Federal Register Vol. 81, No.55,

We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.

We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

EASA, which is the aviation authority for Italy, has issued AD No. 2015-0054, dated March 27, 2015, to correct an unsafe condition for Model A109A with retrofit kit part number 109-0820-27-101 installed, and Model A109A II, A109C, A109E, A109K2, A109LUH, A109S, and AW109SP helicopters.

EASA advises that during scheduled maintenance on a Model A109S helicopter, three cracks were found on the drive shaft. An investigation could not determine the cause of the cracking but concluded it could not have been caused by fatigue. This condition, if not detected and corrected, could lead to tail rotor failure, possibly resulting in loss of helicopter control, EASA advises. EASA AD No. 2015-0054 consequently requires a one-time inspection of the drive shaft, and replacing the drive shaft if cracks are found.

These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.

We reviewed AgustaWestland Bollettino Tecnico (BT) No. 109-147 for Model A109A helicopters with retrofit kit P/N 109-0820-27-101 installed, Model A109A II, and Model A109C helicopters; BT No. 109EP-143 for Model A109E helicopters; BT No. 109K-68 for Model A109K2 helicopters; BT No. 109S-067 for Model A109S helicopters; and BT No. 109SP-094 for Model AW109SP helicopters. All of the BTs are dated March 25, 2015. AgustaWestland reports that during a scheduled servicing of an A109S helicopter, three cracks were found on drive shaft P/N 109-8412-02-1. The BTs prescribe a one-time drive shaft inspection for cracks.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This proposed AD would require, within 50 hours time-in-service, visually inspecting the drive shaft for a crack and replacing the drive shaft if it is cracked.

The EASA AD applies to Agusta Model A109LUH helicopters. This proposed AD would not because that model does not have an FAA type certificate.

We consider this proposed AD to be an interim action. The design approval holder has not determined the cause of the unsafe condition identified in this proposed AD. If a cause is determined and actions developed to address the cause, we might consider additional rulemaking.

We estimate that this proposed AD would affect 142 helicopters of U.S. Registry and that labor costs average $85 per work-hour. Based on these estimates, we expect the following costs:

• Inspecting the drive shaft would require 9 work-hours and no parts. The estimated cost would be $765 per helicopter and $108,630 for the U.S. fleet.

• Replacing the drive shaft would not require additional labor hours. Parts would cost $6,082 per helicopter.

According to Agusta service information, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Agusta. Accordingly, we have included all costs in our cost estimate.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 6C0305), submitted by Milton W. Chu, M.D., 5800 Santa Rosa Rd., Suite 111, Camarillo, CA 93012. The petition proposes to amend the color additive regulations in § 73.3126 Titanium dioxide (21 CFR 73.3126) and § 74.3045 [Phthalocyaninato (2-)] copper (21 CFR 74.3045) to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.

We have determined under 21 CFR 25.32(l) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

The Medical Device Amendments of 1976 (Pub. L. 94-295) (the amendments), amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321 et seq.), became law on May 28, 1976. Among other provisions, the amendments added section 516 to the FD&C Act (21 U.S.C. 360f), which authorizes FDA to ban by regulation any device intended for human use if FDA finds, based on all available data and information, that such device presents a “substantial deception” or an “unreasonable and substantial risk of illness or injury,” which cannot be, or has not been, corrected or eliminated by labeling or a change in labeling.

FDA is proposing to ban powdered surgeon's gloves (21 CFR 878.4460), powdered patient examination gloves (21 CFR 880.6250), and absorbable powder for lubricating a surgeon's glove (21 CFR 878.4480). Non-powdered gloves are not included in this ban. In order to clarify this distinction, we are proposing to amend the descriptions of these devices in the regulations to specify that, if the ban were to be finalized, these regulations would apply only to non-powdered gloves. FDA's conclusions, which are discussed in this document, are based on an evaluation of all available data and information known to the Agency. However, to the extent that there is additional information that we should consider regarding the risks and benefits of powdered gloves, comments should be submitted as described previously.

The proposed rule would apply to all powdered gloves except powdered radiographic protection gloves. FDA has determined that the banning standard does not apply to this type of glove. In addition, we are not aware of any powdered radiographic protection gloves that are currently on the market. The proposed ban would not apply to powder used in the manufacturing process (e.g., former-release powder) of non-powdered gloves, where that powder is not intended to be part of the final finished glove. Finished non-powdered gloves are expected to include no more than trace amounts of residual powder from these processes, and the Agency encourages manufacturers to ensure finished non-powdered gloves have as little powder as possible. In our 2008 Medical Glove Guidance Manual (Ref. 1), we recommended that non-powdered gloves have no more than 2 milligrams of residual powder and debris per glove, as determined by the Association for Testing and Materials (ASTM) D6124 test method (Ref. 2). The Agency continues to believe this amount is an appropriate maximum level of residual powder, but may reevaluate this amount if more information becomes available. The proposed ban would also not apply to powder intended for use in or on other medical devices, such as condoms. FDA has not seen evidence that powder intended for use in or on other medical devices, such as condoms, presents the same public health risks as that on powdered medical gloves.

Medical gloves play a significant role in the protection of both patients and health care personnel in the United States. Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.

Various types of powder have been used to lubricate gloves so that wearers could don the gloves more easily. The first lubricant powder used to aid in surgical glove donning, introduced in the late nineteenth century, was composed of Lycopodium spores (club moss spores) or ground pine pollen (Refs. 3 and 4). By the 1930s, Lycopodium powder was recognized to cause wound granulomas and adhesion formation and was replaced by talcum powder (chemically hydrous magnesium silicate), a nonabsorbable lubricant powder. In the 1940s, talcum powder (talc) was also recognized to be a cause of postoperative adhesions and granuloma formation. In 1947, modified cornstarch powder was introduced as an absorbable and non-irritating glove powder, and it largely replaced talc as a donning lubricant for surgical gloves by the 1970s. Cornstarch is currently the most commonly used type of absorbable glove powder.

In the 1980s, preventing the transmission of acquired immunodeficiency syndrome (AIDS) became a major public health concern. The Centers for Disease Control and Prevention (CDC) recommended that health care workers use appropriate barrier precautions to prevent exposure to the human immunodeficiency virus (HIV) and other bloodborne pathogens. Responding to heightened concerns about cross-contamination between patients and health care workers, in the Federal Register of January 13, 1989 (54 FR 1602), FDA revoked the exemption for patient examination gloves from certain current good manufacturing practice requirements in order to ensure that manufacturers provide an acceptable manufacturing quality level. FDA similarly revoked the exemption from premarket notification requirements for patient examination gloves.

On December 12, 1990, FDA published regulations describing certain circumstances under which surgeon's and patient examination gloves would be considered adulterated (55 FR 51254). The regulations established the sampling plans and test methods for glove leakage defects that we would use to determine whether gloves were adulterated (see 21 CFR 800.20). These sampling plans and test methods were further updated in 2006 (December 19, 2006, 71 FR 75865 at 75876). Subsequently, we initiated inspections of glove manufacturers to ensure conformance with the acceptable quality levels identified in the regulation.

In 1997, FDA issued its Medical Glove Powder Report (Ref. 5), which described the risks presented by glove powder and the state of the medical glove market at that time. We reviewed the clinical and experimental data on the risks and adverse events associated with the use of powder on surgical and medical gloves available at that time in the medical literature. We also reviewed the information in our MedWatch database on the adverse events associated with the use of powdered gloves. In addition, the Agency reviewed the commercial information available at that time on sources for medical gloves, relative numbers and types of gloves, and the costs of different glove types. FDA found that glove powder could cause inflammation and granulomas, and that aerosolized glove powder on natural rubber latex (NRL) gloves can carry allergenic proteins that have the potential to cause respiratory allergic reactions.

Even though the Agency was aware of certain health risks presented by glove powder, based on the totality of information available in 1997, the Agency opted not to initiate a ban. At the time, use of chlorination was the most common alternative to powder for the purpose of lubricating NRL surfaces. However, the chlorination process was recognized to cause physical damage to gloves and to alter the physical properties of treated gloves if not performed properly (Ref. 5). In 1997, FDA was concerned that widespread use of glove chlorination would compromise some of the mechanical and physical properties of gloves including shelf life, grip, and in-use durability, since these were widely recognized risks of poorly managed chlorination processes. Polymer coatings to replace glove powder for glove lubrication had been developed but, because of their increased cost, were not yet in widespread use at the time. The report concluded that banning powdered gloves in 1997 would cause a market shortage of medical gloves, which could result in inferior glove products and increased costs to the U.S. health care system due to a lack of immediate availability of suitable alternatives.

We identified two options in 1997: (1) Provide adequate information for the consumer to make an informed decision by, among other things, requiring that the amount of water-soluble NRL proteins and the amount of glove powder present in powdered gloves be stated on the product label and establishing upper limits for the amount of these substances allowed in gloves, or (2) initiate the process to ban glove powder at some predetermined time in the future and require manufacturers to convert to powder-free production or provide safety data, including foreign body and airborne allergen concerns, by a certain date.

At that time, the Agency determined that the first option was preferable and issued the draft guidance entitled “Draft Guidance for Industry and FDA Staff: Medical Glove Guidance Manual” on July 30, 1999 (Ref. 6). In addition to other changes, including the natural rubber latex caution statement for gloves made of NRL, this document advised industry that FDA recognized the newly issued consensus standard ASTM D6124, “Standard Test Method for Residual Powder on Medical Gloves,” which established an accepted method to measure residual powder or debris on medical gloves (Ref. 2). In the draft guidance, we recommended that medical gloves have no more than 2 mg of residual powder or debris per glove in order to label that glove as “powder-free.” Since 1999, gloves with low amounts of residual powder after manufacturing have been referred to as “powder-free” or “powderless.” Such gloves may have residual powder from the manufacturing process removed by washing and chlorination, and they may be coated with a polymer to aid donning. For comparison, powdered medical gloves contain approximately 120 to 400 mg of residual particulates, mold release, and donning powder.

In addition to the draft guidance issued in 1999, in the same issue of the Federal Register, FDA proposed regulations to reclassify all surgeon's and patient examination gloves as class II medical devices (July 30, 1999, 64 FR 41710). While the proposed rule was never finalized, the preamble provided FDA's rationale for choosing not to initiate a ban for powdered surgeon's and patient examination gloves at the time. We explained that: (1) A ban would not address exposure to natural latex allergens from medical gloves with high levels of natural latex proteins; (2) a ban of powdered gloves might compromise the availability of high quality medical gloves; and (3) a ban of powdered gloves might greatly increase annual costs by almost as much as $64 million over the alternative approach proposed by FDA in the “Draft Guidance for Industry and FDA Staff: Medical Glove Guidance Manual.”

FDA did not finalize the 1999 Draft Guidance. The Draft Guidance was withdrawn when we issued our “Guidance for Industry and FDA Staff—Medical Glove Guidance Manual,” on January 22, 2008 (Ref. 1). Recognition and use of ASTM D6124 to reduce the powder burden on medical gloves continued in the revised guidance. Since we issued the draft guidance in 1999, the number of adverse events reported to FDA related to glove use and the number of powdered glove devices seeking premarket clearance have decreased.

FDA has received several citizen petitions regarding the use of glove powder. In 1998, a citizen petition was submitted by Public Citizen requesting that FDA ban the use of cornstarch powder in the manufacture of latex surgeon's and patient examination gloves (see Docket No. FDA-2008-P-0531). While there was scientific evidence in 1998 that indicated that the use of glove powder was associated with negative health consequences (partly due to the ability of glove powder to facilitate sensitization of health care workers to NRL and partly due to adverse effects due only to contact with glove powder), as discussed previously, quality concerns, the lack of suitable alternatives, and costs weighed against FDA initiating the process to remove powdered gloves from the market. Moreover, the impact of reductions in the amount of NRL protein used in gloves and in the amount of powder added to gloves, which were being done as means to mitigate the risk of health care worker sensitization to NRL, had not yet been studied for a reasonable length of time. As a result of these considerations, we did not grant the 1998 petition to ban the use of glove powder.

Approximately a decade later, between 2008 and 2011, FDA received three petitions requesting, among other things, that the Agency ban the use of cornstarch powder on NRL and synthetic latex surgical and examination gloves (FDA-2008-P-0531-0001, FDA-2009-P-0117-0001, and FDA-2011-P-0331-0001). These petitions prompted us to evaluate new data on the risks of using powdered gloves, to consider new information regarding the current availability and costs of alternatives to glove powder for glove lubrication, and to reassess the frequency of use of powdered medical gloves. As a result of these petitions, FDA published in 2011 in the Federal Register a document requesting comments related to the risks and benefits of powdered gloves (February 7, 2011, 76 FR 6684; FDA-2011-N-0027). In addition, although we believed that additional labeling would not correct or eliminate the risks associated with glove powder, we decided that it was important to inform consumers about the risks of powdered gloves while FDA assessed whether glove powder had benefits that might affect the determination of whether or not a ban on the devices was appropriate at this time. Accordingly, on February 7, 2011, FDA issued the draft guidance entitled “Draft Guidance for Industry and FDA Staff: Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder,” which proposed a general voluntary warning for powdered glove devices, regardless of whether the devices were surgeon's gloves or patient examination gloves (Ref. 7). As we reviewed the comments received on the benefits and risks of glove powder, we determined that a ban on powdered gloves is appropriate and determined not to finalize the draft guidance. This draft guidance was withdrawn on May 6, 2015 (80 FR 26059) as part of a mass withdrawal effort to remove draft guidance documents issued before 2014 that have not been finalized. When final, this rule will address the risks of powdered gloves that were addressed in the draft guidance.

FDA is proposing to ban the following devices: (1) Powdered surgeon's gloves (21 CFR 878.4460), (2) powdered patient examination gloves (21 CFR 880.6250), and (3) absorbable powder for lubricating a surgeon's glove (21 CFR 878.4480).

Because the classification regulations for these device types do not distinguish between powdered and non-powdered versions, FDA is proposing to amend the descriptions of these devices in the regulations to specify that, if this proposed ban is finalized, these regulations will apply only to non-powdered gloves while the powdered version of each type of glove will be added to 21 CFR 895 Subpart B—Listing of Banned Devices.

Section 516(a)(1) of the FD&C Act authorizes FDA to ban a device intended for human use by regulation if it finds, on the basis of all available data and information, that such a device “presents substantial deception or an unreasonable and substantial risk of illness or injury.” A banned device is adulterated under section 501(g) of the FD&C Act (21 U.S.C. 351(g)).

In determining whether a deception or risk of illness or injury is “substantial,” FDA will consider whether the risk posed by the continued marketing of the device, or continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued marketing (see 21 CFR 895.21(a)(1)). Although FDA's device banning regulations do not define “unreasonable risk,” in the preamble to the final rule promulgating 21 CFR part 895, we explained that, with respect to “unreasonable risk,” it “will conduct a careful analysis of risks associated with the use of the device relative to the state of the art and the potential hazard to patients and users” (44 FR 29214 at 29215, May 18, 1979). The state of the art with respect to this proposed rule relates to current technical and scientific knowledge and medical practice as it pertains to the various medical gloves that are used when treating patients.

Thus, in determining whether a device presents an “unreasonable and substantial risk of illness or injury,” FDA analyzes the risks and the benefits the device poses to patients and, in the case of powdered gloves, other individuals who come in contact with these devices, by comparing those risks and benefits to the risks and benefits posed by alternative devices and/or treatments being used in current medical practice. Actual proof of illness or injury is not required; we need only find that a device presents the requisite degree of risk on the basis of all available data and information (H. Rep. 94-853 at 19; 44 FR 29215).

Whenever FDA finds, on the basis of all available data and information, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury, and that such deception or risk cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, FDA may initiate a proceeding to ban the device (see 21 CFR 895.20). If FDA determines that the risk can be corrected through labeling, FDA will notify the responsible person of the required labeling or change in labeling necessary to eliminate or correct such risk (see 21 CFR 895.25).

Section 895.21(d) requires this proposed rule to summarize: (1) The Agency's findings regarding substantial deception or the unreasonable and substantial risk of illness or injury; (2) the reasons why FDA initiated the proceeding; (3) the evaluation of the data and information FDA obtained under provisions (other than section 516) of the FD&C Act, as well as information submitted by the device manufacturer, distributer, or importer, or any other interested party; (4) the consultation with the classification panel; (5) the determination that labeling, or a change in labeling, cannot correct or eliminate the deception or risk; (6) the determination of whether, and the reasons why, the ban should apply to devices already in commercial distribution, sold to ultimate users, or both; and (7) any other data and information that FDA believes are pertinent to the proceeding.

We have grouped some of these together within broader categories and address them in the following order:

• Evaluation of data and information regarding glove powder, including data and information FDA obtained under provisions other than section 516 of the FD&C Act, information submitted by the device manufacturer and other interested parties, the consultation with the classification panel, and other data and information that FDA believes are pertinent to the proceeding, with respect to:

• The reasons FDA initiated the proceeding, our determination that glove powder presents an unreasonable and substantial risk of illness or injury (FDA has not made a finding regarding substantial deception);

• FDA's determination that labeling, or a change in labeling, cannot correct or eliminate the risk; and

• FDA's determination that the ban applies to devices already in commercial distribution and sold to ultimate users, and the reasons for this determination.

A thorough review of the information that has become available since FDA issued the Medical Glove Powder Report in 1997 (Ref. 5) supports FDA's conclusion that powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove should be banned. As discussed in the paragraphs that follow, FDA has concluded that the risks posed by powdered gloves, including health care worker and patient sensitization to NRL allergens, surgical complications related to peritoneal adhesions, and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder, outweigh the benefits that these devices pose to patients. FDA's position is bolstered when the state of the art for medical gloves is considered, which includes viable non-powdered alternatives that do not carry any of the risks associated with glove powder. Further, unlike when this decision was considered previously, FDA believes that this ban would likely have minimal economic and shortage impact on the health care industry. Thus, a transition to alternatives in the marketplace should not result in any detriment to public health.

In reaching the conclusions that form the basis for this proposed rule, FDA considered evidence from multiple sources. FDA re-examined the 1997 Report on Medical Glove Powder (Ref. 5) along with its scientific and clinical literature references, its analysis of reported adverse events due to the use of gloves, and its analysis of glove market availability (Ref. 5). In addition, we performed a more contemporary analysis of relevant scientific literature and of adverse events related to medical glove use from 1992 through 2014 and obtained new market availability data on medical glove use by type. We also reviewed the information contained in related citizen petitions, as well as the comments associated with the petitions. Further, the Agency reviewed the public statements and actions of other U.S. government Agencies, U.S. health care organizations, and of foreign governments concerning powdered natural rubber latex gloves.

