regulatory approval of permits, licenses or new products), cheaper (reduction in costs through additional compliance options or elimination of redundant

41 requirements) or clearer (greater clarity/certainty of regulatory requirements), 60 percent of respondents preferred cheaper.

In interviews, compliance officials offer a more nuanced perspective: the biggest headaches are posed by changing regulations, regardless of whether the change is due to a brand-new regulatory program or a new interpretation of an old regulatory requirement. “The challenge is the new, the unfamiliar,” said one company executive. This perspective is understandable—manufacturing is most efficient when required tasks are routinized and predictable. Once a company develops a system for compliance and implementation becomes routine, it becomes less worrisome. This is why differential enforcement of a regulatory requirement across geographies (i.e., inspectors interpreting a regulation differently in two different manufacturing locations) is so troubling to compliance officials.

The information gleaned from this study supports three general policy recommendations aimed at regulatory reform: Reform ought to focus on (1) reducing the cumulative burden associated with regulation; (2) emphasizing compliance assistance over enforcement; and (3) minimizing the opportunity cost of reduced market innovation.

Although the executive branch recognizes the need to reduce the cumulative burden,92 we are not aware of any federal effort to identify objectively the cumulative burden of regulation on manufacturing or any other sector of the economy. The reason is simple: there is no established technique to measure cumulative burden. Without an ability to measure cumulative burden, it will be impossible to evaluate policies that aim to reduce it.

This study showed one attempt to identify cumulative regulatory burden at the federal level, and the methodology employed can be improved through the use of modern data analytics. Reform efforts can and should aim at employing data analysis that can identify the full panoply of regulatory requirements imposed on any particular sector of the economy, including manufacturing, or on any particular business establishment. Such an analytical tool—and its ease of use— will have a powerful and positive influence on compliance (which should increase net benefits to the public). According to the NAM survey, the most challenging aspect of regulatory compliance is determining which requirements might apply. Making this compliance step easier would be a significant, positive development.

To emphasize compliance assistance, regulators would be wise to consider the five-step compliance process that this study found is common across the manufacturing sector. Particular emphasis should be placed on enhanced public engagement prior to the writing of a proposed rule so regulators can best

92 Executive Order 13563, “Improving Regulation and Regulatory Review,” states that to the extent permitted by law, each agency must take into account “among other things, and to the extent practicable, the costs of cumulative regulations.” See also the March 20, 2012, memorandum to executive agencies from OMB/OIRA Administrator Cass Sunstein on the cumulative effect of regulations.

42 understand the businesses they aim to regulate, and businesses can find out which new regulations are coming their way. As one company compliance official noted, “The single biggest problem is that people who write the rules have never spent time in the field implementing them.”

Regulators should spend more time and effort developing and disseminating compliance tools. For example, according to one compliance official interviewed for this study, agency-approved answers to FAQs is one of the most helpful documents that regulators can develop to enhance compliance. Other tools or policies can advance compliance assistance by focusing on specific steps of the five-step compliance process: development of educational materials to educate employees on compliance and expansion of self-audit policies at the state and federal level (which encourage self-audits).

To minimize the opportunity cost of reduced innovation, reform should take aim at excessive compliance burden (e.g., when regulation is particularly prescriptive and additional regulatory compliance options are possible), ambiguous or unclear regulatory requirements (e.g., where regulatory programs show significant rates of noncompliance) and inordinately delayed regulatory decisions (e.g., pre-market product approvals that take years or decades, infrastructure permit applications that languish). A review of the academic literature93 exploring regulation and its impact on innovation shows that such a focus will bear fruit as long as the regulatory objective is not sacrificed. This would not require a change in policy; Executive Order 13563 asks federal regulators to minimize the negative impact of regulation on innovation.94 For example, the president could direct federal agencies to focus their plans for retrospective review of existing regulations to eliminate unnecessary barriers to innovation.

It is important to note that in some cases, markets may be more effective regulators than governments. Manufacturers will go beyond compliance (and often do) if the regulatory objective is being pushed by consumers/customers. Several of those interviewed for this study say that industry consensus standards often go beyond regulatory requirements to address market demand. This is consistent with a survey finding that the market often compels a beyond- compliance response. This suggests support for the NTTAA of 1995, which requires federal regulators to first consider consensus standards before developing a government-unique standard.

93 Stewart, L. 2010. “The Impact of Regulation on Innovation in the United States: A Cross- Literature Review,” paper commissioned by the National Institute of Medicine Committee on Patient Safety and Health IT. 94 Section three of this executive order reads as follows: “Some sectors and industries face a significant number of regulatory requirements, some of which may be redundant, inconsistent or overlapping. Greater coordination across agencies could reduce these requirements, thus reducing costs and simplifying and harmonizing rules. In developing regulatory actions and identifying appropriate approaches, each agency shall attempt to promote such coordination, simplification and harmonization. Each agency shall also seek to identify, as appropriate, means to achieve regulatory goals that are designed to promote innovation.”

43 Appendix A: Interview Instrument

Introduction

This interview will help us to better understand how NAM members comply with a wide array of regulatory requirements, identify some of the more challenging regulations from a compliance perspective, and describe the opportunity cost posed by government regulations. The interviews will help us craft a more in- depth email survey to a large sample of the NAM membership.

You and your company will not be cited in our project report to NAM. If you provide an anecdote that we may want to use in our final report without attribution, we will come back to you and seek your permission first.

1. Do you have any questions before we begin?

2. Can you tell me your title and describe briefly your role in the company?

Internal Compliance Systems

The first group of questions relate to how your company ensures compliance with government regulation.

3. Let’s start with organizational structure. In particular, I am interested in whether compliance falls within just one part of the organization, or are responsibilities spread across organizational units depending on the type of regulation (e.g., tax, EH&S, health care, etc.)? If responsibilities are diffuse, is there someone with responsibility for all compliance, like a chief compliance officer who reports to the CEO or the ? Describe the organizational structure.

4. Is there a compliance budget? Capital expenses versus recurring expenses? How is regulatory compliance built into the budget?

5. I would like to understand how companies create compliance systems for regulatory requirements. Can you describe how compliance is ensured within your company? Think of a new regulation that is about to become final and which imposes requirements on your manufacturing operations. Take me through— step-by-step, how the company will comply, year after year.

6. Every company may utilize different tools to ensure compliance with government regulations. Such tools might include, for example, auditing teams, development of standard operating procedures, and employee training. Please describe the tools/techniques your company uses to ensure compliance.

7. Which of these tools are most important or critical for compliance within your company?

44 8. Please list a few of the biggest challenges faced by those responsible for compliance within your company. These could be challenges such as keeping up with new regulations affecting your operations, resourcing compliance, recordkeeping, integrating compliance into the manufacturing process, etc. Feel free to identify your own unique challenges.

9. If your company’s compliance resources could be reduced permanently by 25%, to what purpose would your company use the saved resources?

Compliance Assistance

I now want to ask you some questions about compliance assistance provided by regulatory agencies. The term “compliance assistance” includes the incentives (think carrots, not sticks) regulators may use to increase compliance with a regulation or regulatory program.

10. Consider a five-category scale: very good, good, average, bad, very bad. In general, how would you describe the quantity and quality of compliance assistance provided by regulatory agencies?

11. Can compliance assistance be better? How so?

12. Can you think of a regulation in which the requirements are not easily understood and where compliance assistance is lacking or non-existent? For this particular regulation, what could regulators do in terms of compliance assistance to help manufacturers like your company?

13. Can you think of a regulation in which the requirements are easily understood and where compliance assistance is very helpful? What specifically did regulators do that was so helpful?

14. Regulators utilize many different tools to assist regulated entities with compliance. I am going to read you a list of such tools. After I finish reading this list, please indicate, based on your experience, which tools are missing from my list, and of this expanded list of tools, which are particularly or most helpful.

• self audit policies • guidance documents • “safe ” • webinars/workshops • official written responses to compliance questions (i.e., compliance letters)

15. Does your company utilize external expertise (e.g., trade associations, consultants) to identify best practices for your internal compliance systems? Are any professional associations geared specifically toward corporate compliance officials? How helpful/valuable are these resources?

45 16. Does your company go beyond compliance to minimize the risk of litigation? If the answer is yes, how so?

Regulatory Challenges

17. Overall, how challenging are local or state regulations relative to federal regulations? Is one more burdensome than the other? Can you give me examples of local or state regulations that are most heavily resourced by your company?

18. Overall, existing regulations more or less challenging compared to pending regulations? Which existing regulations is most challenging from a compliance perspective? Which pending regulations is most challenging from a compliance perspective?

19. Some regulations represent a direct barrier to market entry. These are regulations where regulatory approval must occur before commercial activity can begin (e.g., an operating permit for a production unit, a government-issued license, pre-market product approval, etc.). Do such regulatory barriers to entry represent a high priority for your company compared to other kinds of regulatory requirements? How so? Can you provide an example?

20. Do you keep a list of regulations affecting the company? For example, if you use an audit team, what does the audit team use a checklist?

21. I am going to describe specific sequential steps in a generic manufacturing process and shared services common to a generic manufacturer, and after I go through the list, I will go back and ask you whether regulation of that particular step or shared service is more challenging than most regulatory requirements, less challenging that most regulatory requirements, or about the same level of challenge as most regulatory requirements.

Here are the sequential steps of a generic manufacturing process:

1. sourcing of materials 2. initial processing of materials 3. production and assembly of product 4. quality control/testing 5. labeling and packaging 6. distribution/shipping 7. customer service and follow up

Here are shared services common to a generic manufacturer:

• human resources • accounting/tax • marketing/sales • R&D/product design

46 • governance

22. For those steps or shared services where you indicated greater than average regulatory challenges, can you give an example as to why the challenge is greater than average?

23. For those steps or shared services where you indicated a greater than average regulatory challenge, suppose those regulatory challenges were suddenly reduced such that the regulatory challenge was now below average. How would your company likely allocate the saved resources?

24. For each of the following types of regulation, can you think of a particular regulatory requirement that is especially challenging for your company?

• EH&S • Financial • Energy • Labor • Tax • Commercial practices (advertising, marketing, etc.)

25. Can you think of particular regulatory requirements that are imposed on your suppliers or your customers and have a tangible, indirect impact on your company?

26. Think of which regulatory issues have risen to the level of your CEO or your Board of Directors. What makes these regulatory issues such a high priority?

27. Are you aware of duplication across regulatory requirements, such as similar regulatory requirements from multiple regulatory agencies? Explain with examples, if possible. How much of a resource drain is this on your company?

28. In your company’s experience, do enforcement personnel at regulatory agencies interpret regulatory requirements differently from your compliance staff? And if so, how?

Opportunity Cost of Compliance

29. If the company needs more resources for compliance, where do the resources come from? What opportunities are foregone?

30. Consider a situation in which your company’s overall compliance costs were suddenly and permanently cut by 25%, to what purpose would the resources saved be diverted?

47 31. Can you think of [a] regulatory requirement[s] that costs X for compliance but for which your company would be willing to pay >>X if it were repealed? Which regulatory requirement[s] comes to mind?

32. Aside from redirecting resources, are you aware of particular regulatory requirements that create a new problem different from the problem the regulation was intended to address? (For example, consider a regulation that requires reducing your use of chemical X, and so you use more of chemical Y, which changes the performance characteristics of the product in a negative manner.) Can you provide examples?

Thank you and Follow-up

33. Thank you for your time today. Are there any questions you information I can provide you?

34. Can I follow-up with you by email or by phone if I have additional questions?

48 Appendix B: Survey Results

1. Please select one of the NAICS codes below that best describes your manufacturing business.

Answer Options Response Response Percent Count 311 food manufacturing 1.4% 7 312 beverage and tobacco manufacturing 0.2% 1 313 textile mills 0.2% 1 314 textile product mills 0.4% 2 315 apparel manufacturing 0.4% 2 316 leather and allied products manufacturing 0.0% 0 321 wood product manufacturing 2.1% 10 322 paper manufacturing 0.4% 2 323 and related support manufacturing 0.6% 3 324 petroleum and coal products 4.6% 22 325 chemical manufacturing 6.0% 29 326 plastics and rubber products manufacturing 7.9% 38 327 nonmetallic mineral product manufacturing 3.1% 15 331 primary metal manufacturing 5.4% 26 332 fabricated metal product manufacturing 21.5% 104 333 machinery manufacturing 8.9% 43 334 computer and electronic product manufacturing 2.1% 10 335 electric equipment, appliance, and component 7.7% 37 manufacturing 336 transportation equipment manufacturing 4.3% 21 337 and related product manufacturing 0.6% 3 339 miscellaneous manufacturing 4.6% 22 Other (please specify) 17.6% 85 Answered 483 Skipped 3

2. How many full time equivalents (FTEs) does your firm employ in the USA?

Answer Options Percent Response Response Count

0-25 13.3% 64 26-50 13.3% 64 51-75 11.4% 55 76-100 10.2% 49 >101 51.9% 250 Answered 482 Skipped 4

49

3. Are you generally familiar with the cost pressures affecting your company?

Answer Options Percent Response Response Count

Yes 97.7% 472 No 2.3% 11 Answered 483 Skipped 3

4. If you answered yes to Question 3, which of the following represents the greatest cost pressures facing your business over the next 6-12 months? Please rank just the top three, with 1 indicating the greatest cost pressure, 2 indicating the second-greatest cost pressure, and 3 indicating the third-greatest cost pressure.

