Federal Register Vol. 83, No.98,

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Glen Ullin Regional Airport, in support of standard instrument approach procedures for IFR operations at the airport.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0312; Airspace Docket No. 18-AGL-07.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air-traffic/publications/airspace-amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Glen Ullin Regional Airport, Glen Ullin, ND, to accommodate new standard instrument approach procedures developed for the airport. This action would enhance safety and the management of IFR operations at the airport.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

In a document published in the Federal Register on October 28, 2015 (80 FR 65978), we announced that we filed FAP 5A4811 (“petition”) submitted by the Grocery Manufacturers Association, 1350 I St. NW, Suite 300, Washington, DC 20005 (“petitioner”). The petitioner requested that we amend the food additive regulations in 21 CFR part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in the following food applications at specified maximum use levels: as a carrier or component thereof for flavors or flavorings, as a diluent or component thereof for color additives, as an incidental additive or processing aid, and as a direct additive in approximately 60 food categories. The petition was submitted in response to FDA's declaratory order issued on June 17, 2015 (80 FR 34650), announcing our final determination that there is no longer a consensus among qualified experts that PHOs are generally recognized as safe for any use in human food. In the declaratory order, we invited submission of food additive petitions with scientific evidence for one or more specific uses of PHOs for which the petitioner believes that safe conditions of use may be prescribed (as further discussed in section II).

FAP 5A4811 was submitted by GMA to FDA on June 11, 2015. During our initial review, we determined that the petition did not contain an environmental assessment as required under 21 CFR 25.15(a); therefore, we informed GMA that their petition did not meet the minimum requirements for filing in accordance with 21 CFR 171.1(c). On September 18, 2015, GMA resubmitted a complete FAP 5A4811, which we subsequently filed on October 1, 2015. During our initial review of FAP 5A4811, we identified several deficiencies that required resolution by GMA for us to continue with our review. We issued a letter to GMA on March 21, 2016, explaining the additional information required to resolve the petition's deficiencies. On May 5, 2016, GMA submitted a partial response to the deficiencies. The petition was then placed in abeyance by FDA, consistent with our procedures for food additive petitions.1 The petitioner and FDA met several times in the months following to discuss the deficiencies.

On March 7, 2017, the petitioner submitted a substantive amendment to FAP 5A4811 that addressed the deficiencies identified by FDA. In accordance with 21 CFR 171.6, the petition was assigned a new filing date of March 7, 2017. The amended petition contained significant revisions to the proposed uses, exposure estimate, and safety assessment of PHOs. The revised petitioned uses of PHOs were limited to the following: (1) As a solvent or carrier for flavoring agents, flavor enhancers, and coloring agents; (2) as a processing aid, and (3) as a pan release agent for baked goods. Based on the revisions, the petitioner asserted that the amended uses of PHOs would present a de minimis increase in risk (in other words, a negligible increase in risk) and, therefore, are safe under the conditions of intended use. References to the “petition” henceforth in this document will denote the amended petition received on March 7, 2017.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines “food additive,” in relevant part, as any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food, if such substance is not generally recognized by experts as safe under the conditions of its intended use (section 201(s) of the FD&C Act (21 U.S.C. 321(s))). Food additives are deemed unsafe and prohibited except to the extent that FDA approves their use (sections 301(a) and (k) (21 U.S.C. 331(a) and (k)) and 409(a) (21 U.S.C. 348(a)) of the FD&C Act.)

The FD&C Act provides a process through which persons who wish to use a food additive may submit a petition proposing the issuance of a regulation prescribing the conditions under which the additive may be safely used (section 409(b)(1) of the FD&C Act). When FDA concludes that a proposed use of a food additive is safe, we issue a regulation authorizing a specific use of the substance.

On November 8, 2013, FDA issued a document (the tentative determination, 78 FR 67169), announcing our tentative determination that PHOs are no longer generally recognized as safe (GRAS) under any condition of use in food and therefore are food additives subject to section 409 of the FD&C Act. Because PHOs are the primary dietary source of industrially-produced trans fatty acids (IP-TFA), FDA's evaluation of the GRAS status of PHOs centered on the trans fatty acid (TFA, also referred to as “trans fat”) component of these fats and oils. The tentative determination cited current scientific evidence of significant human health risks, namely an increased risk in coronary heart disease (CHD), associated with the consumption of IP-TFA (78 FR 67169 at 67172). The scientific evidence included results from controlled feeding studies on trans fatty acid consumption in humans, findings from long-term prospective epidemiological studies, and the opinions of expert panels that there is no threshold intake level for IP-TFA that would not increase an individual's risk of CHD (78 FR 67169 at 67172). Based on the evidence outlined in the tentative determination, we determined that there is no longer a consensus among qualified experts that PHOs are safe for human consumption (i.e., PHOs do not meet the GRAS criteria.) The tentative determination also requested interested parties to submit comments and additional scientific data related to our tentative determination that PHOs are no longer GRAS (78 FR 67169 at 67174).

We received over 6000 comments in response to the tentative determination. We reviewed the comments before issuing our final determination as a declaratory order published on June 17, 2015 (the declaratory order, 80 FR 34650). The declaratory order included four major provisions: (1) PHOs are not GRAS for any use in human food; (2) for the purposes of the declaratory order, FDA defined PHOs as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value greater than 4 as determined by an appropriate method; (3) any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s); and (4) FDA established a compliance date of June 18, 2018 (80 FR 34650 at 34651).

In our declaratory order finding that PHOs are no longer GRAS for any use in human food, we acknowledged that scientific knowledge advances and evolves over time. The declaratory order invited submission of scientific evidence as part of food additive petitions under section 409 of the FD&C Act for one or more specific uses of PHOs for which industry or other interested individuals believe that safe conditions of use may be prescribed. We also established a three-year delayed compliance date (compliance required no later than June 18, 2018) to provide time for submission and review and, if applicable requirements are met, approval of food additive petitions for uses of PHOs (80 FR 34650 at 34668).

A food additive cannot be approved for use unless the data presented to us establish that the food additive is safe for that use (section 409(c)(3)(A) of the FD&C Act). To determine whether a food additive is safe, the FD&C Act requires us to consider among other relevant factors: (1) Probable consumption of the additive; (2) cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substances in the diet; and (3) safety factors generally recognized by experts as appropriate for the use of animal experimentation data (section 409(c)(5) of the FD&C Act). Our determination that a food additive use is safe means that there is a “reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use” (§ 170.3(i) (21 CFR 170.3(i))).

FAP 5A4811 is not a typical food additive petition in that it is requesting food additive approval for existing uses of PHOs that industry, independent of FDA, had concluded were GRAS, but FDA subsequently determined such uses are not GRAS. Most food additive petitions seek premarket approval for new uses of food additives. Additionally, the approach that we normally use to evaluate safety of a direct food additive is not applicable for assessing the safety of IP-TFA in PHOs. Food additives are typically evaluated based on toxicological studies in animals, as described in our guidance, Toxicological Principles for the Safety of Assessment of Food Ingredients (also known as Redbook 2000).2 However, key scientific evidence for the association of trans fat and CHD is based on human studies, including controlled feeding trials of trans fat intake and blood cholesterol levels in humans and long-term, prospective observational studies of trans fat intake and CHD risk in human populations (Ref. 1).

To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, we typically consider the projected human dietary exposure to the additive, the additive's toxicological data provided by the petitioner, and other relevant information (such as published literature) available to us. FDA scientists use these toxicological data (usually derived from animal and in vitro studies) to determine a no-observed effect level or a no-observed-adverse-effect-level, apply an appropriate safety factor to account for differences between animals and humans and differences in sensitivity among humans, and calculate the acceptable daily intake (ADI) for the food additive. The ADI is usually expressed in milligrams of food additive per kilogram body weight of humans. We compare an individual's estimated daily intake (EDI) of the additive from all food sources to the ADI established by toxicological data. The EDI is determined based on the amount of the additive proposed for use in particular foods and the amount of those foods consumed containing the additive, and on the amount of the additive from all other dietary sources. We typically use the EDI for the 90th percentile consumer of a food additive as a measure of high chronic dietary exposure. A food additive is generally considered safe for its intended uses if the EDI of the additive is less than the ADI. This approach assumes that a physiological threshold may exist below which exposure to an additive will not cause harm. In the case of PHOs, which contribute IP-TFA to the diet, the main toxicological data available to assess safety consists of controlled feeding trials and prospective observational studies in humans where the adverse health outcomes associated with the additive are increased CHD risk and other non-cancer risks (e.g., stroke). To receive approval for the petitioned uses of PHOs, the petitioner has the responsibility to provide scientific evidence that establishes that the intended uses of PHOs are safe, including the expected dietary exposure to trans fat resulting from the intended uses of PHOs.

Our declaratory order references three safety memoranda prepared by FDA that document our review of the available scientific evidence regarding human health effects of trans fat, focusing on the adverse effects of trans fat on risk of CHD (Refs. 2-4). In addition, we previously reviewed the health effects of IP-TFA and PHOs in support of our tentative determination that PHOs are not GRAS in food (78 FR 67169) and in 1999 and 2003 in support of our proposed and final rules requiring declaration of trans fat in nutrition labeling of food (64 FR 62746 and 68 FR 41434). The safety reviews for the declaratory order, together with the previous safety reviews of IP-TFA and PHOs, provide important background scientific information for our review of FAP 5A4811.

The petition contains a review of recent scientific literature and expert opinions on trans fat consumption. GMA asserted that this information supports the following three conclusions, which are their reasons why they believe the petitioned uses of PHOs are safe:

1. “The conservatively estimated probability of coronary heart disease risk falls below the probable de minimis non-cancer risk range.” 3

2. “iTFA 4 exposure from the petitioned uses of PHOs (i.e., 0.05%en [total energy intake per day]) is well below exposure levels in controlled feeding trials, and effects at these low iTFA exposures levels cannot be empirically established based on the currently available evidence.”

3. “The incremental increase in iTFA intake of 0.05%en from the petitioned uses of PHOs is infinitesimally small and negligible in comparison to existing background dietary TFA exposure from intrinsic sources.”

In this petition denial, we discuss our evaluation of the petitioner's request and supporting information in section IV organized according to the following headings: A. Chemical Identity, Intended Technical Effects, and Petitioned Uses of PHOs; B. Estimated Exposure to Trans Fat; C. Recent Scientific Literature and Expert Opinions on Trans Fat Consumption; D. Recent Threshold Dose-Response Research; and E. Risk Estimates and Safety Arguments. Each of these sections provides a summary of the information provided by the petitioner followed by our evaluation of that information, prefaced with “FDA Assessment.” Additional information regarding our evaluation of the petition can be found in our three review memoranda (Refs. 5-7).

The PHOs that are the subject of FAP 5A4811 are made from the following vegetable oils: Soy, cottonseed, coconut, canola, palm, palm kernel, and sunflower oils, or blends of these oils, and consist of up to 60 percent trans fatty acids. As discussed in section I, GMA requested approval of three uses of PHOs, which are as follows:

• PHO, or a blend of PHOs, used as a solvent or carrier, or a component thereof, for flavoring agents, flavor enhancers, and coloring agents intended for food use, provided the PHOs in the solvent or carrier contribute no more than 150 parts per million (ppm) (150 milligrams per kilogram (mg/kg)) IP-TFA to the finished food as consumed;

• PHO, or a blend of PHOs, used as a processing aid, or a component thereof, provided the PHOs in the processing aid contribute no more than 50 ppm (50 mg/kg) IP-TFA to the finished food as consumed;

• PHO, or a blend of PHOs, used as a pan release agent for baked goods at levels up to 0.2 grams/100 grams (0.2 g/100 g) in pan release spray oils, provided the PHO contributes no more than 0.14 g IP-TFA/100 g spray oil.