The sections that follow discuss the information that FDA evaluated as part of the decision to propose this ban. Sections II.A and II.B provide a concise summary of the benefits and risks that FDA believes are posed by the use of powdered gloves. Section II.C provides a discussion on the state of the art as it pertains to medical gloves. Sections II.D, II.E, and II.F provide detailed discussions of the scientific literature, actions of other regulatory and professional organizations, and adverse event reports that formed the basis of the summaries in sections II.A and II.B.

To help determine whether powdered gloves present an unreasonable and substantial risk of illness or injury, FDA issued a notice in the Federal Register requesting public input on the risks and benefits of powdered gloves (February 7, 2011, 76 FR 6684; FDA-2011-N-0027). FDA received nearly 300 comments to the docket, the large majority of which addressed the continuing risks associated with the use of powdered gloves, which are discussed later in this document. Comparatively, very few comments addressed the benefits of gloves that are powdered, and the benefits that were addressed were minimal. The primary benefits described in the comments were almost entirely related to greater ease of donning and doffing gloves and decreased tackiness of gloves packaged together. These benefits apply to both powdered surgeon's gloves and powdered patient examination gloves. The benefits of absorbable powder for lubricating a surgeon's glove derive from the benefits of powdered surgeon's gloves, which include ease of donning and doffing gloves and decreased tackiness.

Some studies have reported that alternatives to powdered gloves, such as vinyl gloves, may not provide as good of dexterity and biological impermeability as NRL gloves (Ref. 8). However, this proposed ban does not include non-powdered NRL gloves, which offer the same performance characteristics of powdered NRL gloves, and several studies have found that alternatives, such as nitrile and neoprene gloves, offer the same level of protection, dexterity, and performance as NRL gloves (Ref. 9 to 14). Thus, the only benefits to using powdered gloves that FDA has been able to identify is a greater ease of donning and doffing and decreased tackiness of gloves packaged together.

Although some risks of these devices are similar for all glove types, the level and types of risks presented by powdered gloves can vary depending on the composition of the glove (synthetic versus NRL) and its indicated uses (surgeon's glove versus patient examination glove). While we acknowledge that powdered synthetic patient examination gloves present less risk than powdered NRL surgeon's gloves, we concluded that the risks posed by either of these glove types is unreasonable and substantial in relation to the minimal benefits that powdered gloves offer, especially when considering the benefits and risks posed by readily available alternative devices (discussed in section II.C). The identified risks of powdered gloves are as follows:

The powder used for lubricating a surgeon's glove, which is often used to lubricate patient examination gloves as well, presents risks not only to the user and patient, but also to other individuals that might be exposed to it. This powder, often referred to as Absorbable Dusting Powder or ADP, has been shown to cause acute severe airway inflammation, granulomas, and adhesions. These risks are present before the glove is lubricated with the powder. Then, during the lubrication process, the powder particles may absorb harmful contaminants (Ref. 15). As mentioned previously, the risks presented by glove powder can vary depending on the type of glove on which it is used. When used on NRL gloves, powder has the ability to adhere to latex allergenic proteins that, when aerosolized and inhaled, present significant risks to patients, including inflammatory responses, hypersensitivity reactions, and allergic reactions (see risks on powdered NRL gloves in the paragraphs that follow). Additionally, latex sensitive individuals can experience cutaneous reactions upon skin exposure to the latex allergenic proteins adherent to the powder (Refs. 15 and 16). These consequences of powder may persist even after patients or health care workers are no longer in contact with the powder. Risks such as allergic reactions, granulomas, and adhesions can be long-lasting, and may not be mitigated by removing powder after exposure (Refs 17 to 19).

When absorbable dusting powder is used on NRL gloves, the combination presents specific risks that apply to both surgeon's and patient examination gloves. The powder used to lubricate these gloves may bind to natural rubber latex proteins. The powder carries the latex protein, resulting in a latex aerosol whenever health care workers put on or remove the gloves. Clinical and laboratory studies indicate that glove powder facilitates impaired respiratory function due to allergic and inflammatory responses to NRL in health care personnel and in animals exposed to glove powder because aerosolized powder particles carrying NRL antigens into the health care environment and the respiratory tracts of exposed health care personnel and patients make NRL sensitization a much more efficient process than it would be in the absence of glove powder (Ref. 8, 20 to 23). As a result, health care workers that are sensitive to latex occasionally develop allergic reactions when they inhale too much powder. Sensitization to latex and subsequent allergic reactions also may result from exposure to aerosolized powder carrying the NRL proteins (Ref. 24). Allergic reactions include asthma, allergic rhinitis, conjunctivitis, and dyspnea. As discussed in the paragraphs that follow, the majority of studies suggest that use of low NRL protein powder-free gloves significantly reduces occupational asthma and the incidence of individuals developing allergies to NRL in the health care workplace (Refs. 21, 23, 25 to 35).

Although powdered synthetic surgeon's gloves do not present the risk of allergic reactions due to aerosolized powder that is carrying latex, the use of powdered synthetic gloves still presents the risk of exposing individuals to the powder via inhalation, which can lead to airway inflammation. Additionally, use of these gloves by health care providers can expose patients' tissues during surgery and invasive examinations to deposits of glove powder, which could then result in granuloma formation in any exposed site, as well as peritoneal and other tissues adhesions. Recent studies show that cornstarch glove powder causes peritoneal adhesion formation and granulomatous reactions in experimental animal models (Refs. 24, 36 to 39) as well as in exposed patient tissues with resulting patient injury (Refs. 40 and 41). In addition to risk of powder-induced adhesion formation, many in vitro and animal studies have shown the adverse effects of glove powder on wound healing, including increases in wound inflammation (Refs. 42 to 44). These studies indicate that powder may promote infection in wounds, which can lead to wound healing complications.

Although the powder on patient examination gloves is not exposed to internal organs during surgery, these gloves still present a substantial risk of illness or injury because they are nevertheless exposed to internal tissue when employed in procedures such as oral, vaginal, gynecological, and rectal examinations. Powder may be introduced to the female reproductive tract during gynecological exams (Refs. 45 to 47), which may lead to female reproductive complications (Refs. 18, 48 to 50). The migration of powder into the reproductive tract was demonstrated in an animal model and human clinical studies (Refs. 21, 40, 51). The wearers of these gloves can also facilitate the migration of powder from these gloves into the body when handling instruments such as endoscopes or when performing postsurgical wound care. Thus, the powder on synthetic patient exam gloves presents risks similar to those of the powder on synthetic surgeon's gloves, including granulomas and adhesions, and the resulting complications. Finally, as with synthetic surgeon's gloves, powdered patient examination gloves also can expose those in their proximity to the risk of powder inhalation, even if not carrying NRL.

FDA has considered the reasonableness of the risks of powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's gloves relative to the state of the art, i.e., the state of technical and scientific knowledge and modern practices of medicine, for medical protective gloves (see 44 FR 29214; May 18, 1979). Given that alternatives are readily available that do not carry the risks posed by powdered gloves, we have concluded that powdered gloves now lag behind the state of the art. As discussed further in sections II.D and II.E, this conclusion is illustrated both by market trends indicating that the health care industry is moving to non-powdered alternatives and by the actions of certain regulatory entities and professional organizations that have banned or restricted the use of glove powder.

Over the last two decades FDA has observed a progressive increase in the use of non-powdered gloves. Since 1998, medical glove manufacturers have developed a variety of non-powdered gloves, which can be made from various materials, including NRL, polyvinyl chloride, nitrile, and neoprene. Both non-powdered patient examination and non-powdered surgeon's gloves are currently marketed. These alternatives are readily available at similar costs to powdered gloves. As a result, both industry and glove users appear to be shifting away from the use of powdered gloves, which has led to an increase in the manufacturing and usage of alternative non-powdered gloves. Annual sales figures from 2000 through 2008 indicate a consistent increase in non-powdered surgeon's and patient examination glove sales as a percent of total glove sales, and recent projections of annual gloves sales indicate that at least 93 percent of medical providers have switched to non-powdered gloves (Ref. 52).

These trends can be at least partially attributed to scientific studies that have been conducted in this area that have helped raise public awareness of powder-induced latex hypersensitivity, peritoneal adhesions, granulomas, and other adverse events that can result from using powdered gloves. These trends can also be partially attributed to increased public awareness resulting from the availability of studies that have examined the effects of glove powder and the public health benefits that result from its removal from the market, along with industry initiatives to improve donning, doffing, and protection of non-powdered gloves, which have helped to move the state of the art forward to the use of alternative non-powdered gloves.

As described previously, some users of powdered gloves have noted ease of donning or doffing as a benefit over non-powdered gloves. However, a study of various brands of powdered and non-powdered NRL gloves by Cote et al. found that there are non-powdered latex gloves that are easily donned with wet or dry hands with relatively low force compared to the forces required to don powdered latex examination gloves (Ref. 53). Additional non-powdered alternatives to powdered gloves include synthetic gloves, which are traditionally non-powdered and offer similar levels of performance to powdered gloves and non-powdered NRL gloves (Refs. 9, 14, 54).

Studies that have examined the effects of removing powdered gloves from health care environments have shown that removing these devices consistently results in a reduction of the types of adverse events associated with glove powder. Korniewicz et al. examined the effect of conversion from powdered NRL surgical gloves to non-powdered NRL surgical gloves on operating room personnel (Ref. 32). This study found that conversion to non-powdered NRL gloves reduced adverse events related to exposure to NRL, including a significant decrease in skin and upper respiratory symptoms. During the course of the study, the authors also evaluated user satisfaction for non-powdered gloves and found that users rated their satisfaction, on average, the same or better than before conversion from powdered gloves to non-powdered gloves in categories including quality, comfort, safety, performance, standardization, and needle stick injuries.

In another study on the effects of eliminating powdered NRL gloves from a hospital, Allmers et al. found that eliminating powdered NRL gloves reduced aerogenic NRL allergen loads and allowed latex-sensitized or latex-allergic health care workers to continue working (Ref. 25). Allmers et al. further assessed the effects of switching to non-powdered NRL gloves on the incidence of NRL allergy in personnel working in multiple health care facilities insured by the German Professional Association for Health Services and Welfare (Ref. 27). This study concluded that there was a significant correlation between an increase in the purchase of non-powdered NRL gloves and a decline in NRL-induced occupational asthma. In a subsequent study, Allmers et al. further showed that a reduction in the use of powdered NRL gloves correlated with a dramatic decline in reported NRL-induced occupational skin disease (Ref. 26). The authors of these studies concluded that removing powdered NRL gloves from health care environments successfully reduced the development of NRL-induced allergies. These observations have been confirmed by several other studies that are described further in section II.D (Refs. 21, 30, 32 to 35, 55).

FDA also expects that the removal of powdered gloves from health care environments will reduce the risks of using powdered synthetic gloves, such as granuloma formation in any exposed site, as well as peritoneal and other tissues adhesions. As discussed previously, recent literature has shown that cornstarch glove powder causes peritoneal adhesion formation and granulomatous reactions in experimental animal models (Refs. 24, 36 to 39) as well as in exposed patient tissues with resulting patient injury (Refs. 40 and 41). In addition to risk of powder-induced adhesion formation, many in vitro and animal studies have shown the adverse effects of glove powder on wound healing, including increases in wound inflammation (Refs. 42 to 44). Non-powdered gloves do not carry these risks, and their exclusive use should greatly reduce the risk of these adverse health effects in health care settings.

In comparison to the evidence considered in 1997, FDA has concluded that this proposed ban would likely have minimal economic and shortage impact on the health care industry, such that, if they have not already, health care entities that currently use powdered gloves should have little trouble transitioning to non-powdered alternatives. As described previously, there are many readily available alternatives to powdered gloves that provide similar or better protection and utility without the risks associated with powdered gloves, and available market projections and data have shown that these alternatives that represent the state of the art have already resulted in a shift away from powdered gloves. Further, more studies are now available on the positive health benefits associated with the restriction or elimination of the use of powdered gloves in health care environments where they were previously prevalent. Based on an examination of all these factors, FDA has determined that the state of the art, i.e., the state of technical and scientific knowledge and modern practices of medicine, has moved beyond the use of powdered gloves in the health care industry.

In 1997, FDA issued the Medical Glove Powder Report (Ref. 5), discussing the potential adverse health effects of medical glove powder, along with alternatives and market information available at that time. Adverse health events documented in the scientific literature review section of the Medical Glove Powder Report included a discussion on aerosolized glove powder on NRL gloves carrying allergenic proteins that efficiently sensitized health care providers to NRL antigens. This exposure subsequently triggered respiratory allergic reactions including asthma and allergic rhinitis, conjunctivitis, and dyspnea. In addition, as discussed previously, the powdered gloves of health care providers expose patients to certain risks, including granuloma formation, as well as peritoneal and other tissue adhesions when exposed during surgery or an invasive procedure.

Since the publication of the Medical Glove Powder Report, there have been additional scientific studies published regarding the risks related to the use of medical glove powder. Many of these references were submitted to the Agency in support of the petitions received in 2008, 2009, and 2011. We also performed our own review of the scientific literature to ensure that all available evidence, including all available scientific evidence, was considered in its decision-making process. The most relevant articles gathered from these sources are briefly summarized in this document.

Clinical and laboratory studies published after 1998 still indicate that glove powder facilitates impaired respiratory function due to allergic and inflammatory responses to NRL in health care personnel and in animals exposed to glove powder because aerosolized powder particles carrying NRL antigens into the health care environment and the respiratory tracts of exposed health care personnel and patients make NRL sensitization a much more efficient process than it would be in the absence of glove powder (Refs. 8, 20 to 23). The newer studies also continue to show that cornstarch glove powder causes adhesion formation and granulomatous reactions in experimental animal models (Refs. 24, 36 to 39), as well as in exposed patient tissues with resulting patient injury (Refs. 40 and 41).

In vitro and animal studies continue to show the adverse effects of glove powder on experimental wound healing, including increases in wound inflammation (Refs. 42 to 44). Most importantly, since 1997, more data have become available on the positive health benefits associated with the restriction or elimination of the use of powdered gloves in health care environments where they were previously permitted. We reviewed studies from clinics and hospitals that have converted to either non-powdered NRL gloves or to powder-free gloves of all materials. These studies reported reductions in NRL allergy development and respiratory symptoms among health care workers (Refs. 20, 21, 23, 25 to 27, 29 to 34, 39). Although this has not been a universal finding, FDA recognizes the positive association between decreased usage of glove powder, especially on NRL gloves, and decreased adverse health events in the health care setting.

Epidemiological studies comparing the adverse health events and economic consequences in health care settings before and after conversion to powder-free gloves have limitations, such as the size of studies, the endpoint data collected, and the different populations studied. Some studies include the period before the amount of NRL protein in surgical and examination gloves was reduced. Others were performed abroad where U.S. regulations do not apply and the amounts of NRL protein and powder remaining on gloves are not stated. Despite these limitations, the preponderance of evidence suggests that use of low NRL protein powder-free gloves significantly reduces occupational asthma and the incidence of individuals developing allergies to NRL in the health care workplace (Refs. 20, 21, 23, 25 to 27, 29 to 34, 39). Importantly, these studies did not report difficulty in replacing powdered gloves with non-powdered ones and did not note any decrease in glove performance in the replacement gloves (Refs. 32, 53).

Charous et al. (Ref. 20) reported in 2000 that a dental office was able to reduce airborne NRL antigen levels to undetectable levels with the exclusive use of non-powdered NRL gloves, permitting a highly sensitized staff member to continue to work there. Also in 2002, Kujala et al. (Ref. 22) studied NRL gloves agitated in laboratory test chambers and found that the concentration of airborne NRL allergens correlated with high levels of airborne glove powder rather than with the NRL antigen concentrations in the medical glove material. In addition, Ahmed et al. (Ref. 8) reviewed the literature to 2004 on occupational NRL allergy and concluded that the use of low NRL protein powder-free gloves reduced symptoms and markers of sensitization in hospitals that had removed powdered NRL gloves from their workplaces; however, they noted that alternatives such as nitrile and vinyl gloves may not provide as good dexterity and biological impermeability as natural rubber latex gloves. The practicality of using non-powdered gloves was studied in 1998 by Cote et al. (Ref. 53) who performed a prospective randomized trial measuring the force required for volunteers to don various gloves in the laboratory without tearing the glove. They concluded that there were available powder-free gloves that can be donned easily with forces that are comparable to those required for powdered glove donning.

Individual hospitals, health care systems, regional authorities and countries have evaluated the extent of NRL allergies among their staff and the effects of removing glove powder from the gloves used in their facilities. In 1998, Handfield-Jones (Ref. 56) found that at least 0.9 percent of health care workers in an English district general hospital had confirmable NRL allergies. Anecdotal accounts suggested that problems had worsened as glove use increased. Allmers et al. (Ref. 25) in 1998 reported a prospective study in a single hospital in Germany to evaluate the effect of eliminating powdered NRL gloves from the workplace and also giving NRL-free gloves to sensitized workers. Six of seven sensitized health care workers showed a decrease in NRL-specific Immunoglobulin E antibody concentration during followup after the elimination of powdered NRL gloves in that hospital. Two other health care workers were able to stop using asthma medication and antiallergic drugs. The study authors concluded that eliminating powdered NRL gloves reduced aerogenic NRL allergen loads and allowed sensitized or allergic health care workers to continue working.

Not every physician or locality was equally concerned about the risk associated with the use of glove powder. In 1999, Sellar and Sparrow (Ref. 57) surveyed ophthalmologists in northern England and found that, despite relatively high awareness of risks associated with powdered glove use during ophthalmic surgery, such as sterile endophthalmitis or iritis in patients, up to 15 percent of surveyed United Kingdom ophthalmic surgeons were using powdered gloves in their surgical practices. However, in 2000, Petsonk (Ref. 58) found that the role of glove powder in binding and transferring NRL antigens was widely acknowledged in the scientific literature and noted that interventions, such as limiting the use of glove powder, seemed likely to result in a decline in the prevalence of NRL allergies. Additionally, in 2000, Jackson et al. (Ref. 31) reported that 70 hospitals in the United States and 3 in Europe had registered on an Internet Web site as institutions using only powder-free gloves; however, the article did not specify whether these hospitals had removed only NRL powdered gloves from their workplaces or whether synthetic latex powdered gloves were removed from use as well, and the Web site is no longer registered. The conclusion of Jackson et al. was that the leadership shown by the hospitals that registered as not using powdered gloves should serve as a catalyst for FDA to ban the use of cornstarch on examination and surgical gloves.