Answer Options 1 2 3 Response Count

Labor cost (wages 119 128 84 331 and salary) Health care cost 147 113 87 347 Pension cost 2 7 12 21 Materials cost 89 54 77 220 Energy cost 10 23 45 78 Regulatory cost 77 87 111 275 Litigation cost 7 18 17 42 Answered 438 Skipped 48

50 5. Does your business operate in international markets?

Answer Options Response Percent Response count

Yes 68.1% 303 No 31.7% 141 I don’t know 0.2% 1 Answered 445 Skipped 41

6. If your answer to Question 5 is yes, how would you characterize the cumulative burden of the US regulatory system on your business relative to other developed in which you operate?

Answer Options Response Percent Response Count

Much more 38.1% 114 More 33.8% 101 About the same 23.1% 69 Less 4.3% 13 Much less 0.7% 2 Answered 299 Skipped 187

How would you characterize the cumulative burden of the U.S. regulatory system on your business relative to other developed economies in which you operate?

much more more about the same less much less

51 7. Are you generally familiar with regulatory requirements affecting your company?

Answer Options Response Percent Response Count

Yes 96.3% 421 No 3.7% 16 Answered 437 Skipped 49

8. If you answered yes to Question 7, how would you characterize the general trend in regulatory burden imposed on your company over the last five years?

Answer Options Response Percent Response Count

Significantly higher 72.1% 282 Slightly higher 21.5% 84 About the same 5.9% 23 Slightly lower 0.3% 1 Significantly lower 0.3% 1 Answered 391 Skipped 95

How would you characterize the general trend in regulatory burden imposed on your company over the past five years?

significantly higher slightly higher about the same slightly lower significantly lower

52 9. If you answered yes to Question 7, please respond to the following: Regulation directly affects many aspects of a manufacturing operation. From the following list of activities common to manufacturers, indicate all of those in which regulatory requirements on your company are, in your opinion, significant.

Answer Options Response Percent Response Count

R&D/product design 37.2% 145 Human resources/labor 79.7% 311 Tax/trade 67.4% 263 Advertising/marketing/sales 9.2% 36 Environment, health, and 87.9% 343 safety Corporate governance 40.3% 157 Materials sourcing 33.1% 129 Product/production standards 35.6% 139 Quality control/product 29.2% 114 testing Packaging and labeling 27.9% 109 Distribution/shipping 30.5% 119 Customer service/follow-up 7.7% 30 Answered 390 Skipped 96

10. If you answered yes to Question 7, please respond to the following: Regulation directly affects many aspects of a manufacturing operation. From the following list of activities common to manufacturers, choose as many as three in which regulatory requirements are of greatest concern to your company.

Answer Options Response Percent Response Count

R&D/product design 20.9% 82 Human resources/labor 66.6% 261 Tax/trade 49.7% 195 Advertising/marketing/sales 1.8% 7 Environment, health, and 72.4% 284 safety Corporate governance 15.3% 60 Materials sourcing 12.2% 48 Product/production standards 16.1% 63 Quality control/product 10.2% 40 testing Packaging and labeling 9.4% 37 Distribution/shipping 11.0% 43 Customer service/follow-up 0.3% 1 Answered 392 Skipped 94

53 11. If you answered yes to Question 7, please respond to the following: Please rank the following levels of regulation in terms of relative regulatory burden on your company, with 1 being the level posing the greatest relative burden and 4 being the level posing the least relative burden.

Answer Options 1 2 3 4 Rating Response Average Count Federal 297 60 21 3 1.29 381 State 64 217 82 13 2.12 376 Local / 12 38 190 128 3.18 368 municipal International 12 65 81 194 3.30 352 (non-US) Answered 390 Skipped 96

Please rank the following levels of regulation in terms of relative regulatory burden on your company, with “1” being the level posing the greatest relative burden and “4” being the level posing the least relative burden. international (i.e., non-U.S.)

local/municipal

state

federal

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50

54 12. Are you familiar with the way your company is organized with respect to compliance with regulations?

Answer Options Response Percent Response Count

Yes 95.6% 387 No 4.4% 18 Answered 405 Skipped 81

13. If you answered yes to Question 12, how would you best characterize your company’s compliance efforts?

Answer Options Response Percent Response Count

centralized 79.8% 308 decentralized 20.2% 78 Answered 386 Skipped 100

14. If you answered yes to Question 12, do you have a single employee who is in charge of regulatory compliance (e.g., a chief compliance officer)?

Answer Options Response Percent Response Count

Yes 38.4% 149 No 61.6% 239 Answered 388 Skipped 98

55 15. Are you generally familiar with your company’s regulatory compliance activities?

Answer Options Response Percent Response Count

Yes 94.8% 385 No 5.2% 21 Answered question 406 Skipped question 80

16. If you answered yes to Question 15, please respond to the following: Regulatory compliance can be challenging for any manufacturer. Please rank the following compliance activities in terms of burden/complexity, with 1 indicating the most challenging and 6 indicating the least challenging. A--identifying regulatory requirements applicable to your company B--familiarization/understanding of applicable regulatory requirements C--development of standard operating procedures to ensure company compliance D--educating and training of employees, contractors, etc. on regulatory requirements and standard operating procedures to ensure company compliance E--developing and operating company-wide management systems, including the use of self auditing, to ensure company compliance F--establishing priorities and allocating resources for compliance

Answer 1 2 3 4 5 6 Response Response Options Average Count

A 132 93 38 27 20 32 2.43 342 B 95 132 41 28 33 12 2.44 341 C 31 26 102 92 58 32 3.63 341 D 19 49 68 76 67 67 3.94 346 E 29 32 58 64 88 72 4.07 343 F 46 22 41 52 68 114 4.21 343 Answered 358 Skipped 128

56 17. If you answered yes to Question 15, please respond to the following: In the past 12 months, has your company employed outside advisors to assist your business in ensuring your operations comply with governmental regulations?

Answer Options Response Percent Response Count

Yes 69.4% 250 No 30.6% 110 Answered question 360 Skipped question 126

57 18. If you answered yes to Question 15, please respond to the following: Which of the following statements best represents the experience of your company? The most challenging regulations to comply with are due to A--Congress or the state legislature enacting laws that force regulatory agencies to issue challenging regulations. B--regulatory agencies writing a final rule absent an adequate understanding of my business and my compliance challenges. C--regulatory agencies using their legal discretion to set a standard that is more stringent than it should be. D--regulatory agencies enforcing ambiguous requirements inconsistently or inappropriately. E--inconsistency between regulations issued by different levels of government (e.g., between USA and another country, between federal and state regulatory agencies, etc.)

Answer Options Response Percentage Response Count

A 12.0% 29 B 41.7% 101 C 28.1% 68 D 9.9% 24 E 8.3% 20 Answered 242 Skipped 244

Which of the following statements best represents the experience of your company? Congress or the state legislature enacting laws that force regulatory agencies to issue challenging regulations

regulatory agencies writing a final rule absent an adequate understanding of my business and my compliance challenges

regulatory agencies using their legal discretion to set a standard that is more stringent than it should be

regulatory agencies enforcing ambiguous requirements inconsistently or inappropriately

inconsistency between regulations issued by different levels of government (e.g., between the United States and another country, between federal and state regulatory agencies)

58

19. If you answered yes to Question 15, please respond to the following: True or False. In some areas of regulation affecting my company, market demand imposes requirements that go well beyond current regulatory requirements.

Answer Options Response Percent Response Count

True 67.1% 161 False 32.9% 79 Answered question 240 Skipped question 246

59 20. If you answered yes to Question 15, please respond to the following: If your existing regulatory compliance costs were suddenly and permanently reduced significantly, how would your company redirect the saved resources? Select only one of the following choices. A--increase investment in R&D/new technologies/new products B--increase investment in capital replacement (i.e., operational efficiency) C--increase investment in hiring D--increase shareholder E--increase compensation for employees and managers

F—unknown

Answer Options Response Percentage Response count

A 29.5% 71 B 34.4% 83 C 13.3% 32 D 1.7% 4 E 9.5% 23 F 11.6% 28 Answered 241 Skipped 245

Please respond to the following: If your existing regulatory compliance costs were suddenly and permanently reduced significantly, how would your company redirect the saved resources? Select only one of the following choices. increase investment in R&D/new technologies/new products

increase investment in capital replacement (i.e., operation efficiency) increase investment in hiring

increase shareholder dividends

increase compensation for employees and managers

unknown

60 21. If you answered yes to Question 15, please respond to the following: If your existing regulatory compliance costs were suddenly and permanently increased significantly, from which activity would your company pull resources to fill the gap? Select only one of the following choices. A--decrease investment in R&D/new technologies/new products B--decrease investment in capital replacement (i.e., operational efficiency) C--decrease investment in hiring D--decrease shareholder dividends E--decrease compensation for employees and managers F--unknown

Answer Options Response Percent Response Count

A 14.5% 35 B 28.2% 68 C 34.4% 83 D 1.2% 3 E 12.4% 30 F 9.1% 22 Answered 241 Skipped 245

Please respond to the following: If your existing regulatory compliance costs were suddenly and permanently increased significantly, from which activity would your company pull resources to fill the gap? Select only one of the following choices. decrease investment in R&D/new technologies/new products decrease investment in capital replacement (i.e., operational efficiency) decrease investment in hiring

decrease shareholder dividends

decrease compensation for employees and managers

unknown

61

22. If you answered yes to question 15, in the space below, please identify a specific example of how a regulation has negatively affected your plans to hire new employees and/or expend capital in the last five years.

Answer Options Response Count 134 Answered 134 Skipped 352

23. If you answered yes to Question 15, please answer the following: In your opinion, where would your company prefer to see the focus of federal efforts to reform regulation?

Answer Options Response Percent Response Count

Reducing the cost of new 17.0% 41 major regulations Reducing the cumulative cost 75.9% 183 of existing regulations I don’t know 7.1% 17 Answered 241 Skipped 245

In your opinion, where would your company prefer to see the focus of federal efforts to reform regulation?

reducing the cost of new major regulations reducing the cumulative cost of existing regulations I don’t know

62 24. If you answered yes to Question 15, please answer the following: Of the following ways in which compliance can be made easier through regulatory reform, which would be most beneficial for your business operations?

A--faster decisions by regulators on permits, licenses, and product approvals B--lower compliance cost through more compliance options and/or elimination of duplicative requirements C--greater clarity/certainty over regulatory requirements and/or the timing of future regulatory requirements

Answer Options Response Percent Response Count

A 7.5% 18 B 59.6% 134 C 36.9% 89 Answered 241 Skipped 245

Of the following ways in which compliance can be made easier through regulatory reform, which would be most beneficial for your business operations?

faster decisions by regulators on permits, licenses and product approvals

lower compliance costs through more compliance options and/or elimination of duplicative requirements

greater clarity/certainty over regulatory requirements and/or the timing of future regulatory requirements

63 25. In the past 12 months, has your company been adversely affected through government delay in making a regulatory decision and/or taking a regulatory action on a permit, license, or product approval?

Answer Options Response Percent Response Count

Yes 35.1% 131 No 48.8% 182 unknown 16.1% 60 Answered 373 Skipped 113

In the past 12 months, has your company been adversely affected through government delay in making a regulatory decision and/or taking regulatory action on a permit, license or product approval?

Yes No Unknown

64 26. If the answer to Question 25 is yes, how was your company adversely affected? Check all that apply.

A--delay in building and/or construction of new, expanded, or more efficient production or production capacity B--delay in market introduction of a new product or service C--delay in improving the efficiency of our supply chain D--other E--unknown

Answer Options Response Percent Response Count

A 47.7% 62 B 41.5% 54 C 32.3% 42 D 3.8% 5 E 21.5% 28 Answered 130 Skipped 356

How was your company adversely affected? Check all that apply.