These proposed uses excluded dietary supplements. The physical and technical effects of the petitioned uses of PHOs were specified as: Release agents, either alone or in combination with other components (§ 170.3(o)(18)); processing aids or components thereof (§ 170.3(o)(24)); and as solvents, carriers and vehicles for fat soluble coloring agents, flavoring agents, and flavor enhancers (§ 170.3(o)(27)).

To better understand how PHOs would be used as processing aids, we requested that the petitioner provide specific examples. In an email dated May 15, 2017, the petitioner provided several examples of how PHOs may be used as processing aids. Many of the petitioner's examples involved the use of PHOs as a topical coating to prevent rancidity (e.g., PHO-coated almond slices or candy pieces used as ingredients in cookies). We view this use of PHOs as having an ongoing technical effect in food (e.g., to prevent rancidity and oxidation) and, therefore, we do not agree that this use would be considered a processing aid in accordance with §§ 170.3(o)(24) and 101.100(a)(3)(ii) (21 CFR 101.100(a)(3)(ii)). Because we are denying this petition, we did not need to resolve this issue regarding characterization of the technical or functional effect of these additives.

The petitioner provided exposure estimates for TFA from the petitioned uses of PHOs and from intrinsic (i.e., naturally-occurring) sources such as dairy and meat from ruminant animals. To estimate exposure, the petitioner used food disappearance data from 2014 compiled by the U.S. Department of Agriculture (USDA) Economic Research Service, food consumption data from either the 2007-2010 or 2009-2012 National Health and Nutrition Examination Surveys (NHANES), and the intrinsic concentrations of TFA in the USDA National Nutrient Database for Standard Reference Release 27. The petitioner estimated the exposure to naturally-occurring TFA from intrinsic sources for the U.S. population (aged 2 years or more) to be 1.04 grams/person/day (g/p/d) at the mean and 1.91 g/p/d at the 90th percentile. If expressed as a percentage of total energy intake per day (%en), based on a 2000 calorie daily diet, the exposure to TFA from intrinsic sources would be 0.46%en at the mean and 0.75%en at the 90th percentile for the U.S population. The petitioner estimated the cumulative exposure to IP-TFA from all petitioned uses of PHOs in foods for the U.S. population aged 2 years or more to be 0.121 g/p/d (0.05%en) at the mean and 0.122 g/p/d (0.05%en) at the 90th percentile.

FDA agrees with the petitioner's estimated exposure to TFA from intrinsic sources, and we have no concerns regarding the general methodology used by the petitioner to estimate exposure to IP-TFA from the petitioned uses of PHOs. However, we believe the petitioner likely underestimated exposure to IP-TFA from the petitioned uses of PHOs for various reasons, such as their determination that 43 percent of the U.S. diet consists of processed foods, which we believe is too low, and not including all relevant NHANES food codes in their exposure estimate (Ref. 5). Although the petitioner's exposure estimate could be refined, we consider it sufficient for approximating exposure from the petitioned uses of PHOs.

FAP 5A4811 included sections on dietary guidelines and expert panel opinions pertaining to trans fat consumption. In addition, the petition presented a summary of studies assessing the effects of dietary TFA on intermediate biomarkers such as low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and other emerging biomarkers of CHD risk, and the association of dietary TFA intake with risk of CHD and risk of adverse health outcomes other than CHD (e.g., stroke, metabolic syndrome). Controlled feeding trials, prospective observational studies, and meta-analyses of these studies were included in the petitioner's scientific literature review.

As discussed in our review memorandum (Ref. 7), we found that the petitioner provided incomplete information on certain topics or misinterpreted some scientific conclusions.

The petition discussed the major expert panel reports on the health effects of trans fat consumption from the U.S., Australia, Canada, the United Kingdom, the World Health Organization (WHO), the Food and Agriculture Organization, and the European Food Safety Authority. We note that while the petition provided a generally accurate summary of these expert reports, some important information was missing or understated. For example, the petition omits the expert opinions on the role of HDL-C as a biomarker for CHD. The petition also omits that, in addition to the Institute of Medicine's 2005 report (Ref. 8), many other expert panels have concluded that TFA has a progressive and linear adverse effect on blood lipids and associated CHD risk. Furthermore, the petition understated the recommendation from several expert panels that trans fat intake should be kept as low as possible by specifically limiting intake of IP-TFA from PHOs.

The petition identified five meta-analysis studies (which are combined analyses of multiple feeding trials) that quantified the effect of changes in trans fat intake on LDL-C and HDL-C in the blood of human test subjects. The petition's summary of these studies was appropriate; however, we note that two available meta-analyses studies were not included in the petition's discussion: Zock and co-workers (Refs. 9-11) and Brouwer (Ref. 12). In particular, the 2016 meta-analysis by Brouwer was an important study, commissioned by the WHO Nutrition Guidance Expert Advisory Group (NUGAG) Subgroup on Diet and Health, that affirmed the linear, progressive effect of trans fat intake on blood cholesterol levels (Ref. 12).

The petition mentioned another meta-analysis of newer studies conducted by Hafekost et al. (2015) which reported no significant effect on LDL-C from a 1%en TFA intake (including both naturally-occurring TFA and IP-TFA) in exchange for cis-monounsaturated fatty acids (cis-MUFA) (Ref. 13). The petition claimed that these results support the potential for a threshold trans fat intake below which no significant effect on blood lipids is observed. However, we disagree with the petitioner's interpretation of this study's conclusions (Ref. 7). We note that the criteria for inclusion of feeding trials in this meta-analysis were not rigorous. In several of the included studies, the diets were not fully controlled. We also note that Hafekost et al. did not conclude that their results supported the potential for a safe threshold intake level of TFA. Rather, the authors stated, “An increase in LDL was consistent with the results of Brouwer et al., who identified a significant increase in LDL cholesterol with a percent increase in the intake of industrial TFA.” Furthermore, Hafekost et al. conducted an additional analysis, including the earlier Brouwer et al. meta-analysis results together with their analysis of newer studies alone. The petition did not discuss these additional analyses. The combined results for the newer studies alone, together with the earlier meta-analysis, showed a statistically significant increase in LDL-C due to an increase of 1%en intake from TFA. In their overall summary, Hafekost et al. stated, “The results of the current review are consistent with previous evidence which indicates a detrimental effect of consumption of TFA on changes in LDL and HDL blood cholesterol” (Ref. 13).

Regarding HDL-C and CHD risk, the petition underemphasized the impact of trans fat intake on HDL-C. We note that the observed decrease in HDL-C due to TFA intake is consistently reported across the existing body of TFA research and that HDL-C has been recognized as a major risk factor for CHD (Ref. 7).

The petition reviewed the results of prospective observational studies that estimate the association of long-term, habitual TFA intake with CHD risk in large, free-living populations. The petition reviewed five meta-analysis studies (that provided combined analyses of several individual prospective observational studies). The petition stated that the results of a recent meta-analysis by de Souza et al. in 2015 (Ref. 14) were consistent with previous meta-analyses in finding a statistically significant increased risk of CHD when comparing high to low TFA intake. Regarding individual prospective observational studies, the petition stated that, “The results from these studies, while not able to demonstrate causality, provide supporting evidence that, although a relationship between increased CHD risk and high levels of TFA intake exists, this observed relationship is largely based on comparisons of differences in TFA intake above 1%en and has not been established at lower levels of intake.”

We note that the overall results of the meta-analyses and recently published prospective observational studies were generally summarized accurately in the petition. However, the petition tended to understate the strength of the evidence from the observational studies reviewed. In particular, the meta-analysis by de Souza et al., a rigorously conducted study commissioned by WHO NUGAG, stated that the “positive associations between trans fat intake and CHD and CHD mortality” were “reliable and strong” and provided supplementary analyses supporting a progressive and linear association of TFA intake and CHD risk (Ref. 14). Additionally, recently published studies by Li et al. in 2015 (Ref. 15) and Wang et al. in 2016 (Ref. 16), with long-term followup and increased statistical power, show significant increases in CHD or cardiovascular disease (CVD) risk at lower increments of TFA intake than the 1%en stated by the petitioner.

The petitioner concluded, after reviewing recent scientific literature, that there is limited, inconsistent, and/or weak evidence for any effects of trans fat intake on other health outcomes including stroke, all-cause mortality, cancer, and metabolic syndrome. We do not agree with the petitioner's conclusion, in particular regarding stroke. In support of the declaratory order, we reviewed several well-conducted studies that provided a reasonable basis to conclude that TFA intake is associated with an increased risk of ischemic stroke (a blockage of blood flow to the brain) (Ref. 2). Furthermore, in our review memorandum for this petition, we described more recent studies that provide additional evidence supporting the association of TFA with stroke, as well as total mortality and elements of metabolic syndrome (Ref. 7).

The petition acknowledged that all five of the aforementioned meta-analyses (see section C) relied on a linear, no-threshold dose-response relationship between TFA intake and blood levels of LDL-C and HDL-C, which assumes any amount of TFA greater than 0%en causes adverse effects on blood cholesterol levels. The petition stated, “Recent research suggests that a non-threshold linear dose-response model overlooks the complexities of the physiological effects of macronutrients and other contributing factors to LDL-C levels besides TFAs.” In particular, the petition cited two recent articles to support the claims that a linear dose-response model is inappropriate for assessing the effects of TFA consumption on blood lipids, and that a threshold level of trans fat intake exists (Refs. 17 and 18). In the first publication, Reichard and Haber (Ref. 17) presented and evaluated a hypothesis for the biological mode of action (MOA) for the effect of TFA on LDL-C based on animal studies. According to the petition, “. . . the authors concluded the key events in the MOA are the increased production of very low density-lipoprotein (VLDL) and decreased LDL-clearance due to a reduction in the LDL-C mediated receptor activity.” The authors further concluded the effect of TFA on LDL-C is non-linear and there is evidence that either a threshold exists or the dose-response slope is very shallow at low dose levels (Ref. 17).

In the second article, Allen et al. (Ref. 18) conducted a meta-regression study of human controlled feeding trials, that considered both linear and nonlinear dose-response models to assess the effect of IP-TFA intake on LDL-C and determine which shape fit best with the MOA proposed by Reichard and Haber based on animal studies. (In this case, the meta-regression is a meta-analysis that focuses on dose-response relationships.) The Allen et al. meta-regression used an evidence map to identify additional experimental data for the effect of IP-TFA intake on LDL-C, particularly in the low dose region of the response curve where IP-TFA intake is between zero and 3%en (Ref. 19). According to Allen et al., an S-shaped model with an assumed threshold at low IP-TFA doses explained more of the study-to-study variability compared to the linear dose-response model (Ref. 18). Using assumptions about intra-individual measurement variation for LDL-C and the S-shaped model, the authors concluded that the change in LDL-C associated with a change in IP-TFA intake of 2.2%en represented a biologically meaningless change (Ref. 18). The petition stated that this analysis supports the existence of a threshold level of IP-TFA intake, below which negligible changes in LDL-C would occur.