In 2001, Liss and Tarlo (Ref. 33) reviewed the number of allowed occupational asthma claims in health care workers reported to the Ontario Workplace Safety and Insurance Board over time as the replacement use of powder-free synthetic latex or low protein NRL gloves was encouraged, starting in 1996, throughout the province of Ontario. Reported health care-related occupational asthma claims ranged from 7 to 11 per year during 1991 to 1994 and fell to 1 to 2 claims per year in 1997 to 1999 as exposure to powdered NRL gloves decreased. Tarlo et al. (Ref. 55) also reported on the experience with occupational allergy to NRL in an Ontario teaching hospital network of two hospitals. In this hospital system, the number of workers identified with NRL allergy each year rose from 1 in 1988 to 6 in 1993 and to 25 in 1994 after staff education and surveillance for the manifestations of NRL allergy. Powder-free, low protein NRL gloves replaced non-sterile gloves in 1995 in this hospital system, after which new workers with reported NRL allergy dropped to eight in 1995, to three in 1997 and to one in 1999. NRL allergy-related time lost from work and workers' compensation claims fell significantly after powder-free, low protein NRL gloves replaced powdered non-sterile gloves in this Ontario hospital system. In 2002, Saary et al. (Ref. 23) resurveyed the upper-year students and faculty of a dental school in Ontario for NRL allergy using the same methods as those used in the study performed by Tarlo et al. (Ref. 55). In 1995, the school was using powdered NRL gloves in patient care. Following the 1995 survey, the school changed to powder-free, low protein NRL gloves. In 2000, the incidence of positive prick tests to NRL fell from 10 percent (in 1995) to 3 percent and there were significant reductions in the incidence of urticaria and immediate pruritus after glove contact reported by the dental students.

Allmers et al. (Ref. 27) reported in 2002 occupational allergy to NRL data from the German Professional Association for Health Services and Welfare, which covered approximately half of all German hospitals and all dental offices. In 1998, Germany banned the use of powdered NRL gloves in health care facilities. From 1996 through 2001, the incidence of suspected occupational NRL allergy declined steadily as the use of powder-free NRL examination gloves and powder-free NRL sterile gloves overtook the use of powdered gloves in 1998 and 2000, respectively, in German acute care hospitals. The authors concluded that primary prevention of occupational NRL allergies could be achieved through practical interventions such as decreasing the use of powdered NRL gloves. Allmers et al. (Ref. 26) reassessed the effects of the 1998 German ban on powdered NRL gloves in 2004 and found that between 1996 and 2002, the incidence of suspected cases of NRL-induced occupational allergies reported to the German statutory accident insurance carrier decreased by almost 80 percent.

Charous et al. (Ref. 28) reviewed the scientific literature available in 2002 and subsequently recommended using only non-powdered sterile NRL gloves or low-protein NRL powdered sterile gloves as evaluation of the effect on occupational NRL allergic reactions continued, in order to reduce the burden of NRL allergy and its effects on health care personnel. Cuming (Ref. 29) also noted that the link between glove powder and the occurrence of NRL allergies and postoperative complications in surgical patients was well supported scientifically and described how his four hospital system (not identified) with multiple ambulatory care centers and associated medical practices successfully eliminated powdered glove use after appropriate alternate glove product evaluation.

Edelstam and colleagues (Ref. 21) described the implementation of a powder-free environment in a Stockholm hospital. These authors administered symptom questionnaires to hospital staff designed to detect symptoms highly suggestive of occupational NRL allergy. They found that 8 months after a powder-free policy was fully implemented in the hospital there was a significant reduction in reported hand itching, eczema, and upper respiratory tract disorders in health care workers. The authors also noted that reduced costs associated with lower work absence rates may offset higher costs associated with the use of powder-free medical gloves.

In 2005, Korniewicz et al. (Ref. 32) examined whether switching to low NRL protein powder-free surgical gloves in the operating room suite of a single U.S. university hospital was worth the cost. Surveys prior to and 7 to 12 months after the conversion to powder-free surgical gloves found that 27 percent fewer health care workers reported skin symptoms and 12 percent fewer health care works reported upper respiratory symptoms related to NRL exposure. These authors concluded that the use of powder-free low protein NRL gloves reduced symptoms and resulted in workers compensation cost savings. In addition, because fewer different types of gloves were purchased after the conversion to non-powdered surgical gloves, a glove cost savings of $10,000 per year was estimated for the hospital. In a 2006 report, Filon and Radman (Ref. 30) described the results of following 1,040 health care workers in Trieste for 3 years before and after the introduction of powder-free gloves with low NRL levels. After the introduction of powder-free gloves, no new cases of NRL allergy, as diagnosed by skin test hypersensitivity to NRL were identified in the followup survey. The authors concluded that avoiding unnecessary NRL glove use and using non-powdered NRL gloves (and non-NRL gloves for sensitized health care workers) could stop the progression of symptoms of NRL allergy and avoid new cases of health care provider sensitization to NRL.

In 2008, Malerich et al. (Ref. 34) studied the effect of transitioning from powdered to powder-free NRL gloves on workers' compensation claims in a U.S. multihospital system, the Geisinger Health System, between 1997 and 2005. They estimated that 52 percent of the system work force at that time was occupationally exposed to NRL gloves. In 2001, the system transitioned to powder-free NRL gloves. The incidence of NRL-related workers' compensation claims decreased progressively after 2001, from 62 claims over the 5 year period before the change to only 18 claims in the next 4 years. The average annual savings in NRL-related compensation claims was estimated to be over $30,000. Although the cost of the powder-free NRL gloves resulted in a 36 percent increase in the cost of gloves, this was partially offset by the elimination of the costs of washing powder off the surgical gloves, estimated at about $57,000.

Vandenplas et al. (Ref. 35) reported in 2009 on changes in the incidence of NRL-related occupational asthma (OA) claims from health care providers submitted to the Workers' Compensation Board of Belgium from 1992 through 2004. Definite and probable NRL-related OA incidence per 100,000 full-time equivalents for health care workers was 10.9 per 100,000 in 1991, 19.7 per 100,000 in 1998, and 3.8 per 1,000,000 in 2003. The overall usage index of NRL-powdered glove use was 80.9 percent in 1989 and fell to 17.9 percent by 2004. The non-sterile NRL-powdered glove use index fell from 80.5 percent to 14.4 percent. However, the sterile procedure, NRL-powdered glove use index changed only from 84.6 percent to 48.9 percent over this 15-year period.

Although the adverse event risks of glove powder on a variety of tissues were well-documented before 1997, investigations to understand the pathogenesis of tissue damage caused by glove powder have continued. In 1999, Chegini and Rong (Ref. 36) studied the effect of glove powder, NRL proteins, and lipopolysaccharide added directly to the peritoneal cavity of mice and found that glove powder worsened the inflammatory response to tissue injury caused by NRL proteins and lipopolysaccharide alone. The study suggested that this interaction could contribute to inflammatory or immune reactions and the development of adhesions after abdominal surgery. Sjösten et al. (Ref. 38) published a study in 2000 showing that the intravaginal deposition of free glove powder in rabbit vaginas prior to laparotomy led to dense pelvic adhesions and even attachment of the Fallopian tube to the peritoneal wall after laparotomy with standardized trauma on the left Fallopian tube and the ipsilateral peritoneum. The control group was not exposed to glove powder and experienced only loose adhesions after laparotomy with standardized trauma. The authors recommended against the use of powdered gloves during gynecologic surgery.

In 2001, van den Tol et al. (Ref. 39) found that starch, either washed from gloves or pure base starch, when added to the peritoneal cavity of rats during laparotomy plus surgical peritoneal trauma, caused increased peritoneal adhesion formation. When tumor cells were added to the peritoneal cavity at the end of the experimental surgery, increased adhesion and growth of the tumor cells occurred in rats who also received powder contamination of the peritoneal cavity. These authors recommended that powdered gloves no longer be used during intra-abdominal surgery on the basis of these results. In 2003, Barbara et al. (Ref. 24) found that after guinea pigs were sensitized to NRL antigens, with or without added cornstarch powder given by intraperitoneal injection, the guinea pigs who received NRL antigens mixed with cornstarch had increased antibody production and antigen-induced constriction of the bronchial tubes when challenged with an aerosol of NRL antigens compared to animals who received intraperitoneal NRL antigens alone. They concluded that cornstarch powder used as a donning agent on NRL gloves can increase sensitization to NRL compared to exposure to NRL antigens alone.

In 2002, Smither et al. (Ref. 41) presented a case report of a 58-day-old male infant with bilateral scrotal masses due to a foreign body reaction to glove powder following a pyloromyotomy performed shortly after birth. In 2004, Sjösten et al. (Ref. 40) extended their prior work on the adverse effects of glove powder in animals to a clinical observational study. They found that in patients who underwent vaginal examination 1 or 4 days prior to a scheduled hysterectomy with either powdered or non-powdered gloves, examination of the removed tissues postoperatively detected more starch particles in the cervix and uterus of patients examined with powdered gloves. There were no differences between the patient groups in the numbers of starch particles seen in the distant sites of the Fallopian tubes or the peritoneal fluid. In 2 patients examined with powdered gloves, no starch particles were found, and 3 patients examined with only powder-free gloves had a few starch particles in their tissues.

Odum et al. (Ref. 43) studied a guinea pig model of paravertebral abscess formation. They reported that when slurries of either calcium carbonate (CaCO3) or cornstarch were added to guinea pig wounds along with Staphylococcus aureus, the wounds with added CaCO3 had higher bacterial counts 4 days later than did the wounds with added cornstarch, and both had higher bacterial counts than the control wounds with only S. aureus inoculated. This study was considered by the authors to support an increased risk of wound infection after wound exposure to powdered gloves. In addition, Dave et al. (Ref. 42) reviewed the literature on glove powder relating to dental powdered glove use and noted that cornstarch promoted wound infection in reported animal model studies and that cost-effective powder-free gloves were available. The authors recommended the use of non-powdered gloves in place of powdered gloves. Dwivedi et al. (Ref. 37) studied both NRL and synthetic latex gloves, both powdered and unpowdered in a rat laparotomy model. They found that both non-powdered natural rubber latex and powdered surgical gloves resulted in peritoneal adhesions. However, powdered NRL gloves further promoted increased tissue adhesions, which correlated with elevated serum cytokine levels. They suggested that the use of NRL free, powder-free gloves would be most effective in decreasing peritoneal adhesion formation. In 2010, Suding et al. (Ref. 44) performed another study of the effect of cornstarch on experimental model abscess formation. They found that the injection of starch into wound sites increased the likelihood of methicillin-resistant S. aureus injection abscess formation in a rat model.

Over the past several years, some domestic health care organizations, health care systems, and other nations have banned or restricted the use of glove powder because of its deleterious effects on the body. Organizations such as the National Institute for Occupational Safety and Health (NIOSH), the American Academy of Allergy, Asthma, and Immunology (ACAAI), the American College of Surgeons (ACS), and the American Nurses Association have all issued statements discouraging the use of powdered NRL gloves (Refs. 59 to 61). In June 1997, the NIOSH of the CDC issued an Alert titled “Preventing Allergic Reactions to Natural Rubber Latex in the Workplace” (Ref. 59) in which it recommended that if NRL gloves are used in the workplace, they should not be powdered. The ACS issued a statement from their Committee on Perioperative Care in 1997 that recommended that surgeons should insist on using only non-powdered (“powder-free”) surgeons gloves (Ref. 62). The ACAAI issued a recommendation (Ref. 60) on the use of NRL gloves in 1997 and stated that only non-powdered (“powder-free”) NRL gloves should be purchased and used in order to reduce NRL aeroallergen levels and exposure to them.

Moreover, health care systems including the Johns Hopkins Hospital, the Cleveland Clinic's network of nine hospitals, and the University of Virginia Healthcare System have all restricted or banned the use of powdered NRL gloves in their facilities (Refs. 63-64). Finally, the international health care systems of Germany and the United Kingdom have also independently taken steps against the use of powdered NRL gloves due to the dangers of the devices and the hazards they pose in the health care setting (Refs. 65-66).

The Occupational Safety and Health Administration (OSHA) of the Department of Labor (DOL) issued a Technical Information Bulletin (TIB 99-04-12) in 1999 and updated it in 2008 (SHIB 01-28-2008) (Ref. 67) describing the risk of sensitization to natural rubber latex products used in the workplace. In both of its documents, OSHA recommended that, if NRL gloves must be used, they should be non-powdered (“powder-free”).

In the 1998 CDC Guideline for Infection Control in Hospital Personnel-1998 (Ref. 68), CDC addressed the issues of NRL sensitization in the health care workplace and recommended that the use of non-powdered natural rubber latex gloves would be more efficient than other interventions such as trying to wash powder off gloves in reducing NRL allergy in the workplace when NRL gloves were retained instead of replaced.

In January 2000, the New Jersey Department of Health and Senior Services (DHSS) issued “Guidelines on the Management of Natural Rubber Latex Allergy; Selecting the Right Glove for the Right Task” (Ref. 69) for the health care facility environment. The New Jersey DHSS recommended that reduced powder or, preferably, non-powdered NRL gloves be used when NRL gloves are selected.

Allmers and colleagues (Ref. 25) reported that a revised version of the technical regulations for dangerous substances (TRGS 540) was published in Germany in December 1997 that stated that the use of powdered natural rubber latex gloves was not permissible in the workplace; only “powder-free” NRL gloves could be used.

In the United Kingdom in 2008, the National Health Service (NHS) Plus Occupational Health Clinical Effectiveness Unit, in association with the Royal College of Surgeons, issued evidence-based guidelines (Ref. 70) on “the occupational aspects of latex allergy management.” These guidelines include the recommendation that when NHS employers determine that a NRL glove is the most suitable choice for use against a specific hazard, the NRL glove selected should be a low NRL protein glove without glove powder.

In 2011, the Association of Professionals in Infection Control and Epidemiology (APIC) responded to the FDA's request for comments on information related to risks and benefits of powdered gloves (Docket No. FDA-2011-N-0027). APIC stated (Ref. 71) that it supported the use of powder-free surgeon's gloves in health care. It stated also that it agreed with the position of the ACS and that of the Association of Perioperative Registered Nurses (AORN) that powdered gloves increase the risk of sensitization to NRL antigens. APIC also noted that the evidence for the role of glove powder in surgical site infection risk is limited.

On its own initiative, FDA evaluated adverse event reports for medical gloves that use powder as additional information to help determine whether the standard for initiating a ban was met and, if so, whether a ban was the appropriate regulatory action to address the unreasonable and substantial risk of illness or injury presented by powdered gloves.

We performed a search of our Manufacturer and User Facility Device Experience (MAUDE) database to isolate reports through September 30, 2015, to evaluate the number of adverse events reported for all types of medical gloves. A total of 3,780 reports were identified, including some that identify inflammation and granulomas. The reports retrieved in this query date back to 1992. Charting the reports entered by year indicates a bell curve in which the majority of reports were entered in 1999 with 783 reports. Since 1999, the number of adverse events reported for these devices has consistently decreased, and since 2003, the number of adverse events reported for these devices has tapered off to consistently remain below 100 per year. FDA believes that this reduction can be attributed to the risks of powdered gloves becoming better known, which has led to suitable powder-free alternatives being developed and becoming more widely available on the market.

As discussed in section VIII “Economic Analysis of Impacts,” market analysis clearly indicates that use of powdered gloves is declining, but some individuals and organizations continue to use them despite the risks of illness or injury they present. As such, health care workers, patients, and other individuals who come in contact with glove powder are being exposed to risks unnecessarily, which is one of the reasons that FDA decided to initiate this ban.

As described in section 1.D, section 516(a)(1) of the FD&C Act authorizes FDA to ban a device intended for human use by regulation if it finds, on the basis of all available data and information, that such a device “presents substantial deception or an unreasonable and substantial risk of illness or injury” In this section, we describe the reasons we initiated the proceeding to ban powdered gloves, including the determination that powdered gloves present an unreasonable and substantial risk of illness or injury. In order to make this determination, we analyzed both the benefits and the risks that these devices pose to those that may come into contact with them, comparing those benefits and risks to the benefits and risks posed by similar alternative devices.

As explained in section II, the level and types of risk presented by powdered gloves varies depending on the composition and intended use of the glove. While some glove types present less risk than others, we have concluded that the public's exposure to such risk is substantial in relation to the nominal public health benefit derived from the continued marketing of these devices. Further, it is FDA's position that exposure to these risks is unreasonable in the current market where suitable alternatives are readily available that carry none of the risks presented by powdered gloves.

The risk of acute severe airway inflammation due to ADP inhalation is a risk presented by all powdered glove types and absorbable powder alone and is considered important, material, and significant in relation to the minimal potential benefits of greater ease of donning and doffing and decreased tackiness. In considering these risks relative to the state of the art and alternative non-powdered gloves that do not present risks of acute severe airway inflammation, FDA has determined that these risks are substantial and unreasonable.

The risks of inflammatory responses, hypersensitivity reactions, and allergic reactions, including asthma, allergic rhinitis, conjunctivitis, and dyspnea, are risks presented by all powdered latex glove types. FDA has determined that these risks are important, material, and significant risks in relation to the minimal potential benefits of greater ease of donning and doffing and decreased tackiness. In relation to the state of the art of alternative non-powdered gloves that do not present risks of inflammatory responses, hypersensitivity reactions, and allergic reactions, we conclude that these risks are substantial and unreasonable.

The risk of granuloma and adhesion formation is presented to patients and health care workers via exposure to internal tissue through the use of powdered latex or synthetic surgeon's and patient examination gloves. FDA has determined that this risk is important, material, and significant in relation to the minimal potential benefits of greater ease of donning and doffing and decreased tackiness. In relation to the state of the art of alternative non-powdered gloves that do not present risk of granuloma and adhesion formation, we have concluded that this risk is substantial and unreasonable.

A critical aspect of these devices that FDA considered in coming to the decision to propose this ban is their ability to affect persons other than the individual who decides to wear or use them. Patients often do not know the type of gloves being worn by the health care professional treating them, but are still exposed to the potential dangers of those gloves. Glove powder's expansive danger zone includes persons, including other health care workers, completely unaware or unassociated with its employment. In addition, users wear gloves as a conventional prophylactic measure to prevent harm, but may be exposed to the myriad harms posed by powdered gloves. Although we have noticed a progressive reduction in the market share of powdered gloves, some individuals and institutions continue to use them. This, in turn, has led to continued exposure to the risks presented by powdered gloves.