60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% delay in building delay in market delay in unknown Other (please and/or introduction of a improving the specify) construction of new product or efficiency of our new, expanded service supply chain or more efficient production or production capacity

65 27. Are you aware of a specific regulation or regulatory requirement that is outdated or unduly burdensome on your company and therefore a good candidate for elimination or reform?

Answer Options Response Percent Response Count

Yes 45.1 165 No 54.9 201 Answered question 366 Skipped question 120

28. If the answer to Question 27 is yes, please identify this regulation and explain why it is outdated or unduly burdensome.

Answer Options Response Count

152 Answered 152 Skipped 334

29. May we contact you if we wish to obtain greater detail on one or more of your answers to these survey questions?

Answer Options Response Percent Response Count

Yes 41.5% 149 No 58.5% 210 Answered question 359 Skipped question 127

30. If the answer to Question 29 is yes, please provide your name and contact information (email and phone number).

Answer Options Response Percent Response Count

Name 99.4% 155 Company 98.1% 153 Email address 99.4% 155 Phone number 94.2% 147

Answered 156 Skipped 330

66 Appendix C: List of Federal Regulations

In the table below, each CFR part is assigned to one of twelve categories: A is sourcing of raw materials including energy, C is preliminary processing, production, and assembly; E is quality control; F is labeling/packaging; G is distribution; H is post-sale follow-up; I is human resources; J is tax; K is governance; L is marketing and sales: M is R&D and the design of new products; and N is environment, health, and safety. The number of restrictions is a count of certain words in each part and comes from the RegData 2.2 database (see the 2014 CFR entries in the megadata file) developed by the Mercatus Center at the George Mason University. For some CFR parts, the database does not have a count of restrictions. In such cases, the table cell is left blank.

CFR Number of Part Heading Code Title Restrictions 7 28 COTTON CLASSING, TESTING, E 273 AND STANDARDS 7 51 FRESH FRUITS, VEGETABLES AND C 1,061 OTHER PRODUCTS (INSPECTION, CERTIFICATION, AND STANDARDS) 7 52 PROCESSED FRUITS AND C 250 VEGETABLES, PROCESSED PRODUCTS THEREOF, AND CERTAIN OTHER PROCESSED FOOD PRODUCTS 7 54 MEATS, PREPARED MEATS, AND C 160 MEAT PRODUCTS (GRADING, CERTIFICATION, AND STANDARDS) 7 60 COUNTRY OF ORIGIN LABELING A FOR FISH AND SHELLFISH 7 65 COUNTRY OF ORIGIN LABELING A 27 OF LAMB, CHICKEN, AND GOAT MEAT, PERISHABLE AGRICULTURAL COMMODITIES, MACADAMIA NUTS, PECANS, PEANUTS, AND GINSENG 7 205 NATIONAL ORGANIC PROGRAM C 420 7 250 DONATION OF FOODS FOR USE IN C 642 THE UNITED STATES, ITS TERRITORIES AND POSSESSIONS AND AREAS UNDER ITS JURISDICTION

67 7 252 NATIONAL COMMODITY C 123 PROCESSING PROGRAM 7 868 GENERAL REGULATIONS AND C 325 STANDARDS FOR CERTAIN AGRICULTURAL COMMODITIES 7 3300 AGREEMENT ON THE INTERNATIONAL CARRIAGEE OF 54 PERISHABLE FOODSTUFFS AND ON THE SPECIAL EQUIPMENT TO BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT

8 214 NONIMMIGRANT CLASSES I 1,437 8 299 IMMIGRATION FORMS I 13 9 102 LICENSES FOR BIOLOGICAL C 44 PRODUCTS 9 103 EXPERIMENTAL PRODUCTION, M 14 DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING 9 104 PERMITS FOR BIOLOGICAL A 57 PRODUCTS 9 112 PACKAGING AND LABELING F 128 9 113 STANDARD REQUIREMENTS E 2,681 9 114 PRODUCTION REQUIREMENTS C 124 FOR BIOLOGICAL PRODUCTS 9 317 LABELING, MARKING DEVICES, F 793 AND CONTAINERS 9 320 RECORDS, REGISTRATIONS, AND E 37 REPORTS 9 381 POULTRY PRODUCTS INSPECTION C 2,177 REGULATIONS 9 424 PREPARATION AND PROCESSING C 63 OPERATIONS 9 430 REQUIREMENTS FOR SPECIFIC E 8 CLASSES OF PRODUCT 9 442 QUANTITY OF CONTENTS F 12 LABELING AND PROCEDURES AND REQUIREMENTS FOR ACCURATE WEIGHTS 9 530 GENERAL REQUIREMENTS; E DEFINITIONS 9 532 REQUIREMENTS FOR INSPECTION E

9 533 SEPARATION OF ESTABLISHMENT; E FACILITIES FOR INSPECTION; FACILITIES FOR PROGRAM

68 EMPLOYEES; AND OTHER REQUIRED FACILITIES 9 534 PRE-HARVEST STANDARDS AND A TRANSPORTATION TO PROCESSING ESTABLISHMENT 9 537 SANITATION REQUIREMENTS AND E HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEMS; NOTIFICATION REGARDING ADULTERATED OR MISBRANDED PRODUCTS 9 539 MANDATORY DISPOSITIONS; E PERFORMANCE STANDARDS RESPECTING PHYSICAL, CHEMICAL, OR BIOLOGICAL CONTAMINANTS 9 540 HANDLING AND DISPOSAL OF CONDEMNEDE AND OTHER INEDIBLE MATERIALS

9 541 MARKS, MARKING, AND LABELING F OF PRODUCTS AND CONTAINERS 9 544 FOOD INGREDIENTS PERMITTED C 9 548 PREPARATION OF PRODUCTS E 9 550 RECORDS REQUIRED TO BE KEPT E 10 60 DISPOSAL OF HIGH-LEVEL N 315 RADIATIVE WASTES IN GEOLOGIC REPOSITORIES 10 61 LICENSING REQUIREMENTS FOR N 265 LAND DISPOSAL OF RADIACTIVE WASTE 10 62 CRITERIA AND PROCEDURES FOR N 37 EMERGENCY ACCESS TO NON- FEDERAL AND REGIONAL LOW- LEVEL WASTE DISPOSAL FACILITIES 10 70 DOMESTIC LICENSING OF C 409 SPECIAL NUCLEAR MATERIAL 10 71 PACKAGING AND F 392 TRANSPORTATION OF RADIOACTIVE MATERIAL 10 429 CERTIFICATION, COMPLIANCE, C 399 AND ENFORCEMENT OF CONSUMER PRODUCTS AND COMMERCIAL AND INDUSTRIAL EQUIPMENT

69 10 430 ENERGY CONSERVATION C 1,867 PROGRAM FOR CONSUMER PRODUCTS 10 431 ENERGY EFFICIENCY PROGRAM C 525 FOR CERTAIN COMMERCIAL AND INDUSTRIAL EQUIPMENT 10 765 REIMBURSEMENT FOR COSTS OF N 79 REMEDIAL ACTION AT ACTIVE URANIUM AND THORIUM PROCESSING SITES 10 835 OCCUPATIONAL RADIATION N 197 PROTECTION 10 850 CHRONIC BERYLLIUM DISEASE N 170 PREVENTION PROGRAM 12 45 MARGIN AND CAPITAL J REQUIREMENTS FOR COVERED SWAP ENTITIES 14 21 CERTIFICATION PROCEDURES C 490 FOR PRODUCTS AND ARTICLES 14 23 AIRWORTHINESS STANDARDS: M 2,154 NORMAL, UTILITY, ACROBATIC, AND COMMUTER CATEGORY 14 25 AIRWORTHINESS STANDARDS: M 2,642 TRANSPORT CATEGORY AIRPLANES 14 26 CONTINUED AIRWORTHINESS AND SAFETYM 152 IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES

14 27 AIRWORTHINESS STANDARDS: NORMAL CATEGORYM 1,177 ROTORCRAFT

14 29 AIRWORTHINESS STANDARDS: M 1,623 TRANSPORT CATEGORY ROTORCRAFT 14 31 AIRWORTHINESS STANDARDS: M 123 MANNED FREE BALLOONS 14 33 AIRWORTHINESS STANDARDS: M 512 AIRCRAFT ENGINES 14 34 FUEL VENTING AND EXHAUST M 52 EMISSION REQUIREMENTS FOR TURBINE ENGINE POWERED AIRPLANES 14 35 AIRWORTHINESS STANDARDS: M 114 PROPELLORS

70 14 36 NOISE STANDARDS: AIRCRAFT M 621 TYPE AND AIRWORTHINESS CERTIFICATION 14 39 AIRWORTHINESS DIRECTIVES M 13 14 43 MAINTENANCE, PREVENTIVE MAINTENANCE,M 98 REBUILDING, AND ALTERATION

14 45 IDENTIFICATION AND REGISTRATION MARKINGM 82

15 315 DETERMINATION OF BONA FIDE A 5 MOTOR-VEHICLE MANUFACTURER 15 732 STEPS FOR USING THE EAR G 33 15 734 SCOPE OF THE EXPORT G 67 ADMINISTRATION REGULATIONS 15 736 GENERAL PROHIBITIONS G 10 15 738 COMMERCE CONTROL LIST G 24 OVERVIEW AND THE COUNTRY CHART 15 740 LICENSE EXCEPTIONS G 367 15 742 CONTROL POLICY—CCL BASED G 110 CONTROLS 15 743 SPECIAL REPORTING AND G 62 NOTIFICATION 15 746 EMBARGOES AND OTHER G 22 SPECIAL CONTROLS 15 750 APPLICATION PROCESSING, G 74 ISSUANCE, AND DENIAL 15 762 RECORDKEEPING G 43 15 764 ENFORCEMENT AND PROTECTIVE G 57 MEASURES 15 772 DEFINITION AND TERMS G 123 15 774 THE COMMERCE CONTROL LIST G 0 16 1 GENERAL PROCEDURES L 128 16 20 GUIDES FOR THE REBUILT, L 0 RECONDITIONED, AND OTHER USED AUTOMOBILE PARTS INDUSTRY 16 23 GUIDES FOR THE JEWELRY, L 7 PRECIOUS METALS, AND PEWTER INDUSTRIES 16 24 GUIDES FOR SELECT LEATHER L 0 AND IMITATION LEATHER PRODUCTS 16 233 GUIDES AGAINST DECEPTIVE L 7 PRICING

71 16 238 GUIDES AGAINST BAIT L 0 ADVERTISING 16 239 GUIDES FOR THE ADVERTISING L 0 OF WARRANTIES AND GUARANTEES 16 240 GUIDES FOR ADVERTISING L 5 ALLOWANCES AND OTHER MERCHANDISING PAYMENTS AND SERVICES 16 251 GUIDE CONCERNING USE OF THE L 7 WORD “FREE” AND SIMILAR REPRESENTATIONS 16 255 GUIDES CONCERNING USE OF L 31 ENDORSEMENTS AND TESTIMONIALS IN ADVERTISING 16 259 GUIDE CONCERNING FUEL L 28 ECONOMY ADVERTISING FOR NEW AUTOMOBILES 16 260 GUIDES FOR THE USE OF L 9 ENVIRONMENTAL MARKETING CLAIMS 16 300 RULES AND REGULATIONS UNDER A 182 THE WOOL PRODUCTS LABELING ACT OF 1939 16 301 RULES AND REGULATIONS UNDER A 234 FUR PRODUCTS LABELING ACT 16 303 RULES AND REGULATIONS UNDER THE TEXTILEA 238 FIBER PRODUCTS IDENTIFICATION ACT

16 305 ENERGY AND WATER USE F 435 LABELING FOR CONSUMER PRODUCTS UNDER THE ENERGY POLICY AND CONSERVATION ACT (“ENERGY LABELING RULE”) 16 306 AUTOMOTIVE FUEL RATINGS, F 70 CERTIFICATION AND POSTING 16 309 LABELING REQUIREMENTS FOR F 72 ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES 16 310 TELEMARKETING SALES RULE 16 L 85 CFR PART 310 16 311 TEST PROCEDURES AND F 4 LABELING STANDARDS FOR RECYCLED OIL 16 315 CONTACT LENS RULE L 35 16 316 CAN-SPAM RULE L 10

72 16 317 PROHIBITION OF ENERGY MARKET MANIPULATIONL 7 RULE

16 408 UNFAIR OR DECEPTIVE L ADVERTISING AND LABELING OF CIGARETTES IN RELATION TO THE HEALTH HAZARDS OF SMOKING 16 410 DECEPTIVE ADVERTISING AS TO SIZES OF VIEWABLEL 2 PICTURES SHOWN BY RECEIVING SETS

