FSIS administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 453 et seq. ), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ) to protect the health and welfare of consumers by regulating the meat, poultry, and egg products produced in federally inspected establishments. Through its inspections, the Agency endeavors to prevent the distribution in commerce of any such products that are adulterated or misbranded, thereby reducing the risk of foodborne illness from FSIS-regulated products. One way in which the Agency effects its regulatory program is through the United States National Residue Program (NRP). The NRP is designed to protect the public from exposure to harmful levels of chemical residues in meat, poultry, and egg products produced or imported into the United States. The NRP requires the cooperation and collaboration of several agencies for successful design and implementation. FSIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) of the Department of Health and Human Services are the Federal agencies primarily involved in managing this program. EPA and FDA have statutory authority to establish residue tolerances through regulations that limit the quantity of a chemical for the protection of public health. FDA, under the Federal Food, Drug, and Cosmetic Act, establishes tolerances or action levels for veterinary drugs, food additives, and environmental contaminants. EPA, under the Federal Insecticide, Fungicide and Rodenticide Act (as modified by the Food Quality Protection Act), establishes tolerance levels for registered pesticides. Title 21 CFR sets out tolerance levels established by FDA; Title 40 CFR sets out tolerance levels established by EPA.

The NRP is designed to provide a structured process for identifying and evaluating chemical compounds of concern in food animals; collecting, analyzing and reporting results; and identifying the need for regulatory follow-up when violative levels of chemical residues are found. The NRP tests for the presence of chemical compounds, including approved (legal) and unapproved (illegal) veterinary drugs, pesticides, hormones, and environmental contaminants that may appear in meat, poultry, and egg products.

A scheduled residue sampling program is developed annually by representatives from FSIS, FDA, EPA, and other Federal agencies, including the USDA Agricultural Research Service (ARS) and Agricultural Marketing Service (AMS) and the Centers for Disease Control and Prevention (CDC). These agencies meet at least once a year as part of the Surveillance Advisory Team (SAT). The SAT creates the annual sampling plan (per calendar year) using sample results from the NRP, information that the agencies have accumulated during investigations, and information from veterinary drug inventories that FDA has compiled during on-farm visits. The agencies create a list of chemical compounds for testing and rank them using mathematical equations that include variables for public health risk and regulatory concern. In addition to establishing a relative ranking for the chemicals, the SAT determines the compound/production class pairs of public health concern and evaluates FSIS laboratory capacity and analytical methods to devise a final sampling plan. FSIS publishes the final sampling plan in the National Residue Program Sampling Plan, which is traditionally referred to as the Blue Book.

Since 1967, FSIS has administered the NRP by collecting samples from meat, poultry, and egg products and analyzing the samples at one of three FSIS laboratories. A basis for concern appears when an FSIS laboratory detects a chemical compound level in excess of an established tolerance or action level in a sample. FSIS shares laboratory findings that exceed established tolerances and action levels with FDA and EPA. If the findings are for imported product, FSIS shares them with the competent authority in the foreign country from where the product originated. FDA has jurisdiction on-farm, and FSIS assists FDA in obtaining the names of producers and other parties involved in offering the animals for sale. FSIS informs producers through certified letters when an animal from their business has a violative level of a residue. FDA and cooperating State agencies investigate producers linked to residue violations. If a problem is not corrected, subsequent FDA visits could result in an enforcement action, including prosecution.

At the request of industry, FSIS posts a weekly list of repeat residue violators. The Residue Repeat Violators List includes producers associated with more than one violation on a rolling 12-month basis. Because FSIS updates this list weekly, FDA may not have investigated each violation. The list provides helpful information to processors and producers who are working to avoid illegal levels of residues, serves to deter violators, and enables FSIS and FDA to make better use of their resources.

Recognizing that a scientifically sound chemical residue prevention program is essential to encourage the prudent use of pesticides and veterinary drugs in food animals, in the late 1990s FSIS implemented the Hazard Analysis and Critical Control Points (HACCP) inspection system in all federally inspected meat and poultry establishments to verify that, among other things, the establishments have effective residue controls in their food production systems. In pertinent part, the HACCP regulations (9 CFR Part 417) require that FSIS-inspected slaughter establishments identify all food safety hazards, including drug residues, pesticide residues, and chemical contaminants, that are reasonably likely to occur before, during, and after entry into the establishment and establish preventive measures to control these hazards. FSIS will take regulatory action against an establishment that does not have an adequate chemical residue control program in place.

In practice, the NRP consists of three separate but interrelated chemical residue testing programs: Scheduled sampling, inspector-generated sampling, and import sampling. This basic structure has been in existence since 1967, though modified over the years to adjust to emerging and reemerging chemical residue concerns and to improvements in testing methodologies.

Under the current scheduled sampling program, FSIS calculates the number of samples needed for the scheduled sampling as part of a “paired sampling” protocol. Since the 2006 residue program, FSIS has sampled 230 or 300 animals for each chemical compound/production class pair. For instance, if FSIS scheduled heifers to be tested for four different chemical compound classes (for example, antibiotics, chlorinated hydrocarbons, β-agonists, and sulfonamides), FSIS inspectors would collect approximately three hundred samples for each of the chemical compound classes. Therefore, FSIS inspectors would collect samples from approximately 1,200 heifers (300 samples by four chemical compound classes = 1,200 samples collected). Applying sampling rates of 230 or 300 in food animals and egg products assures FSIS a 90 percent and 95 percent probability, respectively, of detecting chemical residue violations if the violation rate is equal to or greater than one percent. For the Calendar Year (CY) 2011 domestic scheduled sampling program, FSIS laboratories completed 21,555 analyses across multiple production classes and chemicals. Several of the analytical methods tested for multiple compounds.

During CY 2012, in contrast, FSIS is significantly modifying the scheduled sampling approach by eliminating the “paired sampling” protocol. FSIS will be analyzing fewer samples but by using multi-residue methods will actually be assessing more compounds per sample. As part of this new approach, FSIS is establishing three tiers of sampling for the NRP.

The new Tier 1 resembles the current scheduled sampling program and should be understood as an exposure assessment. Where the current scheduled sampling program has collected samples from each production class, the new FSIS program will rotate production classes through Tier 1. Where FSIS has allocated a maximum of 300 samples per chemical compound class in the traditional program, the new structure will allocate approximately 800 samples per chemical compound class for each of the production classes tested in Tier 1.

Under Tier 1 during CY 2012 domestic scheduled sampling program, FSIS will run 6,400 samples through 12 multi-residue methods across nine production classes of meat and poultry, which represent 95 percent of the meat and poultry consumed domestically. Eliminating the “paired sampling” protocol will result in more samples run per production class and more analytes targeted. Samples from Tier 1 will be analyzed at either the FSIS Eastern or Western laboratories.

The new Tier 2 will resemble the traditional inspector-generated sampling program at the establishment level. The inspector-generated program is a targeted testing program in which field public health veterinarians make the determination to perform in-plant screens on carcasses because they suspect that animals or carcasses contain higher than allowable levels of chemical residues. Samples from carcasses having positive in-plant screens are sent to the FSIS Midwestern Laboratory for confirmation, and the carcass is held pending results. In 2010, field personnel completed more than 200,000 in-plant screens resulting in almost 7,000 positive samples submitted to the FSIS Midwestern Laboratory for confirmation. FSIS implemented the newest in-plant screen (Kidney Inhibition Swab (KIS TM ) test) in 2009, and since then, the Midwestern Laboratory has instituted a policy of repeating the KIS TM test on positive in-plant KIS TM screens received from the field. In 2012, FSIS will begin using a multi-analytic screening method discussed below on inspector-generated in-plant screen positives submitted to the Midwestern Laboratory.

Simultaneously, FSIS will discontinue the use of the 7-plate bioassay in the Midwestern Laboratory as a primary screen for field positive samples. Inspector-generated samples will be tested using the updated multi-residue analytic screening method on in-plant samples described below in the section on New Methodology. Because the multi-analytic method is significantly superior to the KIS TM test, it will be unnecessary to repeat the KIS TM test on field-screen positive samples submitted to the Midwestern Laboratory. Hence, the turnaround time for availability of regulatory results will be reduced.

FSIS will continue, however, to use the bioassay for quantification of those veterinary drugs having tolerances associated with the bioassay as required by FDA New Animal Drug Applications (NADA).

The new Tier 2 also will absorb the traditional exploratory assessment program at the production class and compound class level. Exploratory assessments are targeted sampling plans designed, for example, in response to information gained from previous exposure assessments and intelligence from other agencies. Consequently, FSIS may use the data results from Tier 1 sampling to inform the type of sampling that will occur in Tier 2.

FSIS is further planning a Tier 3 level, which the Agency anticipates will be similar in structure to the exploratory assessment program in Tier 2, with the exception that Tier 3 will encompass targeted testing at the herd or flock level. FSIS anticipates that certain chemical exposures may occur that involve more than one animal or bird. For instance, producers may administer some veterinary drugs to a herd or a flock (for example, growth promotants or antibiotics given in the feed) in a way that involves misuse. In addition, livestock and birds may be exposed unintentially to an environmental contaminant. Therefore, a targeted testing program designed for livestock or flocks originating from the same farm or region may be necessary on occasion to determine the level of a chemical or chemicals to which the livestock or the birds in the flock have been exposed. Tier 3 will provide a vehicle for developing information that will support future policy development within the NRP. FSIS is evaluating implementation issues and requirements for Tier 3 activities.

The import-sampling program will be structured using the Tier 1 and 2 frameworks. In CY 2012, FSIS intends to collect approximately 1300 import samples—500 samples under Tier 1 and 800 samples under Tier 2. It also intends to screen a subset of these samples for unknown compounds in the FSIS Food Emergency Response Network (FERN) laboratory.

The analytical methods that have been used for many years in the NRP to measure veterinary drug residues in meat, poultry, and egg products are laborious, expensive, and time consuming and, as a result, sometimes prevent the timely testing of food products before they are released into the marketplace. More modern, performance-based analytical methods can reduce cost, increase the number of analytes that can be measured, and improve precision and accuracy while also shortening turn-around time. Modern methods use multi-residue techniques to quantify a larger number of analytes with greater precision (repeatability) and accuracy (degree of closeness to actual value). Such methods can often be performed with faster throughput and at lower cost than conventional single residue methods. In the food regulation arena, improved analytical methods are necessary if regulatory agencies are to effectively monitor for the increasing number of chemical residues and to protect public health.

This notice announces the adoption by FSIS of a new screening method for antibiotics and environmental contaminants. The current official FSIS screening methodology for antibiotics is a 7-plate bioassay. The 7-plate bioassay screen has several drawbacks: (1) It only works for microbial growth-inhibiting residues (certain antibiotics within and among classes); (2) it is not sensitive enough for sulfonamides and fluoroquinolones in relation to their tolerances, but it is much too sensitive as a screen for tetracyclines and certain aminoglycosides with high tolerances; (3) it does not distinguish one drug from another in the same class; (4) the results can be difficult to interpret, especially when multiple drugs are present; (5) it is prone to unknown microbial inhibition responses; (6) it takes a team of personnel to set up the assay and more than 16 hours to obtain the results; and (7) the measurement uncertainty associated with the 7-plate bioassay is large compared with other methods.

The new multi-residue method (MRM) being implemented by FSIS provides significant improvements: (1) It can screen for a variety of analytes, not just antibiotics; (2) the method can be validated at levels appropriate in relation to tolerances; (3) because of the power of mass spectrometry, it can clearly distinguish individual analytes, even if multiple drugs are present in the same sample; (4) unknown microbial inhibition responses would be mitigated; and (5) the time and personnel needed to obtain results is reduced.

The 52 analytes shown in the following table are appropriate for inclusion in the new MRM at and above the level specified. Analytes that were not analyzed during the 2011 NRP sampling plan and had not been included for testing in previous years are in italics.

With the new sampling and analytic methods, approximately 6,400 samples of two pounds of muscle and one pound each of kidney and liver will be collected, in contrast to approximately 20,000 samples collected per year under the current system in which the Agency collects one pound each of muscle, kidney, and liver. Although FSIS inspectors will be collecting more muscle with every sample, they will be collecting far fewer samples.

The new methodologies will result in additional costs for the Agency only for the purchase and maintenance of new equipment that will enable the FSIS laboratories to use the new multi-residue method. Equipment for the Midwestern Laboratory was replaced and charged under the old program. The additional purchase of the same equipment for the Eastern and Western Laboratories is anticipated to cost $250,000 per instrument, resulting in a total cost in the second year of implementation of $550,000 for two instruments and service maintenance. (Maintenance of the 2 instruments is at the rate of 10 percent of the cost of each instrument.) FSIS is exploring the possibility of leasing this equipment, which would significantly reduce the startup cost and eliminate the maintenance cost. The annualized cost of the instruments plus maintenance over 6 years at 7 percent equals approximately $112,000 and, if discounted at 3 percent, equals about $108,000. The Agency does not expect a significant impact on other laboratory resources because of the instrument purchases. In sum, FSIS sees only a small cost to the taxpayer in implementing the new methodology.

As stated above, under the new system approximately 6,400 samples of two pounds of muscle and one pound each of kidney and liver will be collected, in contrast to approximately 20,000 samples collected per year under the current system in which the Agency collects one pound each of muscle, kidney, and liver. The muscle samples will be larger, but the total number of samples collected will be much smaller. The smaller number of samples required will result in cost savings to FSIS that will be realized through reductions in special delivery shipments and in inspector time spent collecting samples. At approximately $20 a shipment, a reduction of approximately 13,600 samples that will not need to be collected will equal approximately $272,000 saved annually. At approximately 30 minutes allowed for an inspector to collect and package a sample, the savings for 13,600 samples will equal approximately $218,280.

Thus, given annualized costs of approximately $112,000 (7 percent) or $108,000 (3 percent) and annual recurring benefits of $490,280, net annual benefits exceed the costs by approximately $378,280.

Benefits to the public health are likely to occur because the Agency will be able to test for more residues with the additional new methods, but those benefits cannot be quantified at this time.

The new sampling program will operate according to a scheduling algorithm that will ensure that establishments are sampled in proportion to their production volume, and the Agency expects no negative impact on small businesses. Because of the design of the algorithm used for the new sampling program, small businesses may be sampled less frequently than is the case under the current system. This differential in frequency of sampling is likely to offset any economic losses conceivably resulting from the increased size of an individual sample.

The nine classes to be sampled for CY 2012 under the new program are specified as Bob Veal, Beef Cows, Dairy Cows, Steers, Heifers, Market Swine, Sows, Young Chicken, and Young Turkey. The number of samples taken for nine species classes for CY 2012 will be 800 per class except for steers and heifers, which have 400 each. The total allocation per species class and the number of samples allocated per species class may change, as will the species classes sampled in successive years. Assuming a constant rate of violations estimated from those in CY 2011, the number of expected violations will tend to increase in some but not all cases even though the total number of samples will decrease. This is because the number of analyses run per sample will be increased in CY 2012 compared to CY 2011. Specifically, based on historical data on chemical residue violations, the Agency expects that Bob Veal, Beef Cows, and Sows may show some increase in violations, while Dairy Cows, Steers, Heifers, Market Swine, Young Chicken, and Young Turkey may show no change in violations. The total net increase in violations expected is unlikely to have a significant impact because the residue violative rate is very low.

The proposed plan remains statistically structured relative to sample collection of imported products. FSIS and other federal agencies will continue to select chemicals tested within the U.S. program using a risk-based approach. FSIS expects countries exporting meat, poultry, and egg products to the United States to control chemical residues in the products that they export. FSIS will continue to require foreign countries to maintain equivalent residue control programs (9 CFR 327.2(a)(2)(iv)(C)). Therefore, FSIS does not anticipate any trade issues or international consequences.

States that administer “at least equal to” cooperative State meat or poultry inspection (MPI) programs need to complete and sign an “Annual Statement of Defensible Laboratory Results” as part of their annual “at least equal to” self-assessment. States under the Cooperative Interstate Shipment Program must demonstrate that their laboratory services used to analyze regulatory samples are capable of producing results that are the “same as” those obtained by FSIS laboratories. Requirements for demonstrating “same as” status can be found at http://askfsis.custhelp.com/app/answers/detail/a_id/1622/related/1. State laboratories operating under the Cooperative Interstate Shipment Program need to use the protocols for analytical tests required for FSIS regulatory activities on meat and poultry and egg products described in the FSIS Chemistry, Microbiological, and Pathology Laboratory Guidebooks. The authorities of affected States should take note of the methodological developments described in this notice.

FSIS will announce this document online through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp. FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

I. Introduction

The NRC is amending its regulations in Title 10 of the Code of Federal Regulations (10 CFR) Chapter I to make technical corrections. These changes include correcting the authority citations for 10 CFR parts 1, 2, 4, 7, 9, 10, 12, 13, 14, 15, 16, 19, 20, 21, 26, 30, 31, 32, 33, 34, 35, 36, 39, 40, 50, 51, 52, 54, 55, 60, 61, 62, 63, 70, 71, 72, 73, 74, 75, 76, 81, 95, 100, 140, 150, 160, 170, and 171; updating the street address for its Region I office; correcting typographical and spelling errors; and making other edits and conforming changes.

Revise Nomenclature. The words “handicap” and “handicapped” are replaced with the words “disability” and “disabled,” as appropriate.

Correct Title Designation. The position formerly entitled, “Deputy Executive Director for Information Services and Administration and Chief Information Officer,” no longer exists. A new position has been created and designated the title of “Deputy Executive Director for Corporate Management.” This new title designation replaces the former title in 10 CFR part 10.

Revise Office of Management and Budget (OMB)-Approved Information Collection List. In § 20.1009(b), the list of the OMB-approved information collection requirements is revised to remove the reference to § 20.2008 because the section no longer exists.

Revise Mailing Address. In § 34.20(a)(1), the mailing address of the American National Standards Institute, Inc., is revised to include their new mailing address.