We do not agree that these two studies cited by the petitioner provide convincing evidence to refute a linear dose-response or provide convincing evidence of a threshold in the effect of IP-TFA on LDL-C. In our review, we identified several design flaws and questionable data interpretations associated with these two studies (Ref. 7). One major concern about the MOA paper (Ref. 17) is that the authors relied largely on data from laboratory animal models to hypothesize an MOA that suggests the existence of a threshold effect of TFA on LDL-C in humans, despite the differences in biological response to dietary fats and fatty acid metabolism between humans and the animal species used in the study (e.g., rodents). The authors acknowledged that trans fatty acids such as elaidic acid do not increase serum LDL-C in hamsters, and suggest that animal models may underestimate the effect of TFA in humans (Ref. 17).5

Regarding the meta-regression paper (Ref. 18), we found that duplicate data points were erroneously used in the analysis; the validity of data points for low TFA levels below 3%en was questionable, and the low TFA data did not come from PHO test diets; and incorrect variances were applied in the weighting of the data based on the study designs (Ref. 7). We also question the authors' suggestion that the within person, day-to-day variability of blood LDL-C levels can be used to represent the minimum increment in LDL-C that is adverse (Ref. 7). Additionally, we note that the authors' proposed S-shaped dose-response model that levels off at high trans fat doses (above 3%en) is not consistent with the results of numerous controlled feeding trials of IP-TFA at higher doses or with prospective observational studies which show increases in serum LDL-C levels or CHD risk with higher intakes of trans fat (Ref. 7).

The petition contained an estimate of “hypothetical change” in CHD risk associated with 0.05%en IP-TFA intake (the daily amount of energy from IP-TFA contributed by the petitioned uses of PHOs) that was based on FDA's four deterministic quantitative risk assessment methods referenced in the declaratory order (Ref. 4). The petitioner stated that they included this analytical approach in the petition “for expediency and at the request of FDA”, although the petition questioned the validity of a linear-no threshold dose-response model for IP-TFA intake and LDL-C and HDL-C on which the FDA method is based. The deterministic quantitative risk assessment approach used by the petitioner estimated the change in CHD risk due to effects on blood lipoproteins from controlled feeding trials, and also estimated the change in CHD risk using direct observations of CHD from prospective studies when there is an isocaloric replacement of cis-MUFA with IP-TFA in the diet. The petitioner estimated that the change in CHD risk associated with a 0.05%en added IP-TFA intake from petitioned uses ranged from 0.062 percent to 0.665 percent depending on the risk method used. When expressed as a population-based risk estimate, the annual probability of CHD cases per 100,000 U.S. adults aged 35 and older ranged from 0.42 to 4.54. In other words, for every 100,000 U.S. adults, there could be up to 4.54 additional cases (fatal and non-fatal) of CHD attributed to an intake of 0.05%en IP-TFA from the petitioned uses of PHOs.

The petition asserts a standard of “de minimis risk.” According to the petitioner, a de minimis risk implies that a risk is so small that it should be ignored, and the petitioned use should be considered safe. The petitioner referenced three arguments to explain its de minimis risk principle: (1) The probability of a risk is below an acceptable cutoff (i.e., “bright line” or threshold); (2) there is a lack of scientific data to establish that the risk exists (i.e., the risk is non-detectable); or (3) the probability of the risk is less than the natural occurrence of the risk (Ref. 20). While neither the FD&C Act nor FDA's regulations regarding the evaluation of the safety of food additives in response to a food additive petition refer to de minimis risk, we review each of these arguments in turn.

The petition referenced an article by Castorina and Woodruff (Ref. 21) in which the authors estimated risks for non-cancer health outcomes from hypothetical lifetime ingestion or inhalation exposures to select environmental chemicals at the U.S. Environmental Protection Agency's (EPA) established reference doses (RfDs) or reference concentrations. The authors concluded that the non-cancer risk associated with RfDs ranged from 1 in 10,000 (1 × 10−4) to 5 in 1,000 (5 × 10−3) using a linear dose-response relationship for the environmental chemicals the authors selected. The petitioner applied a safety factor to the authors' risk estimates associated with RfDs to arrive at a proposed probability of risk, ranging from 2 in 100,000 (2 × 10−5) to 1 in 1,000 (1 × 10−3), which the petitioner deemed to be a de minimis risk. The petitioner compared this risk range to the results of their quantitative risk estimate, which predicted the annual probability of CHD cases attributed to 0.05%en IP-TFA intake from the petitioned PHO uses to be in the range of 0.42 per 100,000 adults (or 4.2 × 10−6) to 4.5 per 100,000 adults (or 4.5 × 10−5). The petition concluded that the estimated risk from 0.05%en IP-TFA intake from petitioned PHO uses is de minimis because it is well below the probable de minimis risk ranges for non-cancer risk calculated by applying a safety factor to the risks presented in the Castorina and Woodruff article.

We will first address the petitioner's reliance on the Castorina and Woodruff paper to determine the concept of de minimis risk, followed by our comments on the petitioner's deterministic risk assessment. We will also include a discussion of the probabilistic risk assessment that we conducted as part of our review.

We disagree with the petitioner's interpretation of the Castorina and Woodruff article on which the petitioner's safety conclusion is based. The application of the Castorina and Woodruff study results has limitations as a basis for inferring that IP-TFA from petitioned PHO uses is safe because it represents de minimis risk. The study is a single, exploratory analysis of whether EPA reference values represent negligible risk levels; it is not a consensus that defines a concept of de minimis risk or safe exposure. In fact, the study authors themselves question whether the non-cancer risks associated with the EPA's reference values represent “acceptable levels” of exposure from a public health perspective (Ref. 21). Furthermore, we note that in the Castorina and Woodruff paper, the estimated risks were based on biochemical and physiological changes associated with several non-cancer health outcomes that are much less serious than CHD cases or CHD deaths. For example, some of the biochemical and physiological changes the authors considered included small intestinal lesions, fatty cyst formation in the liver, elevated serum glutamate-pyruvate transaminases, chronic irritation of stomach, decreased lymphocyte count, changes in red blood cell volumes, decreased mean terminal body weights, and decreased maternal body weight gain. Therefore, we conclude that the petitioner's use of this single article to support their de minimis risk argument regarding the risk of CHD or CHD death associated with IP-TFA exposure is inadequate.

The petitioner relied on the de minimis risk principle to conclude that the petitioned uses of PHOs are safe because the estimated probability of CHD risk associated with IP-TFA from the petitioned uses of PHOs falls below the probable de minimis non-cancer risk range. The petition included a quantitative deterministic risk assessment that estimated the annual probability of CHD cases that may be associated with IP-TFA from petitioned uses of PHOs ranged from 0.42 to 4.54 per 100,000 U.S. adults. We note, though, that the petition did not include an estimated annual number of CHD cases or estimated annual number of CHD deaths associated with IP-TFA from the proposed uses of PHOs. Using the petitioner's estimated annual rate of CHD cases per 100,000 adults, the U.S. Census estimate of 166.7 million adults in the U.S. population in 2014, and a 32 percent CHD fatality rate reported by the Centers for Disease Control and Prevention (CDC), we expanded the petitioner's risk estimates associated with IP-TFA from petitioned uses of PHOs to estimate a range of 700 to 7,570 cases of CHD per year including between 224 and 2,422 deaths from CHD per year, which FDA does not consider to be insignificant (Ref. 7). Additionally, we conducted our own deterministic risk assessment to verify that the petitioner's methods were appropriate, and we expanded our analysis to include a probabilistic risk assessment to further bolster our decision that the estimated risks associated with the petitioned uses of PHOs cause them to be unsafe food additives (Ref. 6).

The deterministic risk assessment approach that was used by both the FDA in our declaratory order and by the petitioner in FAP 5A4811 to assess CHD risk associated with IP-TFA exposure is a risk assessment approach using assigned values for discrete scenarios (e.g., using most likely scenarios or mean values) (Ref. 6). The deterministic approach determines the robustness of the risk of CHD. However, it has limitations in that it is inadequate in applying population or other parameter variability information and it takes into consideration only a few discrete results (e.g., mean risk estimates), overlooking many others (e.g., probability distributions of risk estimates). The impact of different risk parameter values and uncertainty in risk methods relative to results also cannot be quantified (Ref. 6).

The probabilistic approach allows for the analysis of human variability and uncertainty in the risk method to be incorporated into both the exposure and risk assessments, if high quality empirical data with the probability distribution information for key parameters are used in the risk assessment (Ref. 6). We considered that at the petitioned IP-TFA exposure of 0.05%en, there would be greater uncertainty in the CHD risk estimates than the IP-TFA exposure of 0.5%en which was used in the declaratory order, and that the mean risk estimates alone would not be sufficient to demonstrate safety. Therefore, we conducted a probabilistic risk assessment for the CHD risk associated with an IP-TFA exposure of 0.05%en taking into consideration the variability and uncertainty associated with IP-TFA exposure and the risk parameters, and estimated both the probabilistic means and the uncertainty around the means.

We used FDA's four risk methods based on a linear no-threshold dose-response model (Ref. 6) to estimate changes in CHD risk when replacing cis-MUFA or saturated fatty acids at 0.05%en, with the same percentage of energy from IP-TFA. The probabilistic means were in line with the results estimated using the deterministic approach. The probabilistic approach also quantified the probability distribution of the risk estimates (e.g., the lower and upper 95 percent statistical uncertainty intervals (95 percent UIs)). The results included estimated changes in percent CHD risk, increases in the rate of annual CHD cases (both fatal and non-fatal) per 100,000 U.S. adults, and increases in the number of annual CHD cases, including CHD deaths, among U.S. adults. We also extended Method 4 (prospective observational studies) to estimate the annual number of CVD deaths among this same population. (CVD deaths include deaths from CHD, strokes, and other vascular diseases.) Our assessment methodology is documented in our review memorandum (Ref. 6).

Results from our probabilistic risk assessment demonstrate that consuming IP-TFA at a level of 0.05%en per person per day, instead of cis-MUFA, can cause a mean increase in annual CHD cases per 100,000 U.S. adults from 0.478 (95 percent UI 0.299 to 0.676) using the FDA risk method based on changes of LDL-C alone (Method 1) to 4.038 (95 percent UI 2.120 to 6.280) using the FDA risk method based on prospective observational studies (Method 4). These increases correspond to a mean increase in annual CHD cases from 814 (95 percent UI 510 to 1,151, using Method 1) to 6,877 (95 percent UI 3,611 to 10,694, using Method 4), which includes annual deaths from CHD from 290 (95 percent UI 182 to 410, using Method 1) to 2,450 (95 percent UI 1,287 to 3,811, using Method 4). The other two FDA risk methods produced increases in risk values from CHD that were between those estimated by Method 1 and Method 4.

The same amount of IP-TFA replacing saturated fatty acids would result in lower estimates of annual CHD cases and CHD-related deaths than those estimated by replacing cis-MUFA with IP-TFA. We estimated the mean increase in annual CHD cases to be 170 (using Method 1) to 5,110 (using Method 4), which includes 60 to 1,821 annual deaths from CHD. Using extended Method 4, the same amount of IP-TFA replacing either saturated fatty acids or carbohydrate could cause more than 6,500 CVD deaths per year in U.S. adults. The results of our analyses are described further in our review memorandum (Ref. 6).

Our deterministic and probabilistic quantitative risk assessments demonstrate that there is a probable significant health risk associated with 0.05%en from IP-TFA from the petitioned uses of PHOs. Our analyses do not support the petitioner's claims that 0.05%en from IP-TFA results in de minimis risk or that there is a reasonable certainty that PHOs are not harmful under the intended conditions of use.