In aggregate, the risks posed by these devices include severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), allergic rhinitis, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue. The state of the art of both surgeon's and patient examination gloves includes non-powdered alternatives that provide similar performance as the various powdered glove types do: That is, there are many non-powdered gloves available that have the same level of protection, dexterity, and performance. The benefits of these devices appear to only include ease of donning and doffing and increased tackiness. We have concluded that these benefits are nominal, and that the risks that are posed by the continued marketing of powdered gloves outweigh those benefits in all instances, especially in light of the current state of the art, and the fact that readily available alternatives exist in today's market that carry none of these risks. As such, FDA has determined that the standard to ban powdered gloves has been met, and that it is appropriate to issue this proposal to ban.

FDA has determined that powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove present an unreasonable and substantial risk of illness or injury to individuals, and that no change in labeling could correct the risk of illness or injury presented by the continued use of these devices. FDA has determined that a ban is the appropriate regulatory approach to addressing risks posed by glove powder. No labeling or warnings can mitigate the risks posed by these devices.

As discussed previously, powdered gloves have additional or increased risks to health compared to non-powdered gloves related to the spread of powder and powder-transported contaminants such as latex allergens through aerosols and inhalation or direct or indirect contact with wounds, oral, vaginal, rectal tissue, etc. Although labeling can raise awareness of these risks, we do not conclude that labeling can effectively mitigate these risks because it cannot prohibit the spread of glove powder or powder-transported contaminants. In addition, an important aspect of these devices is their ability to affect persons other than the individual who decides to wear or use them. For example, patients often do not know the type of gloves being worn by the health care professional treating them, but are still exposed to the potential dangers. Similarly, glove powder's ability to aerosolize and carry NRL proteins exposes individuals to harm via inhalation or surface contact. Glove powder's expansive danger zone includes persons completely unaware or unassociated with its employment and without the opportunity to consider the devices' labeling. Because of this inherent quality, adequate directions for use cannot be written that would ensure the safe and effective use of these devices for all persons that might come in contact with them.

In the now withdrawn draft guidance entitled “Draft Guidance for Industry and FDA Staff: Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder,” FDA proposed a general voluntary warning for powdered glove devices in order to alert users to the potential adverse health effects of medical glove powder while FDA assessed the benefits and risks of glove powder (Ref. 7) (80 FR 26059). In order to facilitate this assessment, concurrent with the issue of this draft guidance document, we issued a notice in the Federal Register requesting public input on the benefits and risks of powdered gloves (76 FR 6684, February 7, 2011; FDA-2011-N-0027). Many of the comments we received, in addition to a citizen petition filed in 2011 (FDA-2011-P-0331-0001), indicated that labeling would not sufficiently address the risks posed by glove powder because a warning label would not be visible to everyone affected by risks of glove powder.

Although the use of powdered gloves has declined in recent years, the use of these devices has not been eliminated, and patients and health care workers continue to be exposed to the risks of glove powder. Due to the ability of powder to affect people who would not have an opportunity to read warning labels, such a label would be ineffective at informing the affected persons of potential risks. In addition, potential warning labels would raise awareness of the risks, but would not eliminate the risks posed by glove powder. Therefore, despite declining use of powdered gloves and previous warning label suggestions, FDA has determined no label or warning can mitigate the risks posed by these devices.

Due to the nature of the risks presented by glove powder that are posed simply by virtue of the powder being used, we do not conclude that additional or new labeling can adequately correct or eliminate the risks. As such, in light of all available data and information, FDA has determined that it should address the risks posed by glove powder by banning its use.

FDA has determined that this ban, if finalized, should apply to devices already in commercial distribution and devices already sold to the ultimate user, as well as to devices that would be sold or distributed in the future. (See 21 CFR 895.21(d)(7).) This means that powdered gloves currently being used in the marketplace would be subject to this ban, and thus adulterated under section 501(g) of the FD&C Act and would be subject to enforcement action.

FDA made this determination because the risks of illness or injury to individuals who are currently exposed to these devices is equally unreasonable and substantial as it would be for future individuals that might be exposed to powdered gloves. Indeed, because suitable alternatives already exist in the current marketplace, and because the market trends have shown that powder glove use is steadily decreasing, it is likely that the remaining users of powder gloves will be able to quickly transition to alternatives that are equally effective and carry none of the risks associated with powdered gloves. Further, because of the steady decrease in powdered glove use, it is likely that the greatest number of people that might benefit from the ban include those who would be exposed to powdered gloves already in distribution. It is our conclusion that this group is being unnecessarily exposed to risks that can be eliminated through the use of alternative gloves that are readily available. For these reasons, FDA has determined that the ban should apply to powdered gloves and glove powder already in commercial distribution.

This proposed rule, if finalized, would amend §§ 878.4460, 878.4480, 880.6250, 895.102, 895.103, and 895.104. FDA's legal authority to modify §§ 878.4460, 878.4480, 880.6250, 895.102, 895.103, and 895.104 arises from the device and general administrative provisions of the FD&C Act (21 U.S.C. 352, 360f, 360h, 360i, and 371).

FDA has carefully considered the potential environmental effects of this proposed rule and of possible alternative actions. In doing so, we focused on the environmental impacts of its action as a result of disposal of unused powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove that will need to be handled after the rule is finalized.

The environmental assessment (EA) considered each of the alternatives in terms of the need to provide maximum reasonable protection of human health without resulting in a significant impact on the environment. The EA considered environmental impacts related to landfill and incineration of solid waste. The proposed action, if finalized, will result in an initial batch disposal of unused powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove at user facilities nationwide, followed by a rapid decrease in the rate of disposal of these devices, as supplies are depleted. The proposed action does not change the ultimate disposition of these devices but expedites their rate of disposal and ceases future production. Overall, given the limited number of powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove, currently in commercial distribution, the proposed action is expected to have no significant impact on landfill and solid waste facilities and the environment in affected communities.

The Agency has concluded that the proposed rule will not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA's finding of no significant impact (FONSI) and the evidence supporting that finding, contained in an EA prepared under 21 CFR 25.40, may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday (Ref. 72). FDA invites comments and submission of data concerning the EA and FONSI.

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule imposes no new burdens, we propose to certify that the final rule would not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

The proposed rule, if finalized, would prohibit marketing of powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon's gloves. The rule does not cover or include powdered radiographic gloves. In the past, powdering gloves was a popular method to make the gloves easier to put on and remove. However, recent studies indicate that these powders pose an unnecessary risk to medical workers (Ref. 73 and 74). Their results note that these powders carry the latex material on latex gloves. As a result, medical workers who are sensitive to latex are occasionally exposed to enough latex to develop an allergy.

Adopting the proposed rule is expected to provide a positive net benefit (estimated benefits minus estimated costs) to society. Banning powdered glove products is not expected to impose any costs to society because improvements to non-powdered gloves have made these products as affordable and easy to put on as powdered gloves. The ban is expected to reduce the adverse events associated with using powdered gloves. Total annual benefits are estimated to range between $26.6 million and $29.3 million.

The Economic Analysis of Impacts of the proposed rule performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is available at http://www.regulations.gov under the docket number(s) (FDA-2015-N-5017) for this proposed rule and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 75). We invite comments on this analysis.

FDA is proposing that any final rule based on this proposed rule become effective 30 days after the date of its publication in the Federal Register. FDA proposes that manufacturers must not market any new units of affected devices after the effective date of any final rule based on this proposal. FDA requests comment on the proposed effective date for this proposed rule. Once this rule is finalized, all powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's gloves must be removed from the market by the effective date provided in the final rule or the device will be deemed adulterated. Section 501(g) of the FD&C Act deems a device to be adulterated if it is a banned device.

FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain State requirements “different from or in addition to” certain Federal requirements applicable to devices (21 U.S.C. 360k; See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)). This proposed rule, if finalized, would create a requirement under 21 U.S.C. 360k that bans Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove.

The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 878, 880, and 895 be amended as follows:

Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.

Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document is available at http://www.regulations.gov for easy reference.

The DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purposes of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c) and the current list of scheduled substances is published at 21 CFR part 1308. 21 U.S.C. 812(a).

Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he * * * finds that such drug or other substance has a potential for abuse, and * * * makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed * * *.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on her own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS),1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This proposed action (80 FR 27611, May 14, 2015) is supported by a recommendation from the Assistant Secretary of the HHS and an evaluation of all other relevant data by the DEA. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles, or proposes to handle, UR-144, XLR11, or AKB48.

UR-144, XLR11, and AKB48 are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 80 FR 27854, May 15, 2015. On May 14, 2015, the Administrator of the DEA published a notice of proposed rulemaking (NPRM) to permanently schedule (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) into schedule I pursuant to the CSA. 80 FR 27611.

In the NPRM, the DEA inadvertently proposed the addition of these substances in schedule I under 21 CFR 1308.11(g), cannabimimetic agents, by adding paragraphs (g)(16) through (18). These substances should have been proposed to be added in schedule I under 21 CFR 1308.11(d), hallucinogenic substances. This rulemaking therefore corrects the NPRM by proposing the placement of these substances in 21 CFR 1308.11(d) by adding paragraphs (d)(48) through (50). Because the DEA is proposing to classify these substances as schedule I hallucinogenic substances, then by operation of 21 U.S.C. 802(14), this classification will include any optical, positional, or geometric isomers. Interested persons may file written comments on this change in accordance with 21 CFR 1308.43(g). The DEA is requesting comments on this change only and is not soliciting comments on other aspects of the May 14, 2015, NPRM. The DEA previously had provided an opportunity for comments on other aspects of the NPRM on May 14, 2015, through June 15, 2015.

This correction has no effect on the regulatory analyses statements that were published with the notice of proposed rulemaking published in the Federal Register on May 14, 2015, at 80 FR 27611.

In proposed rule FR Doc. 2015-11762, beginning on page 27611 in the issue of May 14, 2015, make the following corrections.

Congress amended the Outer Continental Shelf Lands Act, 43 U.S.C. 1331-1356 (OCSLA, or the Act), in 1994 to authorize the Secretary of the Interior to negotiate noncompetitive agreements with any person for the use of OCS sand, gravel and shell resources in a program of or project for shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, State or local government agency, or in a construction project either authorized or funded in whole or in part by the Federal Government. See 43 U.S.C. 1337(k)(2). The Secretary may assess a fee based on an assessment of the value of the resources and the public interest served by promoting development of the resources. No fee shall be assessed directly or indirectly against a Federal, State, or local government agency. See 43 U.S.C. 1337(k)(2)(B).

Generally, shore protection and beach and coastal wetlands restoration projects are initiated to rebuild eroding shoreline segments, such as beaches and dunes, barrier islands, and wetlands. In sensitive wetland areas, these projects are intended to forestall further erosion, restore habitat and/or to provide protection from hurricanes, storms, and coastal erosion. These projects are typically accomplished by placing sand directly on the beach, in open water areas that are the former location of an eroded beach, and/or within breaches in the shoreline that compromise integrity of the beach or barrier island system to form, and subsequently maintain, a beach. Material may also be placed updrift from the beach, allowing longshore processes to redistribute the sand, gravel and shell resources along the beach.

The Act authorizes BOEM to enter into a negotiated agreement when the use of OCS sand, gravel and shell resources is authorized for qualifying projects. This negotiated agreement will take the form of a lease or a Memorandum of Agreement (MOA), depending on the identity of the applicant(s) requesting use of OCS sand, gravel and shell resources. If a non-Federal entity requests the use of OCS sand, gravel and shell resources, the negotiated agreement required by the Act would generally take the form of a lease. If a Federal agency requests the use of OCS sand, gravel and shell resources, BOEM and the Federal agency, as well as their Federal, State or local government agency counterparts on the project, would enter into a MOA. For example, when a Federal agency partially or wholly funds a non-Federal entity to conduct a project that is otherwise eligible for OCS sand, gravel and shell resources, the negotiated agreement may take the form of a three-party MOA. As warranted, the Federal applicant(s) and BOEM would designate a lead agency and enter into a cooperating agency agreement for the environmental analysis and review. Likewise, if a non-Federal applicant is involved, BOEM would ensure that appropriate environmental analysis and review is completed. The negotiated agreement in each of these situations would describe the project and procedures that would be followed and identify environmental and administrative requirements that must be met.

BOEM and its predecessor agencies, the Minerals Management Service and the Bureau of Ocean Energy Management, Regulation and Enforcement, through the Marine Minerals Program, have been exercising statutory authority regarding OCS sand, gravel and shell resources under the Act pursuant to written guidelines, without the benefit of implementing regulations. Nearly fifty agreements have been negotiated, providing for the use of more than 100 million cubic yards of OCS sand, gravel and shell resources for shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, State or local government agency, and for Federally authorized or funded construction projects. BOEM believes that the promulgation of regulations at this time is advisable in order to provide additional clarity and certainty and to help ensure continuity of the Marine Minerals Program.

This section would explain BOEM's authority for IC activities related to this proposed part 583. It would explain the reasons the information is being collected and establish the OMB approval of the collection.

This section would explain that the purpose of this proposed rule is to refine and formally adopt procedures for entering into negotiated noncompetitive agreements for the use of OCS sand, gravel and shell resources for shore protection, beach or wetlands restoration by a Federal, State or local government agency or for construction projects authorized or funded, in whole or in part, by the Federal Government. This section would explain that the rule would apply exclusively to negotiated noncompetitive use of sand, gravel and shell resources in the OCS and would not apply to competitive leasing of minerals, including oil, gas, sulphur, geopressured-geothermal and associated resources, and all other minerals which are authorized by an Act of Congress to be produced from “public lands” as defined in section 103 of the Federal Land Policy and Management Act of 1976, as amended (FLPMA). (43 U.S.C. 1701 et seq.)

This section would explain that in proposing these regulations, BOEM is operating under authority granted to the Secretary of the Interior by the Act.

This section would define many of the terms commonly used in the Marine Minerals Program and now used in the proposed regulation, including “borrow area,” “placement area,” and “project.” This section would also define new terms for purposes of this subpart, including “Act,” “agreement,” “amendment,” “BOEM,” “Director,” “Federal agency,” “local government,” “modification,” “outer continental shelf,” “program,” “Regional Director,” and “Secretary.”

This section would explain who is qualified to enter into an agreement with BOEM for the use of OCS sand, gravel, and shell resources, and would explain the requirements to comply with the relevant debarment regulations.

This section would set out the kinds of decisions that would be subject to reconsideration or appeal, and the process that would be utilized by an unsuccessful applicant or adversely affected party for resolution of such reconsideration or appeal.

This section would explain who would be allowed to use OCS sand, gravel and shell resources, and would explain that use authorizations would be in the form of agreements that are negotiated on a case-by-case basis. It would also explain that the agreements would identify the location, type and volume of OCS sand, gravel and shell resources allowed to be used under the agreement. In addition, it would explain that any authorizations to use sand, gravel and shell resources would not be exclusive.

This section would explain who may submit a request to BOEM to obtain an agreement for the use of OCS sand, gravel, and shell resources. It would list the information the request must include, such as a detailed description of the proposed project and how it qualifies as a project eligible under the Act to receive OCS sand, gravel and shell resources pursuant to a negotiated noncompetitive agreement; a description of borrow and placement areas; certain maps and data; a description of the environmental evaluations that have been completed or are being prepared that cover the project, including both onshore and offshore components; a target date or date range when the resources will be needed; a description of the Federal, State, or local agencies that are undertaking the project and points of contact; and a statement explaining who authorized the project and how the project will be funded.

This section would lay out the factors that BOEM would use to determine whether a project qualifies for use of sand, gravel and shell resources under a negotiated noncompetitive agreement. The section would enumerate the evaluation criteria, including: The project purpose; other uses of OCS sand, gravel and shell resources authorized from the same borrow area; the project funding source(s) and amounts; the proposed design and feasibility of the project; any potential environmental and safety risks associated with the project; other Federal interests located near or within the specified borrow area; comments received from potentially affected governments; the applicant's background and experience working on similar projects or activities; and whether the project is consistent with applicable statutes and their implementing regulations, which may include, but are not limited to, the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq.), the Marine Debris Research, Prevention, and Reduction Act (MDRPRA) (33 U.S.C. 1951 et seq.), the Marine Plastic Pollution Research and Control Act (MPPRCA) (33 U.S.C. 1901 et seq.), the Federal Water Pollution Control Act (FWPCA) (33 U.S.C. 1381 et seq.), and the International Convention for the Prevention of Pollution from Ships (MARPOL), MARPOL-Annex V Treaty.

This section would explain the process that BOEM would follow to evaluate a project that qualifies for the use of OCS sand, gravel and shell resources to decide whether to enter into a negotiated noncompetitive agreement. It states that BOEM would coordinate with relevant Federal agencies, States, and local governments, and potentially affected Federally recognized Indian Tribes. It also describes how BOEM would evaluate the project and additional information provided under §§ 583.300 and 583.301 to determine if the information is sufficient to conduct necessary technical and environmental reviews to comply with the requirements of applicable statutes and regulations, which may include, but are but not limited to, the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.), the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.), the MMPA (16 U.S.C. 1361 et seq.), the Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA) (16 U.S.C. 1801 et seq.), the National Historic Preservation Act (NHPA) (16 U.S.C. 470 et seq.), and the Coastal Zone Management Act (CZMA) (16 U.S.C. 1451 et seq.). Finally, this section would provide that BOEM would not enter into a negotiated noncompetitive agreement until the information requested for the evaluation has been provided and BOEM has evaluated it.

This section would describe the steps BOEM would take once it has completed its technical, environmental and other evaluations. This section would provide further that, once BOEM has completed its review of an application, BOEM would decide whether to enter into an agreement. This section would provide further that BOEM would negotiate the terms of the agreement and prepare a draft agreement for the applicant's review and comment. The section would also provide that, after BOEM considers the applicant's comments and suggestions, it would finalize the agreement for signature. This section would provide that, once the applicant signs the agreement, BOEM would execute the agreement and distribute it to the parties to the agreement. Finally, this section would describe the process BOEM would use when an application is not approved.

This section would describe the minimum information that an agreement would be required to include, such as an agreement number assigned by BOEM; the purpose of, and authorities for, the agreement; designated and delineated borrow area(s); the project description, including the timeframe within which the project is to be started and completed; the terms and conditions of the agreement, including any reporting requirements; all obligations of the parties; and the signatures of appropriate individuals authorized to bind the applicant and BOEM.

This section would describe what determines the effective date of the agreement.