Correct Reference. In § 30.34(h)(1)(ii), the section number under the reference to Title 11 of the United States Code (11 U.S.C.) is incorrect. In this paragraph, the reference “11 U.S.C. 101(14)” is replaced with the reference “11 U.S.C. 101(15).”

Revise OMB-Approved Information Collection List. In § 40.8, a new paragraph (c)(6) is added to the list of OMB-approved information collection requirements to include references to §§ 40.25 and 40.35, which have been approved by OMB.

Insert Missing Language. In appendix A to 10 CFR part 40, section I, criterion 4(d), the phrase “(on the order of 10 m or greater); impoundment slopes are very gentle (on the order of 10 h:1v)” was included in the original final rule, but was inadvertently omitted in the most recent amendments, even though Criterion 4 has not been amended since the original final rule. This resulted in incomplete language. In criterion 4(d), the phrase is added to read “(on the order of 10 m or greater); impoundment slopes are very gentle (on the order of 10 h:1v or less).”

Correct Typographical Error. In appendix A to 10 CFR part 40, section I, criterion 8A, the phrase “that is not corrected” is revised to read “that if not corrected.” In this phrase, the word “is” is replaced with “if.”

Revise OMB-Approved Information Collection List. In § 50.8(b), the list of OMB-approved information collection requirements is revised to add references to § 50.150 which was inadvertently omitted in the most recent amendments.

Correct Typographical Error. In appendix R to 10 CFR part 50, section III, paragraph G.3, the phrase “Alternative or dedicated” was inadvertently revised to read “Alternative of dedicated.” In this phrase, the word “of” is replaced with “or.”

Correct Address . In § 51.121(b), the addressee section, “ATTN: Chief, Rules and Directives Branch, Office of Administration” is revise to read, “ATTN: Rules, Announcements, and Directives Branch, Office of Administration” and the email address, “ NRCREP@nrc.gov ” is removed.

Correct Office Title. In § 51.122, the name of the office, formerly called, “Office of Information Resources Management,” is revised to read “Office of Information Services.”

Revise Table Entries and Footnote for Consistency. In appendix A to 10 CFR part 71, Table A-1, the values for the entries Bi-205, Cm-248, Eu-150 (long lived), and Te-132 (a), are revised for consistency with Title 49 of the Code of Federal Regulations, section 173.435. In addition, in Table A-1, footnote b is revised for clarity.

Revise OMB-Approved Information Collection List. In § 72.9(b), the list of OMB-approved information collection requirements is revised to remove the reference to §§ 72.8 and 72.216 because these sections no longer exist.

Revise OMB-Approved Information Collection List. In § 73.8(b), the list of OMB-approved information collection requirements is revised to add references to §§ 73.23 and 73.51 which have been approved by OMB.

Revise Language for Clarity. In § 73.55(e)(1)(ii), the word “physical” is added. The insertion of the word “physical” in this paragraph aids the reader in identifying the correct plan from among the ones defined in § 73.55(a).

In § 73.55(k)(8)(ii), the phrase, “indirect and neutralize the threat” is revised to read, “indirect and neutralize threats” for clarity and consistency with § 73.55(k)(1).

In § 73.55(m)(2), the phrase, “but not be limited to” is revised to read “but not limited to” for clarity and consistency with § 73.55(n)(1)(ii).

In § 73.55(m)(3), the first and second sentences are revised so that the word “and” is added, the comma following the word “form” is removed, and the word “operation” is revised to read “operations.” In § 73.55(m)(3), the sentence structure is revised for clarity.

In § 73.55(n)(1)(v), the word “component” has been revised to a plural term for consistency with § 73.55(o)(1).

In § 73.56(h)(4), the paragraph heading for the introductory text of paragraph (h)(4)(ii) is revised to provide clarification between the two types of interruptions discussed in this section. In paragraphs (h)(4)(ii)(A) and (B), paragraph headings are added for clarity and consistency.

In § 73.56(i)(1)(iv), the first sentence is revised to provide clarity and specify the amount of days that constitute an annual supervisory review.

In appendix C to 10 CFR part 73, section I, the word “Licensee” has been revised to a plural term to be consistent with the rest of the entities listed in the sentence.

In appendix C to 10 CFR part 73, section II, paragraphs B.3.c.(i) and B.3.c.(v)(4), the compound word “defense in depth” was not hyphenated. In these paragraphs, the compound word “defense in depth” is revised to read “defense-in-depth” for consistency with § 73.55(b)(3)(ii).

In appendix C, section II, paragraph B.3.c.(iii) is revised to remove the phrase, “training and qualification plans” for clarity and consistency with § 73.55(a)(1).

In appendix C to 10 CFR part 73, section II, paragraph B.3.c.(v)(1), the reference “performance objectives of § 73.55(a) through (k)” is replaced with the reference “performance requirements and objectives of § 73.55(a) through (k).”

In appendix C to 10 CFR part 73, section II, paragraph C.2, the phrase “Cyber Security Plan” is added as this plan is now part of the security program review.

Correct References. In § 73.55(c)(4), (d)(3), (g)(8)(iii), and appendix C to 10 CFR part 73, section II, paragraph A.(4), the title of appendix B to 10 CFR part 73 is removed and replaced with the title of section VI of appendix B to 10 CFR part 73.

In § 73.55(c)(5), the title of appendix C to 10 CFR part 73 is removed and replaced with the correct title and reference to section II of appendix C to 10 CFR part 73.

In appendix B to 10 CFR part 73, section VI, paragraph H.1., the reference to § 73.55(r) is replaced with the reference “§ 73.55(q).”

In appendix B to 10 CFR part 73, section VI, paragraph I, the reference to § 73.55(n) is replaced with the reference “§ 73.55(m).”

In appendix C to 10 CFR part 73, section II, paragraph C.1, the reference to § 73.55(n) is replaced with the reference “§ 73.55(m).”

In appendix C to 10 CFR part 73, section II, paragraph C.3, the reference to § 73.55 is replaced with the reference “§ 73.55(q).”

Correct Typographical Error. In § 73.55(i)(4)(ii)(G), the word “the” was omitted due to a clerical error. In this paragraph, the word “the” is added between the words “of” and “final” to correct the sentence structure.

In § 73.56(h)(4)(i) and (h)(4)(ii)(B), the word “proceeding” has been replaced with the word “preceding.”

In appendix B to 10 CFR part 73, section VI, paragraph C.3.(k)(3), an “r” was inadvertently omitted in the word “though.” In this paragraph, the word “though” is replaced with the word “through.”

The street address of the NRC Region I office has been changed. The new address is incorporated into the following sections of the NRC's regulations: § 1.5(b)(1), appendix D to 10 CFR part 20, § 30.6(b)(2)(i) and (b)(2)(ii), § 40.5(b)(2)(i) and (b)(2)(ii), § 55.5(b)(2)(i), § 70.5(b)(2)(i), and appendix A to 10 CFR part 73.

The authority citations for the following NRC regulations are revised to include conforming administrative changes: 10 CFR parts 1, 2, 4, 7, 9, 10, 12, 13, 14, 15, 16, 19, 20, 21, 26, 30, 31, 32, 33, 34, 35, 36, 39, 40, 50, 51, 52, 54, 55, 60, 61, 62, 63, 70, 71, 72, 73, 74, 75, 76, 81, 95, 100, 140, 150, 160, 170, and 171.

Under the Administrative Procedure Act (5 U.S.C 553(b)), an agency may waive the normal notice and comments requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. The NRC finds that notice and comment for these amendments are unnecessary and contrary to the public interest because it will have no substantive impact, are technical in nature, and relate only to management, organization, procedure, and practice. The Commission is exercising its authority under 5 U.S.C. 553(b)(3)(B) to publish these amendments as a final rule. The amendments are effective August 6, 2012. These amendments do not require action by any person or entity regulated by the NRC. Also, the final rule does not change the substantive responsibilities of any person or entity regulated by the NRC.

As authorized by 5 U.S.C. 553(b)(3)(B), the NRC finds good cause to waive notice and opportunity for comment on the revisions listed above because these revisions are administrative in nature and do not change substantive requirements under the regulations. Specifically, the revisions are of the following types: corrections to cross-references where the cross-reference is now incorrect due to changes in the regulations; typographical and grammatical corrections; nomenclature changes that do not affect any requirements under the regulations; revisions to titles and office re-designations; address changes; revision to the OMB-approved list of information collections; revisions to table entries and footnotes for consistency; insertion of language that had been unintentionally deleted during the most recent revisions; and other minor changes in wording that do not change the substantive requirements for clarity and consistency. These corrections will reduce confusion among any person or entity regulated by the NRC, and therefore notice and comment is unnecessary.

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(2), which excludes from a major action rules which are corrective or of a minor or nonpolicy nature and do not substantially modify existing regulations. Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this rule.

This final rule does not contain information collection requirements and, therefore, is not subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

The NRC has determined that the administrative changes in the final rule do not constitute backfitting, and therefore a backfit analysis is not included. The revisions are administrative in nature, including typographical corrections and updates to references and authorities. They impose no new requirements and make no substantive changes to the regulations. The revisions do not involve any provisions that would impose backfits as defined in 10 CFR chapter I, or would be inconsistent with the issue finality provisions in 10 CFR part 52. For these reasons, the issuance of the rule in final form would not constitute backfitting. Therefore, a backfit analysis was not prepared.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 1, 2, 4, 7, 9, 10, 12, 13, 14, 15, 16, 19, 20, 21, 26, 30, 31, 32, 33, 34, 35, 36, 39, 40, 50, 51, 52, 54, 55, 60, 61, 62, 63, 70, 71, 72, 73, 74, 75, 76, 81, 95, 100, 140, 150, 160, 170, and 171.

Authority for This Rulemaking

The FAA has broad authority and responsibility to regulate the operation of aircraft, the use of the navigable airspace and to establish safety standards for and regulate the certification of airmen, aircraft, and air carriers. (49 U.S.C. 40104 et seq., 40103(b)). The FAA's authority for this rule is contained in 49 U.S.C. 40103 and 44715. Under section 40103, the Administrator of the FAA has authority to “prescribe air traffic regulations on the flight of aircraft (including regulations on safe altitudes) for * * * (B) protecting individuals and property on the ground. (49 U.S.C. 40103(b)(2)). In addition, section 44715(a), provides that to “relieve and protect the public health and welfare from aircraft noise,” the Administrator of the FAA, “as he deems necessary, shall prescribe * * * (ii) regulations to control and abate aircraft noise * * *”

In response to continued concerns from a large number of local residents who are disturbed by the level of noise from helicopters operating over Long Island, the FAA adopts this final rule, as proposed, to require helicopter pilots whose route of flight takes them over the north shore of Long Island to fly the North Shore Helicopter Route. This route is based on a voluntary route that the FAA established in 2008. The route is published on the New York Helicopter Route Chart. This rule also provides that when necessary for safety, weather, or when transitioning to or from a point of landing, a pilot may deviate from the published altitudes and routes. This action is part of an on-going process to enhance public health and welfare by reducing helicopter noise for residents along the north shore of Long Island.

The FAA believes this rule is justified for several reasons. Maximizing the utilization of the existing route by making it mandatory is expected to help to further decrease levels of noise that have already been voluntarily achieved. Because the route is approximately one mile off the northern shore of Long Island and away from the residential communities on Long Island that are the source of hundreds of comments supporting the rule, it should not in itself cause any environmental harm. Other than necessary deviations or transitions, the noise from the helicopters would be over water, and there is no evidence of any significant effect of the rule on water quality, ecological resources, or other aspects of the environment.

The rule fully addresses any safety concerns by beginning the route at a point that minimizes interaction with LaGuardia's airport traffic, and allowing deviations at the pilot's discretion for safety and weather concerns.

Since the extra distance traveled is relatively minor to get to and return from the approximately one-mile offshore route, the costs for fuel and extra time would also be minimal. In addition, no new equipment is required.

The FAA has noted five circumstances, the combination of which is likely unique to Long Island, that support using our statutory authority to move forward with a final rule.

1. Because Long Island is surrounded by water, it was possible to develop a route that took helicopters a short distance off the shoreline. Thus, the North Shore Helicopter Route does not adversely affect other communities and operators can use the route without significant additional costs.

2. There are disproportionately more multi-engine helicopters flying in Long Island than the national averages (approximately 65% versus 10-15% nationally.) This allows for greater use of the off-shore route.

3. There are visual waypoints along the route that allow pilots to fly along the route with no additional equipment during good weather.

4. The helicopter traffic along the north shore of Long Island is largely homogenous, in that it is primarily point-to-point transit between New York City and the residential communities along the northern and eastern shores of Long Island.

5. The population corridor along the north shore of Long Island is significant, and coupled with the number of airports/heliports on the island, the FAA found it reasonable to develop a route to mitigate noise impacts.

Since a voluntary route already exists, the only available remaining option to further abate this noise problem is to make the route mandatory to the extent consistent with aviation safety. In light of the minimal costs imposed and the substantial number and volume of complaints, the FAA finds that this rule is justified. However, the FAA recognizes that there may already be a high rate of compliance with the voluntary route and that it is imprudent to mandate that all helicopters follow the route under all circumstances. Accordingly, it is possible that the actual rates of compliance may not improve significantly or that noise levels that are currently dispersed may inadvertently be concentrated as a result of the rule. Consequently, the FAA has decided to sunset the rule in 2 years in the event the agency concludes that the rule does not reduce or alleviate noise concerns or is otherwise unjustified. During the time that the rule is in effect, the FAA will continue to review and monitor the implementation of this rule and work with stakeholders to ensure that the rule addresses the problem and is otherwise justified; if not, the FAA will allow the rule to lapse at the end of 2 years. Alternatively, the FAA may amend the rule to implement meaningful changes should they be identified.

Helicopter traffic between New York City and eastern Long Island has traditionally followed one of three paths. The helicopters fly along the north shore of Long Island and then travel to the south to the intended destination; they travel across the middle of the island along the Long Island Expressway until branching off to the destination; or they travel along the south shore of Long Island and then turn inland to the final destination. Many of the helicopters take off or land in the Hamptons. There are two airports and a helipad that service the Hamptons. Other operators take off or land at one of the many other airports or heliports throughout the island. There are no airports and very few heliports along the north shore of Long Island. Accordingly, one might think that operators would prefer to travel along the south shore or along the Long Island Expressway. In fact, many operators prefer to travel along the north shore of Long Island and then travel inland to the desired landing spot. This is because this is a faster route and because at some locations, most notably the Hamptons, weather delays are common for aircraft approaching from the south.

In October 2007, Senator Charles Schumer and Representative Tim Bishop conducted a meeting with the FAA, local helicopter operators and airport proprietors to specifically address noise complaints stemming from helicopter operations along the north shore of Long Island. As a result of this meeting, the FAA designed a visual flight rules (VFR) helicopter route, the North Shore Helicopter Route, for helicopters to use when transiting the area that would reduce the noise impact of helicopter traffic on populated areas by having these operations offshore.

The FAA published the route on the Helicopter Route Chart for New York, effective May 8, 2008. Subsequently, New York public officials advised the FAA that they continue to receive noise complaints in this area even with the voluntary North Shore Helicopter Route in place. The local FAA Flight Standards District Office has also received similar complaints.

There are a number of unique characteristics that, taken together, made development of an alternative over-water route along the north shore of Long Island appropriate and feasible and consistent with the FAA's safety mandate. First, because Long Island is surrounded by water, it was possible to develop a route that took helicopters a short distance off the shoreline. Thus, the North Shore Helicopter Route does not negatively impact other communities, and operators can use the route with minimal additional costs. Second, the fleet mix in Long Island consists of significantly more multi-engine helicopters than the national mix, allowing more operators to use the route. There are limits on the distance certain helicopters can prudently operate from shore without being equipped for overwater operation. Unlike fixed wing aircraft, helicopters are not able to glide in the event of total loss of power for any significant distance. Thus, pilots of single-engine rotorcraft not equipped for overwater operation need to operate close to shore so they can land safely in the event of a loss of power. Nationally, the vast majority (roughly between 85 and 90 percent)  1 of helicopters have only one engine. However, the FAA believes that about two-thirds of commercial helicopters flying from New York City to Long Island are multi-engine helicopters, while about one-third of the helicopters being used for this purpose have only one engine. 2 Thus, the need to stay close to land is less of an issue along the North Shore than it would be in other areas of the country where the number of single-engine helicopters is significantly greater. This highly unusual situation allows us to implement an inexpensive alternative that should effectively and safely address the considerable complaints. Third, there are visual waypoints along the route that allow pilots to fly along the route with no additional equipment during good weather. While many pilots use Global Positioning System (GPS) coordinates to track a portion of the route, they are not required to do so. Fourth, the helicopter traffic along the north shore of Long Island is largely homogenous, in that it is primarily point-to-point transit between New York City and the residential communities along the northern and eastern shores of Long Island. Unlike helicopter traffic in urban areas, where the destination points and reasons for using a helicopter diverge widely (e.g., news reporting, aerial traffic updates, as well as point-to-point transit), the nature of helicopter traffic over and along the North Shore lends itself to the development of a single route that could be used consistently. Finally, the population corridor along the north shore of Long Island is significant, and coupled with the number of airports/heliports on the island, the FAA found it reasonable to develop a route to mitigate noise impacts.

In developing this route, the FAA considered the potential safety implications associated with helicopters flying in VFR conditions off the coastline and the interaction with other traffic at or above the specified minimum altitude. The route begins approximately 20 miles northeast of LaGuardia in order to minimize interaction of the traffic operating to or from that airport.

The FAA, airport sponsors, state and local government, aircraft operators, and local communities all have a role to play in reducing aircraft noise. Community noise concerns about aircraft overflights are uniquely local in nature and are best resolved in a voluntary manner, at the local level, and with the participation of all affected parties. In this instance, local participation was crucial to the development of the voluntary route. Based on the number of complaints and public comments to the proposed rule, the local effort, while successful in many regards, has not fully resolved community annoyance with helicopters flying over homes in northern Long Island.