The petitioner argued that the estimated exposure to IP-TFA from petitioned uses of PHOs (i.e., 0.05%en) is well below the exposure levels in controlled feeding studies and effects at these low IP-TFA levels cannot be empirically established based on the currently available evidence. The petition questioned the appropriateness of using a linear dose-response model for quantifying the effect of lower levels of trans fat intake (i.e., <3%en) on LDL-C and HDL-C, and maintained that there is a general lack of empirical evidence that consumption of low levels of trans fat increases CHD risk due to an adverse effect on blood lipoproteins. The petition highlighted one study (Ref. 18) suggesting that a linear dose-response model was not appropriate for quantifying effects of lower levels of IP-TFA intake on LDL-C. In addition, the petition noted that the trans fat content of control diets used in published feeding studies ranged from non-detectable to 2.4%en and suggested, by example, that the non-detectable level of TFA in a test diet could be at 0.15%en, which is three times higher than IP-TFA from petitioned uses of PHOs. Moreover, the petition noted that overall the IP-TFA intake from petitioned uses of PHOs (0.05%en) is well below the intake level of diets tested in the controlled feeding trials that were relied upon in the meta-analyses to assess the effect of IP-TFA on CHD risk. Because the impact of low level IP-TFA intakes cannot be detected by scientific studies, the petition concluded that the IP-TFA intake from petitioned uses of PHOs could be considered de minimis.

We will address the petitioner's non-detectability argument with a three-prong response. First, we will discuss the issue of statistical power and how it relates to detectable changes in clinical feeding trials. Next, we will review empirical evidence of adverse effects of lower IP-TFA intakes from several recent population studies. Lastly, we will comment on the body of evidence that supports a no-threshold, linear dose-response model to characterize the adverse health effects of trans fat intake.

Statistical power is the probability that a study will correctly detect an effect when an effect exists (Ref. 22). Larger sample sizes generally result in higher statistical power, increasing the likelihood that a study will be able to identify differences in the study subjects. We acknowledge that there are limits to the statistical power of controlled feeding trials to measure changes in LDL-C from low levels of TFA exposure. However, the lack of data from controlled feeding trials on the effect of TFA intake on blood lipids at lower TFA intake is not due to a potential threshold below which TFA intake has no effect on LDL-C and other blood lipids. Rather, the lack of data at lower TFA intake is due to the limited statistical power to detect significant changes in LDL-C at TFA intake below about 3 percent of energy in controlled feeding trials with feasible sample size of about 100 participants. For example, we estimated that it would require more than 300,000 participants in hypothetical PHO feeding trials to detect statistically significant changes LDL-C at the IP-TFA dietary exposure of 0.05%en (Refs. 6 and 7).

Recent population studies have shown empirical evidence of adverse effects of lower IP-TFA intake levels on CHD risk. Two recent prospective observational studies with long term follow-up found significant increases in CHD risk or CVD mortality at trans fat intake increments as low as 0.3%en to 0.6%en (Refs. 15 and 16). This is about 1/10 of the approximately 3 percent of energy from TFA intake that can be studied in controlled feeding trials of lipid biomarkers, and is roughly tenfold higher than the 0.05%en IP-TFA exposure from petitioned PHO uses.

Two recent studies independently examined the public health effects of restricting trans fat in eateries in several New York state counties between 2007 and 2011 (Refs. 23 and 24). In one study, the authors compared records of hospital admissions for heart attack and stroke in counties that had TFA restrictions and in control counties that had no restrictions (Ref. 23). They found that there was an additional 6.2 percent decline in hospital admissions for heart attacks and strokes in the populations of counties with TFA restrictions. This reduction corresponds to 43 CVD events prevented annually per 100,000 persons. In another study, the authors analyzed the association of trans fat restrictions in certain New York state counties and annual CVD mortality rates (Ref. 24). They found a 4.5 percent decrease in CVD mortality in counties with trans fat restrictions compared with control counties. This reduction corresponds to 13 fewer CVD deaths annually per 100,000 persons. Both studies, using separate data sources, showed consistent results of a “real-world” public health impact associated with the removal of trans fat in restaurant food.

Four studies published in 2017 examined data on plasma trans fatty acid concentrations in U.S. adults from the NHANES of 1999-2000 and 2009-2010 (Refs. 25-28). These studies showed the association between plasma TFA and serum lipid and lipoprotein (i.e., LDL-C and HDL-C) concentration before and after reductions in TFA consumption occurred in the U.S. population. On average, plasma TFA concentrations in U.S. adults were about 54 percent lower in 2009-2010 compared to 1999-2000 (Refs. 26 and 27). Significant improvements in blood lipids (e.g., lower LDL-C and triglycerides, higher HDL-C) occurred over time as plasma TFA concentrations decreased (Refs. 25 and 26). Despite substantial reductions in TFA intake over time, plasma TFA concentrations were significantly and consistently associated with serum lipid and lipoprotein concentrations at both time periods (Ref. 27). Results were similar for metabolic syndrome and most of its components such as large waistline, high fasting glucose, and high triglycerides (Ref. 28). The authors concluded that these studies do not support the existence of a threshold under which the association between plasma TFA concentration and lipid profiles might become undetectable (Refs. 27 and 28).

In response to the petitioner's argument of a non-linear dose-response, we note that the vast majority of scientific studies have been consistent in their conclusions that trans fat consumption has a progressive and linear adverse effect on blood lipids and CHD risk (Ref. 7). FDA's 2015 review of the scientific evidence for human health effects of TFA concluded: (1) There is no evidence of a threshold below which TFA does not affect blood lipids and (2) both controlled feeding trials and prospective observational studies strongly support the conclusion that trans fat intake has a progressive and linear effect that increases CHD risk, with no evidence of a threshold (Ref. 2). Numerous expert panels discussed in our 2015 review and in the current review also support this conclusion. Additional evidence from newer studies also supports the conclusion that TFA has a progressive and linear adverse effect on blood lipids and CHD risk (Refs. 12 and 29). This is discussed in detail in our review memorandum (Ref. 7).

The petitioner based its third argument on a “natural occurrence” theory which purports that a risk due to human activity may be de minimis and would not cause the activity to be considered unsafe provided that the risk does not exceed the natural occurrence of the same risk (Ref. 20). Specifically, the petitioner argued that the petitioned uses of PHOs are safe because the incremental increase in IP-TFA intake from petitioned PHO uses (i.e., 0.05%en) is infinitesimally small and negligible in comparison to existing background dietary TFA exposure from intrinsic sources. As described in section IV.B, the petitioner estimated the mean exposure to TFA from intrinsic sources (e.g., naturally-occurring TFA from meat and dairy foods) to be 0.46%en. The petition stated that the estimated intake of IP-TFA of 0.05%en from petitioned uses of PHOs equates to the 1.2th percentile of the TFA intake distribution from intrinsic sources. The petition explained further that this amount of IP-TFA intake is within the variability of the TFA intake from intrinsic sources and below the 5th percentile. Thus, the petition concluded that the petitioned uses are safe because the incremental increase in IP-TFA exposure from the petitioned uses of PHOs is infinitesimally small and negligible in comparison to existing background dietary TFA exposure from intrinsic sources.

For our safety assessment, we considered as a worst-case scenario the assumption that TFA from intrinsic sources is chemically and pharmacologically related to IP-TFA from PHOs. In general, TFA from intrinsic sources and IP-TFA contain the same trans fatty acid isomers, although in different proportions (Ref. 12). The most recent evidence from controlled feeding trials shows comparable effects on blood lipoproteins such as LDL-C and HDL-C by naturally-occurring TFA and IP-TFA (Ref. 7). Results of prospective observational studies specifically of TFA from intrinsic sources (rather than total TFA) are relatively sparse, and generally do not show an association of naturally-occurring TFA with CHD risk, possibly due to limitations of the studies (Ref. 7). Regarding the effect of TFA from intrinsic sources on adverse health outcomes other than CHD (e.g., metabolic syndrome and diabetes), study results are divergent (Refs. 6 and 7). Although there are inconsistencies in the data overall, we considered for the purposes of our safety assessment that TFA from intrinsic sources is, in general, chemically and pharmacologically related to IP-TFA from PHOs.

We disagree with the petitioner's assertion that the IP-TFA exposure from the petitioned uses of PHOs is safe because it is insignificant in comparison to existing background dietary TFA exposure. We note that the per capita IP-TFA intake of 0.05%en from petitioned uses of PHOs is approximately 10 percent of mean TFA intake from intrinsic sources; we do not consider this to be an infinitesimally small or negligible amount. The contribution of IP-TFA intake from petitioned uses of PHOs is not trivial, but rather will increase the mean population TFA exposure by 10 percent. Food sources of naturally-occurring TFA are widely consumed in the population, and therefore few members of the population consume 0.05%en TFA or less. As the petition indicated, 0.05%en from IP-TFA from petitioned uses of PHOs corresponds to about the 1.2th percentile of population TFA intake from intrinsic sources. We assert that this comparison is not particularly relevant to whether the per capita IP-TFA intake is significant because the contribution of IP-TFA exposure from the petitioned uses is in addition to, not substitutional for, exposure to TFA from intrinsic sources. Rather, the relevant comparison is that the per capita IP-TFA intake, 0.05%en, is approximately 10 percent of mean TFA intake from naturally-occurring sources. For these reasons, we disagree with the petitioner's argument that the petitioned uses of PHOs are safe because they are negligible in comparison to existing background dietary TFA exposure from intrinsic sources.

As stated earlier, there is no explicit reference to de minimis risks under either the FD&C Act or FDA's regulations regarding the evaluation of the safety of food additives in response to a food additive petition. Based on the data submitted by the petitioner, FDA has determined that the petitioned uses present more than a de minimis or negligible risk. Therefore, FDA has not found it necessary as part of its petition response to determine how the concept of de minimis risk may apply to the safety analysis under section 409 of the FD&C Act.

We received 10 comments in response to the petition's filing notification. Seven comments expressed opposition to the petition, one comment was about labeling of PHOs, one comment did not pertain to the petition, and one comment was a duplicate submission. All of the comments opposing the petition cited the adverse health effects associated with the consumption of TFA. None of the comments provided information to support the petitioner's conclusion that the proposed uses of PHOs are safe.

FAP 5A4811 requested that the food additive regulations be amended to provide for the safe use of PHOs as a solvent or carrier for flavoring agents, flavor enhancers, and coloring agents; as a processing aid; and as a pan release agent for baked goods at specific use levels. After reviewing the petition, as well as additional data and information relevant to the petitioner's request, we determined that the petition does not contain convincing evidence to support the conclusion that the proposed uses of PHOs are safe. Therefore, FDA is denying FAP 5A4811 in accordance with 21 CFR 171.100(a).

As discussed in section II, the declaratory order concluded that PHOs are no longer GRAS for any use in human food and established a compliance date of June 18, 2018 (80 FR 34650). In light of our denial of FAP 5A4811, we acknowledge that the food industry needs additional time to identify suitable replacement substances for the petitioned uses of PHOs and that the food industry has indicated that 12 months could be a reasonable timeframe for reformulation activities (Ref. 30). Therefore, elsewhere in this issue of the Federal Register, we have extended the compliance date to June 18, 2019, for the manufacturing of food with the petitioned uses of PHOs. Food manufactured with the petitioned uses after June 18, 2019 may be subject to enforcement action by FDA.

In addition, for food manufactured with the petitioned uses before June 18, 2019, elsewhere in this issue of the Federal Register, we are extending the compliance date to January 1, 2021. This time frame will allow manufacturers, distributors, and retailers to exhaust product inventory of foods made with the petitioned uses before the manufacturing compliance date. All foods containing unauthorized uses of PHOs after January 1, 2021 may be subject to FDA enforcement action.