This section would describe how BOEM would enforce the terms of an agreement and the consequences, including termination, for failure to comply with any applicable law or with the agreement terms. This section would also provide that the failure to comply in a timely and satisfactory manner with any provision, term or condition of the agreement may delay or prevent BOEM's approval of future requests for use of OCS sand, gravel and shell resources on the part of the parties to the agreement.

This section would explain when an agreement would terminate, either by a specified date, when parties to the agreement notify BOEM that sufficient resources have been removed to complete the project, or for other reasons specified in this section. This section would also explain that, absent extraordinary circumstances, no agreement would have an initial term that is longer than five years from its effective date. Examples of extraordinary circumstances where an initial term longer than five years may be appropriate would include a program of multiple individual projects to be carried out over multiple seasons or where the Congressional authorization for a project called for multiple phases. It would be within BOEM's sole discretion to determine when extraordinary circumstances warrant an initial term longer than five years. The parties would have the option to request an extension, modification or change to the terms of the agreement, as set forth in § 583.309.

This section would explain that the applicant has the obligation to ensure that all contracts and transactions related to an agreement issued under this part comply with the suspension and debarment regulations at 2 CFR part 180 and 2 CFR part 1400.

This section would explain how an applicant may seek to extend, modify or change an agreement and would spell out the time frames when this might be accomplished. It would provide that BOEM is under no obligation to extend, modify or change an agreement and cannot be held liable for the consequences of the expiration of an agreement. If BOEM approves a modification, BOEM would prepare an amendment to the agreement and provide it for review by the parties to the agreement prior to execution of the amendment. Should BOEM deny the request, BOEM would notify the parties to the agreement and reconsideration could be requested of the Director.

This section would explain under what circumstances the Director could terminate an agreement. The termination factors include fraud; noncompliance with the agreement; national security or defense reasons; situations in which continuing with the agreement would cause serious harm or damage to natural resources, property, the environment or historical structures; and other reasons described in this section. This section would also explain the process for terminations and suspensions.

E.O. 12866 provides that the Office of Information and Regulatory Affairs (OIRA), a part of the OMB, will review all significant rules. OIRA has determined that this rule is not significant.

(1) This proposed rule contains virtually the same reporting and recordkeeping requirements as those in the current uncodified guidelines and procedures. A regulatory impact analysis is not required. This proposed rule formalizes existing policies and procedures that govern the use of OCS sand, gravel and shell resources. The existing policies, procedures, consultations and monitoring requirements for the noncompetitive use of OCS sand, gravel and shell resources are longstanding and have remained relatively consistent for two decades. This proposed rule does not materially change the existing requirements for the use of OCS sand, gravel and shell resources through leases or MOAs for shore protection, beach or wetlands restoration by a Federal, State or local government agency, or for construction projects authorized or funded, in whole or in part, by the Federal Government. The regulatory baseline is essentially the same as the proposed rule. BOEM believes that any changes between the current BOEM process and this proposed rule are immaterial and would not impose additional compliance obligations or costs upon the regulated entities.

Formalizing the existing conveyance process will provide certainty to the public entities requesting noncompetitive leases or MOAs for OCS sand, gravel and shell resources. BOEM believes there is a benefit to the regulated entities in the form of regulatory certainty when Federal, State and local government agencies desire to use OCS sand, gravel and shell resources for qualifying projects. Entities affected by this rulemaking have the opportunity to comment through the rulemaking process on the proposed provisions, which are consistent with current practices for the conveyance of sand, gravel and shell resources.

(2) This proposed rule does not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. It reflects the existing process developed over the life of the program in cooperation with other Federal agencies, including the U.S. Fish and Wildlife Service (FWS), National Marine Fisheries Service (NMFS) and U.S. Army Corps of Engineers, and State and local governments.

(3) This proposed rule does not have an annual effect on the economy of $100 million or more. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities.

(4) This rule does not alter the budgetary effects of existing entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.

(5) This rule does not raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, reduce uncertainty, and use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. BOEM has developed this rule in a manner consistent with these requirements.

BOEM certifies this proposed rule would not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq.). A Regulatory Flexibility Analysis is not required. Small public entities affected by this rulemaking may be cities, counties, towns, townships, villages or special districts, with a population of less than 50,000. Small entities are occasionally parties to an agreement for the use of OCS sand, gravel and shell resources. Over the last two decades, BOEM has issued nearly 50 leases or MOAs with 22 parties, of which 5 were small public entities. Four out of the 5 small public entities received significant Federal cost-shares to conduct beach nourishment projects. The proposed application and monitoring requirements are necessary to comply with Federal law and provide BOEM and the public the best information on the changes in the sand borrow areas. Since BOEM is not proposing any material changes to the longstanding requirements for borrowing OCS sand, gravel and shell resources, this rulemaking will not have a substantial effect on small entities.

The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small businesses about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of BOEM enforcement activities, you may call 1-888-734-3247. You may comment to the Small Business Administration without fear of retaliation. Allegations of discrimination/retaliation filed with the Small Business Administration will be investigated for appropriate action.

This proposed rule is not a major rule under the SBREFA (5 U.S.C. 804(2)). This proposed rule:

(a) Would not have an annual effect on the economy of $100 million or more;

(b) Would not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and,

(c) Would not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This proposed rule would not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. A statement containing the information required by Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.) is not required.

Under the criteria in E.O. 12630, this proposed rule would not have significant takings implications. The proposed rule is not a governmental action capable of interference with constitutionally protected property rights. A Takings Implication Assessment is not required.

Under the criteria in E.O. 13132, this proposed rule would not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. This proposed rule would not substantially and directly affect the relationship between the Federal and State and local governments. To the extent that State and local governments have a role in OCS activities, this proposed rule would not affect that role. A Federalism Assessment is not required.

This rule would comply with the requirements of E.O. 12988. Specifically, this rule would:

(a) Meet the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and,

(b) Meet the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The U.S. Department of the Interior (DOI) strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self governance and tribal sovereignty. BOEM's Tribal Liaison Officer has certified that this regulation does not have tribal implications as defined in section 1(a) of E.O. 13175 and has determined that the regulation does not have substantial and direct effects on Federally recognized tribes or any Alaska Native Corporation established pursuant to the Alaska Native Claims Settlement Act (ANCSA), 43 U.S.C. 1601 et seq.

As it relates to any Federally recognized Indian tribe, this proposed rule merely formalizes existing policies and procedures that govern the use of OCS sand, gravel and shell resources. The existing policies, procedures, consultations and monitoring requirements for the noncompetitive use of sand, gravel and shell resources are longstanding and have remained relatively consistent for two decades. If BOEM determines an individual project authorized under this part may have effects on Federally recognized tribes or any Alaska Native Corporation, BOEM will initiate consultation as soon as possible consistent with E.O. 13175 and DOI tribal consultation policies. A tribe may also request BOEM initiate consultation pursuant to E.O. 13175.

This proposed rule contains a new collection of information request that is being submitted to OMB for review and approval under 44 U.S.C. 3501 et seq. The rule proposes to add a new part 583 to address the use of OCS sand, gravel and shell resources for shore protection or replenishment, wetland restoration, or qualified construction projects. This part describes the negotiated noncompetitive agreement process for qualifying projects and would codify procedures. The title of the IC request is 30 CFR 583, Negotiated Noncompetitive Leasing for the Use of Sand, Gravel and Shell Resources on the OCS.

Respondents that would be required to submit information under this part are other Federal, State, and local government agencies; corporations; and individual entities. Responses would primarily be required in order to obtain or retain a benefit. The frequency of response would vary depending on the requirement. BOEM would protect proprietary information according to the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR part 2). BOEM proposes to collect the information under this part to evaluate applications for leases/agreements to access sand, gravel or shell resources on the OCS; to balance multiple uses of the OCS; and to monitor activities for environmental protection and safety.

The following table provides a breakdown of the IC requirements and burdens in this proposed part.

As part of our continuing effort to reduce paperwork and response burdens, we invite the public and other Federal agencies to comment on any aspect of the reporting and recordkeeping burden. We specifically solicit comments on the following questions:

(1) Is the proposed collection of information necessary for BOEM to properly perform its functions, and will it be useful?

(2) Are the estimates of the burden hours of the proposed collection reasonable?

(3) Do you have any suggestions that would enhance the quality, clarity, or usefulness of the information to be collected?

(4) Is there a way to minimize the IC burden on those who must respond, including the use of appropriate automated electronic, mechanical, or other forms of information technology?

In addition, the PRA requires agencies to estimate the total annual reporting and recordkeeping non-hour cost burden resulting from the collection of information, and we solicit your comments on this item. For reporting and recordkeeping only, your response should split the cost estimate into two components: (1) Total capital and startup cost component; and (2) annual operation, maintenance, and purchase of services component. Your estimates should consider the costs to generate, maintain, and disclose or provide the information. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you expect to incur costs. Generally, your estimates should not include equipment or services purchased (1) before October 1, 1995; (2) to comply with requirements not associated with the IC; (3) for reasons other than to provide information or keep records for the Government; or (4) as part of customary and usual business or private practices.

OMB is required to make a decision concerning the collection of information contained in these proposed regulations between 30 to 60 days after publication of this document in the Federal Register. Therefore, a comment to OMB is best assured of having its full effect if OMB receives the comment by April 21, 2016. This does not affect the deadline for the public to comment to BOEM on the proposed regulations.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. BOEM has analyzed this rule under the criteria of the NEPA and DOI's NEPA implementing regulations at 43 CFR 46. This rule meets the criteria set forth in 43 CFR 46.210(i) for a Departmental “categorical exclusion” in that this rule is “ . . . of an administrative, financial, legal, technical, or procedural nature. . . .” We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215.

In accordance with the IQA, DOI has issued guidance regarding the quality of information that it relies upon for regulatory decisions. This guidance is available at DOI's Web site at http://www.doi.gov.

Send your comments to the U.S. Department of the Interior, Bureau of Ocean Energy Management, Office of Policy, Regulation and Analysis, Attn: IQA Comments, 45600 Woodland Road, VAM-BOEM DIR, Sterling, Virginia 20166.

This rule is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.

We are required by E.O. 12866, E.O. 12988, and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized;

(b) Use the active voice to address readers directly;

(c) Use clear language rather than jargon;

(d) Be divided into short sections and sentences; and

(e) Use lists and tables wherever helpful.

If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help BOEM revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

For the reasons stated in the preamble, BOEM proposes to amend 30 CFR to add part 583 to read as follows:

Throughout this document, the terms “we,” “us,” and “our” refer to EPA.

CAA sections 110(a)(1) and (2) require states to address basic SIP requirements to implement, maintain and enforce the NAAQS no later than three years after the promulgation of a new or revised standard. Section 110(a)(2) outlines the specific requirements that each state is required to address in this SIP submission that collectively constitute the “infrastructure” of a state's air quality management program. SIP submittals that address these requirements are referred to as “infrastructure SIPs” (I-SIP). In particular, CAA section 110(a)(2)(D)(i)(I) requires that each SIP for a new or revised NAAQS contain adequate provisions to prohibit any source or other type of emissions activity within the state from emitting air pollutants that will “contribute significantly to nonattainment” (prong 1) or “interfere with maintenance” (prong 2) of the applicable air quality standard in any other state. CAA section 110(a)(2)(D)(i)(II) requires SIP provisions that prevent interference with measures required to be included in the applicable implementation plan for any other State under part C to prevent significant deterioration of air quality (prong 3) or to protect visibility (prong 4). This action addresses the section 110(a)(2)(D)(i) requirements of prongs 1, 2 and 4 with respect to Arizona's I-SIP submissions.

On March 27, 2008, EPA issued a revised NAAQS for ozone.1 This action triggered a requirement for states to submit an I-SIP to address the applicable requirements of section 110(a)(2) within three years of issuance of the revised NAAQS.

On September 13, 2013, EPA issued “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),” which provides “advice on the development of infrastructure SIPs for the 2008 ozone NAAQS . . . as well as infrastructure SIPs for new or revised NAAQS promulgated in the future.” 2 EPA followed that guidance with an additional memo specific to 110(a)(2)(D)(i)(I) (prongs 1 and 2) requirements for the 2008 O3 standard on January 22, 2015 entitled, “Information on the Interstate Transport “Good Neighbor” Provision for the 2008 Ozone NAAQS Under CAA Section 110(a)(2)(D)(i)(I)” (2015 transport memo).3 While this memo did not provide specific guidance to western states on interstate transport, it did contain preliminary modeling information for western states. This 2015 transport memo, following the approach used in EPA's prior Cross-State Air Pollution Rule (CSAPR),4 provided data identifying ozone monitoring sites that were projected to be in nonattainment or have maintenance problems for the 2008 ozone NAAQS in 2018. Also, EPA provided the projected contribution estimates from 2018 anthropogenic oxides of nitrogen (NOX) and volatile organic compound (VOC) emissions in each state to ozone concentrations at each of the projected sites.

On August 4, 2015, EPA published a Federal Register Notice entitled, “Notice of Availability of the Environmental Protection Agency's Updated Ozone Transport Modeling Data for the 2008 Ozone NAAQS.” 5 This Notice of Data Availability (NODA) is an update of the preliminary air quality modeling data that was released January 22, 2015. This NODA provided data identifying ozone monitoring sites that are projected to be nonattainment or have maintenance problems (following the CSAPR approach) for the 2008 ozone NAAQS in 2017.6 Also, EPA provided the projected ozone contribution estimates from 2017 anthropogenic NOX and VOC emissions in each state to ozone concentrations at each of the projected monitoring sites. The 2017 modeling released in the NODA was used to support EPA's proposed update to CSAPR to address CAA section 110(a)(2)(D)(i)(I) requirements with respect to the 2008 ozone NAAQS in the eastern U.S. (“CSAPR Update Rule”).7 CSAPR and its predecessor transport rules, the NOX SIP Call and CAIR, were designed to address the collective contributions from the 37 states in the eastern U.S. and ozone contribution information was not calculated to or from the 11 states in the western U.S. The proposed CSAPR Update Rule and the supportive modeling released in the NODA include data relevant to the West but did not evaluate potential interstate transport impacts in 11 western states, including Arizona. In this action, we are utilizing these data to evaluate the state's submittals and any interstate transport obligations under section 110(a)(2)(D)(i)(I).

EPA is obligated, pursuant to a judgement issued by the Northern District of California in Sierra Club vs. McCarthy, to take final action on 110(a)(2)(D) prongs 1, 2, and 4 of Arizona's December 2012 SIP revision by June 7, 2016.8 In our July 2015 partial approval and partial disapproval of Arizona's I-SIP submittals for the 2008 Pb and 2008 ozone NAAQS, for the I-SIP elements C, D, J, and K, EPA partially approved and partially disapproved the submittals for purposes of 110(a)(2)(D)(i)(II) prong 3 and partially approved and partially disapproved the submittals for purposes of 110(a)(2)(D)(ii) (relating to CAA sections 115 and 126). We also stated our intention to propose action on the I-SIP for the 2008 ozone NAAQS 110(a)(2)(D)(i) prongs 1, 2, and 4 in a separate action.9 We subsequently took action on I-SIP elements A, B, E-H, L, and M for the 2008 Pb and 2008 ozone NAAQS in August 2015.10

On December 27, 2012, the Arizona Department of Environmental Quality (ADEQ) submitted its 2008 ozone NAAQS I-SIP (2012 submittal). This submittal briefly summarized the CAA requirements of sections 110(a)(2)(D)(i), 110(a)(2)(D)(ii), and EPA's I-SIP action for the previous 1997 ozone NAAQS, but as to prongs 1, 2, and 4 did not identify or address any potential interstate transport impacts between Arizona and other states or interstate transport visibility requirements for the 2008 ozone NAAQS. On December 3, 2015, ADEQ submitted a supplement to the 2012 submittal addressing 110(a)(2)(D)(i) prongs 1, 2, and 4.11 For the purposes of this action, we will refer to the supplemental submittal as the “2015 submittal.” The 2015 submittal represents ADEQ's comprehensive analysis of ozone transport from Arizona to surrounding states and addresses potential interstate transport linkages between Arizona and the El Centro, CA and Los Angeles, CA nonattainment receptors that were identified in the 2015 ozone transport memo and the 2015 NODA. The 2015 submittal also addresses the requirements of prong 4 (interstate transport visibility requirements).

In the 2015 submittal, ADEQ summarizes the state's impact on downwind states. While Arizona's impact on the El Centro and Los Angeles monitors is in each case above 1%, Arizona impacts only one of the seven projected nonattainment or maintenance receptors in the Los Angeles area, and contributes less than 1% to all other maintenance and nonattainment receptors. ADEQ further states that, “In eastern states, the EPA has chosen a 1% of the standard threshold as a significant contribution. However, Arizona considers the southwest to be different.” The state goes on to say that, “It is unclear at this point what threshold is significant for southwestern states.” EPA's assessment of these statements is described in the next section. The submittal also summarizes sources of VOCs and NOX statewide, outlining the controls on anthropogenic emission sources with a focus on efforts to reduce NOX through controls implemented via Arizona's Regional Haze SIP and EPA's Regional Haze Federal Implementation Plan (FIP) and current and future Maricopa County stationary source controls in the Arizona SIP. For more information on Arizona's source categories and emissions controls, please see the technical support document (TSD) associated with today's proposed rulemaking.

EPA proposes to approve Arizona's SIP submissions pertaining to CAA section 110(a)(2)(D)(i)(I), prongs 1 and 2, with respect to the 2008 ozone NAAQS. As explained below, EPA's proposal is based on the state's submission and EPA's analysis of several factors and available data.