The FAA's experience with aircraft noise has shown that community flight path preferences vary significantly; some communities prefer to concentrate noise over a particular area while others prefer to disperse the flight paths so that individual neighborhoods experience less noise overall. Thus, the FAA's policy is to respond to requests for noise abatement flight procedural changes from airport sponsors and to encourage the development of such proposals through the FAA's Airport Noise Compatibility Program established under the Aviation Safety and Noise Abatement Act of 1979.

While helicopter noise appears to have recently roused the greatest number of noise complaints, over time helicopters will incorporate better technology and become less noisy. The FAA is developing rules to impose more stringent noise standards for all new rotorcraft models being certificated. As these quieter aircraft are built and incorporated into the fleet, noise levels associated with helicopter operations should correspondingly decrease. 3

However, these standards are not yet in place. Given the existence of a voluntary route that reduces noise to some extent, the only available remaining option to further abate this noise problem is to require utilization of the route to the extent consistent with aviation safety.

On May 26, 2010, the FAA published the NPRM titled “The New York North Shore Helicopter Route” (75 FR 29471). The FAA proposed requiring civil helicopters operating along Long Island, New York's northern shoreline to utilize the published New York North Shore Helicopter Route between the fixed waypoint Visual Point Lloyd Harbor (VPLYD) and Orient Point. Specifically, the mandatory portion of the route begins at a waypoint 20 miles northeast of LaGuardia Airport (LGA) and near Huntington, NY; remains approximately one mile offshore, extends to the eastern end of Long Island; and terminates at Orient Point, near the eastern edge of Long Island. Helicopters operating on this route would have to remain at or above 2,500 feet mean sea level (MSL). The proposal contemplated helicopter pilots would deviate from the published altitude and route under several conditions. The conditions take into consideration the wide variety of helicopters, their associated performance and mission profiles, the dynamic weather environment along the route, and the pilot's responsibility to conduct safe operations at all times. The proposal also contemplated allowing operators to deviate from the route in order to reach their final destination. 4 The comment period closed on June 25, 2010.

The FAA received approximately 900 comments. Many comments were from residents, local government, citizen groups, and businesses. Slightly more than a third of the total number of commenters complained about the levels of helicopter noise that they are exposed to, particularly during the summer months. The FAA also received numerous comments from individual pilots, many of whom were opposed to the implementation of a mandatory route on principle. In addition, the agency received comments from the Aircraft Owners and Pilots Association (AOPA), the Eastern Region Helicopter Council (ERHC), the General Aviation Manufacturers Association (GAMA), the National Air Transportation Association (NATA), the National Business Aviation Association (NBAA), and United Technologies Corporation (UTC/UTFlight).

The number and tenor of the comments demonstrates affected parties at odds with each other.

On the one hand, the residents along the north shore of Long Island emphatically agreed that helicopter overflights during the summer months are unbearable and negatively impact their quality of life. They opposed any route over communities, even sparsely settled areas, and suggested the route go over the ocean. One commenter noted he had counted over 25 helicopter operations in a 2-hour period. He also said the flights started early in the morning and continued to early evening. Other commenters noted that the helicopter noise interferes with sleep, conversation, and outdoor activities. Still others complained that the helicopters fly so low that their walls vibrated.

On the other hand, helicopter operators and their associations argued that the helicopter noise levels over Long Island are not appreciable, that operators are already largely flying on the voluntary route, and that any mandated route would result in an unacceptable imposition of cost and safety risk.

The FAA received more specific comments on the following general areas of the proposal:

• Justification for the rule,

• Safety issues,

• Route location,

• Environmental concerns,

• Procedural/miscellaneous, and

• Economic evaluation.

Several commenters alleged that the proposal does not have adequate factual support. Some commenters argued that according to industry measurements, compliance on the voluntary route is very high already and that mandating this route is therefore not necessary. According to data collected by ERHC after the voluntary route was implemented, roughly 85-95 percent of operators observed over multiple holiday weekends comply with the North Shore Helicopter Route. 5 ERHC noted that it believes the noise complaints are coming from a relatively small number of households. While ERHC can demonstrate that relatively few households call its noise hotline, it cannot demonstrate these individuals are the only ones disturbed by the existing noise levels.

Other commenters stated that the lack of environmental analysis makes it impossible to determine that the rule actually addresses the concerns. ERHC and the Town of East Hampton contended that without such analysis, it is arbitrary and capricious to conclude that the route reduces noise on nearby communities.

As stated earlier, the original reason for establishing the North Shore Helicopter Route was to reduce noise from helicopter flights over communities along the north shore of Long Island by moving those flights offshore and establishing a minimum altitude. Because the route applies only to VFR flights, the FAA cannot definitively determine its current level of use. Even assuming the level of use is high, as alleged by the commenters, it is neither arbitrary nor capricious for the FAA to conclude, even without a specific noise analysis, that increasing use of the route by making it mandatory will further reduce noise impacts from helicopters operating along the north shore of Long Island. ERHC's contention that only a small number of households object to the helicopter noise levels is called into question by the hundreds of comments the FAA received supporting the mandatory use of the offshore route and the complaints filed with local government and FAA.

No one contends that pilots are using the route 100 percent of the time, and the FAA cannot determine how long operators fly along the route (either geographically or at the specified altitudes) when they do use it. While the final rule allows operators to deviate from the route for safety (including adverse weather) or to reach their destination, the FAA is unable to determine whether operators are currently deviating for other reasons. However, based on comments to the NPRM and the continued concerns expressed by the residents' elected officials, the FAA understands that helicopter overflights continue to be a problem for the residents along the north shore of Long Island.

The FAA, with the assistance of the John A. Volpe National Transportation Systems Center (Volpe Center), analyzed data from the Performance Data Analysis and Reporting System (PDARS) to assess the noise of flight operations along the north shore of Long Island. 6 The FAA reviewed helicopter traffic for the Memorial Day and Fourth of July weekends in the summer of 2011. That data indicated that helicopter traffic is greater on the Fridays before the long holiday weekends and on the last day of the holiday weekend than in the interim period. Based on this limited data set, as well as the assertions in the comments that the problem is greater in the summer, it is reasonable to assume that traffic is not evenly distributed throughout the year and on all days of the week. Thus, while overall cumulative noise levels may be low when averaged across the year, helicopter overflights could be more disturbing on certain days when they are experienced several times over a period of several hours or the course of a day. Maximizing the utilization of the existing route by making it mandatory will secure and improve upon the decreased levels of noise that have been voluntarily achieved.

ERHC objected to the over-water route because it places some helicopters beyond the autorotation performance distance needed to reach land in the event of an engine failure or other emergency.

The FAA notes that safety is its highest priority. To the extent a helicopter operator cannot safely fly along the North Shore Helicopter Route, this rule specifically allows for deviation.

The FAA recognizes the varying capabilities of helicopters, and this rule permits pilots to deviate from the rule for safety, weather, or when transitioning to or from a destination or point of landing. Under § 91.3, the pilot in command is directly responsible for and is the final authority as to the operation of that aircraft. Therefore, if flight along this route places a helicopter beyond the autorotation performance distance to the shore and the helicopter is not equipped with flotation devices, such as life jackets or helicopter floats, the pilot is permitted to deviate from the route and altitude.

AOPA stated there is no altitude discrimination between opposite direction helicopter traffic transiting the route. AOPA further stated that the FAA, at a minimum, should provide additional guidance on altitude assignments for opposite direction traffic in order to decrease the risk of a mid-air accident over Long Island.

As an initial matter, the FAA agrees that additional guidance is useful and is developing guidance that will be available before use of the route becomes mandatory. The FAA also acknowledges that opposite direction VFR traffic takes place along this route, but this is not unusual. There already are rules governing rights of way in VFR conditions, and §§ 91.113 and 91.155 are applicable to pilots operating along this route. These rules respectively address right of way rules for converging aircraft, approaching aircraft head on, overtaking aircraft, and the appropriate visibility minimums.

The FAA encourages operators to identify industry best practices and operational procedures for use on the route. The FAA also will develop a voluntary training awareness course for operators, which will include these best practices and emphasize industry's “fly neighborly” program as described on the New York Helicopter Route Chart. Most importantly, this rule provides pilots with the needed flexibility to maneuver off the route and/or altitude for weather, safety, or transition to/from a point of landing. FAA guidance on conducting operations subject to this rule will enhance pilot awareness and the safety of flights operating within the vicinity of this route. Should the level of traffic indicate an unacceptable level of safety risk, the FAA may choose to mandate separation standards for east- and westbound traffic in a subsequent rulemaking. Nothing in this rule should be construed as restricting or limiting in any way an air ambulance operator's ability to deviate from this route in order to provide emergency medical services.

ERHC argued that under the current rules, only the New York Helicopter Route Chart and New York Sectional depict the North Shore Helicopter Route, neither of which is required to be carried by pilots operating under VFR. ERHC further argued that the New York Sectional and New York Terminal Area Chart would need to be updated with the mandatory route and would need to be made mandatory for flight. ERHC asserted that the FAA would have to address the charting of the route as well as requirements to carry charts and sectionals, as no such requirements currently exist.

In accordance with § 91.103, the pilot in command is responsible before the beginning of a flight to become familiar with all information concerning the flight. Under this final rule, that responsibility includes being aware of the mandatory route when planning to fly along the north shore of Long Island. Though there is no specific requirement for pilots to carry aeronautical charts, the FAA believes that prudent pilots would carry charts, especially given the complexity and volume of air traffic in the greater New York City metropolitan area. The FAA will issue a notice to airmen (NOTAM) providing the operational requirements of this rule to augment information available to pilots.

Some commenters alleged this route would mix together VFR and instrument flight rules (IFR) aircraft. Portions of the route are located in Class E airspace where both IFR and VFR operations are conducted. However, this is not a unique situation for any Class E airspace area. Existing FAA regulations and air traffic control procedures provide for the safe integration of VFR and IFR operations. VFR pilots are responsible to see and avoid other traffic, which is how they operate today. Again, it must be emphasized that utilizing this route does not exempt pilots from this responsibility.

This action requires helicopter operators to use the currently published North Shore Helicopter Route when transiting the north shore of Long Island. The mandatory portion of the route begins at VPLYD waypoint located approximately 20 miles northeast of LGA, remains approximately one mile offshore, and extends to the eastern end of Long Island, terminating at Orient Point.

Some commenters stated that the definition of the geographical boundaries of the route is insufficient and difficult to identify visually.

The FAA believes the route is sufficiently defined. A VFR route is to be flown under visual conditions. Pilotage, as defined in 14 CFR 1.1, is an acceptable means by which to conduct operations along the route. Most of the route is located just one mile off the shoreline, which provides adequate visual reference for navigation purposes. The route was developed and designed by the FAA in cooperation with local helicopter operators, many of whom according to ERHC, have been flying this route for several years. The FAA meets regularly with local helicopter operators to discuss safety and noise issues. In the four years since this route was published, the FAA is not aware of any concerns regarding navigating the route.

ERHC asserted proposed airspace changes would lower Class B dimensions and impose higher workloads on air traffic controllers and IFR traffic. ERHC further asserted that since the controllers have no ability to deny VFR operators clearance, the burden would be higher on the air traffic controllers (ATC) and IFR operators. ERHC posited that if the North Shore Helicopter Route falls within the redesigned Class B Airspace, the VFR helicopter operators would further burden ATC controllers as they would be required to receive special VFR (SVFR) clearances whenever weather minimums are less than those prescribed in the Code of Federal Regulations.

The FAA notes that while airspace changes for the New York Class B Airspace area have been under discussion for many years, there are no formal proposals under consideration to date. With respect to the ATC workload, controllers provide services on a first come, first serve basis. If necessary, controllers may direct aircraft to remain clear of the Class B airspace or to standby, or controllers may refuse traffic from other sectors. If weather conditions deteriorate to the point where a pilot requires a SVFR clearance, the same first come first serve basis applies. The FAA notes that fixed wing SVFR operations are currently prohibited in the New York Class B Airspace Area.

Most residents and local government groups supported the over-water location of the route, and moving the helicopter traffic away from their communities by overflying the water. However, numerous commenters expressed opposition to the route, mistakenly believing the route would pass over land and therefore, bring helicopter overflights over their homes and communities. Obviously all helicopter operators planning on landing on Long Island will, at some point, have to fly inland in order to land. Were there no provision to allow operators to leave the route to transit to their destination, the likely impact on a few communities, notably those near VPLYD and Orient Point, would bear the brunt of the noise associated with the majority of helicopters flying over their communities. However, there are nine airports and 16 heliports on Long Island to the east of VPLYD. The noise associated with flying to an airport or other landing site should be dispersed among the affected communities. This is because this final rule allows pilots to deviate from the route for purposes of reaching their destination. The FAA notes that a local news article published during the comment period incorrectly placed the route over land. It is possible that some of the commenters were responding to the incorrect information contained in that news article.

ERHC also objected to the route, stating the route is difficult to navigate, and will require the purchase of helicopter charts and GPS equipment to comply with the regulation.

The NPRM did not propose any changes to the current published route, which is over water. This route was the result of many meetings and consultations between the FAA, local helicopter operators, residents, and elected officials. The FAA and the interested parties selected and agreed on the waypoints that are located near, or parallel to easily seen and identified locations along the shore. For example, VPLYD and VPJAY were chosen because of their proximity to two physically prominent locations (Lloyd Point, situated at the northern most spot on Lloyd Neck, and Old Field Point, a lighthouse location near Port Jefferson, respectively). The FAA designed the route to be over water, as it would prevent helicopter traffic from overflying residential areas. This voluntary route was charted and has been flown by helicopter operators for several years. The FAA is not aware of any navigational or safety issues associated with the use of this route.

Several commenters contended that the FAA has failed to analyze adequately the final rule's environmental consequences, as required by the National Environmental Policy Act of 1969 (NEPA), as amended, 42 U.S.C. 4321 et seq. ERHC alleged that without an adequate description of the proposed route, it is impossible to provide comments on whether there would be extraordinary circumstances that would preclude use of a categorical exclusion to comply with NEPA. ERHC further noted the lack of analysis to determine whether increased noise and operations over the water would affect water quality or ecological resources. Several commenters asserted that the rule would cause noise to concentrate over some communities.

The FAA's analysis of its PDAR data indicates that existing levels of helicopter noise is below levels at which homes are significantly impacted. 7 Beyond making use of the North Shore Helicopter Route mandatory, the rule does not change the existing route, which has been charted and flown by helicopter operators for several years. The rule allows pilots to deviate from the route when transitioning to or from a destination or point of landing, thus avoiding concentrated operations at any particular point of entry or exit along the route. Therefore, it is reasonable to assume that those pilots currently complying with the voluntary route will continue to follow the same flight paths to the extent they have been following them in the past, with the same resulting pattern of noise dispersion among underlying communities.

The FAA does not believe that this rule will create a negative impact on the public welfare. It is possible that compliance with the rule by pilots not currently complying with the voluntary route could result in some additional flights over some communities. However, because of the deviation allowed by the rule, the FAA cannot reliably predict the specific flight paths these pilots will follow on their way to or from the route. As a result, any specific noise impacts of such flight paths are not reasonably foreseeable.

In accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” the FAA has determined that the rule is categorically excluded from environmental review under paragraph 312f of the order, which applies to “regulations * * * (excluding those which if implemented may cause a significant impact on the human environment).” There are no significant noise or emissions impacts, which would be the primary concerns. The FAA determined that there are no extraordinary circumstances that would preclude the applicability of this categorical exclusion, and ERHC does not provide any facts supporting the presence of any such circumstances. Moreover, ERHC does not identify any significant effects the rule would have on water quality, ecological resources, or any other aspect of the environment, and the FAA has no reason to believe that any such effects would occur.

Were the rule to require pilots to follow the route in its entirety without regard to their origin or destination, it would be reasonable to expect an increase in noise in communities near the route's termination points (i.e., the VPLYD waypoint and Orient Point), due to the resulting concentration of operations entering and exiting the route at those locations. However, the rule allows pilots to deviate from the route when transitioning to or from a destination or point of landing. Therefore, it is reasonable to assume that those pilots currently complying with the voluntary route will continue to follow the same flight paths they have been following, with the same resulting pattern of noise dispersion among underlying communities. Compliance with the rule by pilots not currently complying with the voluntary route could result in additional flights over some communities. However, because of the deviation allowed by the rule, the FAA cannot reliably predict the specific flight paths these pilots will follow on their way to or from the route. As a result, any specific noise impacts of such flight paths are not reasonably foreseeable. In any event, based on the number of helicopter operations the ERHC estimates occur along the north shore of Long Island, any noise increase in residential communities from further concentration of those operations would not be significant. This conclusion is further supported by an FAA analysis of radar and flight plan data, a copy of which has been placed in the docket for this rulemaking.

The FAA notes that it is likely noise impacts will be felt most keenly near airports or heliports, as the helicopters descend to land. Nothing in this rule makes that a unique phenomenon. Rather, aircraft noise is typically concentrated near airports, which is why the FAA typically addresses aircraft noise through the Airport Noise Compatibility Program. 8

Several commenters alleged that the rule would require helicopter operators to fly more miles and therefore burn more fuel, and that this would cause significant environmental impacts. Specifically, ERHC alleged, without supporting documentation, 9 that compliance with the rule would increase average flight time by 10 minutes, resulting in the consumption of nearly 117,000 additional gallons of fuel per year.

As stated above, the rule does not mandate entry or exit points, nor does it require operators to fly any specific route to or from the North Shore Helicopter Route. Therefore, it is not possible to reliably determine the amount of any increase in fuel consumption that might occur as a result of the rule. However, assuming ERHC is correct that average flight time would increase by 10 minutes, the commenter's estimated increase of 117,000 gallons per year would result in air emissions well below levels determined by the U.S. Environmental Protection Agency (EPA) to be de minimis. 10 One commenter stated that aircraft on the North Shore Helicopter Route could impact wildlife. However, the commenter does not provide any information in support of this assertion, and the FAA is not aware of any reasonably foreseeable adverse impacts on wildlife from helicopters flying on the route at or above 2,500 feet MSL.