Any persons that may be adversely affected by this document may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

The following references are on display in the Dockets Management Staff (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 website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

On January 30, 2018, the Offshore Powerboat Association of Brick Township, NJ, notified the Coast Guard through submission of a marine event application that this year's Ocean City Grand Prix would be held on a different date this year from that published in the Code of Federal Regulations (CFR) at Table to 33 CFR 100.501 at (b.)19. The estimated date for this annual event listed in the regulation is either the first or second Saturday or Sunday of May, or the second or third Saturday and Sunday of September. This year, the Ocean City Grand Prix is being held on June 23, 2018, and June 24, 2018. The high-speed power boat racing consist of approximately 40 participating offshore race boats of various classes, 21 to 50 feet in length, operating along a designated, marked racetrack-type course located in the North Atlantic Ocean, at Ocean City, MD. Details of the proposed event were provided to the Coast Guard on March 12, 2018. Hazards from the power boat racing event include participants operating near a designated navigation channel, as well as injury to persons and damage to property that involve vessel mishaps during high-speed power boat races conducted on navigable waters located near the shoreline. The Captain of the Port (COTP) Maryland-National Capital Region has determined that potential hazards associated with the power boat races would be a safety concern for anyone intending to operate within certain waters of the North Atlantic Ocean at Ocean City, MD.

The purpose of this rulemaking is to protect event participants, spectators and transiting vessels on certain waters of North Atlantic Ocean before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233, which authorize the Coast Guard to establish and define special local regulations.

The COTP Maryland-National Capital Region is proposing to establish special local regulations that will be enforced from 9:30 a.m. to 5:30 p.m. on June 23, 2018 and from 9:30 a.m. to 5:30 p.m. on June 24, 2018. The regulated area is a polygon in shape measuring approximately 4,500 yards in length by 1,600 yards in width. The area would cover all navigable waters of the North Atlantic Ocean, within an area bounded by the following coordinates: Commencing at a point near the shoreline at latitude 38°21′42″ N, longitude 075°04′11″ W, thence east to latitude 38°21′33″ N, longitude 075°03′10″ W, thence southwest to latitude 38°19′25″ N, longitude 075°04′02″ W, thence west to the shoreline at latitude 38°19′35″ N, longitude 075°05′02″ W, at Ocean City, MD.

This proposed rule provides additional information about areas within the regulated area and their definitions. These areas include “Race Area”, “Buffer Zone”, and “Spectator Area”.

The duration of the regulated area is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 10 a.m. until 5 p.m. high-speed power boat racing event. Under the proposed rule, the COTP or Coast Guard Patrol Commander may forbid and control the movement of all vessels and persons, including event participants, in the regulated area. When hailed or signaled by an official patrol, a vessel or person in the regulated area would be required to immediately comply with the directions given. Failure to do so could result in expulsion from the area, citation for failure to comply, or both.

Except for Ocean City Grand Prix participants, no vessel or person would be permitted to enter the regulated area without obtaining permission from the COTP Maryland-National Capital Region or the Coast Guard patrol commander. Vessel operators would be allowed to request permission to enter and transit through a regulated area by contacting the Coast Guard patrol commander on VHF-FM channel 16. All persons and vessels not registered with the event sponsor as participants or assigned as official patrols are considered spectators. Official Patrols are any vessel assigned or approved by Commander, Coast Guard Sector Maryland-National Capital Region with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

If permission is granted, spectators would be allowed to enter the spectator area or pass directly through the regulated area as instructed by Coast Guard Patrol Commander and at safe speed and without loitering. All spectator vessels would be required to be anchored or operate at a No Wake Speed within the designated spectator area. Official patrol vessels will direct spectator vessels to the spectator area. Only participant vessels and official patrol vessels would be allowed to enter the race area.

The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, duration and location of the regulated area. Vessel traffic would be able to safely transit around this regulated area, which would impact a small designated area of the North Atlantic Ocean for 16 hours. The Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule would allow vessels to seek permission to enter the regulated area, and vessel traffic would be able to safely transit the regulated area once the COTP Coast Guard Patrol Commander deems it safe to do so.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area lasting for 16 hours. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Memorandum for Record for Categorically Excluded Actions supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking Pub. L. Public Law §  Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

On February 18, 2018, Kent Narrows Racing Association of Chester, MD, notified the Coast Guard that it will be conducting power boat races from 9 a.m. until 6 p.m. on July 28, 2018, and July 29, 2018. The high-speed power boat racing event consists of approximately 60 participants competing on a designated one-mile oval course in the Choptank River in a cove located between Hambrooks Bar and the shoreline at Cambridge, MD. Hazards from the power boat races include risks of injury or death resulting from near or actual contact among participant vessels and spectator vessels or waterway users if normal vessel traffic were to interfere with the event. Details of the proposed event were provided to the Coast Guard at a meeting on April 10, 2018. There it was learned that during past power boat racing events in the area, large wakes created from transient vessels operating on the Choptank River west of the Senator Frederick C. Malkus, Jr. (US-50) Memorial Bridge have caused great concern for event planners. Such wakes are hazardous to participants as their presence in the race area would result in injury or death due to vessel capsizing or collisions among participant vessels during the high-speed races. Allowing the proposed power boat racing event to proceed without including these navigable waters within the regulated area would adversely affect event participants. The Captain of the Port (COTP) Maryland-National Capital Region has determined that potential hazards associated with the power boat races would be a safety concern for anyone intending to participate in this event or for vessels that operate within specified waters of the Choptank River at Cambridge, MD.

The purpose of this rulemaking is to protect marine event participants, spectators and transiting vessels on specified waters of the Choptank River before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233, which authorizes the Coast Guard to establish and define special local regulations.

The COTP Maryland-National Capital Region proposes to establish special local regulations to be enforced from 8:30 a.m. until 6:30 p.m. on July 28, 2018 and July 29, 2018. This special local regulation would include navigable waters of the Choptank River located between the Senator Frederick C. Malkus, Jr. (US-50) Memorial Bridge, at mile 15.5, and Hambrooks Bar Light. The area of the regulated area is approximately 3,000 yards in length and 3,000 yards in width.

The regulated area would include all navigable waters within Choptank River and Hambrooks Bay bounded by a line connecting the following coordinates: Commencing at the shoreline at Long Wharf Park, Cambridge, MD, at position latitude 38°34′30″ N, longitude 076°04′16″ W; thence east to latitude 38°34′20″ N, longitude 076°03′46″ W; thence north across the Choptank River along the Senator Frederick C. Malkus, Jr. (US-50) Memorial Bridge, at mile 15.5, to latitude 38°35′30″ N, longitude 076°02′52″ W; thence west along the shoreline to latitude 38°35′38″ N, longitude 076°03′09″ W; thence north and west along the shoreline to latitude 38°36′42″ N, longitude 076°04′15″ W; thence southwest across the Choptank River to latitude 38°35′31″ N, longitude 076°04′57″ W, terminating at the Hambrooks Bay breakwall. This rule provides additional information about designated areas within the regulated area, including a “Race Area,” “Spectator Area” and “Buffer Zone,” and the restrictions that apply to mariners. The duration of the regulated area is intended to ensure the safety of event participants and vessels within the specified navigable waters before, during, and after the power boat races, scheduled to occur 9 a.m. through 6 p.m. each day. Persons and vessels desiring to transit, moor, or anchor within the regulated area must obtain authorization from COTP Maryland-National Capital Region or Coast Guard Patrol Commander. When authorized to transit the regulated area, all vessels would proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the race course. The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location and duration of the regulated area. Vessel traffic would be able to safely transit through the regulated area, which would impact a small designated area of the Choptank River for 20 hours. The Coast Guard would issue a Broadcast Notice to Mariners via marine band radio VHF-FM channel 16 about the status of the regulated area. Moreover, the rule would, when deemed safe to do so by the Coast Guard Patrol Commander, allow vessel operators to request permission to enter, remain within, or transit through the regulated area for the purpose of either safely entering the “Spectator Area” or transiting the regulated area at the minimum speed necessary to maintain a safe course that minimizes wake near the race course.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a special local regulation lasting for 20 hours. This category of marine event water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Memorandum for Record is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register OMB Office of Management and Budget NPRM Notice of Proposed Rulemaking (Advance, Supplemental) § Section U.S.C. United States Code FL DOT Florida Department of Transportation AICW Atlantic Intracoastal Waterway II. Background, Purpose and Legal Basis

The bridge owner, Florida Department of Transportation, requested changes to the drawbridge operating schedules to better facilitate orderly vehicle traffic flow across the Flagler Memorial, Royal Park and Southern Boulevard bridges when the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago.

On August 17, 2017, the Coast Guard published a notice of deviation from drawbridge regulation with request for comments in the Federal Register (82 FR 39019) to test proposed changes. Three Comments were received during the test period, which were in favor of the regulation changes.

The Flagler Memorial (SR A1A) Bridge, mile 1021.8, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is a double-leaf bascule bridge that has a vertical clearance of 22 feet at mean high water in the closed position. The Royal Park (SR 704) Bridge, mile 1022.6, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is a double-leaf bascule bridge that has a vertical clearance of 21 feet at mean high water in the closed position. The Southern Boulevard (SR 700/80) Bridge, mile 1024.7, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is under construction, a temporary lift bridge is in place that has a vertical clearance of 14 feet at mean high water in the closed position and a 65 foot vertical clearance in the open position. The existing regulations are published in 33 CFR 117.261(u), Flagler Memorial Bridge, § 117.261(v) Royal Park Bridge and § 117.261(w) Southern Boulevard Bridge.

These modified regulations are necessary to alleviate vehicle traffic congestion when the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago. The increase in traffic congestion occurs when the proposed Presidential Security Zone (see 82 FR 28036) is enforced which closes the Southern Boulevard Bridge when the presidential motorcade is in transit. This action requires through traffic to use the Flagler Memorial and Royal Park Bridges.

This NPRM proposes the same schedule as during the temporary deviation. The Flagler Memorial Bridge is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:15 p.m., 3:15 p.m., 4:15 p.m. and 5:15 p.m., weekdays only, if vessels are requesting an opening. The Royal Park Bridge is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:30 p.m., 3:30 p.m., 4:30 p.m. and 5:30 p.m., weekdays only, if vessels are requesting an opening. At all other times the bridges will operate per their normal schedules.

The operating schedule of the Southern Boulevard Bridge, which is closest to Mar-a-Lago, will be allowed to remain closed to navigation whenever the presidential motorcade is in transit. At all other times the bridge shall open on the quarter and three-quarter hour, or as directed by the on-scene designated representative.

We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB) and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the ability that vessels able to pass through the Flagler Memorial and Royal Park Bridges in the closed position may do so at anytime. The bridges will be able to open for emergencies. The Southern Boulevard Bridge will be under the control of the on-scene designated representative.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the bridges may be small entities, for the reasons stated in section IV.A above this proposed rule may impact but would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review under paragraph L49 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this proposed rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacynotice.

Documents mentioned in this NPRM as being available in this docket and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:

The purpose of this rulemaking is to ensure the safety of divers in the water during an underwater military exercise in support of the biennial Exercise Valiant Shield from 6 p.m. on September 16, 2018 to 6 a.m. on September 17, 2018. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.

The COTP proposes to establish a safety zone from 6 p.m. on September 16, 2018 to 6 a.m. on September 17, 2018. The safety zone would cover all navigable waters two miles off of the Port of Rota. This safety zone is necessary to protect all divers participating in this underwater military exercise from potential safety hazards associated with vessel traffic in the area. This proposed rulemaking would prohibit persons and vessels not involved in the exercise from being in the safety zone unless authorized by the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A. above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a safety zone vessel traffic would be able to safely transit around. Normally such actions are categorically excluded from further review under paragraph L60(c) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

The EPA is proposing to approve elements of the State of New Jersey's October 17, 2014 SIP submission, which addresses the section 110(a) infrastructure requirements of the CAA for the following NAAQS: 2012 PM2.5, 2008 ozone, 2008 lead, 2010 nitrogen dioxide (NO2), 2010 sulfur dioxide (SO2), 2011 carbon monoxide (CO), and the 2006 particulate matter of 10 microns or less (PM10). Specifically, this rulemaking proposes to approve the portion of the submission addressing the interstate transport provisions for the 2012 PM2.5 NAAQS under CAA section 110(a)(2)(D)(i)(I), otherwise known as the “good neighbor” provision.