To determine whether the CAA section 110(a)(2)(D)(i)(I), prongs 1 and 2 requirement is satisfied, EPA first must determine whether a state's emissions will contribute significantly to nonattainment or interfere with maintenance of a NAAQS in other states. If a state is determined not to make such contribution or interfere with maintenance of the NAAQS, then EPA can conclude that the state's SIP complies with the requirements of section 110(a)(2)(D)(i)(I). In several prior federal rulemakings interpreting section 110(a)(2)(D)(i)(I), EPA has evaluated whether a state will significantly contribute to nonattainment or interfere with maintenance of a NAAQS by first identifying downwind receptors that are expected to have problems attaining or maintaining the NAAQS.12 EPA has then determined which upwind states contribute to these identified air quality problems in amounts sufficient to warrant further evaluation to determine if the state can make emission reductions to reduce its contribution. CSAPR and the proposed CSAPR Update used a screening threshold (1% of the NAAQS) to identify such contributing upwind states warranting further review and analysis. EPA's NODA used air quality modeling to evaluate contributions from upwind states to downward receptors. Applying the methodology used in CSAPR, the NODA modeling information indicates that emissions from Arizona contribute amounts exceeding the CSAPR 1% threshold at two projected downwind nonattainment sites in El Centro, California, and Los Angeles, California.13

EPA notes that it disagrees with ADEQ's contention that it is unclear what screening threshold is significant for southwestern states when addressing interstate transport contributions. EPA believes contribution from an individual state equal to or above 1% of the NAAQS could be considered significant where the collective contribution of emissions from one or more upwind states is responsible for a considerable portion of the downwind air quality problem regardless of where the receptor is geographically located.14

Accordingly, although EPA's modeling indicates that emissions from Arizona contribute above the 1% threshold to two projected downwind air quality problems, EPA examined several factors to determine whether Arizona should be considered to significantly contribute to nonattainment or interfere with maintenance of the NAAQS at those sites, including the air quality and contribution modeling, receptor data, and the statewide measures reducing emissions of VOCs and NOX. EPA notes that no single piece of information is by itself dispositive of the issue for purposes of this analysis. Instead, EPA has considered the total weight of all the evidence taken together to evaluate whether Arizona significantly contributes to nonattainment or interferes with maintenance of the 2008 ozone NAAQS in those areas.

One such factor that EPA considers relevant to determining the nature of a projected receptor's interstate transport problem is the magnitude of ozone attributable to transport from all upwind states collectively contributing to the air quality problem. In CSAPR and the CSAPR Update Rule, EPA used the 1% air quality threshold to identify linkages between upwind states and downwind maintenance receptors. States whose contributions to a specific receptor meet or exceed the threshold were considered to be linked to that receptor. The linked states' emissions (and available emission reductions) were then analyzed further as a second step to EPA's contribution analysis. States whose contributions to all receptors were below the 1% threshold did not require further evaluation to address interstate transport and we therefore found those states were determined to make insignificant contributions to downwind air quality. Therefore, the states below the threshold do not significantly contribute to nonattainment or interfere with maintenance of the NAAQS in other states. EPA used the 1% threshold in the East because prior analysis showed that, in general, nonattainment problems result from a combined impact of relatively small individual contributions from upwind states, along with contributions from in-state sources. EPA has observed that a relatively large portion of the air quality problem at most ozone nonattainment and maintenance receptors in the East is the result of the collective contribution from a number of upwind states.

Specifically, EPA found the total upwind states' contribution to ozone concentration (from linked and unlinked states) based on modeling for 2017 ranges from 17% to 67% to identified downwind air quality problems in the East, with between 4 and 12 states each contributing above 1% to the downwind air quality problem.15 16 Thus, irrespective of the 1% air quality threshold in the East, EPA has found that the collective contributions from upwind states represent a large portion of the ozone concentrations at projected air quality problems. Further, in the East, EPA found that the 1% threshold is appropriate to capture a high percentage of the total pollution transport affecting downwind receptors. By comparison, according to EPA's modeling, the total upwind (linked or unlinked) states' contribution to ozone concentration at the projected nonattainment sites in El Centro, California and Los Angeles, California, is comparatively small, with only one state contributing above 1% to the downwind air quality problem.

Arizona is the only state that contributes greater than the 1% threshold to the projected 2017 levels of the 2008 ozone NAAQS at the El Centro receptor. The total contribution from all states to the El Centro receptor is 4.4% of the total ozone concentration at this receptor. Arizona is also the only state that contributes greater than 1% to the projected 2017 levels of the 2008 ozone NAAQS at the Los Angeles receptor, and the total contribution from all states is 2.5% of the ozone concentration at this receptor. EPA believes that a 4.4% and 2.5% cumulative ozone contribution from all upwind states is negligible, particularly when compared to the relatively large contributions from upwind states in the East or in certain other areas of the West. For these reasons, EPA believes the emissions that result in transported ozone from upwind states have limited impacts on the projected air quality problems in El Centro, California and Los Angeles, California, and therefore should not be treated as receptors for purposes of determining the interstate transport obligations of upwind states under section 110(a)(2)(D)(i)(I).

Additionally, EPA has evaluated the Arizona VOC and NOX emissions inventory and emissions projections and agrees that emissions will be decreasing over time. Given that emissions within the state are expected to decrease over time due to regional haze measures, Federal engine and fuel standards, and other Federal, State, and local rules,17 EPA believes that the Arizona SIP contains adequate provisions to ensure that air emissions in Arizona do not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in California or any other state in the future.

The modeling data show that Arizona contributes either less than 1% of the NAAQS to projected air quality problems in other states, or where it contributes above 1% of the NAAQS to a projected downwind air quality problem in California, EPA proposes to find, based on the overall weight of evidence, that these particular receptors are not significantly impacted by transported ozone from upwind states. Emissions reductions from Arizona are not necessary to address interstate transport because the total collective upwind state ozone contribution to these receptors is relatively low compared to the air quality problems typically addressed by the good neighbor provision. Additionally, Arizona has demonstrated that both VOC and NOX emissions are going down and will continue to go down. EPA therefore believes that Arizona's contributions to downwind receptors in California are considered insignificant. EPA proposes to find that Arizona does not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in other states.

EPA believes that ozone precursor emissions of NOX may contribute to visibility impairment in Class I areas. EPA's 2013 I-SIP guidance clarifies that a state can rely upon a fully EPA-approved Regional Haze SIP to satisfy the requirements of this sub-element. Arizona's Regional Haze SIP shows that sources in Arizona impact visibility in Colorado (Great Sand Dunes National Monument, Mesa Verde National Park, Black Canyon of the Gunnison National Park, La Garita Wilderness, and Weminuche Wilderness), New Mexico (Bandelier National Monument, San Pedro Parks Wilderness, Pecos Wilderness, Bosque del Apache National Wildlife Reserve, and Gila Wilderness), and Utah (Zion National Park, Bryce Canyon National Park, Capitol Reef National Park, Canyonlands National Park, and Arches National Park).18 Arizona's Regional Haze SIP is not fully approved by EPA. Instead, Arizona's 2012 and 2015 submittals rely, in part, on regulations imposed by FIPs to address visibility impairment in Class 1 Areas caused by NOX, SO2, and PM. These regulations include emission limits on the following facilities: Arizona Public Service Cholla Power Plant,19 Salt River Project Coronado Generating Station,20 Freeport McMoran Miami Smelter,21 ASARCO Hayden Smelter,22 Sundt Generating Station Unit 4,23 and Nelson Lime Plant Kilns 1 and 2.24 Emissions limits have been incorporated into the state SIP, replacing a previous FIP, at AEPCO Apache Station Units 1, 2, and 3.25

Because Arizona's 2012 and 2015 submittals rely in part on FIPs to address interstate transport visibility requirements, they do not meet the requirements of prong 4 for the 2008 ozone NAAQS. However, because FIPs are already in place, no additional FIP obligation would be triggered by a final disapproval of this portion of Arizona's infrastructure SIP. EPA will continue to work with Arizona to incorporate emission limits to address the requirements of the Regional Haze Rule into the Arizona SIP. For further discussion of our analysis of prong 4, please see the TSD associated with this proposal and in the docket for today's rulemaking.

EPA is proposing to approve Arizona's SIP as meeting the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) prongs 1 and 2 for the 2008 ozone NAAQS. EPA is proposing this approval based on the overall weight of evidence from information and analysis provided by Arizona, as well as the recent air quality modeling released in EPA's August 4, 2015 NODA, and other data analysis that confirms that emissions from Arizona will not contribute significantly to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in California or any other state.

EPA is proposing to disapprove Arizona's SIP with respect to the interstate transport requirements of CAA section 110(a)(2)(D)(i)(II) prong 4 for the 2008 ozone NAAQS. Because Arizona's 2012 and 2015 submittals rely, in part, on FIPs to address interstate transport visibility requirements, they do not meet the requirements of this portion of CAA § 110(a)(2)(D) for the 2008 ozone NAAQS. However, because FIPs are already in place, no additional FIP obligation would be triggered by a final disapproval of this portion of Arizona's infrastructure SIP. EPA will continue to work with Arizona to incorporate emission limits to address the requirements of the Regional Haze Rule into the Arizona SIP.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by state law.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, will result from this action.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175, because the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not impose additional requirements beyond those imposed by state law.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.

The EPA lacks the discretionary authority to address environmental justice in this rulemaking.

I. Background

By statute, SIPs meeting the requirements of sections 110(a)(1) and (2) of the CAA are to be submitted by states within three years after promulgation of a new or revised NAAQS to provide for the implementation, maintenance, and enforcement of the new or revised NAAQS. EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Sections 110(a)(1) and (2) require states to address basic SIP elements such as for monitoring, basic program requirements, and legal authority that are designed to assure attainment and maintenance of the newly established or revised NAAQS. More specifically, section 110(a)(1) provides the procedural and timing requirements for infrastructure SIPs. Section 110(a)(2) lists specific elements that states must meet for the infrastructure SIP requirements related to a newly established or revised NAAQS. The contents of an infrastructure SIP submission may vary depending upon the data and analytical tools available to the state, as well as the provisions already contained in the state's implementation plan at the time in which the state develops and submits the submission for a new or revised NAAQS.

Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and 110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct components, commonly referred to as “prongs,” that must be addressed in infrastructure SIP submissions. The first two prongs, which are codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (prong 1) and from interfering with maintenance of the NAAQS in another state (prong 2). The third and fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality in another state (prong 3) or from interfering with measures to protect visibility in another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs to include provisions insuring compliance with sections 115 and 126 of the Act, relating to interstate and international pollution abatement.

Through this action, EPA is proposing to disapprove the prong 4 portions of Mississippi's infrastructure SIP submissions for the 2008 8-hour Ozone, 2010 1-hour NO2, 2010 1-hour SO2, and 2012 annual PM2.5 NAAQS. All other applicable infrastructure SIP requirements for these SIP submissions have been or will be addressed in separate rulemakings. A brief background regarding the NAAQS relevant to today's proposal is provided below. For comprehensive information on these NAAQS, please refer to the Federal Register notices cited in the following subsections.

On March 12, 2008, EPA revised the 8-hour Ozone NAAQS to 0.075 parts per million. See 73 FR 16436 (March 27, 2008). States were required to submit infrastructure SIP submissions for the 2008 8-hour Ozone NAAQS to EPA no later than March 12, 2011. For the 2008 8-hour Ozone NAAQS, today's proposed action only addresses the prong 4 element of Mississippi's infrastructure SIP submissions received on May 29, 2012, and July 26, 2012. EPA took action on the remainder of Mississippi's May 29, 2012, SIP submission, and July 26, 2012, SIP resubmission in separate rulemakings. See 80 FR 11131 (March 2, 2015); 80 FR 14019 (March 18, 2015); 80 FR 48355 (August 12, 2015).

On January 22, 2010, EPA established a new 1-hour primary NAAQS for NO2 at a level of 100 parts per billion, based on a 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. See 75 FR 6474 (February 9, 2010). States were required to submit infrastructure SIP submissions for the 2010 1-hour NO2 NAAQS to EPA no later than January 22, 2013. For the 2010 1-hour NO2 NAAQS, today's proposed action only addresses the prong 4 element of Mississippi's infrastructure SIP submission received on February 28, 2013. EPA will take action on the remainder of Mississippi's February 28, 2013, SIP submission through a separate rulemaking.

On June 2, 2010, EPA revised the primary SO2 NAAQS to an hourly standard of 75 parts per billion based on a 3-year average of the annual 99th percentile of 1-hour daily maximum concentrations. See 75 FR 35520 (June 22, 2010). States were required to submit infrastructure SIP submissions for the 2010 1-hour SO2 NAAQS to EPA no later than June 2, 2013. For the 2010 1-hour SO2 NAAQS, today's proposed action only addresses the prong 4 element of Mississippi's infrastructure SIP submission received on June 20, 2013. EPA will take action on the remainder of Mississippi's June 20, 2013, SIP submission through a separate rulemaking.

On December 14, 2012, EPA revised the primary annual PM2.5 NAAQS to 12 micrograms per cubic meter (μg/m3). See 78 FR 3086 (January 15, 2013). An area will meet the standard if the three-year average of its annual average PM2.5 concentration (at each monitoring site in the area) is less than or equal to 12.0 μg/m3. States were required to submit infrastructure SIP submissions for the 2012 PM2.5 NAAQS to EPA no later than December 14, 2015. For the 2012 PM2.5 NAAQS, today's proposed action only addresses the prong 4 element of Mississippi's infrastructure SIP submission received on December 8, 2015. EPA will take action on the remainder of Mississippi's December 8, 2015 SIP submission through a separate rulemaking.

The requirement for states to make a SIP submission of this type arises out of section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “each such plan” submission must address.

EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of section 110(a)(1) and (2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of Title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of section 169A of the CAA, and nonattainment new source review permit program submissions to address the permit requirements of CAA, Title I, part D.

Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.1 EPA therefore believes that while the timing requirement in section 110(a)(1) is unambiguous, some of the other statutory provisions are ambiguous. In particular, EPA believes that the list of required elements for infrastructure SIP submissions provided in section 110(a)(2) contains ambiguities concerning what is required for inclusion in an infrastructure SIP submission.

The following examples of ambiguities illustrate the need for EPA to interpret some section 110(a)(1) and section 110(a)(2) requirements with respect to infrastructure SIP submissions for a given new or revised NAAQS. One example of ambiguity is that section 110(a)(2) requires that “each” SIP submission must meet the list of requirements therein, while EPA has long noted that this literal reading of the statute is internally inconsistent and would create a conflict with the nonattainment provisions in part D of Title I of the CAA, which specifically address nonattainment SIP requirements.2 Section 110(a)(2)(I) pertains to nonattainment SIP requirements and part D addresses when attainment plan SIP submissions to address nonattainment area requirements are due. For example, section 172(b) requires EPA to establish a schedule for submission of such plans for certain pollutants when the Administrator promulgates the designation of an area as nonattainment, and section 107(d)(1)(B) allows up to two years or in some cases three years, for such designations to be promulgated.3 This ambiguity illustrates that rather than apply all the stated requirements of section 110(a)(2) in a strict literal sense, EPA must determine which provisions of section 110(a)(2) are applicable for a particular infrastructure SIP submission.

Another example of ambiguity within section 110(a)(1) and (2) with respect to infrastructure SIPs pertains to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action.4 Similarly, EPA interprets the CAA to allow it to take action on the individual parts of one larger, comprehensive infrastructure SIP submission for a given NAAQS without concurrent action on the entire submission. For example, EPA has sometimes elected to act at different times on various elements and sub-elements of the same infrastructure SIP submission.5

Ambiguities within section 110(a)(1) and (2) may also arise with respect to infrastructure SIP submission requirements for different NAAQS. Thus, EPA notes that not every element of section 110(a)(2) would be relevant, or as relevant, or relevant in the same way, for each new or revised NAAQS. The states' attendant infrastructure SIP submissions for each NAAQS therefore could be different. For example, the monitoring requirements that a state might need to meet in its infrastructure SIP submission for purposes of section 110(a)(2)(B) could be very different for different pollutants, because the content and scope of a state's infrastructure SIP submission to meet this element might be very different for an entirely new NAAQS than for a minor revision to an existing NAAQS.6

EPA notes that interpretation of section 110(a)(2) is also necessary when EPA reviews other types of SIP submissions required under the CAA. Therefore, as with infrastructure SIP submissions, EPA also has to identify and interpret the relevant elements of section 110(a)(2) that logically apply to these other types of SIP submissions. For example, section 172(c)(7) requires attainment plan SIP submissions required by part D to meet the “applicable requirements” of section 110(a)(2); thus, attainment plan SIP submissions must meet the requirements of section 110(a)(2)(A) regarding enforceable emission limits and control measures and section 110(a)(2)(E)(i) regarding air agency resources and authority. By contrast, it is clear that attainment plan SIP submissions required by part D would not need to meet the portion of section 110(a)(2)(C) that pertains to the PSD program required in part C of Title I of the CAA, because PSD does not apply to a pollutant for which an area is designated nonattainment and thus subject to part D planning requirements. As this example illustrates, each type of SIP submission may implicate some elements of section 110(a)(2) but not others.

Given the potential for ambiguity in some of the statutory language of section 110(a)(1) and section 110(a)(2), EPA believes that it is appropriate to interpret the ambiguous portions of section 110(a)(1) and section 110(a)(2) in the context of acting on a particular SIP submission. In other words, EPA assumes that Congress could not have intended that each and every SIP submission, regardless of the NAAQS in question or the history of SIP development for the relevant pollutant, would meet each of the requirements, or meet each of them in the same way. Therefore, EPA has adopted an approach under which it reviews infrastructure SIP submissions against the list of elements in section 110(a)(2), but only to the extent each element applies for that particular NAAQS.

Historically, EPA has elected to use guidance documents to make recommendations to states for infrastructure SIPs, in some cases conveying needed interpretations on newly arising issues and in some cases conveying interpretations that have already been developed and applied to individual SIP submissions for particular elements.7 EPA most recently issued guidance for infrastructure SIPs on September 13, 2013 (2013 Guidance).8 EPA developed this document to provide states with up-to-date guidance for infrastructure SIPs for any new or revised NAAQS. Within this guidance, EPA describes the duty of states to make infrastructure SIP submissions to meet basic structural SIP requirements within three years of promulgation of a new or revised NAAQS. EPA also made recommendations about many specific subsections of section 110(a)(2) that are relevant in the context of infrastructure SIP submissions.9 The guidance also discusses the substantively important issues that are germane to certain subsections of section 110(a)(2). EPA interprets section 110(a)(1) and (2) such that infrastructure SIP submissions need to address certain issues and need not address others. Accordingly, EPA reviews each infrastructure SIP submission for compliance with the applicable statutory provisions of section 110(a)(2), as appropriate.

As an example, section 110(a)(2)(E)(ii) is a required element of section 110(a)(2) for infrastructure SIP submissions. Under this element, a state must meet the substantive requirements of section 128, which pertain to state boards that approve permits or enforcement orders and heads of executive agencies with similar powers. Thus, EPA reviews infrastructure SIP submissions to ensure that the state's SIP appropriately addresses the requirements of section 110(a)(2)(E)(ii) and section 128. The 2013 Guidance explains EPA's interpretation that there may be a variety of ways by which states can appropriately address these substantive statutory requirements, depending on the structure of an individual state's permitting or enforcement program (e.g., whether permits and enforcement orders are approved by a multi-member board or by a head of an executive agency). However they are addressed by the state, the substantive requirements of Section 128 are necessarily included in EPA's evaluation of infrastructure SIP submissions because section 110(a)(2)(E)(ii) explicitly requires that the state satisfy the provisions of section 128.