The Town of East Hampton raised several objections to the FAA's use of the cited categorical exclusion for the rule. First, the Town asserted that the categorical exclusion is inconsistent with the FAA's intent in proposing the rule. According to the Town, if the rule would not significantly affect the human environment, there is no basis for saying it would reduce noise impact on nearby communities as stated in the NPRM. Second, the Town contended that the FAA mischaracterized the legal standard for a categorical exclusion by limiting the analysis to adverse impacts. Third, the Town claimed that the FAA used the wrong categorical exclusion for the rule.

The FAA does not agree that the cited categorical exclusion, paragraph 312f of FAA Order 1050.1E, is inconsistent with the purpose of the rule. As stated above, the purpose of the rule is to maximize use of the North Shore Helicopter Route and reduce the noise impact of helicopter flights over nearby communities. Categorical exclusion of the rule from further environmental review under NEPA is fully consistent with that purpose and is based on the FAA's analysis of the environmental effects of the rule. The FAA also disagrees with the Town's contention that the agency erred in basing its application of the categorical exclusion on the absence of significant adverse environmental impacts. The agency is not aware of any controlling authority that precludes application of a categorical exclusion to an action because the action has an environmental benefit. Finally, the cited categorical exclusion specifically applies to regulations and therefore is appropriate for this rule.

ERHC argued the FAA has not cited the proper authority for this rule and that reliance on section 44715 is “overstated and misapplied.” ERHC further commented that the FAA failed to consult with the Administrator of the EPA prior to prescribing standards and regulations under section 44715(a), as required. It also contended that § 44715(a) was intended to authorize the FAA to promulgate regulations addressing certification standards, not airspace matters.

NATA, UTC/UTFlight, and AOPA commented that this is the first action by the FAA to mandate the use of a noise abatement procedure without providing some type of operational or environmental analysis. They argued that, historically, the FAA addresses noise abatement action areas initiated by an airport sponsor, as it applies to takeoffs and landings, not to the enroute operation of the aircraft.

In response to the procedural comment, the FAA did consult with the Administrator of the EPA prior to issuing the NPRM, in accordance with the requirements of section 44715(a). That communication and the EPA response have been placed in the docket for this proceeding. In promulgating this rule, the FAA cites to sections 40103(b)(2) and 44715 to articulate the breadth of its authority to address noise stemming from aircraft overflights, aircraft operations in the airport environment and setting aircraft certification standards. Contrary to the commenters' assertion, the FAA possesses and has exercised its authority in the past to address noise issues associated with aircraft overflights. 11 The FAA continues to believe that noise generated by aircraft overflights generally is best addressed locally and with voluntary measures as the primary consideration. However, the FAA is within its authority to address the issue by regulatory action.

UTC/UTFlight argued that the appropriate regulatory structure already exists in 14 CFR 91.119, which provides for minimum safe altitudes. UTC/UTFlight contended that this mandatory route redefines minimum safe altitudes.

The FAA disagrees with UTC/UTFlight that compliance with § 91.119 adequately addresses this issue. Section 91.119 provides the minimum safe altitudes for aircraft and helicopters and is not intended to address aircraft noise. Pilots must follow this provision, unless an altitude is otherwise specified for certain operations. Part 93 in 14 CFR sets forth specific rules for aircraft operations that are necessary for designated airports or defined areas.

GAMA, ERHC, and AOPA contended that the 30-day comment period was too compressed to provide the needed analysis and response to a proposal that raises significant technical, safety, environmental, and operational concerns. A number of the commenters requested that the FAA withdraw the NPRM and some commenters further requested that the FAA instead engage in a series of public meetings and a process to establish routes that would produce effective noise mitigation and provide safety and operational enhancements.

The Administrative Procedure Act  12 does not specify a minimum period for comment. The FAA finds 30 days is not an unreasonable amount of time to comment on the use of a route that has been in place since 2008 and, according to ERHC, has a high rate of use. The FAA also notes that within the 30-day comment period, approximately 900 comments were filed, some of which were extensive. Furthermore, FAA regulations governing rulemaking provide that late filed comments will be considered to the extent possible only if they do not significantly delay the rulemaking process. (See 14 CFR 11.45(b)) The Agency notes that some commenters submitted late comments, and they were considered by this agency.

ERHC also commented the FAA did not perform the required full regulatory evaluation under Executive Order 12866 and Department of Transportation Order 2100.5. ERHC argued that the FAA incorrectly concluded that the cost of the NPRM would be so minimal as to not require full review and that the NPRM was “not a significant regulatory action” and therefore exempt from review of the Office of Management and Budget (OMB).

As further discussed in the section addressing economic concerns, at the NPRM stage and now, the action was—and is—not expected to result in more than minimal additional costs on the affected helicopter operators. Consequently, the FAA properly determined that the proposal was not a significant regulatory action, as defined under Executive Order 12866, was not significant in accordance with DOT's policy, and did not require a full regulatory evaluation under either document. Upon OMB appraisal of the NPRM, it agreed with FAA that it was non-significant.

ERHC commented that the regulatory text is “unconstitutionally vague” and that the “NPRM's lack of clarity would almost certainly result in inadvertent violations and inconsistent enforcement of the rule,” which violates the Due Process Clause of the Fifth Amendment to the U.S. Constitution.

The FAA notes that ERHC was instrumental in working with the FAA to develop the North Shore Helicopter Route. Since this route was charted in 2008, the FAA is not aware of complaints from any operator about inability to navigate along the route, or any concern with the route as designed and charted. Unlike a route designed for IFR use, a VFR route does not have lateral dimension. The mandatory portion of the route follows the northern shoreline of Long Island from the VPLYD waypoint point to the northern tip of Long Island at Orient Point. As stated previously, the FAA chose waypoints that were based on the proximity to easily identifiable visual landmarks. The FAA believes that the route was developed using visual references that pilots can easily identify. We do not conclude that the requirements of this rule are vague and will result in inconsistent enforcement.

As with any other rule, the FAA will enforce this rule to the best of its capabilities. Reports of violations will be investigated to determine if the operator deviated for reasons of safety, weather, or to transit to its destination. While operators will be given the maximum latitude for deviations related to safety, a pattern of deviations would indicate that an operator was interested more in cutting short the route rather than any legitimate safety concerns. Any violation of this rule may result in a civil penalty or the suspension or revocation of the pilot's airman certificate.

The FAA received several comments on our regulatory evaluation and the small business impact. These commenters included ERHC, GAMA, HAI, NATA, and NBAA, who stated the potential economic impact of the proposed regulatory changes, particularly on small businesses, is significant. The commenters believed the rulemaking's cost is significant because the change in flight procedures would drive longer flight paths for rotorcraft operating in the North Shore airspace. This in turn would have an impact on fuel consumed. They also believed that the final rule would force costs for additional avionics equipage.

ERHC asserted that mandating use of the North Shore Helicopter Route, as proposed, would increase the average flight of operations not currently using the route by 10 minutes. It estimated that 15 percent of current operations (approximately 2,250 operations) do not follow the voluntary route. Based on these assumptions, ERHC argued (assuming an 85 percent compliance rate) that the rule would result in the additional consumption of slightly less than 117,000 gallons of fuel per year.

The FAA cannot confirm that the route is currently being used 85 percent of the time. However, for the sake of estimating the cost of the rule, the FAA assumes that ERHC is correct. Using EHRC's numbers, the FAA calculated the cost associated with the use of the additional fuel. The nominal fuel price per gallon from the latest FAA fuel price forecast for the second half of 2012 through the first half of 2014 is $3.17. 13 Multiplying the average fuel price by ERHC's estimate of the additional fuel burn, over 2 years, that nominal cost equals $745,875, or $714,569 at a 7 percent discount rate. Applying the nominal value on a per flight basis, the nominal increase in fuel costs on a per flight basis is approximately $150. However, as noted in footnote 12, the FAA calculated the increase in travel time from the VPLYD and Alexanders East Heliport, which the FAA believes represents the worst case in terms of additional travel time, and found that the increase in time should be approximately 7 minutes. Assuming ERHC's estimate of the amount of fuel burned per minute of flight time is correct, then with an increase in flight time of 7 minutes there would be an increase in fuel cost of $105 for that flight. Since an operation between these two points represents the worst case, the average of all affected flights would be somewhat lower. Thus the total discounted cost over a 2-year period would be significantly lower than $714,569.

The FAA has determined that this action is not expected to result in more than minimal additional costs on the affected helicopters. Operators that cannot comply with the route as published due to operational limitations, performance factors, weather conditions, or safety considerations are allowed to deviate from the provisions of Subpart H.

As discussed above, it is both impractical and imprudent to require all helicopters to fly along the entire North Shore Helicopter Route. Operators must land at some point, and will have to deviate from the route for that reason. Additionally, safety considerations make use of the route imprudent under some circumstances and for some aircraft. As has also been noted above, the FAA does not know what the current rate of compliance with the route is or the circumstances surrounding decisions not to use it. ERHC contends that the current rate of compliance is already very high. There is no reason to retain this rule if the FAA determines that it is not actually improving the noise situation along the north shore of Long Island.

The FAA has decided to sunset this rule in 2 years if we determine there is no meaningful improvement in the effects of helicopter noise on quality of life or that the rule is otherwise unjustified. Should there be such an improvement, the FAA may, after appropriate notice and opportunity for comment, decide to make the rule permanent. Likewise, should the FAA determine that reasonable modifications could be made to the route to better address noise concerns (and any other relevant concerns), we may choose to modify the rule after notice and comment.

The FAA recognizes that we did not contemplate a sunset provision when we published the NPRM. The FAA has decided to finalize this provision without providing an additional opportunity to comment because we have determined that providing such a comment period is unnecessary. The FAA has already received hundreds of comments on the advisability of finalizing this rule. Commenters fall squarely into three camps: those who oppose the rule as burdensome and unnecessary, those who oppose the rule because they believe it does not go far enough, and those who support the rule. The FAA does not anticipate that providing an opportunity to comment on a sunset provision will generate any discussion beyond that which has already been provided in the comments received on the NPRM. The FAA does note that any decision to extend the rule beyond 2 years or to modify the existing route will be subject to notice and an opportunity to comment.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 directs that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it be included in the preamble if a full regulatory evaluation of the cost and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.

This action is not expected to result in more than minimal additional costs on the affected helicopter operators because many of the existing operators already comply with the final rule requirements. Further, no new systems are required. Thus, the rule imposes no more than minimal cost. However, given the number of comments submitted in response to the NPRM, this final rule has been designated as significant under Executive Orders 12866 and 13563.

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

ERHC has 35 members who provide commercial operations. According to ERHC's comments to the NPRM, the majority of these operators fly over Long Island and could be impacted in some way by this final rule. The FAA presumes that all 35 commercial operators have fewer than 1,500 employees. However, assuming ERHC's estimates of current compliance are correct, somewhere between zero and fifteen percent of total operations are likely to be directly affected by this rule.

As noted above, the FAA believes those changes would result in an estimated increase in costs of $105 to $150 dollars per affected flight. The costs of commercial operations between Manhattan and the east end of Long Island generally range between $3,500 and $9,500 per trip, depending on the number of engines and available seats. The FAA believes that the vast majority of operators conduct operations on behalf of paying customers because of the cost associated with owning and maintaining a helicopter for personal use. Accordingly, we base our determination that the impact on small entities will not be significant on the additional cost associated with flying along the North Shore Helicopter Route. At an additional $150, the increase per affected operation would range between 4 and 1.5 percent. At an additional $105, the increase per affected operation would range between 3 and 1.1 percent. The FAA also believes that, given the cost of the overall operation to a paying customer, much of that cost is likely to simply be passed on to the customer. To the extent private operators incur the additional fuel cost, the FAA believes those costs the operators will turn to additional forms of transportation only if they determine the additional cost in fuel justifies the longer times required to reach their destination by other forms of transportation. Given the cost between commercial helicopter rates and the cost to take a train or drive, the FAA believes private operators will likely absorb the additional cost because they value their time at a rate that already far exceeds the existing cost difference between helicopter travel and other forms of transportation. The rule does not require the purchase of additional equipment and allows pilots to deviate from the provisions if necessary, due to operational limitations of the helicopter, performance factors, weather conditions, or safety considerations. Therefore, the rule imposes only minimal operating cost.

The FAA received several comments from the private sector and industry based on our regulatory evaluation and the small business impact. ERHC, GAMA, HAI, NATA, and NBAA commented that the potential economic impact of the regulatory changes, particularly on small businesses, is significant. These commenters believed the rulemaking's cost is significant because the change in flight procedures will drive longer flight paths for helicopters operating in the North Shore airspace, which will have an impact on fuel consumed. They also believed that the final rule would force costs for additional avionics equipage.

The FAA notes that numerous small business helicopter charter operators commented that they were already in compliance with the final rule. The FAA further notes that operators that cannot comply with the route as published due to safety, weather conditions, or transitioning to or from a destination or point of landing are allowed to deviate from the provisions of Subpart H. Therefore, this action is not expected to result in more than minimal additional costs on the affected helicopters because those operators are allowed to deviate from the provisions of the final rule.

Therefore, as the acting FAA Administrator, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $143.1 million in lieu of $100 million. This final rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no current or new requirement for information collection associated with this amendment.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations.

Under regulations issued by the Council on Environmental Quality, Federal agencies are required to establish procedures that, among other things, identify agency actions that are categorically excluded from the requirement for an environmental assessment or environmental impact statement under the National Environmental Policy Act of 1969 because they do not have a significant effect on the human environment. See 40 CFR 1507.3(b)(2)(ii), 1508.4. The required agency procedures must also “provide for extraordinary circumstances in which a normally excluded action may have a significant environmental effect.” See 40 CFR 1508.4. For FAA actions, these “categorical exclusions” and “extraordinary circumstances” are listed in Chapter 3 of FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures.”

The FAA has determined that this final rule qualifies for the categorical exclusion identified in paragraph 312f of FAA Order 1050.1E. That categorical exclusion applies to “[r]egulations, standards, and exemptions (excluding those which if implemented may cause a significant impact on the human environment).” The existing New York North Shore Helicopter Route is a VFR route, use of which is voluntary. Additionally, the route is located entirely over water and away from noise-sensitive locations. Furthermore, the number of helicopter operations along the north shore of Long Island is not high enough for this rule to have any potential to result in significant noise impacts. An analysis of emissions based on an overly conservative fuel burn estimate shows that the resulting air emissions would be well below levels determined by the EPA to be de minimis. 14

Therefore, implementation of this final rule is not expected to result in significant adverse impacts to the human environment. Moreover, implementation of the final rule will not involve any of the extraordinary circumstances listed in Section 304 of FAA Order 1050.1E.

The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The agency determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have Federalism implications.

The FAA analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it is not a “significant energy action” under the executive order and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

An electronic copy of a rulemaking document may be obtained by using the Internet—

1. Search the Federal eRulemaking Portal ( http://www.regulations.gov );

2. Visit the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/ or

3. Access the Government Printing Office's Web page at http://www.fdsys.gov.

Copies may also be obtained by sending a request (identified by notice, amendment, or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680.

Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the docket number for this action. Anyone is able to search the electronic form of all comments received into any of the FAA's dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.).

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document, may contact its local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

I. Background

In a notice published in the Federal Register of April 14, 2011 (76 FR 20992), FDA announced that Sun Chemical Corp., 5020 Spring Grove Ave., Cincinnati, OH 45232, had filed a color additive petition (CAP 1C0290) requesting that FDA amend its regulations for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. As part of CAP 1C0290, Sun Chemical Corp. also requested that FDA remove Appendix A in part 74 (21 CFR part 74), which pertains to the ether-soluble matter specification.

D&C Red No. 6 and D&C Red No. 7 are principally monosulfo monoazo dyes prepared by the coupling of diazotized 2-amino-5-methylbenzenesulfonic acid with 3-hydroxy-2-naphthalenecarboxylic acid in alkaline medium. D&C Red No. 6 is produced as the disodium salt, whereas D&C Red No. 7 is the corresponding monocalcium salt. D&C Red No. 6 is listed in § 74.1306 for use in coloring drugs and in § 74.2306 for use in coloring cosmetics. D&C Red No. 7 is listed in § 74.1307 for use in coloring drugs and in § 74.2307 for use in coloring cosmetics. The identity and specifications in §§ 74.1306 and 74.1307 are referenced by §§ 74.2306 and 74.2307. Both color additives are required to be batch certified by FDA before they may legally be used in drugs and cosmetics marketed in the United States.

In the Federal Register of December 28, 1982 (47 FR 57681), FDA published a final rule that permanently listed D&C Red No. 6 and D&C Red No. 7 for use in coloring drugs and cosmetics. The final rule described how D&C Red Nos. 6 and 7 contained ether-soluble matter for which the proponents of the color additives were not able to determine the chemical identity. FDA's final rule established a specification for ether- soluble matter for both color additives, determined by a pass/fail test described in Appendix A of part 74. In the specified test, ether-soluble matter is extracted from each new sample submitted for batch certification and analyzed by visible spectrophotometry. As explained in the final rule, FDA determined that spectrophotometric analysis provided a means of measuring the ether-soluble matter that may be present in each batch. Appendix A includes a reference spectrum that was based on the D&C Red No. 6 lot (the D&C No. 6 reference lot) that was used for toxicology testing in support of the permanent listing of D&C Red No. 6 and D&C Red No. 7. The sample passes the test if the absorption spectrum of the analyte does not exceed the reference spectrum in Appendix A at any wavelength. The reference spectrum represents 150 percent of the ether-soluble matter in the D&C Red No. 6 reference lot. The test is not capable of further characterizing the analyte.