16 423 CARE LABELING OF TEXTILE F 36 WEARING APPAREL AND CERTAIN PIECE GOODS AS AMENDED 16 425 USE OF PRENOTIFICATION L 10 NEGATIVE OPTION PLANS 16 435 , , OR TELEPHONE G 31 ORDER MERCHANDISE 16 444 CREDIT PRACTICES L 7

16 455 USED MOTOR VEHICLE TRADE L 25 REGULATION RULE 16 456 OPHTHALMIC PRACTICE RULES L 2 (EYEGLASS RULE) 16 460 LABELING AND ADVERTISING OF F 90 HOME INSULATION 16 500 REGULATIONS UNDER SECTION 4 OF THE FAIRF 127 PACKAGING AND LABELING ACT

16 501 EXEMPTIONS FROM F 4 REQUIREMENTS AND PROHIBITIONS UNDER PART 500 16 502 REGULATIONS UNDER SECTION F 22 5(C) OF THE FAIR PACKAGING AND LABELING ACT 16 503 STATEMENTS OF GENERAL F 7 POLICY OR INTERPRETATION 16 700 INTERPRETATIONS OF L 26 MAGNUSON-MOSS WARRANTY ACT 16 701 DISCLOSURE OF WRITTEN L 9 CONSUMER PRODUCT WARRANTY TERMS AND CONDITIONS 16 702 PRE-SALE AVAILABILITY OF L 11 WRITTEN WARRANTY TERMS 16 703 INFORMAL DISPUTE SETTLEMENT PROCEDURESL 74

16 1101 INFORMATION DISCLOSURE C 41 UNDER SECTION 6(b) OF THE

73 CONSUMER PRODUCT SAFETY ACT 16 1107 TESTING AND LABELING E 47 PERTAINING TO PRODUCT CERTIFICATION 16 1109 CONDITIONS AND REQUIREMENTS E 34 FOR RELYING ON COMPONENT PART TESTING OR CERTIFICATION, OR ANOTHER PARTY'S FINISHED PRODUCT TESTING OR CERTIFICATION, TO MEET TESTING AND CERTIFICATION REQUIREMENTS 16 1110 CERTIFICATES OF COMPLIANCE C 24 16 1116 REPORTS SUBMITTED PURSUANT H 24 TO SECTION 37 OF THE CONSUMER PRODUCT SAFETY ACT 16 1130 REQUIREMENTS FOR CONSUMER C 51 REGISTRATION OF DURABLE INFANT OR TODDLER PRODUCTS 16 1145 REGULATION OF PRODUCTS C 10 SUBJECT TO OTHER ACTS UNDER THE CONSUMER PRODUCT SAFETY ACT 16 1199 CHILDREN'S TOYS AND CHILD C 1 CARE ARTICLES CONTAINING PHTHALATES: GUIDANCE ON INACCESSIBLE COMPONENT PARTS 16 1201 SAFETY STANDARD FOR C 92 ARCHITECTURAL GLAZING MATERIALS 16 1202 SAFETY STANDARD FOR C 24 MATCHBOOKS 16 1203 SAFETY STANDARD FOR BICYCLE C 153 HELMETS 16 1204 SAFETY STANDARD FOR OMNIDIRECTIONALC CITIZENS 81 BAND BASE STATION ANTENNAS

16 1205 SAFETY STANDARD FOR WALK- C 94 BEHIND POWER LAWN MOWERS 16 1207 SAFETY STANDARD FOR C 97 SWIMMING POOL SLIDES 16 1209 INTERIM SAFETY STANDARD FOR C 177 CELLULOSE INSULATION

74 16 1210 SAFETY STANDARD FOR C 165 CIGARETTE LIGHTERS 16 1211 SAFETY STANDARD FOR AUTOMATIC RESIDENTIALC 195 GARAGE DOOR OPERATORS

16 1212 SAFETY STANDARD FOR MULTI-PURPOSE LIGHTERSC 186

16 1213 SAFETY STANDARD FOR C 31 ENTRAPMENT HAZARDS IN BUNK BEDS 16 1215 SAFETY STANDARD FOR INFANT C 2 BATH SEATS 16 1216 SAFETY STANDARD FOR INFANT C 1 WALKERS 16 1217 SAFETY STANDARD FOR C 9 TODDLER BEDS 16 1218 SAFETY STANDARD FOR BASSINETS AND CRADLESC 11

16 1219 SAFETY STANDARD FOR FULL- C 8 SIZE BABY CRIBS 16 1220 SAFETY STANDARD FOR NON-FULL-SIZE BABYC CRIBS 8

16 1221 SAFETY STANDARD FOR PLAY C 2 YARDS 16 1222 SAFETY STANDARD FOR BEDSIDE C SLEEPERS 16 1223 SAFETY STANDARD FOR INFANT C 1 SWINGS 16 1224 SAFETY STANDARD FOR C 1 PORTABLE BED RAILS 16 1225 SAFETY STANDARD FOR HAND-HELD INFANTC 1 CARRIERS

16 1226 SAFETY STANDARD FOR SOFT C INFANT AND TODDLER CARRIERS 16 1227 SAFETY STANDARD FOR C CARRIAGES AND STROLLERS 16 1240 SAFETY STANDARD FOR MAGNET C SETS 16 1251 TOYS: DETERMINATIONS C REGARDING HEAVY ELEMENTS LIMITS FOR CERTAIN MATERIALS 16 1303 BAN OF LEAD-CONTAINING PAINT C 10 AND CERTAIN CONSUMER PRODUCTS BEARING LEAD- CONTAINING PAINT 16 1304 BAN OF CONSUMER PATCHING COMPOUNDSC 1

75 CONTAINING RESPIRABLE FREE-FORM ASBESTOS

16 1305 BAN OF ARTIFICIAL EMBERIZING C 0 MATERIALS (ASH AND EMBERS) CONTAINING RESPIRABLE FREE- FORM ASBESTOS 16 1306 BAN OF HAZARDOUS LAWN C 0 DARTS 16 1401 SELF PRESSURIZED CONSUMER C 12 PRODUCTS CONTAINING CHLOROFLUOROCARBONS: REQUIREMENTS TO PROVIDE THE COMMISSION WITH PERFORMANCE AND TECHNICAL DATA; REQUIREMENTS TO NOTIFY CONSUMERS AT POINT OF PURCHASE OF PERFORMANCE AND TECHNICAL DATA 16 1402 CB BASE STATION ANTENNAS, TV C 34 ANTENNAS, AND SUPPORTING STRUCTURES 16 1404 CELLULOSE INSULATION C 10 16 1406 COAL AND WOOD BURNING APPLIANCES—C 52 NOTIFICATION OF PERFORMANCE AND TECHNICAL DATA

16 1407 PORTABLE GENERATORS: REQUIREMENTSC TO 22 PROVIDE PERFORMANCE AND TECHNICAL DATA BY LABELING

16 1420 REQUIREMENTS FOR ALL C 5 TERRAIN VEHICLES 16 1450 VIRGINIA GRAEME BAKER POOL C 1 AND SPA SAFETY ACT REGULATIONS 16 1460 CHILDREN'S GASOLINE BURN C PREVENTION ACT REGULATION 16 1500 HAZARDOUS SUBSTANCES AND C 669 ARTICLES: ADMINISTRATION AND ENFORCEMENT REGULATIONS 16 1501 METHOD FOR IDENTIFYING TOYS AND OTHERC 5 ARTICLES INTENDED FOR USE BY CHILDREN UNDER 3 YEARS OF AGE WHICH PRESENT CHOKING, ASPIRATION, OR INGESTION HAZARDS BECAUSE OF SMALL PARTS

16 1502 PROCEDURES FOR FORMAL C 76 EVIDENTIARY PUBLIC HEARING

76 16 1505 REQUIREMENTS FOR C 267 ELECTRICALLY OPERATED TOYS OR OTHER 27ELECTRICALLY OPERATED ARTICLES INTENDED FOR USE BY CHILDREN 16 1507 DEVICES C 27 16 1510 REQUIREMENTS FOR RATTLES C 3 16 1511 REQUIREMENTS FOR PACIFIERS C 24 16 1512 REQUIREMENTS FOR BICYCLES C 319 16 1513 REQUIREMENTS FOR BUNK BEDS C 32 16 1602 STATEMENTS OF POLICY OR C 0 INTERPRETATION 16 1605 INVESTIGATIONS, INSPECTIONS C 93 AND INQUIRIES PURSUANT TO THE FLAMMABLE FABRICS ACT 16 1608 GENERAL RULES AND C 18 REGULATIONS UNDER THE FLAMMABLE FABRICS ACT 16 1609 TEXT OF THE FLAMMABLE C 0 FABRICS ACT OF 1953, AS AMENDED IN 1954, PRIOR TO 1967 AMENDMENT AND REVISION 16 1610 STANDARD FOR THE C 172 FLAMMABILITY OF CLOTHING TEXTILES 16 1611 STANDARD FOR THE C 85 FLAMMABILITY OF VINYL PLASTIC FILM 16 1615 STANDARD FOR THE C 243 FLAMMABILITY OF CHILDREN'S SLEEPWEAR: SIZES 0 THROUGH 6X (FF 3-71) 16 1616 STANDARD FOR THE C 253 FLAMMABILITY OF CHILDREN'S SLEEPWEAR: SIZES 7 THROUGH 14 (FF 5-74) 16 1630 STANDARD FOR THE SURFACE C 53 FLAMMABILITY OF AND RUGS (FF 1-70) 16 1631 STANDARD FOR THE SURFACE FLAMMABILITYC OF 75 SMALL CARPETS AND RUGS (FF 2-70)

16 1632 STANDARD FOR THE C 148 FLAMMABILITY OF MATTRESSES AND MATTRESS PADS (FF 4-72, AMENDED)

77 16 1633 STANDARD FOR THE C 181 FLAMMABILITY (OPEN FLAME) OF MATTRESS SETS 16 1700 POISON PREVENTION PACKAGING F 224 16 1701 STATEMENTS OF POLICY AND F 4 INTERPRETATION 16 1702 PETITIONS FOR EXEMPTIONS F 52 FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS 16 1750 STANDARD FOR DEVICES TO M 58 PERMIT THE OPENING OF HOUSEHOLD REFRIGERATOR DOORS FROM THE INSIDE 17 33 REGULATION OF COMMODITY L 44 OPTION TRANSACTIONS THAT ARE OPTIONS ON CONTRACTS OF SALE OF A COMMODITY FOR FUTURE DELIVERY 17 50 CLEARING REQUIREMENT AND J 41 RELATED RULES 17 209 FORMS PRESCRIBED UNDER THE K 10 COMMISSION'S RULES OF PRACTICE 17 210 FORM AND CONTENT OF AND K 937 REQUIREMENTS FOR FINANCIAL STATEMENTS, SECURITIES ACT OF 1933, SECURITIES EXCHANGE ACT OF 1934, INVESTMENT COMPANY ACT OF 1940, INVESTMENT ADVISERS ACT OF 1940, AND ENERGY POLICY AND CONSERVATION ACT OF 1975 17 227 REGULATION CROWDFUNDING, K GENERAL RULES AND REGULATIONS 17 229 STANDARD INSTRUCTIONS FOR K 952 FILING FORMS UNDER SECURITIES ACT OF 1933, SECURITIES EXCHANGE ACT OF 1934 AND ENERGY POLICY AND CONSERVATION ACT OF 1975— REGULATION S-K

78 17 230 GENERAL RULES AND K 1,455 REGULATIONS, SECURITIES ACT OF 1933 17 232 REGULATION S-T—GENERAL K 231 RULES AND REGULATIONS FOR ELECTRONIC FILINGS 17 240.12 Definitions. K 5294 (for all b-2 240) 17 240.13 Requirement of report regarding A p-1 disclosure of registrant's supply chain information regarding conflict minerals. 18 292 REGULATIONS UNDER SECTIONS C 118 201 AND 210 OF THE REGULATORY POLICIES ACT OF 1978 WITH REGARD TO SMALL POWER PRODUCTION AND COGENERATION 19 191 DRAWBACK J 756 20 639 WORKER ADJUSTMENT AND I 69 RETRAINING NOTIFICATION 21 1 GENERAL ENFORCEMENT G 334 REGULATIONS 21 4 REGULATION OF COMBINATION E 7 PRODUCTS 21 11 ELECTRONIC RECORDS; C 45 ELECTRONIC SIGNATURES 21 26 MUTUAL RECOGNITION OF E 111 PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY 21 58 GOOD LABORATORY PRACTICE E 165 FOR NONCLINICAL LABORATORY STUDIES 21 70 COLOR ADDITIVES F 68 21 99 DISSEMINATION OF INFORMATION C 81 ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES 21 100 GENERAL F 58 21 101 FOOD LABELING F 1017