As another example, EPA's review of infrastructure SIP submissions with respect to the PSD program requirements in section 110(a)(2)(C), (D)(i)(II), and (J) focuses upon the structural PSD program requirements contained in part C and EPA's PSD regulations. Structural PSD program requirements include provisions necessary for the PSD program to address all regulated sources and NSR pollutants, including Greenhouse Gases (GHGs). By contrast, structural PSD program requirements do not include provisions that are not required under EPA's regulations at 40 CFR 51.166 but are merely available as an option for the state, such as the option to provide grandfathering of complete permit applications with respect to the PM2.5 NAAQS. Accordingly, the latter optional provisions are types of provisions EPA considers irrelevant in the context of an infrastructure SIP action.

For other section 110(a)(2) elements, however, EPA's review of a state's infrastructure SIP submission focuses on assuring that the state's SIP meets basic structural requirements. For example, section 110(a)(2)(C) includes, inter alia, the requirement that states have a program to regulate minor new sources. Thus, EPA evaluates whether the state has an EPA-approved minor new source review program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (i.e., already in the existing SIP) for compliance with the requirements of the CAA and EPA's regulations that pertain to such programs.

With respect to certain other issues, EPA does not believe that an action on a state's infrastructure SIP submission is necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP. These issues include: (i) Existing provisions related to excess emissions from sources during periods of startup, shutdown, or malfunction (SSM) that may be contrary to the CAA and EPA's policies addressing such excess emissions; 10 (ii) existing provisions related to “director's variance” or “director's discretion” that may be contrary to the CAA because they purport to allow revisions to SIP-approved emissions limits while limiting public process or not requiring further approval by EPA; and (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (NSR Reform). Thus, EPA believes that it may approve an infrastructure SIP submission without scrutinizing the totality of the existing SIP for such potentially deficient provisions and may approve the submission even if it is aware of such existing provisions.11 It is important to note that EPA's approval of a state's infrastructure SIP submission should not be construed as explicit or implicit re-approval of any existing potentially deficient provisions that relate to the three specific issues just described.

EPA's approach to review of infrastructure SIP submissions is to identify the CAA requirements that are logically applicable to that submission. EPA believes that this approach to the review of a particular infrastructure SIP submission is appropriate, because it would not be reasonable to read the general requirements of section 110(a)(1) and the list of elements in section 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. Because SIPs have grown by accretion over the decades as statutory and regulatory requirements under the CAA have evolved, they may include some outmoded provisions and historical artifacts. These provisions, while not fully up to date, nevertheless may not pose a significant problem for the purposes of “implementation, maintenance, and enforcement” of a new or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP submission. EPA believes that a better approach is for states and EPA to focus attention on those elements of section 110(a)(2) of the CAA most likely to warrant a specific SIP revision due to the promulgation of a new or revised NAAQS or other factors.

For example, EPA's 2013 Guidance gives simpler recommendations with respect to carbon monoxide than other NAAQS pollutants to meet the visibility requirements of section 110(a)(2)(D)(i)(II), because carbon monoxide does not affect visibility. As a result, an infrastructure SIP submission for any future new or revised NAAQS for carbon monoxide need only state this fact in order to address the visibility prong of section 110(a)(2)(D)(i)(II).

Finally, EPA believes that its approach with respect to infrastructure SIP requirements is based on a reasonable reading of section 110(a)(1) and (2) because the CAA provides other avenues and mechanisms to address specific substantive deficiencies in existing SIPs. These other statutory tools allow EPA to take appropriately tailored action, depending upon the nature and severity of the alleged SIP deficiency. Section 110(k)(5) authorizes EPA to issue a “SIP call” whenever the Agency determines that a state's SIP is substantially inadequate to attain or maintain the NAAQS, to mitigate interstate transport, or to otherwise comply with the CAA.12 Section 110(k)(6) authorizes EPA to correct errors in past actions, such as past approvals of SIP submissions.13 Significantly, EPA's determination that an action on a state's infrastructure SIP submission is not the appropriate time and place to address all potential existing SIP deficiencies does not preclude EPA's subsequent reliance on provisions in section 110(a)(2) as part of the basis for action to correct those deficiencies at a later time. For example, although it may not be appropriate to require a state to eliminate all existing inappropriate director's discretion provisions in the course of acting on an infrastructure SIP submission, EPA believes that section 110(a)(2)(A) may be among the statutory bases that EPA relies upon in the course of addressing such deficiency in a subsequent action.14

Section 110(a)(2)(D)(i)(II) requires a state's SIP to contain provisions prohibiting sources in that state from emitting pollutants in amounts that interfere with any other state's efforts to protect visibility under part C of the CAA (which includes sections 169A and 169B). The 2013 Guidance states that these prong 4 requirements can be satisfied by approved SIP provisions that EPA has found to adequately address any contribution of that state's sources to impacts on visibility program requirements in other states. The 2013 Guidance also states that EPA interprets this prong to be pollutant-specific, such that the infrastructure SIP submission need only address the potential for interference with protection of visibility caused by the pollutant (including precursors) to which the new or revised NAAQS applies.

The 2013 Guidance lays out two ways in which a state's infrastructure SIP may satisfy prong 4. The first way is through an air agency's confirmation in its infrastructure SIP submission that it has an EPA-approved regional haze SIP that fully meets the requirements of 40 CFR 51.308 or 51.309. 40 CFR 51.308 and 51.309 specifically require that a state participating in a regional planning process include all measures needed to achieve its apportionment of emission reduction obligations agreed upon through that process. A fully approved regional haze SIP will ensure that emissions from sources under an air agency's jurisdiction are not interfering with measures required to be included in other air agencies' plans to protect visibility.

Alternatively, in the absence of a fully approved regional haze SIP, a state may meet the requirements of prong 4 through a demonstration in its infrastructure SIP submission that emissions within its jurisdiction do not interfere with other air agencies' plans to protect visibility. Such an infrastructure SIP submission would need to include measures to limit visibility-impairing pollutants and ensure that the reductions conform with any mutually agreed regional haze reasonable progress goals for mandatory Class I areas in other states.

Mississippi's May 29, 2012, 2008 8-hour Ozone submission; July 26, 2012, 2008 8-hour Ozone resubmission; February 28, 2013, 2010, NO2 submission; and December 8, 2015, 2012 PM2.5 submission each cite to the State's regional haze SIP as satisfying prong 4 requirements. The June 20, 2013, 2010 SO2 submission cites to the State's regional haze SIP and to EPA's February 20, 2013 (78 FR 11805) notice of proposed rulemaking (NPRM) on the prong 4 element of the State's infrastructure SIP submissions for the 1997 and 2006 PM2.5 NAAQS. In that notice, EPA proposed to approve the prong 4 element on the basis that Mississippi's regional haze SIP, in combination with its SIP provisions to implement the Clean Air Interstate Rule (CAIR), prevented sources from interfering with measures adopted by other states to protect visibility.

In its regional haze SIP, Mississippi relied on CAIR to satisfy the best available retrofit technology (BART) requirements for its CAIR-subject electricity generating units (EGUs).15 Although this reliance on CAIR was consistent with the CAA at the time that the State submitted its regional haze SIP, CAIR has since been replaced by the Cross-State Air Pollution Rule (CSAPR) and can no longer be relied upon as a substitute for BART or as part of a long-term control strategy (LTS) for regional haze. Therefore, EPA finalized a limited disapproval of the Mississippi regional haze SIP to the extent that it relies on CAIR to satisfy BART and LTS requirements.16 See 77 FR 33642 (June 7, 2012). Because Mississippi's regional haze SIP is not fully approved, the State cannot rely on this plan alone to meet the prong 4 requirements for the 2008 Ozone, 2010 1-hour NO2, 2010 1-hour SO2, and 2012 PM2.5 NAAQS. Furthermore, unlike CAIR, CSAPR does not cover SO2 emissions from EGUs in Mississippi and therefore cannot be relied upon to fully satisfy outstanding regional haze requirements for EGUs in the State.

Mississippi's reference to EPA's February 20, 2013, NPRM to approve the prong 4 element of the State's infrastructure SIP submissions for the 1997 and 2006 PM2.5 NAAQS is not relevant because the legal status of CAIR and CSAPR has changed since publication of that notice. In June 2012, EPA finalized the limited disapproval of the State's regional haze SIP, which relied on CAIR to satisfy affected EGUs' BART requirements. At that time, questions regarding the legality of CSAPR were pending before the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit). The D.C. Circuit subsequently vacated and remanded CSAPR in August 2012, leaving CAIR in place temporarily.17 As of February 20, 2013, when EPA proposed approving the prong 4 element of the State's 1997 and 2006 PM2.5 infrastructure SIP submissions, EPA had not yet asked the United States Supreme Court to review the D.C. Circuit's decision on CSAPR. Based upon the D.C. Circuit's direction to EPA to continue administering CAIR, the Agency believed that it was appropriate for states to rely on CAIR emission reductions for prong 4 purposes. EPA intended to allow this practice until a valid replacement for CAIR was developed and EPA acted on SIPs submitted in compliance with any new rule, or until the CSAPR litigation was resolved in a way that provided different direction regarding CAIR and CSAPR. After publication of the February 20, 2013, prong 4 proposal, EPA asked the Supreme Court to review the DC Circuit's decision and the Supreme Court reversed that ruling and upheld CSAPR.18 EPA began implementation of CSAPR, which replaced CAIR, on January 1, 2015. Therefore, because of this intervening change in the law, EPA cannot finalize its February 20, 2013, proposal to approve the prong 4 element that relies on CAIR, and Mississippi cannot rely on the outdated rationale contained in the NPRM regarding CAIR to satisfy prong 4.

As mentioned above, a state may meet the requirements of prong 4 without a fully approved regional haze SIP by showing that its SIP contains adequate provisions to prevent emissions from within the state from interfering with other states' measures to protect visibility. Mississippi did not, however, provide a demonstration in any of the infrastructure SIP submissions subject to today's proposed action that emissions within its jurisdiction do not interfere with other states' plans to protect visibility.

As discussed above, Mississippi does not have a fully approved regional haze SIP that meets the requirements of 40 CFR 51.308 and has not otherwise shown that its SIP contains adequate provisions to prevent emissions from within the state from interfering with other states' measures to protect visibility. Therefore, EPA is proposing to disapprove the prong 4 portions of Mississippi's May 29, 2012, 2008 8-hour Ozone infrastructure SIP submission; July 26, 2012, 2008 8-hour Ozone infrastructure SIP resubmission; February 28, 2013, 2010 1-hour NO2 infrastructure SIP submission; June 20, 2013, 2010 1-hour SO2 infrastructure SIP submission; and December 8, 2015, 2012 annual PM2.5 infrastructure SIP submission. Mississippi did not submit these infrastructure SIPs to meet requirements for Part D or a SIP call; therefore, if EPA takes final action to disapprove the prong 4 portions of these submissions, no sanctions will be triggered. However, if EPA finalizes this proposed disapproval action, that final action will trigger the requirement under section 110(c) that EPA promulgate a FIP no later than two years from the date of the disapproval unless the State corrects the deficiency through a SIP revision and EPA approves the SIP revision before EPA promulgates such a FIP.

As described above, EPA is proposing to disapprove the prong 4 portions of Mississippi's May 29, 2012, 2008 Ozone infrastructure SIP submission; July 26, 2012, 2008 Ozone infrastructure SIP resubmission; February 28, 2013, 2010 NO2 infrastructure SIP submission; June 20, 2013, 2010 SO2 infrastructure SIP submission; and December 8, 2015, 2012 PM2.5 infrastructure SIP submission. All other outstanding applicable infrastructure requirements for these SIP submissions will be addressed in separate rulemakings.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. EPA is proposing to determine that the prong 4 portions of the aforementioned SIP submissions do not meet Federal requirements. Therefore, this proposed action does not impose additional requirements on the state beyond those imposed by state law. For that reason, this proposed action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

This is a summary of the Commission's Notice of Proposed Rulemaking and Order (NPRM and Order), ET Docket No. 16-56, FCC 16-23, adopted February 25, 2016 and released February 26, 2016. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov.

1. In this NPRM, the Commission proposes and seek comment on revisions to the geo-location and registration requirements for fixed white space devices. It proposes to adopt many of the recommendations outlined in the plan submitted by the National Association of Broadcasters and certain white space device manufacturers (“NAB and Manufacturers' Plan”) and believes that this approach will improve the integrity of the white space database system and better ensure efficient and beneficial use of white spaces while protecting licensees and other authorized users.

2. Location Data. The Commission proposes to modify section 15.711(c) to eliminate the option for professional installation of fixed white space devices, thereby eliminating the possibility that manual data entry could cause incorrect location data to be stored in the white space device or provided to a database. The Commission proposes to instead require that fixed white space devices include a geo-location capability that can automatically determine its geographic coordinates without manual intervention. It also proposes that the geographic coordinates shall be stored automatically in the fixed white space device and transmitted electronically directly from the device to the database, rather than entered manually in the database, thereby further reducing the possibility of introducing data errors.

3. The Commission proposes that when a fixed white space device is moved to another location or its coordinates become altered, its geographic coordinates and antenna height above ground must be re-established and the device re-registered with a database. With regard to the geographic coordinates, it proposes that they be re-established using an incorporated geo-location capability. The Commission seeks comment on these proposals and on whether a re-registration requirement should apply to any change in location or only those changes where the coordinates differ by more than the accuracy requirement (±50 meters) from the last registered location. With respect to the antenna height above ground, the Commission seeks comment on whether it should require that this height be determined automatically using the fixed device's incorporated geo-location capability, such as GPS. Because the vertical height accuracy of GPS is typically less than the horizontal location accuracy, the Commission seeks comment on whether it should allow users, including professional installers and operators, to override an automatically determined height if it proves to be inaccurate, or whether it should simply allow users to manually enter the antenna height above ground in all cases.

4. The Commission proposes to modify the current rule that requires a fixed white space device to contact the database at least once a day to verify that its operating channels continue to be available for its use. It proposes to require a fixed white space device to check its coordinates once each day, except when not in operation, and to report its geographic location to the database when its makes its daily request for a list of available channels. The Commission seeks comment on implementing this proposal. Should the geographic coordinates reported each day be treated by the white space database as a modification of the registration record? Should the registration record be updated only if the difference in location exceeds 50 meters? What would be the impact on device manufacturers and database administrators?

5. The Commission recognizes that there will be many important applications for fixed white space devices in which the device needs to be installed where an incorporated geo-location capability will not function (e.g., indoors). Thus, the Commission proposes to permit fixed white space devices to obtain their geographic coordinates from an external source that is connected to the fixed white space device when the internal geo-location capability does not function. It also proposes that, in cases where the geo-location capability is provided by an external source connected to the fixed white space device, the fixed device and external geo-location source would be required to communicate using a secure method that ensures that the fixed device obtains information only from a source that has been approved for that function by the Commission's equipment certification program. If the fixed white space device is unable to verify that the external source from which it is receiving geo-location data is an approved source, the fixed device would not be allowed to use that received data when reporting its location to the database. The Commission seeks comment on whether each fixed white space device should be associated with specific external geo-location sources or whether manufacturers should have the flexibility to design fixed white space devices to operate with a variety of geo-location sources as long as such sources are approved for use with the fixed white space device.

6. The NAB and Manufacturers' Plan makes specific suggestions for how fixed devices should rely on an external geo-location source for determining the geographic coordinates of a fixed white space device. It suggests that the external geo-location source would be required to be connected at all times to the fixed white space device, and that the fixed white space device would be required to cease transmitting if the connection to the external geo-location source is disconnected or ceased to function properly. NAB and the Manufacturers suggest that the connection between the fixed white space device and the external geo-location source could be by Ethernet, USB, serial port or other connection, and a fixed device would be required to be located within 100 meters of the geo-location source. The parties also suggest that a separate geo-location source may be connected to more than one fixed device at the same general location as long as the white space devices it serves are all located no more than 100 meters from the geo-location source. The Commission requests comment on these specific suggestions. Do the methods suggested by the NAB and Manufacturers' Plan provide sufficient flexibility in the design of fixed devices without compromising our goal of ensuring that a device operates at the location reported to its databases. The Commission seeks comment on whether it is necessary for a fixed white space device to be connected to its external geo-location source by a cable, or whether we could permit the connection to the geo-location source via wireless. Because allowing wireless connections may create a path for entering erroneous location data, commenters are asked to address whether safeguards tailored to the wireless environment are needed to ensure location data is within the required accuracy guidelines, and, if so, what they should be. The Commission also seeks comment on the appropriate method of obtaining the antenna height above ground for indoor fixed devices (automatic determination or manual entry) that is reported to the white space database.

7. As an alternative to using any type of external geo-location source, the Commission seeks comment on whether a fixed white space device could be connected by a long cable to a separate antenna and continue to rely on its internal geo-location capability. What requirements would be necessary to ensure that the coordinates and location uncertainty reported to the white space database are accurate? Would the suggestions in the NAB and Manufacturers' plan be appropriate for this situation?

8. The NAB and Manufacturers' Plan also suggests another approach for low power (40 mW EIRP) fixed white space devices with an internal geo-location capability that operate indoors where their geo-location capability does not function. Under this provision, the rules would allow a fixed white space device operating with 40 mW or less EIRP to establish its location using its incorporated geo-location capability at a point immediately outside the indoor or other enclosure where the device's geo-location capability does not function, and then to register with its database after the device is installed at its fixed location using the location established at the outdoor point. In such applications, the device would store internally the coordinates of an outdoor position as close as possible to the location where it will be installed and also record the time that it obtained those coordinates. The device would then be installed at its fixed location and register with its database within 30 minutes using the coordinates of the outdoor location. If the device does not complete its registration within the 30 minute period, it would need to start over, re-establish its coordinates at a location where its geo-location capability functions, and initiate a new 30 minute time period. The Commission seeks comment on these suggestions and asks whether this is a workable approach that would provide additional flexibility in the methods for determining geo-location for fixed devices located indoors without increasing the potential for inaccurate locations to be recorded in the databases and/or increase the potential for interference.

9. The Commission seeks comment on alternative parameters and approaches. Is 40 mW the appropriate power level at which to define a low power fixed white space device or would 100 mW be more appropriate? Is 30 minutes sufficient time for the installer to re-locate the device to a nearby operating location, activate the device, register the device with a database, and complete any other steps necessary for the installation? Is 30 minutes the appropriate amount of time to balance the need for properly completing the installation and registration of a device while limiting the opportunity for relocating the device to a faraway place where it could cause interference?