Sun Chemical Corp.'s petition is based on the recent identification of 1-[(4-methylphenyl)azo]-2-naphthalenol (CAS No. 6756-41-8), the uncarboxylated-unsulfonated homolog of the dye component, as the major component of the ether-soluble matter. The identity of the ether-soluble matter was confirmed by FDA using liquid chromatography/mass spectrometry (LC/MS) (Ref. 1). As part of this work, FDA chemists prepared and characterized a reference standard for 1-[(4-methylphenyl)azo]-2-naphthalenol for LC analysis (Ref. 1). FDA chemists also determined that the D&C Red No. 6 reference lot, which was used as the reference for Appendix A, contains 0.0099 percent of 1-[(4-methylphenyl)azo]-2-naphthalenol (Ref. 1).

In its petition, Sun Chemical Corp. notes that the spectrum in Appendix A of part 74 represents 150 percent of the ether-soluble matter in the lot that was used as the reference for the appendix, and that this lot was found to contain 0.0099 percent of 1-[(4-methylphenyl)azo]-2-naphthalenol. Based on this finding, the company notes that the pass test result (150 percent) of 0.0099 percent is 0.015 percent and that 0.015 percent therefore corresponds to the maximum amount of ether-soluble matter permitted in D&C Red Nos. 6 and 7. Accordingly, Sun Chemical Corp. requests 0.015 percent as the specification limit for 1-[(4-methylphenyl)azo]-2-naphthalenol. In addition, Sun Chemical Corp. requests that Appendix A be removed from part 74 and asks that the specification for ether-soluble matter in §§ 74.1306 and 74.1307 (which refers to the pass test in Appendix A) be replaced.

In the final rule permanently listing D&C Red No. 6 and D&C Red No. 7, the acute cumulative exposure to these color additives was calculated to be 8 milligrams per person per day (mg/p/d), and the chronic exposure was calculated to be 2 mg/p/d (47 FR 57681 at 57685). These estimates have not changed as a result of the subject petition because both D&C Red No. 6 and D&C Red No. 7 are intended to be used in the same manner as currently permitted. In addition, the maximum amounts of ether-soluble matter permitted in D&C Red Nos. 6 and 7 have not changed, as the proposed specification limit, 0.015 percent, corresponds to the pass test result in Appendix A (150 percent of 0.0099 percent is 0.015 percent). Based on the petitioner's proposed specification limit of 0.015 percent and the exposure to D&C Red Nos. 6 and 7 from their regulated uses, FDA determined that the short-term (acute) exposure would be no greater than 1.2 micrograms per person per day (μg/p/d), and the lifetime average (chronic) exposure to this impurity would be no greater than 0.3 μg/p/d. FDA concludes that no increase in exposure to 1-[(4-methylphenyl)azo]-2-naphthalenol is expected as a result of the proposed changes to §§ 74.1306, 74.1307, 74.2306, and 74.2307 because the maximum amount of this impurity permitted in the color additives has not changed (Ref. 2).

FDA also notes that it conducted a survey of the amounts of 1-[(4-methylphenyl)azo]-2-naphthalenol in D&C Red No. 6 and D&C Red No. 7 straight colors and lakes. In addition to analyzing the D&C Red No. 6 reference lot discussed earlier, FDA analyzed 25 other lots: 4 other lots of D&C Red No. 6, 4 lots of D&C Red No. 7, 8 lots of D&C Red No. 6 lake, and 9 lots of D&C Red No. 7 lake. Of these 25 other lots, only 3 contained detectable amounts of the impurity, specifically, 0.0006 percent, 0.0008 percent, and 0.002 percent (Ref. 1). FDA also analyzed for 1-[(4-methylphenyl)azo]-2-naphthalenol in samples of D&C Red No. 6 and D&C Red No. 7 submitted for batch certification between July 2009 and January 2011. Sixty-four samples of D&C Red Nos. 6 and 7 from eight domestic and foreign manufacturers were analyzed by LC for the impurity. All of the results obtained were well below 0.015 percent, and the average amount found, 0.0016 percent, is nearly an order of magnitude lower than the petitioned specification limit (Ref. 3).

Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(b)(4)), a color additive may not be listed for a particular use unless a fair evaluation of the data and information available to FDA establishes that the color additive is safe for that use. FDA's color additive regulations at 21 CFR 70.3(i) define safe as the existence of “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.” Numerous toxicology studies on D&C Red Nos. 6 and 7 were performed to support their permanent listing (47 FR 57681). The color additives tested contained the ether-soluble matter, now identified as primarily 1-[(4-methylphenyl)azo]-2-naphthalenol. Based on the results from these studies, the Agency concluded that D&C Red Nos. 6 and 7 (including the ether-soluble matter as determined by the test described in Appendix A) for use in drugs and cosmetics, excluding use in the area of the eye (47 FR 57681 at 57686), is safe. Therefore, although the chemical identity of the principal component of the ether-soluble matter (i.e., 1-[(4-methylphenyl)azo]-2-naphthalenol) was not known when D&C Red Nos. 6 and 7 were permanently listed, the safety of the color additives, which contained the unknown ether-soluble matter, was assessed by FDA through the results of toxicological testing of the color additives containing this impurity.

The requested revision would not change the composition of D&C Red No. 6 or D&C Red No. 7 specified in the applicable color additive regulations, including the permissible level of the impurity. Nor would it change the authorized intended use. Therefore, the Agency concludes that the proposed revision would not affect FDA's safety evaluation in the final rule listing D&C Red No. 6 or D&C Red No. 7. Because there is no increase in the intake of the impurity of D&C Red No. 6 and D&C Red No. 7 beyond a level that has already been established as safe, FDA has no safety concerns regarding the petitioned revision.

FDA will no longer analyze the impurity by visible spectrophotometry when new samples of the color additive are submitted for batch certification. Instead, FDA will test the impurity using reversed-phase high performance liquid chromatography and will continue to do so for as long as the Agency determines that reversed-phase high performance liquid chromatography is appropriate. Because Appendix A of part 74 describes the spectrophotometry test for the ether-soluble matter, and because FDA will no longer analyze the impurity using spectrophotometry, FDA agrees with Sun Chemical Corp.'s request that Appendix A be removed from part 74.

FDA reviewed data in the petition from Sun Chemical Corp. and other relevant data and information to evaluate the safety of revising its requirements for D&C Red Nos. 6 and 7 by replacing the current specification for ether-soluble matter with a maximum limit of 0.015 percent for the impurity 1-[(4-methylphenyl)azo]-2-naphthalenol and by removing Appendix A in part 74, which pertains to the ether-soluble matter specification. Based on this information, the Agency does not have any safety concerns with the proposed amendment and concludes that D&C Red Nos. 6 and 7 will continue to be safe and suitable for their listed uses in drugs and in cosmetics. Therefore, the regulations in part 74 should be amended as set forth in this document. In addition, FDA will no longer analyze the impurity by visible spectrophotometry when new samples of the color additive are submitted for batch certification. Instead, FDA will test the impurity using reversed-phase high performance liquid chromatography.

In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 71.15, the Agency will delete from the documents any material that is not available for public disclosure before making the documents available for inspection.

The Agency has previously considered the environmental effects of this rule as announced in the notice of filing for CAP 1C0290 (76 FR 20992). No new information or comments have been received that would affect the Agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

This rule is effective as shown in the DATES section of this document; except as to any provisions that may be stayed by the filing of proper objections. Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES ) either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the objections that the Agency has received or lack thereof in the Federal Register .

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 74 is amended as follows:

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), and the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513 of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.

A preamendments device that has been classified into class III may be marketed by means of premarket notification procedures (510(k) process) without submission of a PMA until FDA issues a final regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) of the FD&C Act establishes the requirement that a preamendments device that FDA has classified into class III is subject to premarket approval. A preamendments class III device may be commercially distributed without an approved PMA or a notice of completion of a PDP until 90 days after FDA issues a final rule requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act, whichever is later. Also, a preamendments device subject to the rulemaking procedure under section 515(b) is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final rule requiring the submission of a PMA for the device. At that time, an IDE is required only if a PMA has not been submitted or a PDP completed.

Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to issue a final rule to require premarket approval shall be initiated by publication of a notice of proposed rulemaking containing: (1) The regulation; (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA or a declared completed PDP and the benefit to the public from the use of the device; (3) an opportunity for the submission of comments on the proposed rule and the proposed findings; and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives a request for a change in the classification of the device within 15 days of the publication of the notice, FDA shall, within 60 days of the publication of the notice, consult with the appropriate FDA advisory committee and publish a notice denying the request for change in reclassification or announcing its intent to initiate a proceeding to reclassify the device under section 513(e) of the FD&C Act. Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).

When a rule to require premarket approval for a preamendments device is finalized, section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for any such device be filed within 90 days of the date of issuance of the final rule or 30 months after the final classification of the device under section 513 of the FD&C Act, whichever is later. If a PMA or notice of completion of a PDP is not filed by the latter of the two dates, commercial distribution of the device must cease because the device would be deemed adulterated under section 501(f).

The device may, however, be distributed for investigational use if the manufacturer, importer, or other sponsor of the device complies with the IDE regulations. If a PMA or notice of completion of a PDP is not filed by the latter of the two dates, and no IDE is in effect, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation under section 304 of the FD&C Act (21 U.S.C. 334), if its distribution continues. Shipment of devices in interstate commerce will be subject to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and the individuals responsible for such shipment will be subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 333). In the past, FDA has requested that manufacturers take action to prevent the further use of devices for which no PMA has been filed and may determine that such a request is appropriate for the class III device that is the subject of this regulation.

The FD&C Act does not permit an extension of the 90-day period after issuance of a final rule within which an application or notice is required to be filed. The House Report on the 1976 amendments states that “* * * [t]he thirty month `grace period' afforded after classification of a device into class III * * * is sufficient time for manufacturers and importers to develop the data and conduct the investigations necessary to support an application of premarket approval” (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).

The SMDA added section 515(i) to the FD&C Act requiring FDA to review the classification of preamendments class III devices for which no final rule requiring the submission of PMAs has been issued, and to determine whether or not each device should be reclassified into class I or class II or remain in class III. For devices remaining in class III, the SMDA directed FDA to develop a schedule for issuing regulations to require premarket approval. The SMDA does not, however, prevent FDA from proceeding immediately to rulemaking under section 515(b) of the FD&C Act on specific devices, in the interest of public health, independent of the procedures of section 515(i). Proceeding directly to rulemaking under section 515(b) of the FD&C Act is consistent with Congress' objective in enacting section 515(i), i.e., that preamendments class III devices for which PMAs have not been previously required either be reclassified to class I or class II or be subject to the requirements of premarket approval.

In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6, 1994, notice), FDA issued a notice of availability of a preamendments class III devices strategy document. The strategy document set forth FDA's plans for implementing the provisions of section 515(i) of the FD&C Act for preamendments class III devices for which FDA had not yet required premarket approval.

In the Federal Register of August 8, 2011 (76 FR 48058) (the August 8, 2011, proposed rule), FDA published a proposed rule to require the filing under section 515(b) of the FD&C Act of a PMA or notice of completion of a PDP for the cardiovascular permanent pacemaker electrode. In accordance with section 515(b)(2)(A) of the FD&C Act, FDA included in the preamble of the proposed rule the Agency's tentative findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the premarket approval requirements of the FD&C Act, and the benefits to the public from use of the device. The August 8, 2011, proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the Agency's findings. Under section 515(b)(2)(B) of the FD&C Act, FDA provided an opportunity for interested persons to request a change in the classification of the devices based on new information relevant to its classification. Any petition requesting a change in classification for the cardiovascular permanent pacemaker electrode was required to be submitted by August 23, 2011. The comment period for the cardiovascular permanent pacemaker electrode closed November 7, 2011.

FDA received no comments on the proposed rule. FDA received no petitions requesting a change in the classification of the devices.

As required by section 515(b) of the FD&C Act, FDA published its findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that this device have an approved PMA or a declared completed PDP and (2) the benefits to the public from the use of the devices.

These findings are based on the reports and recommendations of the advisory committees (panels) for the classification of these devices along with information submitted in response to the 515(i) Order (April 9, 2009 (74 FR 16214)), and any additional information that FDA has encountered. Additional information regarding the risks as well as classification associated with the cardiovascular permanent pacemaker electrode can be found in the following proposed and final rules published in the Federal Register on these dates: March 9, 1979 (44 FR 13379); February 5, 1980 (45 FR 7943); and May 11, 1987 (52 FR 17732 at 17736).

Under section 515(b)(3) of the FD&C Act, FDA is adopting its findings as published in the preamble to the proposed rule. FDA is issuing this final rule to require premarket approval of these generic types of devices for class III preamendments devices by revising part 870.

Under the final rule, a PMA or a notice of completion of a PDP is required to be filed on or before 90 days after the date of publication of the final rule in the Federal Register , for any of this class III preamendments device that were in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device on or before 90 days after the date of publication of the final rule in the Federal Register . An approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180 days after FDA files the application. Any other class III preamendments device subject to this rule that was not in commercial distribution before May 28, 1976, is required to have an approved PMA or a declared completed PDP in effect before it may be marketed.

If a PMA or a notice of completion of a PDP for any of this class III preamendments device is not filed on or before the 90th day past the effective date of this regulation, that device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. The device may, however, be distributed for investigational use, if the requirements of the IDE regulations (part 812) are met.

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because none of the manufacturers of affected products are small businesses, the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $139 million, using the most current (2011) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any one-year expenditure that would meet or exceed this amount.

Under the final rule, FDA will require producers in the cardiovascular permanent pacemaker electrode industry to obtain an approved PMA or establish a PDP before marketing new products. Similarly, producers of cardiovascular permanent pacemaker electrodes that are already on the market will need to submit PMAs or establish PDPs in order to continue commercial distribution of these products. Based on an analysis of registration and listing data, manufacturer Web sites, and responses to previous Federal Register requests for comment, FDA estimates that 5 to 10 manufacturers are marketing approximately 18 to 23 devices that will be affected by this final rule. We therefore estimate that the final rule will generate between 18 and 23 PMA or PDP submissions. FDA has estimated an upper bound on the cost of a PMA at approximately $1,000,000 (see, for example, 73 FR 7501, February 8, 2008), and we assume that the cost of a PDP is roughly equal to that of a PMA; this yields a rule-induced upfront cost of between $18 and $23 million. We lack data with which to estimate how the burden of this cost will be distributed among device manufacturers, patients and insurance providers.

For a new product (i.e., a cardiovascular permanent pacemaker electrode not currently on the market), the rule-induced cost will be the difference between the cost of preparing and submitting a PMA and the cost of preparing and submitting a 510(k) application. However, between August of 2004 and the present, FDA has not received any submissions for new devices of the type subject to the final rule. We expect the recent pattern of zero new product introduction to continue; therefore, the final rule will not generate submission costs on an ongoing basis.

Some producers of devices that are subject to the final rule could be dissuaded from seeking approval by the cost of submitting a PMA or by a low expectation that FDA will grant approval for their products. In these cases, producers will experience a rule-induced cost equal to the foregone expected profit on the withdrawn or withheld cardiovascular permanent pacemaker electrodes, which is necessarily less than the cost of PMA submission (otherwise, the producers in question would not be dissuaded from seeking approval of a PMA). Additionally, there will be a welfare loss experienced by consumers who would, in the absence of the final rule, use the cardiovascular permanent pacemaker electrodes that will be withdrawn or withheld from the market as a result of the call for a PMA or a PDP. Lacking sufficient market data, we cannot quantify these consumers' welfare loss.

In addition to the cost to industry of preparing and submitting PMAs or PDPs, the final rule will impose incremental review costs on FDA. Geiger (2005) estimated that, for devices reviewed by FDA's Center for Devices and Radiological Health in 2003 and 2004, review costs averaged $563,000 per PMA (Ref. 1). Updated for inflation (using U.S. Department of Commerce, 2011) to 2010 dollars, this average review cost becomes $653,000 per PMA. Thus, the final rule's review-related costs are expected to be between $11.8 million (= 18 × $653,000) (Ref. 2) and $15.0 million (= 23 × $653,000). A portion of this total will be paid by industry in the form of user fees, with the remainder borne by general taxpayers. FDA's DUNS database reveals that the manufacturers affected by this final rule have annual revenues over $100 million, so they will not be eligible for small business user fees. The standard user fee is currently set at $236,298 for a premarket application (PMA or PDP) (75 FR 45643), so user fees will likely cover $4.3 million (= 18 × $236,298) to $5.4 million (= 23 × $236,298) of FDA review costs, with the remaining $7.5 to $9.6 million borne by general taxpayers.

The final requirement for PMAs or PDPs for cardiovascular permanent pacemaker electrodes will produce social benefits equal to the value of the information generated by the safety and effectiveness tests that producers will be required to conduct as part of the PMA or PDP process. Provided first to FDA, this information will eventually assist physicians, patients and insurance providers in making more informed decisions about these devices. FDA expects there to be approximately 18 to 23 PMA or PDP submissions as a result of the final rule, but we are unable to quantify the value of information associated with each submission.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

This final rule refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 812 have been approved under OMB control number 0910-0078; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.

The effect of this rule, is to shift certain devices from the 510(k) premarket notification process to the PMA process. To account for this change, FDA intends to transfer some of the burden from OMB Control Number 0910-0120, which is the control number for the 510(k) premarket notification process, to OMB Control Number 0910-0231, which is the control number for the PMA process. As noted in this document, FDA estimates that it will receive 21 new PMAs as a result of this rule. Based on FDA's most recent estimates, this will result in a 21,789 hour burden increase. FDA also estimates that there will be 21 fewer 510(k) submissions as a result of this rule. Based on FDA's most recent estimates, this will result in a 2,860 hour burden decrease. Therefore, on net, FDA expects a burden hour increase of 18,930 due to this regulatory change.

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m. Monday through Friday. FDA has verified Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

Bicycling is a popular recreational activity in national parks. Bicycle riders of all skill levels and ages enjoy riding on park roads and designated bicycle trails for beautiful scenery, exercise, and adventure. People bicycle alone, with friends, or with family—they bicycle to visit points of interest, to be healthy, and because it's fun.