79 21 106 INFANT FORMULA E 408 REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS 21 107 INFANT FORMULA F 100 21 109 UNAVOIDABLE CONTAMINANTS IN FOOD FORF HUMAN 28 CONSUMPTION AND FOOD-PACKAGING MATERIAL

21 110 CURRENT GOOD E 101 MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD 21 111 CURRENT GOOD E 351 MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 21 113 THERMALLY PROCESSED LOW- C 507 ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS 21 117 CURRENT GOOD B MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK- BASED PREVENTIVE CONTROLS FOR HUMAN FOOD 21 118 PRODUCTION, STORAGE, AND C 120 TRANSPORTATION OF SHELL EGGS 21 120 HAZARD ANALYSIS AND CRITICAL CONTROLC POINT 105 (HACCP) SYSTEMS

21 123 FISH AND FISHERY PRODUCTS C 72 21 129 PROCESSING AND BOTTLING OF BOTTLED CDRINKING 76 WATER

21 130 FOOD STANDARDS: GENERAL C 77 21 131 MILK AND CREAM C 132 21 133 CHEESES AND RELATED CHEESE PRODUCTSC 187

21 135 FROZEN DESSERTS C 48 21 136 BAKERY PRODUCTS C 9

80 21 137 AND RELATED C 48 PRODUCTS 21 139 MACARONI AND NOODLE PRODUCTS C 13

21 145 CANNED FRUITS C 285 21 146 CANNED FRUIT JUICES C 90 21 150 FRUIT BUTTERS, JELLIES, C 15 PRESERVES, AND RELATED PRODUCTS 21 152 FRUIT PIES C 5 21 155 CANNED VEGETABLES C 88 21 156 VEGETABLE JUICES C 11 21 158 FROZEN VEGETABLES C 20 21 160 EGGS AND EGG PRODUCTS C 45

21 161 FISH AND SHELLFISH C 55 21 163 CACAO PRODUCTS C 43 21 164 TREE AND PEANUT C 28 PRODUCTS 21 165 BEVERAGES C 88 21 166 MARGARINE C 16 21 168 SWEETENERS AND TABLE SIRUPS C 22 21 169 FOOD DRESSINGS AND C 22 FLAVORINGS 21 170 FOOD ADDITIVES A 90 21 171 FOOD ADDITIVE PETITIONS A 46 21 172 FOOD ADDITIVES PERMITTED FOR A 367 DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 21 173 SECONDARY DIRECT FOOD ADDITIVES PERMITTEDA IN 68 FOOD FOR HUMAN CONSUMPTION

21 174 INDIRECT FOOD ADDITIVES: A 9 GENERAL 21 175 INDIRECT FOOD ADDITIVES: A 58 AND COMPONENTS OF COATINGS 21 176 INDIRECT FOOD ADDITIVES: A 86 PAPER AND PAPERBOARD COMPONENTS 21 177 INDIRECT FOOD ADDITIVES: A 439 POLYMERS 21 178 INDIRECT FOOD ADDITIVES: C 213 ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS 21 179 IRRADIATION IN THE PRODUCTION, PROCESSINGC AND 36

81 HANDLING OF FOOD

21 180 FOOD ADDITIVES PERMITTED IN FOOD OR INA 38 CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

21 181 PRIOR-SANCTIONED FOOD INGREDIENTS A 21

21 182 SUBSTANCES GENERALLY A 5 RECOGNIZED AS SAFE 21 184 DIRECT FOOD SUBSTANCES AFFIRMED AS A 102 GENERALLY RECOGNIZED AS SAFE

21 186 INDIRECT FOOD SUBSTANCES A 3 AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 21 189 SUBSTANCES PROHIBITED FROM USE IN HUMANA 42 FOOD

21 190 DIETARY SUPPLEMENTS A 9 21 201 LABELING F 885 21 202 PRESCRIPTION DRUG L 87 ADVERTISING 21 203 PRESCRIPTION DRUG MARKETING L 82 21 210 CURRENT GOOD E 48 MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 21 211 CURRENT GOOD MANUFACTURING PRACTICEE FOR 374 FINISHED PHARMACEUTICALS

21 212 CURRENT GOOD MANUFACTURING PRACTICEE FOR 124 POSITRON EMISSION TOMOGRAPHY DRUGS

21 225 CURRENT GOOD E 107 MANUFACTURING PRACTICE FOR MEDICATED FEEDS 21 226 CURRENT GOOD MANUFACTURING PRACTICEE FOR 53 TYPE A MEDICATED ARTICLES

21 314 APPLICATIONS FOR FDA M APPROVAL TO MARKET A NEW DRUG 21 328 OVER-THE-COUNTER DRUG C 16 PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

82 21 329 NONPRESCRIPTION HUMAN DRUG E PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 21 330 OVER-THE-COUNTER (OTC) E 78 HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED 21 331 ANTACID PRODUCTS FOR OVER-THE-COUNTERE (OTC) 6 HUMAN USE

21 332 ANTIFLATULENT PRODUCTS FOR E 1 OVER-THE-COUNTER HUMAN USE 21 333 TOPICAL ANTIMICROBIAL DRUG E 4 PRODUCTS FOR OVER-THE- COUNTER HUMAN USE 21 335 ANTIDIARRHEAL DRUG PRODUCTS FOR OVERE -THE- 6 COUNTER HUMAN USE

21 336 ANTIEMETIC DRUG PRODUCTS E 0 FOR OVER-THE-COUNTER HUMAN USE 21 338 NIGHTTIME SLEEP-AID DRUG PRODUCTS FORE OVER- 0 THE-COUNTER HUMAN USE

21 340 STIMULANT DRUG PRODUCTS E 0 FOR OVER-THE-COUNTER HUMAN USE 21 341 COLD, COUGH, ALLERGY, E 36 BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE- COUNTER HUMAN USE 21 343 INTERNAL ANALGESIC, E 13 ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE- COUNTER HUMAN USE 21 344 TOPICAL OTIC DRUG PRODUCTS FOR OVERE- THE- 0 COUNTER HUMAN USE

21 346 ANORECTAL DRUG PRODUCTS E 7 FOR OVER-THE-COUNTER HUMAN USE 21 347 SKIN PROTECTANT DRUG E 20 PRODUCTS FOR OVER-THE- COUNTER HUMAN USE

83 21 348 EXTERNAL ANALGESIC DRUG E 0 PRODUCTS FOR OVER-THE- COUNTER HUMAN USE 21 349 OPHTHALMIC DRUG PRODUCTS E 1 FOR OVER-THE-COUNTER HUMAN USE 21 350 ANTIPERSPIRANT DRUG PRODUCTS FOR OVERE -THE- 2 COUNTER HUMAN USE

21 352 SUNSCREEN DRUG PRODUCTS FOR OVER-ETHE - 62 COUNTER HUMAN USE [STAYED INDEFINITELY]

21 355 ANTICARIES DRUG PRODUCTS FOR OVER-THEE - 19 COUNTER HUMAN USE

21 357 MISCELLANEOUS INTERNAL DRUG PRODUCTSE FOR 5 OVER-THE-COUNTER HUMAN USE

21 358 MISCELLANEOUS EXTERNAL E 8 DRUG PRODUCTS FOR OVER-THE- COUNTER HUMAN USE 21 361 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLYE 28 RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH

21 369 INTERPRETATIVE STATEMENTS E 9 RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE- COUNTER SALE 21 500 GENERAL A 46 21 501 ANIMAL FOOD LABELING F 201 21 502 ANIMAL FOOD LABELING F 21 21 507 CURRENT GOOD E MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK- BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS 21 509 UNAVOIDABLE CONTAMINANTS IN ANIMAL FOODC AND 15 FOOD-PACKAGING MATERIAL

21 510 NEW ANIMAL DRUGS A 50 21 514 NEW ANIMAL DRUG M 172 APPLICATIONS 21 515 MEDICATED FEED MILL LICENSE C 29 21 516 NEW ANIMAL DRUGS FOR MINOR M 138 USE AND MINOR SPECIES 21 520 ORAL DOSAGE FORM NEW C 96 ANIMAL DRUGS

84 21 522 IMPLANTATION OR INJECTABLE DOSAGE FORMC NEW 59 ANIMAL DRUGS

21 524 OPHTHALMIC AND TOPICAL DOSAGE FORMC NEW 6 ANIMAL DRUGS

21 526 INTRAMAMMARY DOSAGE FORM C 31 NEW ANIMAL DRUGS 21 528 NEW ANIMAL DRUGS IN C 0 GENETICALLY ENGINEERED ANIMALS 21 529 CERTAIN OTHER DOSAGE FORM NEW ANIMALC DRUGS 4

21 556 TOLERANCES FOR RESIDUES OF A 18 NEW ANIMAL DRUGS IN FOOD 21 570 FOOD ADDITIVES C 40 21 571 FOOD ADDITIVE PETITIONS C 33 21 579 RADIATION IN THE PRODUCTION, C 0 PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD 21 582 SUBSTANCES GENERALLY C 5 RECOGNIZED AS SAFE 21 584 FOOD SUBSTANCES AFFIRMED AS GENERALLYA 8 RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS

21 589 SUBSTANCES PROHIBITED FROM USE IN ANIMALA 62 FOOD OR FEED

21 600 BIOLOGICAL PRODUCTS: E 198 GENERAL 21 601 LICENSING C 159 21 606 CURRENT GOOD MANUFACTURING PRACTICEE FOR 148 BLOOD AND BLOOD COMPONENTS

21 607 ESTABLISHMENT REGISTRATION C 54 AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS 21 610 GENERAL BIOLOGICAL PRODUCTS E 239 STANDARDS 21 630 REQUIREMENTS FOR BLOOD AND BLOOD E 8 COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE

21 640 ADDITIONAL STANDARDS FOR E 374 HUMAN BLOOD AND BLOOD PRODUCTS 21 660 ADDITIONAL STANDARDS FOR DIAGNOSTICE 191

85 SUBSTANCES FOR LABORATORY TESTS

21 680 ADDITIONAL STANDARDS FOR E 44 MISCELLANEOUS PRODUCTS 21 700 GENERAL C 37 21 701 COSMETIC LABELING F 100 21 740 COSMETIC PRODUCT WARNING F 23 STATEMENTS 21 801 LABELING F 260

21 803 MEDICAL DEVICE REPORTING H 33 21 806 MEDICAL DEVICES; REPORTS OF C 34 CORRECTIONS AND REMOVALS 21 807 ESTABLISHMENT REGISTRATION C 116 AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 21 808 EXEMPTIONS FROM FEDERAL PREEMPTIONC OF STATE31 AND LOCAL MEDICAL DEVICE REQUIREMENTS

21 809 N VITRO DIAGNOSTIC PRODUCTS C 61 FOR HUMAN USE 21 810 MEDICAL DEVICE RECALL H 40 AUTHORITY 21 814 PREMARKET APPROVAL OF MEDICAL DEVICESM 142

21 820 QUALITY SYSTEM REGULATION E 255

21 821 MEDICAL DEVICE TRACKING H 47 REQUIREMENTS 21 822 POSTMARKET SURVEILLANCE H 83 21 830 UNIQUE DEVICE IDENTIFICATION F 58 21 860 MEDICAL DEVICE CLASSIFICATION PROCEDURESC 22

21 861 PROCEDURES FOR C 16 PERFORMANCE STANDARDS DEVELOPMENT 21 862 CLINICAL CHEMISTRY AND C 13 CLINICAL TOXICOLOGY DEVICES 21 864 HEMATOLOGY AND PATHOLOGY DEV C 20

21 866 IMMUNOLOGY AND MICROBIOLOGY DEVICESC 19

21 868 ANESTHESIOLOGY DEVICES C 19 21 870 CARDIOVASCULAR DEVICES C 68 21 872 DENTAL DEVICES C 44 21 874 EAR, NOSE, AND THROAT C 15 DEVICES

86 21 876 GASTROENTEROLOGY-UROLOGY C 39 DEVICES 21 878 GENERAL AND PLASTIC SURGERY C 32 DEVICES 21 880 GENERAL AND PERSONAL USE DEVICESC 21