10. The Commission also seeks comment on where the responsibility would lie in verifying that the fixed white space device registration occurs within the allowable 30 minute time period. Should the capability reside in the fixed white space device whereby after 30 minutes the data would automatically be erased if the device is not successfully registered with a database, or should an associated time stamp for the geo-location data be transmitted to the database which would not permit the registration to proceed if outside the 30 minute window? Should the Commission allow other methods of transferring location data to fixed white space devices—for example, could an outdoor location sensor, such as a GPS receiver, write an encrypted file to an SD Card or USB memory stick that could then be plugged into a fixed white space device? How would such a connection ensure that a fixed device would be located no more than 100 meters from its geo-location source? Under such a scheme, what methods could be used to ensure registration within 30 minutes of determining the fixed white space device's location?

11. Low power fixed white space devices operating indoors where their incorporated geo-location capability does not function would not be able to re-check their coordinates daily and transmit them to the database when verifying their available channel list, unless each day the device was uninstalled and moved to the outdoor location to repeat the entire initial location-determining procedure. The Commission seeks comment on whether in such situations, it should allow these devices to use the coordinates previously obtained at an outdoor position and stored in the device until such time as the device is moved or disconnected from its power supply, at which point the device would again re-establish its coordinates using its incorporated geo-location capability. If using previously obtained coordinates in this manner would not serve the public interest, does the impracticality of obtaining updated coordinates on a daily basis warrant a rejection of this proposal? Are there other methods for updating the location information of these devices, short of using a wired external geo-location source, which could be employed successfully?

12. Because the Commission adopted rules in the Part 15 White Space Report and Order in ET Docket No. 14-165 that provide flexibility to manufacturers and operators of white space devices that use less accurate geo-location methods, it tentatively concludes that it is not necessary to modify the default location accuracy requirement from ±50 meters to ±100 meters as requested in the NAB and Manufacturers Plan. Should parties disagree, the Commission seeks comment on what changes we should make and how they should be implemented.

13. NAB and the Manufacturers request an increase in protection distances that is greater than their requested increase in geo-location uncertainty. If the Commission were to specify a less accurate geo-location requirement, it seeks comment on how much the protection distances to TV contours should change, and on whether and by what amount distances from any other protected service may need to be increased. It also seeks comment on whether rule changes would be needed to account for indoor operations. How could it ensure that the reported geo-location uncertainty of an indoor device is accurate? For example, should a device that obtains its location from a separate geo-location source automatically add a certain amount, such as 100 meters, to its geo-location uncertainty when providing its location to the database? How would such a requirement apply for a device that is moved outdoors to obtain its coordinates and then moved back to an indoor location?

14. The Commission proposes that effective six months after the effective date of the new rules, new applications for certification of fixed white space devices must comply with any rules it adopts in this proceeding requiring incorporated geo-location capability. Further, it proposes that within one year after the effective date of any new rules, manufacturers would no longer be able to manufacture and import fixed white space devices that do not comply with the new requirements. In order to allow manufacturers to deplete any inventory of devices that do not comply with the new requirements, the Commission proposes to permit the marketing of these devices for up to eighteen months after the effective date of the new rules, but seeks comment on whether it should specify only certification and marketing cutoff dates (e.g., six months for certification and 12 or 18 months for marketing), and allow manufacturers to decide their manufacturing and importation cutoff dates. The Commission proposes to permit users of fixed white space devices that do not comply with new rules to continue to operate their devices indefinitely. Because the majority of fixed white space devices in operation today do not include a geo-location capability and would not be able to easily recheck their coordinates every day and transmit them to the database, the Commission seeks comment on whether allowing their continued operation would pose any concerns about the integrity of the data in the database.

15. The Commission proposes to treat equipment changes that simply add an incorporated geo-location capability to an existing certificated device as a permissive change under its equipment authorization rules. It seeks comment on the proposed timeframes for implementing any new requirements for incorporating a geo-location capability into all fixed white space devices and whether they are appropriate to provide for a smooth transition to new devices.

16. Finally, the Commission invites comment on the expected costs and benefits of the proposed rule changes in this section and whether the benefits will outweigh the costs. Parties who make specific suggestions for implementing the proposals also should address the costs and benefits associated with their suggestions.

17. Device Identification, Contact Information and Other Data Issues. The current rules assign responsibility for the accuracy of the registration information either to the party who provides the information to the database or to the party who is responsible for the white space device. Because the rules are not clear as to which party is responsible for the white space device, and thus for entering and maintaining the registration information, the Commission seeks comment on whether the responsible party should be the owner, the contact person, or some other party.

18. The Commission proposes to require the white space database that originates a registration request for a fixed device to confirm the email address and telephone number entered for the contact person. It also proposes that the database not provide service to the device nor share the registration information with other approved white space databases until it receives a confirming response from the party responsible for the device registration. The Commission further proposes that the white space database confirm the contact person's information if any of the identifying information is modified. Under these proposals, a white space database administrator would be allowed to implement the confirmation requirement using a method of its choosing as long as that method obtains a confirming response that (1) the party addressed in the message is responsible for the operation of the subject fixed device, and (2) the email address and telephone number for that party are correct and appropriate to reach that party in a timely manner.

19. Finally, the Commission invites comment on the expected costs and benefits of the proposed rule changes in this section and whether the benefits will outweigh the costs. Parties who make specific suggestions for implementing the proposals also should address the costs and benefits associated with their suggestions.

20. Other Issues. The Commission does not propose to amend its rules to incorporate new accountability and/or enforcement measures to ensure the integrity of the registration information for fixed devices as requested by NAB. The current rules already place responsibility for the accuracy of the data entered for fixed device registrations on the party responsible for the device and hold database administrators responsible for verifying, correcting and removing inaccurate data. These existing rules and the proposals set forth in this Notice, along with the ongoing oversight of Commission staff, are sufficient and appropriate for addressing these issues.

1. 21. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),1 the Commission has prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this Notice of Proposed Rule Making (NPRM). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the NPRM. The Commission will send a copy of the NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA).2 In addition, the NPRM and IRFA (or summaries thereof) will be published in the Federal Register.3

22. The NPRM proposes to amend Part 15 of the Commission' rules to improve the quality of the geographic location and other data submitted for fixed white space devices operating on unused frequencies in the TV Bands and, in the future, the new 600 MHz Band for wireless services. The proposals are designed to improve the integrity of the white space database system and, as white space device deployments grow, to increase the confidence of all spectrum users of these frequency bands that the white space geolocation/database spectrum management scheme fully protects licensees and other authorized users.

23. The NPRM responds to a petition submitted by the National Association of Broadcasters (NAB) alleging that there are data errors in the registration records for fixed devices in the white space databases, and requesting that the Commission undertake rulemaking and other actions to correct and avoid such errors.

24. The proposed action is taken pursuant to sections 1, 4(i), 7(a), 302(a), 303(f), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 157(a), 302(a), 303(f), and 303(r).

25. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted.4 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 5 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.6 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).7

26. Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.” 8 The SBA has developed a small business size standard for Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing, which is: All such firms having 750 or fewer employees. According to Census Bureau data for 2007, there were a total of 939 establishments in this category that operated for part or all of the entire year. Of this total, 912 had less than 500 employees and 17 had more than 1000 employees.9 Thus, under that size standard, the majority of firms can be considered small.

27. White space devices are unlicensed devices that operate in the TV bands, and in the future, the 600 MHz band, at locations where frequencies are not in use by licensed services. The rules provide for three types of white space devices: Fixed, and Mode I and Mode II personal/portable devices. To prevent harmful interference to protected services, the rules generally require that white space devices provide their geographic coordinates to a white space database and operate only on location specific channels provided by that database. The location for fixed white space devices may be determined either through an internal geo-location capability or by a professional installer.10 Additionally, a fixed white space device must register with a database and, in addition to its location, must also provide the device's identifying information (FCC identification number and manufacturer serial number), antenna height, the name of its owner, and contact information for the party responsible for its operation.

28. Most RF transmitting equipment, including white space devices, must be authorized through the certification procedure. Certification is an equipment authorization issued by the Commission or by a designated TCB based on an application and test data submitted by the responsible party (e.g., the manufacturer or importer). The NPRM does not propose to change the authorization procedure for white space devices, but it does propose to establish new technical requirements or modify existing technical requirements for white space devices. Specifically, the NPRM proposes the following changes to the fixed white space device compliance requirements:

29. Fixed white space device geo-location requirements. The proposed rules would eliminate the professional installer option for fixed white space devices. Instead, a fixed white space device would be required to include a geo-location capability that can determine its geographic coordinates without manual intervention. The proposed rules would also require that the geographic coordinates be stored automatically in the fixed white space device and transmitted electronically directly from the device to the databases. In addition, a fixed white space device would be required to check its coordinates once each day using its geo-location capability and to report its geographic location to the database daily when it makes a request for a list of available channels.

30. The NPRM also proposes options to accommodate fixed white space device installations in locations where an internal geo-location capability is not able to provide this information. It proposes to permit fixed white space devices to obtain their geographic coordinates from an external source that is connected to the fixed white space device when the internal geo-location capability does not function. It also proposes that in cases where the geo-location capability is provided by an external source connected to the fixed white space device, the fixed device and external geo-location source would be required to communicate using a secure method that ensures that the fixed device obtains information only from a source that has been approved for that function by the Commission's equipment certification program.

31. Transition requirements for fixed white space device rule changes. The NPRM proposes that, effective six months after the effective date of the new rules, new applications for certification of fixed white space devices must comply with any rules the Commission adopts in this proceeding requiring incorporated geo-location capability. The NPRM also proposes that, within one year after the effective date of any new rules, manufacturers would no longer be able to manufacture and import fixed white space devices that do not comply with the new requirements. In order to allow manufacturers to deplete any inventory of devices that do not comply with the new requirements, the NPRM proposes to permit the marketing of these devices for up to eighteen months after the effective date of the new rules. In addition, the NPRM proposes to permit fixed white space devices that do not comply with new rules to continue to operate indefinitely. Further, it proposes that the Commission would treat equipment changes that simply add an incorporated geo-location capability to an existing certificated device as a permissive change.

32. Fixed white space device registration requirements. The NPRM proposes to require the white space database that receives the initial registration request for a fixed device to confirm the email address and telephone number entered for the contact person. It also proposes that the database not provide service to the device nor share the registration information with other approved white space databases until it receives a confirming response from the party responsible for the device registration. The NPRM further, proposes that the white space database confirm the contact person's information if any of the identifying information is modified (e.g., updating the email address or phone number). A white space database administrator would be allowed to implement the confirmation requirement using a method of its choosing as long as that method obtains a confirming response that (1) the party addressed in the message is responsible for the operation of the subject fixed device, and (2) the email address and telephone number for that party are correct and appropriate to reach that party in a timely manner.

33. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.” 11

34. The proposed requirement for all fixed white space devices to incorporate a geo-location capability would require changes to previously approved devices, because most approved fixed devices rely on the use of a professional installer and do not have a geo-location capability. As discussed above, the NPRM proposes transition and grandfathering provisions to minimize the impact on fixed white space device manufacturers and users. It proposes that manufacturers could continue to apply for certification of devices under the current rules for up to six months after the effective date of any new rules, and that changes that simply add an incorporated geo-location capability to an existing certificated device would be processed under the streamlined “permissive change” rules.12 The NPRM also proposes that parties could continue to manufacture and import devices that comply with the current rules for up to one year after the effective date of any new rules. In order to allow manufacturers to deplete any inventory of devices that do not comply with new requirements, the NPRM proposes to permit the marketing of these devices for up to eighteen months after the effective date of any new rules. Additionally, the NPRM proposes to permit fixed white space devices that do not comply with any new rules adopted in this proceeding to continue to operate indefinitely.

35. None.

36. Paperwork Reduction Act Analysis. This document contains proposed new information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we seek specific comment on how we might further reduce the information collection burden for small business concerns with fewer than 25 employees.

37. Pursuant to sections 1, 4(i), 7(a), 302(a), 303(f), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 157(a), 302a(a), 303(f), and 303(r), this Notice of Proposed Rule Making is adopted.

38. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Notice of Proposed Rule Making, including the Initial Regulatory Flexibility Analysis to the Chief Counsel for Advocacy of the Small Business Administration.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 15 as follows:

This is a synopsis of the Commission's Notice of Proposed Rule Making, MB Docket No. 16-68, adopted March 10, 2016, and released March 11, 2016. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW., Washington, DC 20554. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

Provisions of the Regulatory Flexibility Act of l980 do not apply to this proceeding.

Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all ex parte contacts are prohibited in Commission proceedings, such as this one, which involve channel allotments. See 47 CFR 1.1204(b) for rules governing permissible ex parte contacts.

For information regarding proper filing procedures for comments, see 47 CFR 1.415 and 1.420.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:

FMCSA encourages you to participate by submitting comments and related materials.

If you submit a comment, please include the docket number for this notice (FMCSA-2016-0050), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

To submit your comment online, go to www.regulations.gov and put the docket number, “FMCSA-2016-0050” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period and may grant or not grant this application based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to www.regulations.gov and insert the docket number, “FMCSA-2016-0050” in the “Keyword” box and click “Search.” Next, click “Open Docket Folder” button and choose the document listed to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the Federal Register (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including any safety analyses that have been conducted. The Agency must also provide an opportunity for public comment on the request.

The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).

Under 49 CFR 395.3(a)(2), a property-carrying commercial motor vehicle (CMV) driver is prohibited from operating a CMV after having been on duty for 14 consecutive hours following 10 or more consecutive hours off duty. Once an individual has reached the end of this 14 consecutive-hour period, he or she cannot drive a CMV again without taking a minimum of 10 consecutive hours off duty.

ArcelorMittal (USDOT 1098829) operates a steel plant that is located in East Chicago, Indiana, its principal place of business. The plant currently encompasses an area which has several public roadways that run through its present location. Steel coils produced in one portion of the plant require driver-employees to travel on public roadways at two points to move the coils to another portion of the plant for further processing or for shipment to customers. Both points are controlled intersections, having either traffic lights or a combination of traffic lights and signs in the area, where the vehicles cross. The first public road the CMVs cross is Riley Road. The crossing is controlled by a traffic signal in both directions. The distance traveled at this crossing is 80 feet in length. The average number of crossings at this intersection is 24 per day. The second crossing is at Dickey Road and 129th Street. The distance traveled at this crossing is .2 miles. The trucks cross 129th Street 24 times per day.

All employee-drivers are required to hold CDLs and adhere to the regulations that apply to CMV drivers. Specialized equipment and trailers are used to move steel coils due to the size of the coils. The tractors maximum speed is 30-35 miles per hour, but when moving a fully loaded trailer the maximum speed is 15 miles per hour.

Trailer beds are configured in such a way as create a cradle to hold the steel coils in place on the bed of the trailer. The trailers have a bed height of 68 inches, and bed width of 114 inches. The trailers maximum height is 14 feet.

The tractors and trailer in combination unloaded have a gross combination weight of 77,000 pounds. When fully loaded the gross combination vehicle weight is 263,171 pounds. Additionally, the trailers have off-road tires. These types of tires are necessary to operate both inside and outside the plant safely, given the type of roadway surface inside the plant area and the weight of the loads. These vehicles have many of the same features of a typical tractor and trailer, but do not meet all of the parts and accessories requirements in 49 CFR part 393.

When employee-drivers move these vehicles, they are fully marked as an “oversize load” and have flags on the front of the tractor. The driving of these vehicles amounts to 10 percent of the employee-drivers total work day. ArcelorMittal contends that none of these employee-drivers work more than 16 hours per day and advises that a 16-hour work day is the exception, not the rule.

According to ArcelorMittal, the current hours-of-service (HOS) regulations create problems for employee-drivers as these employees typically work an 8-hour shift plus overtime while employees in the production and shipping areas work 12-hour shifts. Employee-drivers must go home under the current arrangement leaving a 4-hour gap between production and the driver's schedule, creating a possible shortage of coils for shipping or processing. ArcelorMittal asserts that the limited amount of employees used to drive the CMVs make it difficult to schedule when the vehicles move. ArcelorMittal anticipates only 3 of the 24 crossings at each noted intersection would occur after the 14th hour on-duty.

ArcelorMittal requests an exemption from 49 CFR part 395 for its employee-drivers. Under a waiver of the HOS regulations, employee-drivers would be able to follow the same schedule as the employees in the production and shipping areas. ArcelorMittal could then minimize the chances of possible shortages of coils for shipping or processing. ArcelorMittal advises that it would ensure all employee-drivers would not work more than 16 hours per shift, would receive 8 hours off duty between shifts, and would not be allowed to drive more than 10 percent of their total work day.

ArcelorMittal also requests exemptions for its coil carriers from certain sections in 49 CFR part 393 as follows: The heavy hauler trailer definition in § 393.5; the height of rear side marker lights in § 393.11 Table 1—Footnote 4; the tire loading restrictions in § 393.75(f); and the coil securement requirements in § 393.120. As previously noted, the vehicles used to transport steel coils have many of the same features of a typical tractor and trailer, but do not meet all of the parts and accessories requirements in 49 CFR part 393.

According to ArcelorMittal, its equipment was designed for in-facility use and very limited road use. Public roadways are crossed due to operational necessity. ArcelorMittal advises that they have never had an issue at the crossings mentioned with their equipment or drivers. The coils are well-secured in the vehicles with the cradle design of their trailers. The time it would take to secure the coils per the regulations would be longer than the transit time it takes to move the coils from part of the plant to another.

ArcelorMittal asserts that it has taken additional precautions to make sure the public roadway crossings are at the shortest points and only at controlled intersections. ArcelorMittal ensures all lights are properly working on both the tractor and trailer. They also flag and mark the vehicles as “oversize” loads. Trailers have conspicuity tape down the entire side to make them more visible to other traffic. ArcelorMittal believes that the additional precautions ensure a level of safety that is equivalent to or exceeds the level of safety achieved by following the regulations.

ArcelorMittal acknowledges in its application that these drivers would still be subject to all of the other applicable Federal regulations. This includes qualification of drivers, controlled substance and alcohol testing and inspection, and maintenance and repair of vehicles.

Included in ArcelorMittal's application are illustrations of the plant's location, public roads crossed, and pictures of the tractors and trailers used to transport the steel coils. A copy of ArcelorMittal's application for the exemptions is available for review in the docket for this notice.