The National Park Service (NPS) believes that, with proper management, bicycling is an appropriate recreational activity in many park areas. In other areas, due to safety or other concerns, bicycling may not be appropriate. This rule provides park superintendents with a more efficient and effective way to determine whether opening existing trails to bicycles would be appropriate in the park unit they manage. The rule also offers guidance on trail sustainability and bicycle safety.

Regulations promulgated in 1987 provide for the use of bicycles on park roads, in parking areas, and on routes designated for bicycle use (36 CFR 4.30). According to the 1987 regulations, a special regulation, specific to the individual park, must be adopted if bicycles are to be used on routes outside a park's developed areas. The NPS adopted the special regulation requirement to ensure maximum public input on decisions to allow bicycle use on routes outside of developed areas.

For existing trails and for new trails located in developed areas, this final rule requires enhanced planning and environmental compliance procedures and public notice and participation, but does not require promulgation of special regulations. In addition, existing trails may not be designated for bicycle use if doing so would result in a significant impact on the environment. The NPS will continue to require the promulgation of special regulations before constructing bicycle trails outside of developed areas. The rule does not affect other existing statutory or regulatory protections for park resources and enhancement of visitor experiences.

Section 8.2 of NPS Management Policies 2006 states that “enjoyment of park resources and values by the people of the United States is part of the fundamental purpose of all [national] parks” and that the NPS “will maintain within the parks an atmosphere that is open, inviting, and accessible to every segment of American society.” However, the policies emphasize that the NPS “will allow only uses that are (1) appropriate to the purpose for which the park was established, and (2) can be sustained without causing unacceptable impacts. Recreational activities and other uses that would impair a park's resources, values, or purposes cannot be allowed.” NPS Management Policies 2006, 8.1.1. NPS Management Policies establish a process for determining whether a particular use is appropriate in a park unit. NPS Management Policies 2006, 8.1.2.

In compliance with these policies, the final rule places greater emphasis on an individual park planning process that incorporates environmental compliance procedures and input from the public, rather than the special rulemaking process, to decide whether or not bicycle use is appropriate on a trail in a unit of the National Park System. The designation of a particular trail for bicycle use must be considered as part of a park plan addressing trail use, such as a recreation use plan. The final rule also requires that, at a minimum, the plan:

• Evaluates the suitability of existing trail surface and soil condition for accommodating bicycle use, or prescribes a sustainable trail design for the construction of new trails.

• Considers life cycle maintenance costs, safety considerations, strategies to prevent or minimize user conflict, methods of protecting natural and cultural resources, integration with commercial services and alternative transportation systems (if applicable).

The rule utilizes the public outreach aspects of the National Environmental Policy Act (NEPA) process by requiring, at a minimum, preparation of an Environmental Assessment (EA) for any decision to open existing hiking or horse trails to bicycles. The rule precludes the use of categorical exclusions for opening trails to bicycle use. The rule also:

• Requires a trail-specific analysis in the EA or Environmental Impact Statement (EIS). In order to authorize bicycle use on an existing trail, the EA must result in a finding of no significant impact. When an EIS is prepared, the trails must be specifically identified and evaluated within the EIS, and the Record of Decision, or an amended Record of Decision, must document that there will be no significant impacts. See NPS Management Policies 2006, 2.3.1.7.

• Requires that the superintendent must provide the public with notice of the availability of the EA and at least 30 days to review and comment on EAs for bicycle use.

• When there are no significant impacts, requires that public notice of the superintendent's determination (made pursuant to paragraph (d)(3) of the final rule) be published in the Federal Register . If the determination itself is not published in full, then the notice must state where to view or how to obtain a copy of the determination. This Federal Register notice must provide the public a 30-day period to consider and comment on the determination prior to the park opening any trails for bicycle use.

• The comment period for the written determination will be particularly important because it will allow for public comment contemporaneous with the decision to implement an earlier planning process.

• Requires that the superintendent, after considering public comment, submit to the appropriate NPS Regional Director for approval in writing the superintendent's determination that bicycle use on a trail is consistent with the protection of the park area's natural, scenic and aesthetic values, safety considerations, and management objectives and will not disturb wildlife or park resources. See NPS Management Policies 2006, 1.4.7.1 (discussing unacceptable impacts to NPS park resources). The requirement for Regional Director approval is a change from the proposed rule.

• The final rule clarifies that all planning and compliance must be completed before designation of trails for bicycle use.

• The rule also requires that the trail-specific, rigorous planning and compliance process applies to new trails, and continues to require promulgation of a special regulation for construction of a new bicycle trail outside developed areas.

• For existing trails, the final rule prohibits bicycle use where significant impacts would occur.

• For existing trails, even when the environmental compliance analysis has found no significant impacts, the appropriate NPS Regional Director may decide that bicycle use is not consistent with the resources, values, and purposes of the park area, and, after considering public comment on the written determination required by the final rule, withhold approval.

By adopting these requirements, the rule meets the public participation objectives of the NPS without the necessity for promulgating a special regulation in some cases.

Unlike the proposed rule, the final rule does not require that notice of an EA for bicycle use be published in the Federal Register . The NPS believes that NPS Director's Order-12, Conservation Planning, Environmental Impact Analysis, and Decision-Making, and the Department of the Interior NEPA regulations ensure a robust public involvement and notification process without requiring a Federal Register notice. However, the final rule will continue to require that the notice of the availability of the superintendent's written determination be published in the Federal Register before the appropriate NPS Regional Director approves the determination. Because the final rule allows the designation of existing trails for bicycle use without rulemaking only where there are no significant impacts, the final rule departs from the proposed rule and does not apply 36 CFR 1.5 to the designation of trails for bicycle use, or (for reasons discussed below) to closures, conditions, limits and restrictions to bicycle use.

The NPS uses NEPA not only as a tool to look at whether to designate an existing trail or build a trail for bicycle use, but also as a guide in the larger aspects of NPS decision-making. Most NEPA requirements are compatible with or identical to requirements for sound management planning. In most cases, NEPA requirements are easily integrated into the planning process, and they provide the information that decision-makers need to make correct choices. Rather than create additional burdens in the planning process, following NEPA requirements should help facilitate prompt and well-informed decision-making. See NPS Handbook for Environmental Impact Analysis, § 1.5B. In some instances, particularly when bicycle trail planning and NEPA compliance is limited in scope, the superintendent's determination may also be integrated with and completed concurrently with the planning and compliance process.

The NPS will continue to prohibit bicycle use in eligible, study, proposed, recommended, and designated wilderness areas as required by NPS policy. In accordance with Section 6.3.1 NPS Management Policies 2006, all categories of wilderness, including eligible, study, proposed and recommended wilderness, will be managed with the same level of protection and under the same requirements as designated wilderness. Therefore, a superintendent may not propose either use of bicycles on existing trails or propose new bicycle trails on any lands that meet the Management Policies definition of wilderness unless this policy is specifically waived in writing by the Secretary, the Assistant Secretary, or the Director.

Paragraph (b) of the rule addresses bicycle use on administrative roads. The rule clarifies that an administrative road closed to motor vehicle use by park visitors is also closed to bicycle use unless the superintendent makes a written determination and opens the road to such use. Rather than having the determination address the general criteria for managing public use under 36 CFR 1.5 as proposed (73 FR 76987, December 18, 2008), the final rule directs that the superintendent's written determination for opening an administrative road must address the criteria required for bicycle route designation under the existing 36 CFR 4.30 regulations. The same determination—that bicycle use is consistent with the protection of the park area's natural, scenic and aesthetic values, safety considerations, and management objectives and will not disturb wildlife or park resources—is required for authorizing bicycle trails in this rule.

After designating an administrative road as open, the superintendent may find it necessary to impose certain limits or restrictions on the use of bicycles on administrative roads to address safety considerations, avoid visitor use conflicts, or protect park resources and values. Paragraph (f) of the final rule clarifies and strengthens the superintendent's authority to close, limit, restrict, or impose conditions on bicycle use or terminate a closure or restriction on any trail or area designated as open for bicycle use, including administrative roads.

Although state law is already adopted in Part 4, specifically at 36 CFR 4.2 “State law applicable,” paragraphs (g)(2) and (h)(6) of the final rule explicitly provide that state laws are adopted and apply to bicycle use. This is consistent with the NPS's response to public comments on bicycle use in its 1987 rulemaking:

The rule eliminates the term “special use zone” because this term is no longer used in NPS planning documents and therefore has created unnecessary confusion in interpreting its meaning within the context of this regulation.

The NPS recognizes that some parks have completed bicycle trail planning or may have bicycle planning in progress that does not meet the new procedures in this rule for designation of trails without rulemaking. As stated, this rule is intended to provide a more efficient and effective way to determine whether opening existing trails to bicycles would be appropriate. Parks that have completed the planning process may still authorize bicycle use by supplementing their planning and compliance to conform to this rule or by concluding with a special regulation. This includes existing trails, provided that the appropriate NEPA document concludes that such use will have no significant impacts. Existing NPS special regulations authorizing bicycle routes, and routes in developed areas that have been designated through a written determination, remain in effect, and the new rule does not require that they be reissued or reauthorized.

NPS Management Policies 2006 describe backcountry as “primitive, undeveloped portions of parks. This is not a specific management zone, but rather refers to a general condition of land that may occur anywhere within a park.” NPS Management Policies 2006, 8.2.2.4. NPS Natural Resource Management Reference Manual #77 (RM #77) (2006) offers comprehensive guidance to NPS employees responsible for managing, conserving, and protecting the natural resources found in National Park System units. To prevent trail deterioration, RM #77 counsels that backcountry trail corridors be sustainable:

Minimizing impacts to natural and cultural resources is a foundation of NPS management decisions and a management responsibility. The NPS Organic Act (16 U.S.C. 1, et seq. ) mandates conservation of park resources for future generations and precludes impairment of park resources, and these requirements can best be met through sustainable trail design and practices.

Trampling of vegetation, compaction and erosion of trail tread materials, and trail muddiness are impacts associated with trail corridors. Trail erosion causes gullies and can cause impacts immediately adjacent to the trail corridor by exposing tree roots. Erosion of trail materials also dries out the soil substrate adjacent to trails, which is critical to ground cover, grasses, and understory plant health and success, causing further impacts and trail widening. Eroded materials can also be deposited downhill from trails and enter aquatic systems causing changes to water quality and related impacts. See ParkScience, 28(3), The Science of Trail Surveys: Recreation ecology provides new tools for managing wilderness trails, p. 60-65, Marion, Wimpey and Park, available online at http://www.nature.nps.gov/ParkScience/index.cfm?ArticleID=544.

To ensure that trails are sustainable, the NPS recommends an average trail profile grade of 10-12 percent, a maximum trail profile grade of 12-15 percent, and the relationship between the trail profile gradient and prevailing cross slope grade in the immediate vicinity along the trail centerline at less than one quarter (“high slope alignment angle” (Marion, Jeffrey L., 2006)). Design techniques such as grade reversals and rolling contour trails will increase sustainability by ensuring prompt drainage of rainfall and snowmelt off the trail. Construction techniques such as retaining walls, switchbacks, stone paving, and bridges can improve trail surfaces, reduce impacts, increase sustainability, and improve the visitor experience. Trail project guidelines may be augmented by state-of-the-art scientific research and landscape architectural criteria to increase sustainability. See Developing Sustainable Mountain Trail Corridors: An Overview, National Park Service, Denver, Colorado. 1991; Guide to Sustainable Mountain Trails, Trail Assessment, Planning & Design Sketchbook (Sketchbook (2007)), National Park Service, Denver, Colorado. 2007 edition, and other resources available online at the NPS Sustainable Trails page at http://www.nps.gov/dsc/trails.htm.

The NPS must consider the cost of initial construction as well as on-going maintenance in its management decisions. Therefore, the NPS must carefully factor costs into all analyses of trailside decisions that enhance sustainability and minimize impacts to natural and cultural resources, and consider cost variables in the NEPA compliance processes.

The Sketchbook (2007) makes the case that the sustainability of backcountry trails is as much an art as it is a science. To ensure quality and sustainability, it is essential that the expertise of an interdisciplinary team of professionals with experience in backcountry trails be utilized in the NEPA compliance processes. Trails literature since the Civilian Conservation Corps era has emphasized that interdisciplinary teams are best qualified to provide trail sustainability expertise for trail projects. Landscape architects, civil engineers, soil scientists, natural resource specialists, cultural resource specialists, botanists, biologists, interpreters, restoration ecologists, trail design specialists, and others are important members of interdisciplinary backcountry trail teams.

In 1987, states began adopting bicycle laws which require children 18 years of age or younger to wear a helmet. Currently, 22 states and the District of Columbia have enacted these laws. Thirteen states have no state helmet laws (Arkansas, Colorado, Idaho, Indiana, Iowa, Minnesota, Nebraska, North Dakota, South Dakota, South Carolina, Utah, Vermont, and Wyoming). Studies show that helmet use while riding decreases the risk of head and brain injury by 70-88 percent (Thompson et al., 1989) and facial injury to upper and mid-face areas by 65 percent (Thompson et al., 1996). See http://depts.washington.edu/hiprc/practices/topic/bicycles/helmeteffect.html.

Among parks where statistically meaningful injury data is available, bicycling is one of the leading causes of injuries—particularly in urban parks and parks frequented by local visitors. To enhance the safety of visitors who bicycle in parks, the adoption of state law in paragraph (g)(2) includes state helmet-use laws and regulations, and parks will enforce these requirements. Also, as part of an effort to support the Healthy Parks, Healthy People initiative and safe adventures, park superintendents should consider using their authority under 36 CFR 1.5 to mandate helmet use where state laws do not exist, particularly in parks where bicycle use is prevalent in highly populated or other at-risk areas. This effort by superintendents would be consistent with NPS Management Policies, which state:

Both the National Highway Traffic Safety Administration (NHTSA) and Centers for Disease Control and Prevention, partners in traffic injury prevention, support the use of bicycle helmets by all bicyclists, every ride. Bicycle helmets are proven to be the single most important piece of safety equipment to prevent head injuries and fatalities resulting from bicycle crashes. Despite the fact that nearly 60 percent of all fatal bicycle crashes involve head injuries, only about 19 percent of adults and 15 percent of children wear bicycle helmets. According to NHTSA, in 2009 the average age of bicyclists killed and injured was 41 and 31 years old, respectively. This emphasizes the need for all riders, children and adults, to wear a bicycle helmet. NHTSA advocates that adults should be role models by following the same safety principles that they insist be followed by their children. See http://www.cdc.gov/program/performance/fy2000plan/2000xbicycle.htm; and National Strategy for Advancing Bicycle Safety, http://www.nhtsa.gov/people/injury/pedbimot/bike/bicycle_safety/index.htm.

Concession contracts and commercial use authorizations (CUA) give the NPS the ability to regulate commercial bicycle tours. CUAs may be issued to authorize a qualified person to offer suitable commercial services to park area visitors if the superintendent determines that the commercial services will have minimal impact on the park area's resources and values; are consistent with the purposes for which the park area was established; and are consistent with all applicable park area management plans, policies and regulations. A decision to issue a CUA (or to limit the number of CUAs to be issued) must be made in accordance with park area planning policies and procedures, including compliance with NEPA. If a concession contract authorizes the provision of bicycle services or if CUAs are issued, the NPS may include operating standards that limit numbers, require insurance, specify safety standards, and require reports from the operators to help the NPS monitor the effects of the use. Superintendents should refer to the NPS, November 18, 2005, Interim Guidelines for Commercial Use Authorizations.

The planning process can help determine if bicycling opportunities may increase overall visitation, generate youth interest in parks, or expand appreciation for our national parks. Proper planning with public participation also provides the opportunity to consider a range of alternatives to avoid or minimize impacts on natural, historic, and cultural resources and reduce conflicts with other user groups. No matter what type of planning is conducted, “(i)n its role as steward of park resources, the National Park Service must ensure that park uses that are allowed would not cause impairment of, or unacceptable impacts on, park resources and values.” NPS Management Policies 2006, 1.5.

The NPS published the proposed rule at 73 FR 76987 (December 18, 2008) and a correction was made in 73 FR 78680 (December 23, 2008). We accepted comments through the mail, hand delivery, and through the Federal eRulemaking Portal at http://www.regulations.gov. Comments were accepted through February 17, 2009, and a total of 6,576 comment documents were received. A summary of comments and NPS responses is provided below, followed by a table that sets out, section-by-section, the changes we have made from the proposed rule to the final rule based on the analysis of the comments.

1. Comment: The proposed rule should be rejected because bicycle use on trails increases soil erosion and damages trails and nearby vegetation. The proposed rule does not adequately protect natural resources (including wildlife and wildlife habitats) from adverse impacts and would dramatically change the character of the parks. Bicycle use causes greater impacts to wildlife and habitats than other uses, such as hiking and horseback riding.

Response: The NPS has considered this issue and reviewed studies that gauge the environmental impacts of bicycling. It should be noted that this rule does not authorize any trails for bicycle use. This rule revises the procedure for authorizing bicycle use on certain existing trails. Individual parks that use these procedures will have to demonstrate, consistent with NPS Management Policies 2006, 1.4.7.1, that authorizing bicycle use will not cause unacceptable impacts to natural resources, including soils, vegetation, and wildlife. Generally, impacts to soils, vegetation, and wildlife from bicycles are similar to impacts from hiking and less than impacts from horseback riding or motorized vehicle use. When a trail is sustainably located, designed, and constructed, it can support low-impact uses such as hiking and biking with minimal maintenance and with no degradation of the natural resources.

The final rule requires, among other prerequisites for bicycle use, a trail suitability determination for existing trails and the sustainable design of new trails. Superintendents are required to follow NPS Management Policies 2006, including Chapter 8, Use of the Parks (see e.g., sections 8.1 through 8.2.2.4). This rule also provides planning guidelines.