The requirement for states to make an infrastructure SIP submission arises from section 110(a)(1) of the CAA. Pursuant to section 110(a)(1), states must submit “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),” a plan that provides for the “implementation, maintenance, and enforcement” of such NAAQS.1 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 taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address. EPA commonly refers to such state plans as “infrastructure SIPs”.

The EPA has addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) with respect to PM2.5 in several prior regulatory actions. In 2011, we promulgated the Cross-State Air Pollution Rule (CSAPR), 76 FR 48208 (August 8, 2011), in order to address the obligations of states—and of the EPA when states have not met their obligations—under CAA section 110(a)(2)(D)(i)(I) to prohibit air pollution contributing significantly to nonattainment in, or interfering with maintenance by, any other state with regard to several NAAQS, including the 1997 annual and 2006 24-hour PM2.5 NAAQS.2 In that rule, we considered states linked to downwind receptors if they were projected to contribute more than the threshold amount (1 percent of the standard) of PM2.5 pollution for the 1997 and 2006 PM2.5 NAAQS (76 FR 48208, 48239-43). The EPA has not established a threshold amount for the 2012 PM2.5 NAAQS.

EPA addressed interstate transport provisions for the October 17, 2014 SIP submittal concerning the Prevention of Significant Deterioration (PSD) regulations and visibility protection (i.e., section 110(a)(2)(D)(i)(II)) for 2012 PM2.5, 2008 ozone, 2008 lead, 2010 NO2, 2010 SO2, 2011 CO, and the 2006 PM10 NAAQS) on September 19, 2016.3

EPA addressed the CAA section 110(a)(2)(D)(i)(I) for the 2008 Ozone NAAQS in the EPA's update of the CSAPR rule in October 26, 2016 (81 FR 74504) but did not address New Jersey as it had withdrawn 4 that portion of the October 17, 2014 SIP submittal.

The EPA will address the requirements of CAA sections 110(a)(2)(D)(i)(I) for the 2008 lead, 2010 NO2, 2010 SO2, 2011 CO, and the 2006 PM10 NAAQS in a separate action.

EPA highlighted the statutory requirement to submit infrastructure SIPs within 3 years of promulgation of a new NAAQS in an October 2, 2007 guidance document entitled “Guidance on SIP Elements Required Under sections 110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5 National Ambient Air Quality Standards” (2007 guidance). EPA has issued additional guidance documents and memoranda, including a September 13, 2013 guidance document titled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act sections 110(a)(1) and 110(a)(2)” (2013 guidance).

The most recent relevant document was a memorandum published on March 17, 2016, titled “Information on the Interstate Transport `Good Neighbor' Provision for the 2012 Fine Particulate Matter National Ambient Air Quality Standards under Clean Air Act section 110(a)(2)(D)(i)(I)” (2016 memorandum). The 2016 memorandum, which is included in the docket of this rulemaking, describes the approach EPA has previously used to address interstate transport, and provides EPA's general review of relevant modeling data and air quality projections as they relate to the 2012 PM2.5 NAAQS. The 2016 memorandum provides information relevant to EPA Regional office review of the CAA section 110(a)(2)(D)(i)(I) “good neighbor” provision in infrastructure SIPs with respect to the 2012 PM2.5 NAAQS. This rulemaking considers information provided in that memorandum.

In particular, the 2016 memorandum provides states and EPA Regional offices with projected future year annual PM2.5 design values for monitors in the United States based on quality assured and certified ambient monitoring data and air quality modeling. The memorandum further describes how these projected potential design values can be used to help determine which monitors should be further evaluated to potentially address whether emissions from other states significantly contribute to nonattainment or interfere with maintenance of the 2012 PM2.5 NAAQS at those sites. The 2016 memorandum explains that the pertinent year for evaluating air quality for purposes of addressing interstate transport for the 2012 PM2.5 NAAQS is 2021, the attainment deadline for 2012 PM2.5 NAAQS nonattainment areas classified as Moderate. Accordingly, because the available data included 2017 and 2025 projected average and maximum PM2.5 design values calculated through the CAMx 5 photochemical model, the memorandum suggests approaches states might use to interpolate PM2.5 values at sites in 2021.6

As explained in the 2016 memorandum, EPA used the methodology used in the CSAPR rule to determine potential nonattainment and maintenance sites. “Nonattainment sites” refer to those sites that are projected to exceed the 2012 PM2.5 NAAQS of 12 micrograms per cubic meter (µg/m3) based on the average future year design values. Those sites that are projected to exceed the NAAQS based on the maximum future year design values are referred to as “maintenance” sites.

Where EPA had sufficient data to complete its air quality modeling, EPA's analysis showed that, except for one monitoring site in Allegheny County, Pennsylvania, monitors in the eastern United States were expected to both attain and maintain the 2012 PM2.5 NAAQS in both 2017 and 2025. EPA notes that, as further discussed below, EPA's modeling analysis was inconclusive for monitoring sites with incomplete data.

The modeling results provided in the 2016 memorandum also show that out of seven PM2.5 monitors located in Allegheny County, Pennsylvania, only one monitor (ID number 420030064) is expected to be above the 2012 PM2.5 NAAQS in 2017.

Further, that monitor (ID number 420030064 or Liberty monitor) is projected to be above the NAAQS only under the model's maximum projected conditions (used in EPA's interstate transport framework to identify maintenance receptors), and is projected to both attain and maintain the NAAQS (along with all Allegheny County monitors) in 2025. The memorandum therefore indicates that under such a condition (where EPA's photochemical modeling indicates an area will attain the 2012 PM2.5 NAAQS in 2025 but not attain or maintain in 2017) further analysis of the site should be performed to determine if the site may be a nonattainment or maintenance receptor in 2021 (the attainment deadline for moderate PM2.5 areas).

The 2016 Memorandum did note that because of data quality problems, nonattainment and maintenance projections were not done for all or portions of Florida, Illinois, Idaho, Tennessee and Kentucky. Data quality problems were since resolved for Idaho, Tennessee, Kentucky and portions of Florida, identifying no additional potential receptors, with those areas having design values below the 2012 PM2.5 NAAQS and expected to maintain the NAAQS due to downward emission trends for NOX and SO2 (www.epa.gov/air-trends/air-quality-design-values and www.epa.gov/air-emissions-inventories/air-pollutant-emissions-trends-data). As of May 2018, the areas that still have data quality issues preventing projections of nonattainment and maintenance receptors are all of Illinois and four counties in Florida. EPA notes that preliminary design values for the four counties in Florida for the most recent period (2015-2017) have been preliminary deemed complete, and are well below the 2012 PM2.5 NAAQS. This is further discussed in section III below.

This rulemaking proposes action on the portion of New Jersey's October 17, 2014 SIP submission addressing the “good neighbor” provision requirements of CAA section 110(a)(2)(D)(i)(I), which include:

—Prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (otherwise known as prong 1);

—Prohibiting any source or other type of emissions activity in one state from interfering with maintenance of the NAAQS in another state (prong 2).

This rulemaking is evaluating the October 17, 2014 submission, specific to 110(a)(2)(D)(i)(I) (i.e., prongs 1 and 2) for the 2012 PM2.5 NAAQS.

In several previous rulemakings, EPA has developed and consistently applied a framework for addressing the prong 1 and 2 interstate transport requirements with respect to the PM2.5 NAAQS. That framework has four basic steps, including: (1) Identifying downwind receptors that are expected to have problems attaining or maintaining the NAAQS; (2) identifying which upwind states contribute to these identified problems in amounts sufficient to warrant further review and analysis; (3) for states identified as contributing to downwind air quality problems, identifying upwind emissions reductions necessary to prevent an upwind state from significantly contributing to nonattainment or interfering with maintenance of the NAAQS downwind; and (4) for states that are found to have emissions that significantly contribute to nonattainment or interfere with maintenance of the NAAQS downwind, reducing the identified upwind emissions through adoption of permanent and enforceable measures. This framework was most recently applied with respect to PM2.5 in the CSAPR rule, designed to address both the 1997 and 2006 PM2.5 standards, as well as the 1997 ozone standard.

New Jersey's October 2014 SIP submittal includes its SIP-approved New Jersey regulations and control measures that the State has implemented to address the interstate transport of air pollutants for criteria pollutants, including the 2012 PM2.5 NAAQS. New Jersey regulations and control measures that have reduced PM2.5, as well as SO2, NOX, and Volatile Organic Carbon (VOC) precursor emissions include:

New Jersey has indicated that it has addressed the interstate transport requirements of CAA 110(a)(2)(D)(i)(I) by implementing effective rules to control sources that may significantly contribute to nonattainment of a NAAQS in another state, and therefore addressed New Jersey's downwind contributions from New Jersey sources. New Jersey has also indicated that they have no rules that interfere with the ability of another state to maintain attainment of any ambient air quality standard in that state. New Jersey noted that its rules to control air emissions are more stringent than similar rules in nearby states. The complete list of New Jersey regulations and control measures can be found in the October 2014 SIP submittal, which is included in the docket of this rulemaking.

New Jersey noted that the neighboring states of New York and Delaware do not have any PM2.5 nonattainment areas. Additionally, New Jersey indicated that the State of Pennsylvania, in its area designation recommendations 10 to EPA for the 2012 PM2.5 NAAQS, determined that nonattainment in the State was caused by local, not regional sources.

New Jersey completed its technical analysis before EPA issued the 2016 Memorandum, which, as discussed earlier, included modeling projections for 2017 and 2025 annual PM2.5 design values meant to assist states in implementation of their 2012 PM2.5 NAAQS interstate transport SIPs. As discussed below, however, EPA's review of New Jersey's submittal nevertheless concludes that EPA's modeling projections regarding projected future nonattainment and maintenance areas as indicated in the 2016 memorandum, past EPA contribution modeling performed for CSAPR, and certified annual PM2.5 design values recorded since New Jersey's submittal confirm New Jersey's analysis that the State has adequately addressed the interstate transport requirements of CAA 110(a)(2)(D)(i)(I).

As stated above, EPA has developed a four-step approach for addressing the prong one and two interstate transport requirements with respect to the PM2.5 NAAQS. The first step is the identification of potential downwind nonattainment and maintenance receptors. EPA identified potential nonattainment and/or maintenance areas in the 2016 memorandum (see section II, Table 1, above). Most of the potential receptors are in California, located in the San Joaquin Valley or South Coast nonattainment areas. There is also one potential receptor in Shoshone County, Idaho, and one potential receptor in Allegheny County, Pennsylvania. In addition, as noted in section II to account for data quality limitations, EPA also considers potential receptors to include all of Illinois and Miami-Dade, Gilchrist, Broward, and Alachua Counties in Florida.

As stated above, “Step 2” is the identification of states contributing to downwind nonattainment and maintenance receptors, such that further analysis is required to identify necessary upwind reductions. For this step, we will be specifically determining if New Jersey emissions contribute to downwind nonattainment and maintenance receptors.