21 882 NEUROLOGICAL DEVICES C 51 21 884 OBSTETRICAL AND C 73 GYNECOLOGICAL DEVICES 21 886 OPHTHALMIC DEVICES C 35 21 888 ORTHOPEDIC DEVICES C 67 21 890 PHYSICAL MEDICINE DEVICES C 36 21 892 RADIOLOGY DEVICES C 11 21 895 BANNED DEVICES C 25 21 898 PERFORMANCE STANDARD FOR ELECTRODEC LEAD 10 WIRES AND PATIENT CABLES

21 1002 RECORDS AND REPORTS C 57 21 1107 ESTABLISHMENT REGISTRATION, C 4 PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS 21 1140 CIGARETTES AND SMOKELESS L 21 TOBACCO 21 1141 CIGARETTE PACKAGE AND ADVERTISING WARNINGSF 68

21 1150 USER FEES C 21 1230 REGULATIONS UNDER THE F 75 FEDERAL CAUSTIC POISON ACT 21 1301 REGISTRATION OF C 390 MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES 21 1302 LABELING AND PACKAGING F 15 REQUIREMENTS FOR CONTROLLED SUBSTANCES 21 1303 QUOTAS C 89 21 1304 RECORDS AND REPORTS OF REGISTRANTSC 187

21 1309 REGISTRATION OF C 106 MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS 21 1310 RECORDS AND REPORTS OF C 158 LISTED CHEMICALS AND CERTAIN MACHINES

87 21 1315 IMPORTATION AND PRODUCTION C 96 QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE 22 122 REGISTRATION OF C 33 MANUFACTURERS AND EXPORTERS 24 3280 MANUFACTURED HOME C 1629 CONSTRUCTION AND SAFETY STANDARDS 24 3282 MANUFACTURED HOME C 687 PROCEDURAL AND ENFORCEMENT REGULATIONS 24 3285 MODEL MANUFACTURED HOME C 357 INSTALLATION STANDARDS 26 1.11-1 Tax on corporations. J 44,959 (all of 26 CFR 1) 26 1.161- Itemized Deductions for Individuals J 1.199 and Corporations 26 1.301- CORPORATE DISTRIBUTIONS AND J 1.386 ADJUSTMENTS 26 1.401- DEFERRED COMPENSATION, ETC. J 1.436 Pension, Profit-Sharing, Stock Bonus Plans, etc. 26 1.861- TAX BASED ON INCOME FROM J 1.865 SOURCES WITHIN OR WITHOUT THE UNITED STATES 26 1.1361 Small Business Corporations and J - Their Shareholders 1.1378 26 31 EMPLOYMENT TAXES AND J 2,833 COLLECTION OF INCOME TAX AT SOURCE 26 32 TEMPORARY EMPLOYMENT TAX J 3 REGULATIONS UNDER THE ACT OF DECEMBER 29, 1981 (PUB. L. 97-123) 26 35 EMPLOYMENT TAX AND J 225 COLLECTION OF INCOME TAX AT SOURCE REGULATIONS UNDER THE TAX EQUITY AND FISCAL RESPONSIBILITY ACT OF 1982 26 36 CONTRACT COVERAGE OF J 83 EMPLOYEES OF FOREIGN SUBSIDIARIES

88 26 40 EXCISE TAX PROCEDURAL J REGULATIONS 26 46 EXCISE TAX ON CERTAIN J INSURANCE POLICIES, SELF- INSURED HEALTH PLANS, AND OBLIGATIONS NOT IN REGISTERED FORM 26 48 MANUFACTURERS AND J RETAILERS EXCISE TAXES 26 54 PENSION EXCISE TAXES J 232 26 57 HEALTH INSURANCE PROVIDERS J 27 FEE 26 141 TEMPORARY EXCISE TAX J REGULATIONS UNDER THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974 26 143 TEMPORARY EXCISE TAX REGULATIONS UNDERJ THE 3 TAX REFORM ACT OF 1969

26 145 TEMPORARY EXCISE TAX REGULATIONS UNDERJ THE 66 HIGHWAY REVENUE ACT OF 1982 (PUB. L. 97-424)

26 148 CERTAIN EXCISE TAX MATTERS UNDER THEJ EXCISE TAX TECHNICAL CHANGES ACT OF 1958

26 156 EXCISE TAX ON GREENMAIL J 49 26 157 EXCISE TAX ON STRUCTURED J 44 SETTLEMENT FACTORING TRANSACTIONS 27 4 LABELING AND ADVERTISING OF F 278 WINE 27 5 LABELING AND ADVERTISING OF DISTILLEDF SPIRITS 308

27 7 LABELING AND ADVERTISING OF F 161 MALT BEVERAGES 27 13 LABELING PROCEEDINGS F 58

27 16 ALCOHOLIC BEVERAGE HEALTH WARNING F 37 STATEMENT

27 17 DRAWBACK ON TAXPAID J 241 DISTILLED SPIRITS USED IN MANUFACTURING NONBEVERAGE PRODUCTS 27 18 PRODUCTION OF VOLATILE FRUIT- C 61 FLAVOR CONCENTRATE 27 19 DISTILLED SPIRITS PLANTS C 1,446

89 27 20 DISTRIBUTION AND USE OF G 356 DENATURED ALCOHOL AND RUM 27 22 DISTRIBUTION AND USE OF TAX- G 207 FREE ALCOHOL 27 24 WINE C 526

27 25 C 423 27 26 AND ARTICLES FROM C 534 PUERTO RICO AND THE VIRGIN ISLANDS 27 28 EXPORTATION OF ALCOHOL J 447 27 31 ALCOHOL BEVERAGE DEALERS F 236 27 40 MANUFACTURE OF TOBACCO J 724 PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO 27 44 EXPORTATION OF TOBACCO J 384 PRODUCTS AND CIGARETTE PAPERS AND TUBES, WITHOUT PAYMENT OF TAX, OR WITH DRAWBACK OF TAX 27 45 REMOVAL OF TOBACCO F 66 PRODUCTS AND CIGARETTE PAPERS AND TUBES, WITHOUT PAYMENT OF TAX, FOR USE OF THE UNITED STATES 27 46 MISCELLANEOUS REGULATIONS RELATINGJ TO 186 TOBACCO PRODUCTS AND CIGARETTE PAPERS AND TUBES

27 53 MANUFACTURERS EXCISE J 457 TAXES—FIREARMS AND AMMUNITION 29 405 EMPLOYER REPORTS I 29 29 406 REPORTING BY LABOR I 33 RELATIONS CONSULTANTS AND OTHER PERSONS, CERTAIN AGREEMENTS WITH EMPLOYERS 29 516 RECORDS TO BE KEPT BY I 118 EMPLOYERS 29 531 WAGE PAYMENTS UNDER THE I 72 FAIR LABOR STANDARDS ACT OF 1938 29 541 DEFINING AND DELIMITING THE I 69 EXEMPTIONS FOR EXECUTIVE, ADMINISTRATIVE, PROFESSIONAL,

90 COMPUTER AND OUTSIDE SALES EMPLOYEES 29 547 REQUIREMENTS OF A “BONA FIDE I 11 THRIFT OR SAVINGS PLAN” 29 548 AUTHORIZATION OF ESTABLISHED BASIC RATESI FOR 54 COMPUTING OVERTIME PAY

29 549 REQUIREMENTS OF A “BONA FIDE I 4 PROFIT-SHARING PLAN OR TRUST” 29 551 LOCAL DELIVERY DRIVERS AND I 30 HELPERS; WAGE PAYMENT PLANS 29 780 EXEMPTIONS APPLICABLE TO I 177 AGRICULTURE, PROCESSING OF AGRICULTURAL COMMODITIES, AND RELATED SUBJECTS UNDER THE FAIR LABOR STANDARDS ACT 29 785 HOURS WORKED I 60 29 786 MISCELLANEOUS EXEMPTIONS AND EXCLUSIONSI 0 FROM COVERAGE

29 789 GENERAL STATEMENT ON THE I 18 PROVISIONS OF SECTION 12(a) AND SECTION 15(a)(1) OF THE FAIR LABOR STANDARDS ACT OF 1938, RELATING TO WRITTEN ASSURANCES 29 825 THE FAMILY AND MEDICAL LEAVE I 430 ACT OF 1993 29 870 RESTRICTION ON GARNISHMENT I 34 29 1630 REGULATIONS TO IMPLEMENT I 182 THE EQUAL EMPLOYMENT PROVISIONS OF THE AMERICANS WITH DISABILITIES ACT 29 1635 GENETIC INFORMATION I 38 NONDISCRIMINATION ACT OF 2008 29 1904 RECORDING AND REPORTING N 180 OCCUPATIONAL INJURIES AND ILLNESSES 29 1910 OCCUPATIONAL SAFETY AND N 15,759 HEALTH STANDARDS 29 1915 OCCUPATIONAL SAFETY AND HEALTH STANDARDSN 1,185 FOR SHIPYARD EMPLOYMENT

29 1917 MARINE TERMINALS N 1,174

91 29 1918 SAFETY AND HEALTH N 875 REGULATIONS FOR LONGSHORING 29 1926 SAFETY AND HEALTH N 9,045 REGULATIONS FOR CONSTRUCTION 29 1975 COVERAGE OF EMPLOYERS N 9 UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 29 1977 DISCRIMINATION AGAINST EMPLOYEES EXERCISINGI 21 RIGHTS UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970

29 2550 RULES AND REGULATIONS FOR I 365 FIDUCIARY RESPONSIBILITY 29 2590 RULES AND REGULATIONS FOR I 485 GROUP HEALTH PLANS 29 4062 LIABILITY FOR TERMINATION OF I 17 SINGLE-EMPLOYER PLANS 29 4204 VARIANCES FOR SALE OF ASSETS I 28 30 828 SPECIAL PERMANENT PROGRAM C 7 PERFORMANCE STANDARDS— PROCESSING 31 12 RESTRICTION OF SALE AND L 17 DISTRIBUTION OF TOBACCO PRODUCTS 32 507 MANUFACTURE AND SALE OF E 5 DECORATIONS, MEDALS, BADGES, INSIGNIA, COMMERCIAL USE OF HERALDIC DESIGNS AND HERALDIC QUALITY CONTROL PROGRAM 33 159 MARINE SANITATION DEVICES E 199 33 179 DEFECT NOTIFICATION C 20 33 181 MANUFACTURER REQUIREMENTS C 60 33 183 BOATS AND ASSOCIATED C 275 EQUIPMENT 40 59 NATIONAL VOLATILE ORGANIC C 391 COMPOUND EMISSION STANDARDS FOR CONSUMER AND COMMERCIAL PRODUCTS 40 60 STANDARDS OF PERFORMANCE N 14,364 FOR NEW STATIONARY SOURCES

92 40 61 NATIONAL EMISSION STANDARDS N 2,250 FOR HAZARDOUS AIR POLLUTANTS 40 63 NATIONAL EMISSION STANDARDS N 37,984 FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES 40 64 COMPLIANCE ASSURANCE N 120 MONITORING 40 70 STATE OPERATING PERMIT N 463 PROGRAMS 40 71 FEDERAL OPERATING PERMIT C 631 PROGRAMS 40 79 REGISTRATION OF FUELS AND E 1,162 FUEL ADDITIVES 40 80 REGULATION OF FUELS AND FUEL C 5,491 ADDITIVES 40 82 PROTECTION OF STRATOSPHERIC M 1,462 OZONE 40 85 CONTROL OF AIR POLLUTION H 1,087 FROM MOBILE SOURCES 40 86 CONTROL OF EMISSIONS FROM E 6,351 NEW AND IN-USE HIGHWAY VEHICLES AND ENGINES 40 87 CONTROL OF AIR POLLUTION C 67 FROM AIRCRAFT AND AIRCRAFT ENGINES 40 88 CLEAN-FUEL VEHICLES C 272 40 89 CONTROL OF EMISSIONS FROM C 780 NEW AND IN-USE NONROAD COMPRESSION-IGNITION ENGINES 40 90 CONTROL OF EMISSIONS FROM E 799 NONROAD SPARK-IGNITION ENGINES AT OR BELOW 19 KILOWATTS 40 91 CONTROL OF EMISSIONS FROM MARINE SPARKE - 659 IGNITION ENGINES

40 92 CONTROL OF AIR POLLUTION FROM LOCOMOTIVESE 1,142 AND LOCOMOTIVE ENGINES

40 94 CONTROL OF EMISSIONS FROM MARINE E 626 COMPRESSION-IGNITION ENGINES

40 98 MANDATORY GREENHOUSE GAS N 2,765 REPORTING

93 40 122 EPA ADMINISTERED PERMIT N 588 PROGRAMS: THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM 40 125 CRITERIA AND STANDARDS FOR THE NATIONALN 735 POLLUTANT DISCHARGE ELIMINATION SYSTEM