2. Comment: If bicycling on a trail is misused, abused, or disruptive to the environment, the NPS should maintain the right to shut the trail down through a process of public hearings.

Response: We agree, and the final rule provides superintendents with a restriction and closure authority in paragraph (f) that is independent of the general 36 CFR 1.5 “Closures and public use limits” authority. This will allow superintendents to take actions to mitigate or eliminate unforeseen safety issues, resource damage, or other management problems should they arise. Public notice of limits, restrictions, or closures must be provided under 36 CFR 1.7.

3. Comment: An EA should not be required for designating existing trails for bicycle use because bicycles cause no significant environmental impacts (including impacts upon soil and topography), and cause less impacts than horseback riding and no more impacts than hiking. Impacts from bicycle use can be decreased by effective NPS management and visitor education.

Response: Because impacts from bicycle use can vary depending on where a trail is located, an EA or an EIS with a specific finding of no significant impact for a bicycle trail(s) is required to designate an existing trail for bicycle use. When trails are sustainably located, designed, and constructed, impacts are normally insignificant. However, there may be cases where impacts are significant, including soil erosion, safety, and conflicts with other visitors. Consequently, this rule will preclude the use of a categorical exclusion for designating existing trails for bicycle use.

4. Comment: The NPS should evaluate the impact of increased biking and trail construction on wildlife, streams, and fisheries before changing the existing rule which works well.

Response: This new rule clarifies and strengthens planning and NEPA procedural requirements by which bicycle use may be considered on both existing and newly constructed trails. The previous rule simply required promulgation of a special regulation to allow bicycle use on existing or new trails outside of a developed area. This revision requires that bicycle use on trails must be addressed in a planning document that addresses specific key criteria. Some of these criteria are trail suitability or sustainable trail design, lifecycle maintenance costs, safety considerations, methods to prevent or minimize user conflict, and integration with commercial services and alternative transportation systems (if applicable). Bicycle use must also be addressed with a site-specific NEPA analysis. The site-specific EA or EIS would address impacts to wildlife, streams, and fisheries from increased bicycle use and trail construction.

5. Comment: Bicycle use should not be allowed on existing trails in order to avoid conflicts and accidents with established users of such trails (e.g. hikers, equestrians). Each trail should be limited to a single use (e.g. bicycles, hiking, or horseback riding) to avoid user conflicts. The NPS should be more concerned with the safety of hikers and equestrians than the promotion of bicycle use. The proposed rule does not adequately prevent user conflicts and ensure safety on multi-use trails. The proposed rule will displace existing users of trails.

Response: The NPS is concerned with the safety of all park visitors. This rulemaking places more emphasis on planning and impact analysis and requires that safety and user conflict must be evaluated. Specifically, the rule requires that an existing trail cannot be designated for bicycle use unless it is determined that there will be no significant impacts, including impacts to visitor safety. The final rule also requires that “safety considerations [and] methods to prevent or minimize user conflicts” be considered as part of the planning process in paragraph (d)(1)(ii).

6. Comment: Bicycle use should be limited to existing paved roads and should not be permitted on any trails. There are many trails open to mountain bike use in national forests and other federally-owned lands.

Response: Bicycling is a family-oriented activity that contributes to the health and well-being of those that enjoy it, and the NPS believes that bicycle use need not be limited to existing paved roads. In many park areas bicycling on various types of trails, fire roads, abandoned railroad right-of-ways, and canal towpaths is an appropriate method of touring, sightseeing, and otherwise enjoying National Park System resources. In other park areas bicycling may not be appropriate. This determination is best made at the park level with appropriate NPS regional level review. Currently, the NPS has a variety of bicycle use trails in a variety of park areas around the country, including Golden Gate National Recreation Area, Saguaro National Park, Grand Teton National Park and Delaware Water Gap National Recreation Area.

7. Comment: Trails should be open to specific uses at assigned times based upon the amount of traffic on the trails.

Response: This rule implements procedural changes that will provide an opportunity to consider specific uses at assigned times and the appropriateness of other local rules and mitigation measures during the bicycle use planning process undertaken by the individual park areas.

8. Comment: The proposed rule should include rules of the road for bicycle use on roads and trails open to other uses (e.g., hiking, horseback riding). There should be a national standard for “appropriate use” of bicycles on backcountry trails and administrative roads that complies with NPS Management Policies and emphasizes slow-paced sightseeing rather than thrill-seeking at fast speeds.

Response: This rule contemplates consideration of locally crafted rules of the road and equipment restrictions during planning and compliance with NEPA. Time-of-day or alternate-day authorization of uses, one-way riding requirements on loop trails, and requiring bicyclists to dismount and walk their bicycle through congested areas are some options for consideration during planning processes. Paragraph (f) of the rule also authorizes the superintendent to impose use restrictions should the need arise. When implementing this rule, individual parks may, for example, consider ways to accommodate the safe use of bicycle trails for slow to moderate paced access, sightseeing, and exercise. Generally speaking, thrill-seeking at fast speeds would not be an appropriate activity in National Park System units. This issue is also addressed in the trail sustainability discussion of this rule and through NPS service-wide requirements in paragraph (g)(1) and state requirements (where a state has laws that regulate bicycle use) adopted in paragraph (g)(2).

9. Comment: All existing hiking trails should also be designated for bicycle use in order to spread out the amount of traffic on certain trails.

Response: This rule implements procedural changes to the process by which bicycle trails may be authorized. For a number of reasons, including safety and visitor conflicts, all existing hiking trails are not appropriate for bicycle use. As the rule provides, whether an existing trail is appropriate for such use is best determined through an impact analysis of the activity as part planning and environmental compliance on a park-specific, trail-specific basis.

10. Comment: Bicycle use should be allowed in Wilderness Areas and will not affect their wilderness qualities.

Section 4(c) of the Wilderness Act generally prohibits mechanization within designated wilderness areas, stating that “there shall be * * * no use of motor vehicles, motorized equipment or motorboats, no landing of aircraft, [and] no other form of mechanical transport. * * *” The Wilderness Act emphasizes that mechanization, including mechanical transport, is not compatible with wilderness qualities and is contrary to preservation of the wilderness character of an area. As a result, the use of bicycles is already prohibited by law in wilderness areas.

11. Comment: In order to comply with section 6.4.3.3 of NPS Management Policies, the NPS should revise the proposed rule to clarify that bicycle use is prohibited in eligible, studied, proposed, recommended, and designated Wilderness Areas.

Response: The NPS will continue to prohibit bicycle use in eligible, study, proposed, recommended, and designated wilderness areas as a matter of NPS policy. In accordance with Section 6.3.1 of NPS Management Policies 2006, all categories of wilderness, including eligible, study, proposed, and recommended wilderness, will be managed with the same level of protection and under the same requirements as designated wilderness, unless specifically waived or modified in writing by the Secretary, the Assistant Secretary, or the Director.

12. Comment: The proposed rule has no rational basis and it discriminates against bicycle use by presuming with no scientific justification that bicycle use has a greater potential to cause adverse resource impacts than heavy animals like horses or pack stock.

Response: Similar to other uses in parks, bicycle use does have impacts on resources and other visitor activities that must be considered before allowing the use. Bicycle use also has different types of impacts in park areas (such as safety concerns as a result of speed differential) than horses and pack stock. Conflicts between various user groups, including conflicts between hikers and equestrians, hikers and bicyclists, equestrians and bicyclists, and between bicyclists and other bicyclists, are well documented in social-scientific studies and were well represented in the public comments submitted on the proposed rule. See Federal Highway Administration Report Number PD-94-031 (Moore 1994).

This rule addresses visitor use conflicts by requiring that an existing trail cannot be designated for bicycle use unless it is determined that there will be no significant impacts, including impacts to visitor safety. The final rule also requires that “safety considerations [and] methods to prevent or minimize user conflicts” be considered as part of the planning process in paragraph (d)(1)(ii).

13. Comment: Publication in the Federal Register is not an adequate means of notifying the public. The NPS should proactively notify interested members of the public by email and USPS, in addition to notification in local newspapers.

Response: The NPS agrees that notice in the Federal Register is not the only approach to reach interested members of the public. The NPS policy for NEPA compliance encourages parks to use various other methods of notifying the public, including creating mailing lists of interested persons, publication in local newspapers, and the use of new media.

For NEPA compliance, the NPS guidelines for public involvement require an early and open process to determine the scope of environmental issues and alternatives to be addressed in an EA or EIS. EAs are sent out for review by the interested and affected public, including affected agencies and tribes, for a minimum of 30 days. The notice that an EA is available for review will be published in a visible location in the local newspaper of record and posted on the NPS Web site. Publication in the Federal Register may also be appropriate and will be considered by superintendents on a case-by-case basis. Public notice is also accomplished by mail and anyone may request a copy of the EA or EIS for specific bicycle trail designations in park units. If you are interested in actions taking place in a particular park, you can inform the park that you would like to be notified of any proposed action or any environmental impact analysis that might be prepared for that area. The NPS requires that draft EISs be available for public review for a minimum of 60 calendar days from the day the Notice of Availability (NOA) is published in the Federal Register .

In the final rule, the NPS has retained the requirement in the proposed rule that an EA be open for public comment for a minimum of 30 days. In a change from the proposed rule, the NPS will not require that the availability of the EA be published as a notice in the Federal Register . The NPS will instead adhere to its existing guidelines for public notice of the availability of an EA. The final rule also retains the requirement in the proposed rule that, when rulemaking is not required, a NOA of the superintendent's written determination be published in the Federal Register with a 30-day public comment period. It is our intent that this procedure should function similar to the period of public comment provided for in rulemaking.

14. Comment: By allowing increased bicycle use in the parks, the proposed rule violates the conservation mandate of the Organic Act “to conserve the scenery and the natural and historic objects and the wildlife therein and to provide for the enjoyment of the same in such manner and by such means as will leave them unimpaired for the enjoyment of future generations.”

Response: The final rule clearly provides that bicycle use may be allowed on existing trails only if the NPS has determined that there will be no significant impacts to natural and cultural resources and visitor enjoyment. This rule provides protection for resources and values through more uniform and improved planning and NEPA procedures before a bicycle trail designation. The NPS agrees that it cannot take any action that would impair park resources in violation of its 1916 Organic Act. Accordingly, a non-impairment determination would be necessary before any trail could be designated for bicycle use.

15. Comment: Government-to-government consultation with tribes is required and cannot be satisfied by determining that tribes will not be affected by the proposed rule.

Response: This rule implements procedural changes to the methods by which bicycle routes are authorized at individual park areas and does not make any changes to consultation requirements. The Council on Environmental Quality (CEQ) regulations implementing NEPA require agencies to contact affected Indian tribes and provide them with opportunities to participate at various stages in the preparation of an EA or EIS. The Secretary of the Interior's Order No. 3317 (December 1, 2011) requires meaningful consultation early in a planning process. The National Historic Preservation Act requires consultation with Indian tribes regarding places of traditional religious and cultural significance within the area potentially affected by a proposed project activity or program. Consultation is also required with tribes on the effects to historic and sacred places on federal land. Should a park's proposal to authorize bicycle use trigger consultation, the affected tribe(s) will be consulted.

16. Comment: The proposed rule is subject to a categorical exclusion under NEPA and does not require an environmental review rising to the level of an EA or EIS.

Response: We agree. This regulation has been determined to be categorically excluded under 43 CFR 46.210(i). No extraordinary circumstances have been found under 43 CFR 46.215.

17. Comment: The proposed rule should require that the NPS comply with NEPA before designating any trails for bicycle use.

Response: We agree. The proposed rule and the final rule require that NEPA compliance be completed through an EA or an EIS evaluating bicycle use on trails within the park unit, including the specific trail(s) being considered, before the trail may be designated for bicycle use.

18. Comment: Performing NEPA analysis concurrently with the process of accepting public comments is illegal and inappropriate. The NPS should reopen the public comment period for the proposed rule after NEPA analysis is made available for review by the public.

Response: The rulemaking process is governed by the Administrative Procedure Act, and the impact analysis process is governed by NEPA. Nothing in either statute prohibits the NPS from analyzing the impacts of a proposed rule concurrently with consideration of public comments on that proposed rule. The NPS has conducted NEPA analysis subsequent to receiving and analyzing comments on the proposed rule and determined that the final rule is categorically excluded from NEPA under 43 CFR 46.210(i).

19. Comment: The rationale for requiring rulemaking for opening existing backcountry trails to bicycle use applies today as it did when the existing rule was published in 1987. The NPS should keep the current rule to ensure transparency and public engagement in the rulemaking process. The process set forth in the existing rule is workable and should be maintained instead of the proposed rule which would impose additional requirements upon the parks. The requirement of a special regulation in the existing rule provides a needed safeguard against damage to natural resources.

Response: Whether or not bicycle use is an appropriate activity in a unit of the National Park System, and if so on what trail(s), should be considered through an individual park's planning process. Parks can accomplish this either in a specific plan for bicycle use in the park or as part of another plan, such as a recreation use plan. The designation of bicycle use on any particular trail should ideally be considered as part of a comprehensive plan for trail use in a park area, which also involves environmental compliance and input from the public. This rule requires bicycle use planning as part of the authorization process. The NPS believes that the rule achieves a primary benefit of the special regulations process—public notice and comment—by providing two opportunities for public input, while eliminating the time consuming procedural requirements of the rulemaking process when designating existing trails with no significant impacts for bicycle use. The NPS would continue to require the promulgation of special regulations for bicycle trails involving new trail construction outside developed areas.

20. Comment: The NPS should require the purchase of a permit or season pass for bicycle use and use the receipts for trail maintenance. Permits would help keep bicycle riders on designated trails and reduce impacts to sensitive areas.

Response: Bicycle riders will pay entrance fees in those parks that have an established entrance fee. Entrance fees are often used to support trail construction and maintenance. The NPS does not believe establishing a uniform, nationwide bicycle permit and fee in this rule is appropriate. Consideration of such a fee may or may not be appropriate at an individual park area and could be considered as a part of that area's planning process.

21. Comment: The proposed rule transfers too much discretion and decision-making authority to park superintendents which will lead to a loss of uniformity in the way bicycle trails are designated and managed. This could result in adverse consequences as superintendents are vulnerable to political pressure and local pressure which lead to decisions which are not in the best interests of the American taxpayer and the National Park System.

Response: The proposed rule required a more uniform and improved bicycle use planning and NEPA compliance (EA or EIS) with public notice and comment, including review and approval by the respective NPS Regional Office. In response to public comment, the final rule adds a requirement that, before implementing a decision to designate a trail for bicycle use, the respective Regional Director must approve in writing the superintendent's written determination that bicycle use on the specific park trail(s) is consistent with the protection of the park area's natural, scenic and aesthetic values, safety considerations, and management objectives, and will not disturb wildlife or park resources. Except for new trails outside of developed areas where rulemaking is required, notice of the written determination must be published in the Federal Register with an opportunity for public review and comment for at least thirty (30) days. Following review of the comments, the respective Regional Director may consider approving the determination. If the determination is approved, then the superintendent would be authorized to designate the trail(s) for bicycle use. The appropriate NPS Regional Director may instead decide that bicycle use on a trail is not consistent with the resources, values, and purposes of the park area and withhold approval—in which case bicycle use would be prohibited.

22. Comment: The NPS should use the recently published “Guide to Sustainable Mountain Trails: Assessment, Planning & Design Sketchbook, 2007 Edition” as the trail planning and design tool for mountain bike trails. This would significantly improve achievement of sustainability (minimum impact to natural and cultural resources) and the least cost over the long term. Proposed design and construction techniques should be transparent and open to public review and comment.

Response: We agree. The NPS supports and encourages the use of the Sketchbook (2007) as a guide for assessing, planning, designing, and implementing trails with minimum impact to natural and cultural resources at a lower cost for all trails in National Park System units. The Sketchbook (2007) and other resources are available online at the NPS Sustainable Trails page at http://www.nps.gov/dsc/trails.htm.

The Sketchbook (2007) presents a rational and sensible process for: Assessing existing trails for sustainability criteria; planning, establishing and designing new trails; and maintaining, rehabilitating and armoring trails to bring them up to sustainable condition. The Sketchbook (2007) builds upon the language of RM #77, which defines sustainability of natural surface trails, and explains the purpose and means of achieving it. Using the Sketchbook (2007) as the trail planning and design tool reference for backcountry trails would significantly improve sustainability (minimum impact to natural and cultural resources) at a lower cost over the long term. The Sketchbook (2007) was written for use by trail planners for use on all trails, not just hiking and equestrian trails, and principles in the Sketchbook (2007) can be applied to create new backcountry bicycle trails or to adapt existing hiking and equestrian trails for bicycle use. Graphics in the Sketchbook (2007) support and illustrate the concepts presented.

The interdisciplinary team for each park or trail project should apply the NPS sustainable trail principles and guidelines generally, but sufficiently so that the proposed design and construction techniques can be available for comment as a part of the NEPA process. The Sketchbook (2007) shows a hierarchy for design solutions on page 51, which can be a starting point for the interdisciplinary team when developing alternatives. The NPS will continually look for best ideas and best practices to promote sustainable trail design and maintenance.

23. Comment: The proposed rule should include requirements for monitoring and evaluating the resource impacts and visitor use conflicts caused by opening trails to bicycle use. Monitoring records should be open to the public upon request.

Response: The final rule requires that planning for bicycle use includes the consideration of methods for protecting natural and cultural resources. Monitoring for resource impacts is a key component of this requirement. NPS monitoring records are generally open to the public and available on request.

24. Comment: The proposed rule should be abandoned because the NPS does not have the funding and staff needed to effectively enforce, monitor, and maintain the designation of additional trails for bicycle use. Accordingly, the NPS will not be able to meet the needs of public safety and protect natural and cultural resources. The NPS should evaluate the costs of implementing the proposed rule, particularly of rescue and medical response, which is necessary for visitor access to the backcountry. Mountain bike damage in parks costs taxpayers and agencies thousands of dollars per year in additional policing and repairs.