For the 1997 and 2006 PM2.5 NAAQS, we have used air quality modeling and an air quality threshold of one percent of the PM2.5 NAAQS to link contributing states to projected nonattainment or maintenance receptors (76 FR 48237, August 8, 2011). That is, if an upwind state contributes less than the one percent screening threshold to a downwind nonattainment or maintenance receptor, we determine that the state is not “linked” and therefore does not significantly contribute to nonattainment or maintenance problems at that receptor. We have not set an air quality threshold for the 2012 PM2.5 NAAQS and we do not have air quality modeling showing contributions to projected nonattainment or maintenance receptors for this NAAQS.

The EPA believes that a proper and well-supported weight of evidence approach can provide sufficient information for purposes of addressing transport with respect to the 2012 PM2.5 annual NAAQS. We rely on the CSAPR air quality modeling conducted for purposes of evaluating upwind state impacts on downwind air quality with respect to the 1997 annual PM2.5 NAAQS of 15 µg/m3 (as well as the 2006 24-hour PM2.5 NAAQS, and 1997 Ozone NAAQS). Although not conducted for purposes of evaluating the 2012 annual PM2.5 NAAQS, this modeling can inform our analysis regarding both the general magnitude of downwind PM2.5 impacts and the downwind distance in which states may contribute to receptors with respect to the 2012 annual PM2.5 NAAQS of 12 µg/m3. If the same 1% contribution threshold used in CSAPR for the 1997 and 2006 PM2.5 NAAQS applied to the 2012 PM2.5 NAAQS, we could consider the fact that a state's impact was below that value (that is, 0.12 µg/m3). We also note that New Jersey's submittal, described above, relies on several factors to support a finding that emissions from New Jersey sources do not significantly contribute to nonattainment, or interfere with maintenance of, the 2012 PM2.5 NAAQS in downwind states.

We note that no single piece of information is by itself dispositive of the issue. Instead, the total weight of all the evidence taken together is used to evaluate significant contributions to nonattainment or interference with maintenance of the 2012 PM2.5 NAAQS in another state.

Each of the potential receptors is discussed below, with a more in-depth discussion provided in the Technical Support Document (TSD) for this notice. For additional information, links to the documents relied upon for this analysis can be found throughout the document, more information is available in the TSD and the documents can be found in the docket for this action.

Based on distance considerations alone, New Jersey can be ruled out as a potential contributor to downwind nonattainment and maintenance receptors in California and Idaho. The nearest of these receptors (Shoshone County, Idaho) is over 1,800 miles from New Jersey. Accordingly, EPA proposes to find that New Jersey will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM2.5 NAAQS in California and Idaho.

As discussed in the TSD for this rulemaking, EPA has analyzed New Jersey's PM2.5 emissions and/or PM2.5 precursors, and found that they do not significantly impact the Allegheny County, Pennsylvania (Liberty monitor) potential maintenance receptor. In our analysis we found that there were strong local influences throughout Allegheny County and contributions from nearby states that contributed to its nonattainment for both the 1997 and 2006 PM2.5 NAAQS. Contributors to the Liberty monitor in Allegheny County, Pennsylvania have taken steps in recent years, to improve air quality which will likely bring the monitor into compliance with the 2012 PM2.5 annual NAAQS by the 2021 attainment date.

Another compelling fact is that in previous modeling, nonattainment in Allegheny County, Pennsylvania was linked to significant contributions from other states.11 New Jersey was analyzed in this modeling, and New Jersey emissions were not linked to Allegheny County. EPA notes that, in fact, New Jersey's contribution in the CSAPR 2012 base case modeling was 0.024 µg/m3, well below 1% of the standard for linkage to downwind receptors.

For these reasons, we propose to find that New Jersey will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM2.5 NAAQS for Allegheny County, Pennsylvania.

In the CSAPR modeling analysis, Florida did not have any potential nonattainment or maintenance receptors identified for the 1997 or 2006 PM2.5 NAAQS. At this time, it is anticipated that this trend will continue.

As mentioned earlier in this section, as there are ambient monitoring data gaps in the 2009-2013 data that could have been used to identify potential PM2.5 nonattainment and maintenance receptors for Miami/Dade, Gilchrist, Broward and Alachua counties in Florida, the modeling analysis of potential receptors was not complete for these counties. However, EPA notes that the most recent ambient data (2015-2017) for these counties has been preliminarily deemed complete and indicates design values well below the level of the 2012 PM2.5 NAAQS. This is also consistent with historical data: Complete and valid design values in the 2006-2008, 2007-2009, and/or 2008-2010 periods for these counties were well below the 2012 PM2.5 NAAQS. In addition, the highest preliminary value for these observed monitors is 7.5 µg/m3 at a Miami-Dade County monitor (ID 120861016). For these reasons, we find that none of the counties in Florida with monitoring gaps between 2009-2013 should be considered either nonattainment or maintenance receptors for the 2012 PM2.5 NAAQS. Therefore, we propose that New Jersey will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM2.5 NAAQS in Florida.

As indicated previously, data quality issues prevent projections of nonattainment and maintenance receptors in Illinois. Previous CSAPR modeling, however, indicates that New Jersey emissions would not impact potential nonattainment and maintenance receptors in Illinois. New Jersey's contribution in the CSAPR 2012 base case modeling was 0.003 µg/m3 or less to Illinois counties, a very small fraction of the threshold amount (well below 1% of the standard) for linkage to downwind receptors.

For this reason alone, we propose that New Jersey will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM2.5 NAAQS in Illinois.

Since we determined that New Jersey's SIP includes provisions prohibiting any source or other type of emissions activity from contributing significantly to nonattainment in or interfering with maintenance of the NAAQS in another state, steps 3 and 4 of this evaluation are not necessary.

In conclusion, based on our review of the potential receptors presented in the 2016 memorandum, an evaluation identifying likely emission sources affecting these potential receptors, distance considerations, and the 2012 base case modeling in the CSAPR final rule, we propose to determine that emissions from New Jersey sources will not contribute significantly to nonattainment in or interfere with maintenance by, any other state with regard to the 2012 annual PM2.5 NAAQS.

EPA is proposing to approve the portion of New Jersey's October 17, 2014 SIP submission addressing the interstate transport provisions for the 2012 PM2.5 NAAQS under CAA section 110(a)(2)(D)(i)(I).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 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. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this 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);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• 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).

In addition, 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 and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

Sections 108 and 109 of the CAA govern the establishment, review, and revision, as appropriate, of the National Ambient Air Quality Standards (NAAQS) to protect public health and welfare. The CAA requires periodic review of the air quality criteria—the science upon which the standards are based—and the standards themselves. EPA's regulatory provisions that govern the NAAQS are found at 40 CFR part 50—National Primary and Secondary Ambient Air Quality Standards.

On June 25, 2008, TDEC submitted to EPA a SIP revision to the Chattanooga/Hamilton County portion of the Tennessee SIP that contains changes to a number of Chattanooga-Hamilton County's air quality rules in Chapter 4 of Part II, Section 4-41. EPA is proposing to approve changes to the SIP through this action that deletes the current version and substitutes a revised version of Chapter 4 of Part II, Section 4-41, Rule 21 of the Chattanooga City Code “Ambient Air Quality Standards.” 1 Chattanooga-Hamilton County revised its rule to be consistent with changes to federal NAAQS.

On June 25, 2008, TDEC submitted a SIP revision to EPA for review and approval. The revision deletes the current version and substitutes a revised version of Chapter 4 of Part II, Section 4-41, Rule 21 of the Chattanooga City Code “Ambient Air Quality Standards.” Chattanooga/Hamilton County revised rule 21 to reflect all criteria pollutants; Carbon Monoxide (CO), Lead (Pb), Nitrogen Dioxide (NO2), Particulate Matter (PM10), Ozone (O3), and Sulfur Dioxide (SO2), relating to all the national ambient air quality standards (NAAQS). See 76 FR 54294 (August 31, 2011), 73 FR 66964 (November 12, 2008), 75 FR 6474 (February 9, 2010), 61 FR 52852 (October 8, 1996), 73 FR 16436 (March 27, 2008), 75 FR 35520 (June 22, 2010), 38 FR 25678 (September 14, 1973). EPA is approving this revision to the Chattanooga/Hamilton County portion of the Tennessee SIP to maintain consistency with the NAAQS. The Chattanooga/Hamilton County rule revision became state-effective on June 11, 2008. EPA has reviewed these changes to the Chattanooga/Hamilton County regulations for CO, Pb, NO2, PM10, O3 and SO2, and has made the preliminary determination that these changes are consistent with federal regulation.2

Because residual groundwater contamination (cis-1,2-dichloroethene [DCE] and vinyl chloride [VC]) was still present in the Off-Property area, this area remained on the NPL, and groundwater monitoring and five-year reviews were still required.

Groundwater samples were collected from the Off-Property area in July 2016, June 2017, and September 2017 and they were analyzed for cis-1,2-DCE and VC. The reported concentrations of these constituents detected in the analyses of these samples were all below the cleanup levels, with two of the three being “non-detect” (i.e., concentrations were below the laboratory detection limits of 0.5 micrograms per liter). Based on an analysis of all the groundwater monitoring wells and associated contaminant-specific data, it was concluded that the groundwater remedy has achieved the cleanup levels selected for the Site and data analysis indicates that the contaminant levels in the groundwater will remain below these standards. Therefore, the EPA has determined that the response action is completed and that no further monitoring or five-year reviews at the Site are necessary.

The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan. The EPA and the State of New York, through the New York State Department of Environmental Conservation (NYSDEC), have determined that all appropriate response actions under CERCLA have been completed at the Site and that it no longer poses a threat to public health or the environment. Therefore, the EPA and NYSDEC have concluded that this NOID is appropriate. However, this deletion does not preclude future actions under Superfund should future conditions warrant such action.

In the “Rules and Regulations” Section of today's Federal Register, the EPA is publishing a direct final Notice of Deletion (NOD) of the Site without prior NOID because the EPA views this as a noncontroversial revision and anticipates no adverse comment. The EPA has explained its reasons for this deletion in the preamble to the direct final NOD. If the EPA receives no adverse comment(s) on this deletion action, the EPA will proceed with the deletion without further action on this NOID. If the EPA receives adverse comment(s), the EPA will withdraw the direct final NOD, and it will not take effect. The EPA will, as appropriate, address all public comments in a subsequent final NOD based on this NOID. The EPA will not institute a second comment period on this NOID. Any parties interested in commenting must do so at this time.

For additional information, see the direct final NOD, which is in the “Rules” section of this Federal Register.

Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Intended Site Deletion I. Introduction

The EPA Region 10 announces its intent to delete the Frontier Hard Chrome, Inc. Superfund Site from the National Priorities List (NPL) and requests public comment on this proposed action. The NPL constitutes Appendix B of 40 CFR part 300 which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which the EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, 42 U.S.C. 9605. The EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in 40 CFR 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for Fund-financed remedial actions if future conditions warrant such actions.

The EPA will accept comments on the proposal to delete this Site for thirty (30) days after publication of this document in the Federal Register.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that the EPA is using for this action. Section IV discusses the Frontier Hard Chrome, Inc. Superfund Site and demonstrates how it meets the deletion criteria.

The NCP establishes the criteria that the EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), the EPA will consider, in consultation with the State, whether any of the following criteria have been met:

(1) Responsible parties or other persons have implemented all appropriate response actions required;

(2) all appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

(3) the remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

The EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site will be restored to the NPL without application of the hazard ranking system

The following procedures apply to deletion of the Site:

(1) The EPA consulted with the State before developing this Notice of Intent to Delete.

(2) The EPA has provided the state 30 working days for review of this notice prior to publication of it today

(3) In accordance with the criteria discussed above, the EPA has determined that no further response is appropriate;

(4) The State of Washington, through the Department of Ecology, has concurred with deletion of the Site from the NPL.