40 127 NPDES ELECTRONIC REPORTING N 40 129 TOXIC POLLUTANT EFFLUENT N 94 STANDARDS 40 131 WATER QUALITY STANDARDS N 293 40 133 SECONDARY TREATMENT N 33 REGULATION 40 155 REGISTRATION STANDARDS AND M 22 REGISTRATION REVIEW 40 156 LABELING REQUIREMENTS FOR F 292 PESTICIDES AND DEVICES 40 157 PACKAGING REQUIREMENTS FOR PESTICIDESF AND 31 DEVICES

40 158 DATA REQUIREMENTS FOR M 857 PESTICIDES 40 160 GOOD LABORATORY PRACTICE STANDARDSE 168

40 165 PESTICIDE MANAGEMENT AND F 260 DISPOSAL 40 167 REGISTRATION OF PESTICIDE C 35 AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS 40 169 AND RECORDS OF C 68 PESTICIDE PRODUCTION AND DISTRIBUTION 40 174 PROCEDURES AND F 9 REQUIREMENTS FOR PLANT- INCORPORATED PROTECTANTS 40 192 HEALTH AND ENVIRONMENTAL N 80 PROTECTION STANDARDS FOR URANIUM AND THORIUM MILL TAILINGS 40 211 PRODUCT NOISE LABELING F 131 40 240 GUIDELINES FOR THE THERMAL N 41 PROCESSING OF SOLID WASTES 40 241 SOLID WASTES USED AS FUELS OR INGREDIENTSN IN 76 COMBUSTION UNITS

94 40 257 CRITERIA FOR CLASSIFICATION N 172 OF SOLID WASTE DISPOSAL FACILITIES AND PRACTICES 40 260 HAZARDOUS WASTE N 192 MANAGEMENT SYSTEM: GENERAL 40 261 IDENTIFICATION AND LISTING OF N 1,792 HAZARDOUS WASTE 40 262 STANDARDS APPLICABLE TO N 448 GENERATORS OF HAZARDOUS WASTE 40 263 STANDARDS APPLICABLE TO G 75 TRANSPORTERS OF HAZARDOUS WASTE 40 264 STANDARDS FOR OWNERS AND OPERATORSN OF 2,484 HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES

40 265 INTERIM STATUS STANDARDS N 2,169 FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES 40 270 EPA ADMINISTERED PERMIT N 622 PROGRAMS: THE HAZARDOUS WASTE PERMIT PROGRAM 40 405 DAIRY PRODUCTS PROCESSING N 120 POINT SOURCE CATEGORY 40 406 GRAIN MILLS POINT SOURCE N 95 CATEGORY 40 407 CANNED AND PRESERVED FRUITS N 153 AND VEGETABLES PROCESSING POINT SOURCE CATEGORY 40 408 CANNED AND PRESERVED N 327 SEAFOOD PROCESSING POINT SOURCE CATEGORY 40 409 SUGAR PROCESSING POINT SOURCE CATEGORYN 72

40 410 TEXTILE MILLS POINT SOURCE N 67 CATEGORY 40 411 MANUFACTURING POINT SOURCEN 18 CATEGORY

40 413 ELECTROPLATING POINT SOURCE CATEGORYN 126

40 414 ORGANIC CHEMICALS, PLASTICS, N 88 AND SYNTHETIC FIBERS

95 40 415 INORGANIC CHEMICALS N 334 MANUFACTURING POINT SOURCE CATEGORY 40 417 AND DETERGENT N 203 MANUFACTURING POINT SOURCE CATEGORY 40 418 MANUFACTURING N 107 POINT SOURCE CATEGORY 40 419 PETROLEUM REFINING POINT SOURCE CATEGORYN 133

40 420 RON AND STEEL N 263 MANUFACTURING POINT SOURCE CATEGORY 40 421 NONFERROUS METALS N 256 MANUFACTURING POINT SOURCE CATEGORY 40 422 PHOSPHATE MANUFACTURING POINT SOURCEN 71 CATEGORY

40 423 STEAM ELECTRIC POWER GENERATING POINTN 58 SOURCE CATEGORY

40 424 FERROALLOY MANUFACTURING N 60 POINT SOURCE CATEGORY 40 425 LEATHER AND N 121 FINISHING POINT SOURCE CATEGORY 40 426 GLASS MANUFACTURING POINT N 133 SOURCE CATEGORY 40 427 ASBESTOS MANUFACTURING POINT SOURCEN 78 CATEGORY

40 428 RUBBER MANUFACTURING POINT SOURCEN 116 CATEGORY

40 429 TIMBER PRODUCTS PROCESSING POINT SOURCEN 128 CATEGORY

40 430 THE , PAPER, AND N 495 PAPERBOARD POINT SOURCE CATEGORY 40 432 MEAT AND POULTRY PRODUCTS POINT SOURCEN 115 CATEGORY

40 433 METAL FINISHING POINT SOURCE CATEGORYN 37

40 436 MINERAL MINING AND N 125 PROCESSING POINT SOURCE CATEGORY

96 40 438 METAL PRODUCTS AND N 10 MACHINERY POINT SOURCE CATEGORY 40 439 PHARMACEUTICAL MANUFACTURING POINTN SOURCE 72 CATEGORY

40 440 ORE MINING AND DRESSING POINT SOURCEN 125 CATEGORY

40 443 EFFLUENT LIMITATIONS N 32 GUIDELINES FOR EXISTING SOURCES AND STANDARDS OF PERFORMANCE AND PRE-TREAT- MENT STANDARDS FOR NEW SOURCES FOR THE PAVING AND ROOFING MATERIALS ( AND ) POINT SOURCE CATEGORY 40 446 PAINT FORMULATING POINT SOURCE CATEGORYN 8

40 447 NK FORMULATING POINT SOURCE N 8 CATEGORY 40 451 CONCENTRATED AQUATIC ANIMAL N 30 PRODUCTION POINT SOURCE CATEGORY 40 454 GUM AND WOOD CHEMICALS MANUFACTURINGN POINT 24 SOURCE CATEGORY

40 455 PESTICIDE CHEMICALS N 100 40 457 MANUFACTURING N 8 POINT SOURCE CATEGORY 40 458 CARBON BLACK MANUFACTURING POINT SOURCEN 28 CATEGORY

40 459 PHOTOGRAPHIC POINT SOURCE CATEGORYN 5

40 461 BATTERY MANUFACTURING POINT SOURCEN 57 CATEGORY

40 463 PLASTICS MOLDING AND POINT SOURCEN 18 CATEGORY

40 464 METAL MOLDING AND CASTING N 157 POINT SOURCE CATEGORY 40 465 COIL COATING POINT SOURCE N 31 CATEGORY 40 466 ENAMELING POINT SOURCE CATEGORYN 34

40 467 ALUMINUM FORMING POINT N 92 SOURCE CATEGORY

97 40 468 COPPER FORMING POINT N 32 SOURCE CATEGORY 40 469 ELECTRICAL AND ELECTRONIC COMPONENTSN POINT 36 SOURCE CATEGORY

40 471 NONFERROUS METALS FORMING N 391 AND METAL POWDERS POINT SOURCE CATEGORY 40 600 FUEL ECONOMY AND GREENHOUSE GAS EXHAUSTC 382 EMISSIONS OF MOTOR VEHICLES

40 610 FUEL ECONOMY RETROFIT C 36 DEVICES 40 712 CHEMICAL INFORMATION RULES A 35 40 747 METALWORKING FLUIDS A 42 40 750 PROCEDURES FOR RULEMAKING UNDER SECTIONC 6 177 OF THE TOXIC SUBSTANCES CONTROL ACT

40 761 POLYCHLORINATED BIPHENYLS C 804 (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS 40 763 ASBESTOS N 474 40 790 PROCEDURES GOVERNING E 164 TESTING CONSENT AGREEMENTS AND TEST RULES 40 792 GOOD LABORATORY PRACTICE E 177 STANDARDS 40 795 PROVISIONAL TEST GUIDELINES E 405 40 796 CHEMICAL FATE TESTING E 59 GUIDELINES 40 797 ENVIRONMENTAL EFFECTS TESTING GUIDELINESE 275

40 798 HEALTH EFFECTS TESTING E 883 GUIDELINES 40 799 IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCEE 1,847 AND MIXTURE TESTING REQUIREMENTS

40 1033 CONTROL OF EMISSIONS FROM E 362 LOCOMOTIVES 40 1036 CONTROL OF EMISSIONS FROM NEW AND INC -USE 131 HEAVY-DUTY HIGHWAY ENGINES

40 1037 CONTROL OF EMISSIONS FROM E 230 NEW HEAVY-DUTY MOTOR VEHICLES

98 40 1039 CONTROL OF EMISSIONS FROM C 322 NEW AND IN-USE NONROAD COMPRESSION-IGNITION ENGINES 40 1042 CONTROL OF EMISSIONS FROM NEW AND INC -USE 360 MARINE COMPRESSION-IGNITION ENGINES AND VESSELS

40 1043 CONTROL OF NOX, SOX, AND PM C 66 EMISSIONS FROM MARINE ENGINES AND VESSELS SUBJECT TO THE MARPOL PROTOCOL 40 1045 CONTROL OF EMISSIONS FROM E 366 SPARK-IGNITION PROPULSION MARINE ENGINES AND VESSELS 40 1048 CONTROL OF EMISSIONS FROM E 256 NEW, LARGE NONROAD SPARK- IGNITION ENGINES 40 1051 CONTROL OF EMISSIONS FROM RECREATIONALC 318 ENGINES AND VEHICLES

40 1054 CONTROL OF EMISSIONS FROM NEW, SMALLC 375 NONROAD SPARK-IGNITION ENGINES AND EQUIPMENT

40 1060 CONTROL OF EVAPORATIVE C 209 EMISSIONS FROM NEW AND IN- USE NONROAD AND STATIONARY EQUIPMENT 40 1065 ENGINE-TESTING PROCEDURES E 425 40 1066 VEHICLE-TESTING PROCEDURES C 154 40 1068 GENERAL COMPLIANCE C 306 PROVISIONS FOR HIGHWAY, STATIONARY, AND NONROAD PROGRAMS 40 1074 PREEMPTION OF STATE C 8 STANDARDS AND PROCEDURES FOR WAIVER OF FEDERAL PREEMPTION FOR NONROAD ENGINES AND NONROAD VEHICLES 41 60-50 GUIDELINES ON DISCRIMINATION I 1,108 (all of BECAUSE OF RELIGION OR Part 60) NATIONAL ORIGIN 41 60-300 AFFIRMATIVE ACTION AND I NONDISCRIMINATION OBLIGATIONS OF FEDERAL CONTRACTORS AND

99 SUBCONTRACTORS REGARDING DISABLED VETERANS, RECENTLY SEPARATED VETERANS, ACTIVE DUTY WARTIME OR CAMPAIGN BADGE VETERANS, AND ARMED FORCES SERVICE MEDAL VETERANS 41 60-741 AFFIRMATIVE ACTION AND I NONDISCRIMINATION OBLIGATIONS OF FEDERAL CONTRACTORS AND SUBCONTRACTORS REGARDING INDIVIDUALS WITH DISABILITIES 41 60-742 PROCEDURES FOR I COMPLAINTS/CHARGES OF EMPLOYMENT DISCRIMINATION BASED ON DISABILITY FILED AGAINST EMPLOYERS HOLDING GOVERNMENT CONTRACTS OR SUBCONTRACTS 42 409 HOSPITAL INSURANCE BENEFITS I 110 42 417 HEALTH MAINTENANCE , I 454 COMPETITIVE MEDICAL PLANS, AND HEALTH CARE PREPAYMENT PLANS

42 422 MEDICARE ADVANTAGE I 938 PROGRAM 42 423 VOLUNTARY MEDICARE PRESCRIPTION DRUGI 630 BENEFIT

42 424 CONDITIONS FOR MEDICARE I 362 PAYMENT 43 2560 OCCUPANCY AND USE A 43 3195 HELIUM CONTRACTS A 38 43 3200 GEOTHERMAL RESOURCE A 73 LEASING 45 46 PROTECTION OF HUMAN M SUBJECTS 45 144 REQUIREMENTS RELATING TO I 25 HEALTH INSURANCE COVERAGE 45 146 REQUIREMENTS FOR THE GROUP HEALTH I 134 INSURANCE MARKET

45 147 HEALTH INSURANCE REFORM I 451 REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS

100 45 148 REQUIREMENTS FOR THE INDIVIDUAL HEALTHI 52 INSURANCE MARKET

45 153 STANDARDS RELATED TO I 185 , RISK CORRIDORS, AND RISK ADJUSTMENT UNDER THE AFFORDABLE CARE ACT 45 154 HEALTH INSURANCE ISSUER RATE I 27 INCREASES: DISCLOSURE AND REVIEW REQUIREMENTS 45 155 EXCHANGE ESTABLISHMENT STANDARDS ANDI 816 OTHER RELATED STANDARDS UNDER THE AFFORDABLE CARE ACT

45 156 HEALTH INSURANCE ISSUER I 354 STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES 45 157 EMPLOYER INTERACTIONS WITH EXCHANGESI AND 5 SHOP PARTICIPATION

45 158 ISSUER USE OF PREMIUM I 210 REVENUE: REPORTING AND REBATE REQUIREMENTS 45 160 GENERAL ADMINISTRATIVE I 140 REQUIREMENTS 45 162 ADMINISTRATIVE REQUIREMENTS I 59 45 164 SECURITY AND PRIVACY I 460 46 52 POWER BOILERS C 200 46 53 HEATING BOILERS C 37 46 54 PRESSURE VESSELS C 347 46 56 PIPING SYSTEMS AND C 1,104 APPURTENANCES 46 57 WELDING AND BRAZING C 108 46 58 MAIN AND AUXILIARY MACHINERY C 412 AND RELATED SYSTEMS 46 61 PERIODIC TESTS AND E 146 INSPECTIONS 46 62 VITAL SYSTEM AUTOMATION C 212 46 63 AUTOMATIC AUXILIARY BOILERS C 103 46 64 MARINE PORTABLE TANKS AND C 78 CARGO HANDLING SYSTEMS 46 67 DOCUMENTATION OF VESSELS G 214 46 128 MARINE ENGINEERING: C 30 EQUIPMENT AND SYSTEMS

101 48 1 FEDERAL ACQUISITION I 113 REGULATIONS SYSTEM 48 3 IMPROPER BUSINESS PRACTICES L 178 AND PERSONAL CONFLICTS OF INTEREST 48 4 ADMINISTRATIVE MATTERS I 215 48 9 CONTRACTOR QUALIFICATIONS I 272

48 17 SPECIAL CONTRACTING I 120 METHODS 48 22 APPLICATION OF LABOR LAWS TO I 500 GOVERNMENT ACQUISITIONS 48 25 FOREIGN ACQUISITION I 118 48 52 SOLICITATION PROVISIONS AND I 4,283 CONTRACT CLAUSES 49 40 PROCEDURES FOR I 1,225 TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS 49 107 HAZARDOUS MATERIALS C 207 PROGRAM PROCEDURES 49 130 OIL SPILL PREVENTION AND N 8 RESPONSE PLANS 49 171 GENERAL INFORMATION, G REGULATIONS, AND DEFINITIONS 49 172 HAZARDOUS MATERIALS TABLE, N 1,346 SPECIAL PROVISIONS, HAZARDOUS MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, TRAINING REQUIREMENTS, AND SECURITY PLANS 49 173 SHIPPERS—GENERAL G 2,515 REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS 49 174 CARRIAGE BY RAIL G 292 49 175 CARRIAGE BY AIRCRAFT G 180 49 176 CARRIAGE BY VESSEL G 665 49 177 CARRIAGE BY PUBLIC HIGHWAY G 238 49 178 SPECIFICATIONS FOR G 3,755 PACKAGINGS 49 179 SPECIFICATIONS FOR TANK CARS G 962 49 180 CONTINUING QUALIFICATION AND MAINTENANCEG OF 746 PACKAGINGS

102 49 191 TRANSPORTATION OF NATURAL G 57 AND OTHER GAS BY PIPELINE; ANNUAL REPORTS, INCIDENT REPORTS, AND SAFETY-RELATED CONDITION REPORTS 49 192 TRANSPORTATION OF NATURAL G 1,216 AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS 49 193 LIQUEFIED NATURAL GAS FACILITIES: FEDERALG 209 SAFETY STANDARDS

49 194 RESPONSE PLANS FOR ONSHORE G 64 OIL PIPELINES 49 195 TRANSPORTATION OF G 570 HAZARDOUS LIQUIDS BY PIPELINE 49 196 PROTECTION OF UNDERGROUND G PIPELINES FROM EXCAVATION ACTIVITY 49 198 REGULATIONS FOR GRANTS TO AID STATEG PIPELINE 28 SAFETY PROGRAMS

49 199 DRUG AND ALCOHOL TESTING G 206 49 210 RAILROAD NOISE EMISSION G 30 COMPLIANCE REGULATIONS 49 232 BRAKE SYSTEM SAFETY G 659 STANDARDS FOR FREIGHT AND OTHER NON-PASSENGER TRAINS AND EQUIPMENT; END-OF-TRAIN DEVICES 49 238 PASSENGER EQUIPMENT SAFETY G 939 STANDARDS 49 325 COMPLIANCE WITH INTERSTATE G 73 MOTOR CARRIER NOISE EMISSION STANDARDS 49 365 RULES GOVERNING G 87 APPLICATIONS FOR OPERATING AUTHORITY 49 366 DESIGNATION OF PROCESS AGENT G 30

49 367 STANDARDS FOR REGISTRATION WITH STATESG 0

49 368 APPLICATION FOR A CERTIFICATE G 25 OF REGISTRATION TO OPERATE IN MUNICIPALITIES IN THE UNITED STATES ON THE UNITED STATES- MEXICO INTERNATIONAL BORDER

103 OR WITHIN THE COMMERCIAL ZONES OF SUCH MUNICIPALITIES. 49 369 REPORTS OF MOTOR CARRIERS G 44 49 373 RECEIPTS AND BILLS G 12 49 375 TRANSPORTATION OF HOUSEHOLD GOODSG IN 601 INTERSTATE COMMERCE; CONSUMER PROTECTION REGULATIONS

49 376 AND INTERCHANGE OF G 112 VEHICLES 49 377 PAYMENT OF TRANSPORTATION G 38 CHARGES 49 379 PRESERVATION OF RECORDS G 24 49 380 SPECIAL TRAINING G 133 REQUIREMENTS 49 382 CONTROLLED SUBSTANCES AND G 218 ALCOHOL USE AND TESTING 49 383 COMMERCIAL DRIVER'S LICENSE G 369 STANDARDS; REQUIREMENTS AND PENALTIES 49 385 SAFETY FITNESS PROCEDURES G 240 49 387 MINIMUM LEVELS OF FINANCIAL G 193 RESPONSIBILITY FOR MOTOR CARRIERS 49 390 FEDERAL MOTOR CARRIER G 253 SAFETY REGULATIONS; GENERAL 49 391 QUALIFICATIONS OF DRIVERS G 235 AND LONGER COMBINATION VEHICLE (LCV) DRIVER INSTRUCTORS 49 392 DRIVING OF COMMERCIAL MOTOR VEHICLESG 104

49 393 PARTS AND ACCESSORIES G 1,050 NECESSARY FOR SAFE OPERATION 49 395 HOURS OF SERVICE OF DRIVERS G 137 49 397 TRANSPORTATION OF HAZARDOUS MATERIALS;G 149 DRIVING AND PARKING RULES

49 399 EMPLOYEE SAFETY AND HEALTH G 23 STANDARDS 49 451 TESTING AND APPROVAL OF G 21 CONTAINERS 49 525 EXEMPTIONS FROM AVERAGE C 8 FUEL ECONOMY STANDARDS

104 49 526 PETITIONS AND PLANS FOR C 7 RELIEF UNDER THE AUTOMOBILE FUEL EFFICIENCY ACT OF 1980 49 529 MANUFACTURERS OF C 26 MULTISTAGE AUTOMOBILES 49 533 LIGHT TRUCK FUEL ECONOMY C 16 STANDARDS 49 534 RIGHTS AND RESPONSIBILITIES OF MANUFACTURERSC 5 IN THE CONTEXT OF CHANGES IN CORPORATE RELATIONSHIPS

49 535 MEDIUM- AND HEAVY-DUTY C 165 VEHICLE FUEL EFFICIENCY PROGRAM 49 536 TRANSFER AND TRADING OF FUEL C 23 ECONOMY 49 537 AUTOMOTIVE FUEL ECONOMY C 70 REPORTS 49 538 MANUFACTURING INCENTIVES FOR ALTERNATIVEC 10 FUEL VEHICLES

49 541 FEDERAL MOTOR VEHICLE THEFT PREVENTIONC 53 STANDARD

49 542 PROCEDURES FOR SELECTING LIGHT DUTYC TRUCK 7 LINES TO BE COVERED BY THE THEFT PREVENTION STANDARD

49 543 EXEMPTION FROM VEHICLE THEFT PREVENTIONC 11 STANDARD

49 545 FEDERAL MOTOR VEHICLE THEFT PREVENTIONC 9 STANDARD PHASE-IN AND SMALL-VOLUME LINE REPORTING REQUIREMENTS

49 555 TEMPORARY EXEMPTION FROM C 39 MOTOR VEHICLE SAFETY AND BUMPER STANDARDS 49 563 EVENT DATA RECORDERS C 28 49 564 REPLACEABLE LIGHT SOURCE AND SEALEDC BEAM 13 HEADLAMP INFORMATION

49 565 VEHICLE IDENTIFICATION C 114 NUMBER (VIN) REQUIREMENTS 49 566 MANUFACTURER IDENTIFICATION C 10

49 567 CERTIFICATION C 112 49 568 VEHICLES MANUFACTURED IN TWO OR MORED 44 STAGES—ALL INCOMPLETE, INTERMEDIATE AND

105 FINAL-STAGE MANUFACTURERS OF VEHICLES MANUFACTURED IN TWO OR MORE STAGES

49 569 REGROOVED TIRES C 13 49 570 VEHICLE IN USE INSPECTION C 150 STANDARDS 49 571 FEDERAL MOTOR VEHICLE C 4,309 SAFETY STANDARDS 49 572 ANTHROPOMORPHIC TEST E 465 DEVICES 49 573 DEFECT AND NONCOMPLIANCE C 161 RESPONSIBILITY AND REPORTS 49 574 TIRE IDENTIFICATION AND C 63 RECORDKEEPING 49 575 CONSUMER INFORMATION L 363 49 576 RECORD RETENTION C 3 49 577 DEFECT AND NONCOMPLIANCE NOTIFICATIONH 137

49 578 CIVIL AND CRIMINAL PENALTIES H 16

49 579 REPORTING OF INFORMATION AND H 177 COMMUNICATIONS ABOUT POTENTIAL DEFECTS

49 580 ODOMETER DISCLOSURE L 83 REQUIREMENTS 49 581 BUMPER STANDARD C 20

49 582 INSURANCE COST INFORMATION C 6 REGULATION 49 583 AUTOMOBILE PARTS CONTENT F 103 LABELING 49 585 PHASE-IN REPORTING C 135 REQUIREMENTS 49 587 DEFORMABLE BARRIERS C 7 49 588 CHILD RESTRAINT SYSTEMS C 4 RECORDKEEPING REQUIREMENTS 49 591 IMPORTATION OF VEHICLES AND A 74 EQUIPMENT SUBJECT TO FEDERAL SAFETY, BUMPER AND THEFT PREVENTION STANDARDS 49 592 REGISTERED IMPORTERS OF VEHICLES NOTA 117 ORIGINALLY MANUFACTURED TO CONFORM TO THE FEDERAL MOTOR VEHICLE SAFETY STANDARDS

49 593 DETERMINATIONS THAT A A 10 VEHICLE NOT ORIGINALLY MANUFACTURED TO CONFORM

106 TO THE FEDERAL MOTOR VEHICLE SAFETY STANDARDS IS ELIGIBLE FOR IMPORTATION 49 594 SCHEDULE OF FEES AUTHORIZED BY 49 U.S.C.C 30141 20

49 595 MAKE INOPERATIVE EXEMPTIONS C 44 49 665 BUS TESTING E 35 50 17 ENDANGERED AND THREATENED A 566 WILDLIFE AND PLANTS 50 222 GENERAL ENDANGERED AND A 157 THREATENED MARINE SPECIES 50 223 THREATENED MARINE AND A 524 ANADROMOUS SPECIES 50 224 ENDANGERED MARINE AND A 20 ANADROMOUS SPECIES 50 402 INTERAGENCY COOPERATION— A 138 ENDANGERED SPECIES ACT OF 1973, AS AMENDED 50 424 LISTING ENDANGERED AND THREATENED SPECIESA 64 AND DESIGNATING CRITICAL HABITAT

107