(5) Concurrently with the publication of this Notice of Intent to Delete in the Federal Register, a notice is being published in a major local newspaper, the Columbian. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

(6) The EPA placed copies of documents supporting the proposed deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

If comments are received within the 30-day public comment period on this document, the EPA will evaluate and respond appropriately to the comments before making a final decision to delete. The EPA will prepare a Responsiveness Summary to address any significant public comments or data received during the public comment period. After the public comment period, if the EPA determines it is still appropriate to delete the Site, the Regional Administrator will publish a final Notice of Deletion in the Federal Register. Public notices, public submissions and copies of the Responsiveness Summary, if prepared, will be made available to interested parties and in the Site information repositories listed above.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter the EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides the EPA's rationale for deleting the Site from the NPL:

The 1/2-acre Frontier Hard Chrome (FHC), Inc. Superfund Site (EPA ID: WAD053614988) is located at 113 Y Street, Vancouver, Clark County, Washington, approximately 3/4 mile north of the Columbia River. The area was once dominated by light industry but has transitioned to commercial and residential uses. Between 1958 and 1983, two chrome plating businesses, Pioneer Plating (1958 to 1970) and Frontier Hard Chrome (1970 to 1983) occupied the Site. Since 1983, the Site has been used by various businesses. A commercial storage facility and parking lot are currently being constructed at the Site.

In 1976, untreated chromium plating wastes from FHC's operations were temporarily rerouted from the sanitary sewer to an on-Site dry well while an on-site treatment system was constructed. Despite several enforcement actions, the treatment system was never designed or constructed. In January 1983, the Washington Department of Ecology (Ecology) ordered FHC to stop the discharge of chromium plating wastes to the dry well and to prepare a plan to investigate the groundwater. Before taking any action, FHC closed the business.

In 1982, an industrial supply well about 1/4 mile from the Site was found to be contaminated with chromium at more than twice the federal drinking water standard referred to as the “maximum contaminant level” (MCL). Further investigation, indicated the presence of a plume with elevated chromium concentrations downgradient of the dry well on the FHC property.

In December 1982, the EPA proposed that the Site be included on the NPL established by the EPA under Section 105(a) of CERCLA, 42 U.S.C. 9605(a) (47 FR 58476). Following consideration of public comments, the listing was finalized by the EPA in September 1983 (48 FR 40658).

In 1984, Ecology initiated the Remedial Investigation (RI). Initial testing found total chromium levels in groundwater beneath the Site that were more than 2,000 times the MCL [50 micrograms per liter (µg/L)] and had spread approximately 1,600 feet southwest of the source. Later, total chromium concentrations in groundwater near the former dry well were found as high as 300,000 µg/L.

Chromium in soils near the former dry well were identified as the source of the groundwater contamination at FHC. Total chromium levels in surface soils were reported as high as 5,200 milligrams per kilogram (mg/kg) and hexavalent chromium as high as 42mg/kg. Subsurface soil concentrations for total and hexavalent chromium were reported as high as 31,800 mg/kg and 7,506 mg/kg, respectively. Elevated chromium levels were found up to 20 feet below the ground surface and extended beyond the southern property boundary.

The EPA issued a December 1987 Operable Unit 1 (OU 1) Record of Decision (ROD) to address contaminated soils and source areas, and a July 1988 OU 2 ROD to address contaminated groundwater. The objectives of the OU1 soil remedy were to protect human health by preventing the direct exposure to chromium contaminated soils and dusts and to protect the groundwater by controlling the source of the contamination and included excavation, chemical treatment by a chemical binding agent, and off-Site disposal. Based on a Site-specific leachate test, all soils with total chromium concentrations greater than 550 mg/kg (approximately 7,400 cubic yards of soil) were removed and disposed of offsite.

The remedy selected in the OU 2 ROD called for extraction of groundwater from the areas where levels of chromium exceeded 50,000 µg/L, followed by treatment using selective media ion exchange and discharge to the Columbia River or Vancouver's sewer system. To prevent consumption of contaminated drinking water, institutional controls would be used to restrict the use of groundwater in and around the contaminated plume.

During the remedial design for OU 1, bench scale tests indicated that the stabilization methods selected in the remedy would likely not be effective at preventing the leaching of hexavalent chromium from Site soils. In response, the EPA initiated a Focused Feasibility Study that identified and evaluated several new and innovative technologies for addressing the contamination remaining at the Site. The results of bench scale testing indicated that In-Situ Redox Manipulation (ISRM) would be the most effective technology to address the cleanup objectives.

On August 30, 2001, the EPA issued a ROD amendment (RODA) modifying the remedial action selected in the 1987 and 1988 RODs. The amended remedy called for an ISRM Treatment Barrier to be installed at the southern edge of the groundwater hot spot and for reducing compounds to be injected into the contaminated soils and groundwater upgradient of the barrier. After injection, the reductant reacted with naturally occurring iron in the soils to create a permeable reactive zone, thereby reducing hexavalent chromium to trivalent chromium. Groundwater downgradient of the barrier would be restored through natural dispersion and dilution. Regular monitoring would be conducted until all groundwater met the cleanup level of 50 µg/L. Institutional controls (ICs) that limited access to contaminated soils and groundwater and future activities that threaten to remobilize chromium in Site soils were to be evaluated and implemented.

In 1994, to reduce the threat of direct exposure and further impacts to groundwater from the most heavily contaminated surface soils, Ecology excavated surface soils with chromium concentrations above 210 mg/kg (approximately 160 cubic yards) and disposed of them off-Site. The area was backfilled with clean material and a commercial office building was constructed on the property.

In December 2000, in conjunction with a local drainage project, the EPA extended a tight-lined drain pipe with road drains and catch basins to the south and west of the Site. The extension allowed stormwater to drain away from the FHC Site, thus preventing further infiltration of surface water through contaminated soils and into groundwater.

From 2001 to 2003, the EPA designed and implemented the ISRM Treatment selected in the 2001 RODA. Chemical reductant was first injected along the southern edge of an area with the highest chromium levels in the groundwater, forming the ISRM barrier, and then applied to source area soils and groundwater upgradient of the barrier. On September 22, 2003, the EPA signed a Preliminary Close-Out Report documenting the completion of construction activities. On September 28, 2012, the Site was designated as “Sitewide Ready for Anticipated Use”.

In 2003 the EPA also reviewed existing local and state controls that would protect the public from exposure to soils and groundwater impacted by past releases at the Site. The EPA determined that existing controls sufficiently limited access to contaminated soils and groundwater and that no additional ICs were required. Even so, when approached in 2004 by a perspective developer interested in purchasing the property, the EPA entered into an Agreement and Covenant Not to Sue with the developer. The Agreement was recorded on the property deeds and required compliance with seven institutional controls, including prohibitions on the installation of groundwater wells and use of groundwater.

In February 2004, a Long-Term Monitoring Plan was developed by the EPA to track the size of the chromium plume downgradient of the Site and to ensure the protectiveness of the remedy. In 2007, the size of the network and the frequency of sampling were reduced. The final sampling event took place in 2016.

The cleanup levels established in the RODA were based on federal drinking water standards, State cleanup levels established under the Model Toxics Control Act (MTCA), and State surface water standards. Consistent with MTCA, cleanup levels for hexavalent and trivalent chromium in soils were set at 19 mg/kg and 80,000 mg/kg respectively. Also based on MTCA, a groundwater cleanup level of 50 µg/L total chromium was established. Finally, the State's chronic surface water standards were used to establish a cleanup level of 10.5 µg/L for groundwater immediately upgradient of the Columbia River.

Following the 2016 sampling event, the EPA reviewed the data and found that, over the last several years, total chromium had only been detected at one well and that the groundwater concentrations at that well were below the cleanup level of 50 µg/L (WellB-87-8; 8.82 µg/L total chromium). A statistical analysis indicated the groundwater had attained the cleanup level and was expected to continue to do so in the future. Since monitoring began in 2004, the total chromium concentration in the wells closest to the river (well W99-R5A W99-R5B) have been below the cleanup level of 10.5µg/L set for groundwater immediately upgradient of the Columbia River.

A Final Close-Out Report documenting completion of all remedial actions was signed by the EPA on January 29, 2018. The report documented that all soil and groundwater Remedial Action Objectives (RAOs) and cleanup levels established in the 2001 RODA had been attained, the remedy had been successfully implemented, and no further CERCLA actions were required at the Site. However, in 2018, all remaining monitoring wells will be decommissioned by Ecology. No additional monitoring or Operations and Maintenance of the remedy are required.

Three policy five-year reviews (FYR) have been completed at the Site, the last one in January 2018.

No issues or follow-up actions were identified as part of the 2018 Five-Year Review. The protectiveness statement read: “Because the remedial actions at OU 1 and OU 2 are protective, the site is protective of human health and the environment.”

The analysis conducted concurrent with the last FYR indicates that the remedy has been fully implemented and the remedial action objectives and related cleanup levels have been attained. No hazardous substances, pollutants or contaminants remain above levels that could prevent unlimited use and unrestricted exposure (UU/UE). Therefore, no further five-year reviews are required.

Public participation activities have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k) and CERCLA Section 117, 42 U.S.C. 9617. Throughout the remedial process, the EPA has kept the public informed of activities being conducted at the Site by way of informational meetings, fact sheets and public meetings.

Documents in the deletion docket which the EPA relied on for the recommendation for deletion from the NPL are available to the public at the information repositories identified previously. Concurrent with this notice, a notice of availability of the Notice of Intent for Deletion has been published in The Columbian, initiating a 30-day public comment period. EPA will review all comments received before making a final decision on this proposed deletion action.

The EPA, with concurrence of the State of Washington through the Department of Ecology, has determined that the implemented remedy achieves the degree of cleanup or protection specified in the RODs and RODA for all pathways of exposure. All selected remedial and removal action objectives and associated cleanup levels are consistent with agency policy and guidance. No further Superfund response is needed to protect human health and the environment.

In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where all appropriate response actions have been implemented and where no further response is appropriate. Consistent with this, the EPA is proposing deletion of this Site from the NPL.

On March 23, 2018, Congress passed the FY 2018 omnibus spending bill into law, which includes the MOBILE NOW Act under Title VI of RAY BAUM'S Act.1 Section 605(b) of the MOBILE NOW Act requires the Commission to submit a report (3.7-4.2 GHz Report), to appropriate committees of Congress 2 and to the Secretary of Commerce no later than September 23, 2019, “evaluating the feasibility of allowing commercial wireless services, licensed or unlicensed, to use or share use of the frequencies between 3700 megahertz and 4200 megahertz.” 3

The Commission notes that there is currently no federal allocation for the 3.7-4.2 GHz band. Nonetheless, we seek comment on the following questions:

• How should we assess the operations and possible impacts of sharing on Federal and non-Federal users already operating in this band?

• How might sharing be accomplished, with licensed and/or unlicensed operations, without causing harmful interference to Federal and non-Federal users already operating in this band, and in which parts of the band would such sharing be feasible?

• What other considerations should the Commission take into account in preparing the 3.7-4.2 GHz Report?

The Act further provides that the report should include an assessment of the operations of Federal entities that operate Federal Government stations authorized to use the 3.7-4.2 GHz band.4 The Commission intends to consult with National Telecommunications and Information Administration (NTIA) and the heads of each affected Federal agency regarding the Federal entities, stations, and operations in the band, and the required issues and assessments. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified 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).

This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified 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).

This proceeding has been designated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules.5 Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with rule 1.1206(b).