Response: This rule changes the process for authorizing bicycle trails at individual parks. Issues such as funding, staffing, costs, monitoring, enforcement, and emergency medical services, and whether it is provided by the NPS or others, are best resolved through planning and impact analysis on a park-specific, trail-specific basis. The rule's planning requirements ensure that these issues will be analyzed. The NPS recognizes that trails require maintenance and policing; however, bicycle use does not necessarily significantly increase costs for maintenance or ranger services if the trails are well planned and constructed. The NPS will not approve any bicycle use that cannot be properly managed.

The NPS Office of Public Health data from Golden Gate National Recreation Area (2004-2011), a National Park System unit that allows bicycling on park roads and also on backcountry trails, recorded 445 biking accidents. On-road accidents accounted for 90 percent of the total; off-road (mountain) biking 5 percent; and 5 percent were unspecified. Of the road accidents, 20 percent were with rented bicycles.

25. Comment: The proposed rule should stipulate that where two or more parks share one or more common boundaries (e.g., federal and state), all of the adjoining park units must agree before bicycle use is allowed in that area.

Response: The NPS generally agrees, but believes this situation will only arise in a very limited number of circumstances. Section 8.1.2 of NPS Management Policies 2006 requires that the NPS “coordinate with appropriate state authorities regarding activities that are subject to state regulation or to joint federal/state regulation.” The rule's planning requirements will ensure that, where it exists, the issue will be considered.

26. Comment: The proposed rule does not require comprehensive recreation planning and there are no existing NPS planning standards for the development of such plans.

Response: This final rule establishes minimum requirements for bicycle use planning. The current regulations simply require promulgation of a special regulation to allow bicycle use on existing or new trails outside of a developed area. This revision requires that not only must bicycle use on trails be addressed in a planning document which will evaluate key planning criteria (such as sustainable trail design, lifecycle maintenance costs, safety considerations, methods to prevent or minimize user conflict, and integration with commercial services and alternative transportation systems (if applicable)), bicycle use must also be addressed by a site-specific NEPA analysis.

27. Comment: Section 4.30(e) of the proposed rule suggests that existing trails are presumed to be open to bicycle use unless and until a superintendent closes them pursuant to 36 CFR 1.5 and 1.7. The proposed rule should be revised to clarify that bicycle use on existing or new trails will not be permitted unless and until the requirements of 36 CFR 4.30 are met.

Response: That was not the intent, and in the final rule the NPS has added the phrase “[b]efore [designating a trail for bicycle use] the superintendent must ensure that all of the following requirements [of § 4.30] have been satisfied” to paragraph (d) to clarify that designating bicycle use on existing or new trails will not be permitted unless and until the requirements of 36 CFR 4.30 are met.

28. Comment: The designation of new trails for bicycle use outside of developed areas should not require the promulgation of a special regulation, but instead should be treated the same as designating existing trails for bicycle use. New trails offer the greatest opportunity to mitigate environmental and social impacts.

Response: The NPS agrees that constructing new trails using sustainable principles and guidelines provides opportunities to mitigate environmental impacts adjacent to the trail and could provide separation of user groups and consequently reduce conflicts. Nevertheless, constructing trails in undeveloped areas of a park can have significant impacts and result in significant long-term modification in the resource management objectives of a park area. Accordingly, the NPS believes that new trails for bicycle use outside of developed areas should continue to be authorized only through special regulations.

29. Comment: The proposed rule could allow bicycle use on a new trail outside of developed areas without a special regulation. This could happen if a new trail is initially designated for non-bicycle uses only (e.g., hiking) and then, once built and deemed an existing trail, is designated also for bicycle use. This loophole should be closed.

Response: Although the commenter is correct that a special regulation may not be required in such circumstances, we believe that the process required under the regulations remains fully protective of park resources and will fully engage the public in any decision to designate such a trail. A decision to build a new trail for any non-biking purpose (e.g., hiking) would still have been subject to appropriate NEPA compliance. Later, if a designation of that trail for bicycling use is to be made, this regulation requires specific bike use planning, compliance with NEPA (including public notice and comment), and a written determination that park resources will be protected (including public notice and comment) by the superintendent and approved by the respective Regional Director. To the extent the commenter is suggesting that some park officials might seek to utilize such a process to avoid the rulemaking requirement, although we believe that is unlikely, the required processes will ensure that the public is fully engaged and the potential for controversy as a result is itself a check on any such misuse. Accordingly, we have declined to adopt this recommendation in the final rule.

30. Comment: The proposed rule should provide guidance on what types of uses would trigger federal rulemaking under the criteria set forth in 36 CFR 1.5(b).

Response: In a change from the proposed rule, the NPS does not intend 36 CFR 1.5(b) to apply to the designation of trails for bicycle use under 36 CFR 4.30, and has accordingly deleted the reference to 36 CFR 1.5(b) in the regulatory text. The final rule authorizes designation of existing trails without rulemaking, if the enhanced planning and compliance requirements have been met, including public notices and opportunities for public comment, and if there are no significant impacts. The NPS believes that this requirement, in addition to a written determination that bicycle use on the trail is consistent with the protection of the park area's natural, scenic and aesthetic values, safety considerations and management objectives, and will not disturb wildlife or park resources, make the application of 36 CFR 1.5 to the designation of bicycle use on existing trails repetitive and unnecessary.

31. Comment: The proposed rule should include a definition of “administrative road” and distinguish between administrative roads within and outside of developed areas. Designation of bicycle use on administrative roads which are closed to the public and outside of developed areas should require public comment and a decision according to NEPA. The proposed rule should state that administrative roads are closed to bicycle use until opened.

Response: The rule defines administrative roads as “roads closed to motor vehicle use by the public, but open to motor vehicle use for administrative purposes” (e.g., service roads, fire roads). The rule provides that administrative roads may be designated for bicycle use following a determination by the superintendent that such bicycle use is consistent with protection of the park area's natural, scenic and aesthetic values, safety considerations and management objectives, and will not disturb wildlife or park resources. Once the rule is effective, administrative roads are closed to bicycle use unless opened. Opening an administrative road to bicycle use requires compliance with NEPA, although under some circumstances a categorical exclusion may apply. The NPS does not see a need to distinguish between administrative roads within and outside of developed areas for the purpose of allowing bicycle use. Roads wide enough to accommodate vehicular traffic are generally capable of safely accommodating multiple non-motorized user groups, and this must be specifically determined by the superintendent in writing prior to designating administrative roads for bicycle use.

32. Comment: The proposed rule should be amended to clarify that designations can only be made after completion of the park planning document referenced in paragraph (b)(1) and both of the 30-day public review and comment periods referenced in paragraphs (b)(2) and (3).

Response: The NPS agrees and has made this change. The NPS intended the proposed rule to require completion of the steps in paragraphs (b)(1)-(3) before designation could occur. In the final rule, the NPS has split the requirements of proposed paragraph (b)(3) into (d)(3) and (d)(4)(i), and has added the phrase “[b]efore [designating a trail for bicycle use] the superintendent must ensure that all of the following requirements [of § 4.30] have been satisfied” to paragraph (d) to clarify that bicycle use on existing or new trails will not be permitted unless and until the requirements of 36 CFR 4.30 are met.

33. Comment: The proposed rule should be amended to clarify that the EA or EIS required under paragraph (b)(2) be performed on a trail-specific (not park-wide) level.

Response: The final rule (now at paragraph (d)(2)) requires that an impact analysis must be conducted on bicycle use in the park as well as on the specific trails proposed to be designated for bicycle use. The NPS declines to limit the scope of the impact analysis to only those trails considered for bicycle use, as a broader analysis may be required to address indirect and cumulative impacts, and avoid segmentation of an action. For example, a park plan and associated NEPA document may consider bicycle use among a wider range of visitor uses, which would require an impact analysis beyond that suggested by the commenter.

34. Comment: The 30-day public review and comment period after the issuance of an EA under paragraph (b)(2) should be eliminated. This is duplicative with the 30-day public review and comment period in paragraph (b)(3) which is sufficient.

Response: The first opportunity for public comment on the EA, in the final rule at paragraph (d)(2), is important and appropriate for this regulation. The CEQ regulations require the NPS to involve environmental agencies, applicants, and the public, to the extent practicable, in preparing EAs. Moreover, the NPS encourages the public to use this opportunity to make thoughtful, rational suggestions on the impacts and alternatives in the EA. Some of the most constructive and beneficial interaction between the public and the NPS occurs when citizens identify or develop other reasonable alternatives or mitigation strategies that the agency can consider and evaluate in the EA process. The second opportunity for public comment provided by this rule in paragraph (d)(4)(i), follows release of the superintendent's written determination that bicycle use is consistent with the resources, values, and purposes of the park area. Similar to the period of public comment allowed for in rulemaking, it gives the public an opportunity to comment on the agency's decision to implement the bicycle use plan before the decision is made final.

In response to public comment, the final rule has eliminated the requirement for publication of a Federal Register notice announcing the first 30-day opportunity for public comment on the EA. The NPS will instead follow its policy guidelines that encourage a variety of other notification methods. However, because the written determination process is an alternative to special regulation rulemaking, the NPS will retain the Federal Register notice requirement to announce the second 30-day opportunity for public review and comment on the determination.

35. Comment: The proposed rule will improve opportunities for biking in the parks which will increase park visitation and provide economic benefits to the parks and nearby communities.

Response: This rule changes the methods by which bicycle trails are authorized at individual park areas. It does not actually designate a bicycle trail in any park. Nevertheless, this rule will generate positive benefits through procedural specificity and clarity and improved management of bicycle use within parks.

36. Comment: The proposed rule will increase bicycle use in the parks. This will have a negative economic impact as parks will lose revenue from hikers and equestrians who will visit other areas where they can enjoy the outdoors safely and in solitude, without interference from mechanical devices.

Response: According to a U.S. Forest Service study, “Updated Outdoor Recreation Use Values on National Forests and Other Public Lands.” General Technical Report PNW-GTR-658. U.S. Department of Agriculture, Forest Service (Loomis, J. 2005.), the net economic benefits of mountain biking generally exceed those of either hiking or horseback riding. Nevertheless, the rule provides that new bicycle use on existing trails can be designated only if there will be no significant impacts, including impacts to visitor safety and user conflict. Therefore, any increased bicycle use resulting from this rule can only happen if the park determines that the designation of bicycle use will not impose significant impacts on other users, including hikers and equestrians.

After taking the public comments into consideration and after additional review, the NPS made the following changes in the final rule:

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

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

The Department of the Interior certifies that this document will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). This certification is based on information contained in the report titled, “Benefit-Cost/Unfunded Mandates Act Analysis, Small Business and Regulatory Flexibility Act Analysis” (U.S. Department of the Interior, National Park Service, Environmental Quality Division) available on-line at: http://www.nature.nps.gov/socialscience/docs/RegulatoryAnalyses2012.pdf.

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

a. Does not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

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

This determination is based on information contained in the report titled “Benefit-Cost/Unfunded Mandates Act Analysis, Small Business and Regulatory Flexibility Act Analysis” (U.S. Department of the Interior, National Park Service, Environmental Quality Division) available online at http://www.nature.nps.gov/socialscience/docs/RegulatoryAnalyses2012.pdf.

This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. The designated bicycle routes will be located entirely within NPS Units and will not result in direct expenditures by State, local, or tribal governments. This rule addresses public use of NPS lands, and imposes no requirements on other agencies or governments. A statement containing the information required by the UMRA (2 U.S.C. 1531 et seq. ) is not required.

Under the criteria in Executive Order 12630, this rule does not have significant takings implications. No taking of real or personal property will occur as a result of this rule. Access to private property located within or adjacent to National Park Service parks will not be affected by this rule, and this rule does not regulate uses of private property. Therefore, a takings implication assessment is not required.

Under the criteria in Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Summary Impact Statement. This rule only affects use of NPS-administered lands and imposes no requirements on other agencies or governments. A Federalism summary impact statement is not required.

This rule complies with the requirements of Executive Order 12988. Specifically, this rule:

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

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

Under the criteria in Executive Order 13175 we have evaluated this rule and determined that it has no potential effects on federally recognized Indian tribes. This rule is administrative, legal and procedural in nature. The effect on tribes is too speculative for analysis at this stage, and will be evaluated later on a case-by-case basis as new bicycle trail designations are considered.

This rule does not contain information collection requirements and a submission under the PRA is not required.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the NEPA of 1969 is not required because the rule is covered by a categorical exclusion under 43 CFR 46.210(i): “Policies, directives, regulations, and guidelines: that are of an administrative, financial, legal, technical, or procedural nature; or whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case-by-case.” We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under the NEPA.

This rule is not a significant energy action under the definition in Executive Order 13211. A statement of Energy Effects is not required.

The primary author of this rule is Russel J. Wilson, Chief, Regulations and Special Park Uses, National Park Service. Michael Tiernan, Division of Parks and Wildlife, Office of the Solicitor, Department of the Interior; Michael B. Edwards, Environmental Protection Specialist, Environmental Quality Division, Planning and Compliance Branch, National Park Service; Hugh Duffy, PLA, ASLA, PMP, LEED Green Associate, Project Manager, Denver Service Center, National Park Service; and CDR Sara B. Newman, DrPH, MCP, U.S. Public Health Service, Deputy Chief, Office of Risk Management, National Park Service, also contributed.

For the reasons stated in the preamble 36 CFR Part 4 is amended as set forth below:

Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA. On February 28, 2012 (77 FR 11839), EPA published a notice of proposed rulemaking (NPR) for the State of Maryland. The NPR proposed approval of Maryland's Regional Haze Plan for the first implementation period through 2018. The formal SIP revision (MDE SIP Number 12-01) was submitted by the State of Maryland on February 13, 2012. EPA proposed to approve this revision since it assures reasonable progress toward the national goal of achieving natural visibility conditions in Class I areas for the first implementation period. EPA also proposed to approve this SIP revision as meeting the infrastructure requirements of section 110(a)(2)(D)(i)(II) and (a)(2)(J) of the CAA, relating to visibility protection for the 1997 8-hour ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS.

The revision includes a long term strategy with enforceable measures ensuring reasonable progress towards meeting the reasonable progress goals for the first planning period through 2018. Maryland's Regional Haze Plan contains the emission reductions needed to achieve Maryland's share of emission reductions agreed upon through the regional planning process. Other specific requirements of the CAA and EPA's Regional Haze Rule (RHR)  1 and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. Timely adverse comments were submitted on EPA's February 28, 2012 NPR. A summary of the comments and EPA's responses are provided in Section III of this document. As discussed more fully in the Response to Comments below, EPA is also clarifying herein its approval of the BART determinations for sulfur dioxide (SO 2 ), nitrogen oxides (NO X ), and particulate matter (PM) for Unit 25 at the NewPage Luke Pulp and Paper Mill located in Allegany County in Luke, Maryland (NewPage Luke Mill) which we are approving into the Maryland SIP.

EPA received a number of comments on our proposal to approve Maryland's Regional Haze SIP submittal. Comments were received from the Luke Paper Company and the U.S. Forest Service. A joint letter from the Sierra Club and the National Parks Conservation Association (NPCA) was also received. The U.S. Forest Service acknowledged the work that the State of Maryland has accomplished and encouraged the State of Maryland to continue to reduce regional haze. The complete comments submitted by all of the aforementioned entities (hereafter referred to as “the Commenter”) are provided in the docket (EPA-R03-OAR-2012-0144) for today's final action. A summary of the comments and EPA's responses are provided below.

Comment 1: The Commenter recommended that emission controls for a coal cleaning facility and three electric generating units (EGUs) which are not BART subject sources in Maryland should be evaluated under the reasonable progress provisions of the RHR as was done in Wyoming and North Dakota. The Commenter stated that initially the coal cleaning facility was identified as BART-eligible and modeling for this source demonstrated that it may impact visibility at one or more Class I areas located in West Virginia (e.g., Dolly Sods Wilderness Area and Otter Creek Wilderness Area.) This source was subsequently found not to be subject-to-BART.

Response 1: EPA finds Maryland's decision not to further evaluate controls at the coal cleaning facility and the three EGUs under the reasonable progress provisions of the RHR to be reasonable. First, as discussed in the NPR, two of the EGUs are subject to Maryland's Healthy Air Act (HAA)  2 which requires significant emission reductions at those EGUs. More generally, as explained below, Maryland followed a specific strategy for addressing reasonable progress. Pursuant to EPA's Guidance for Setting Reasonable Progress Goals under the Regional Haze Program (Reasonable Progress Guidance), states may identify key pollutants and source categories for the first planning period. 3 The regional planning organizations VISTAS and MANE-VU and the State of Maryland determined that the key pollutant which contributes to visibility impairment in the VISTAS and MANE-VU Class I areas is sulfate. Therefore, in accordance with EPA's Reasonable Progress Guidance, 4 VISTAS, MANE-VU and Maryland focused on SO 2 for the first planning period. To ensure reasonable progress for the first planning period, MANE-VU recommended and Maryland agreed to pursue the following emission reductions: Timely implementation of BART; 90 percent reduction in SO 2 emissions from the 167 highest visibility impacting EGUs; a reduction in the sulfur content of distillate and residual oil; and continued evaluation of other emission reduction strategies. Section III.B.4. of the NPR discusses how Maryland met the 90 percent reduction in SO 2 emissions from the 167 highest visibility impacting EGUs and the equivalent reduction to account for the reduced sulfur content of distillate and residual oil. During the consultation process, Maryland provided West Virginia with the intended emission reductions resulting from their long term strategy for sources that are in the Area of Influence for Dolly Sods which included emission reductions projected to be achieved by the HAA. After review, West Virginia did not request additional emission reductions from neighboring states for the first planning period other than what has already been planned. Therefore, EPA does not agree that additional controls beyond BART and the HAA should be evaluated for these particular sources for reasonable progress.

Comment 2: The Commenter questioned the BART-eligibility of a coal cleaning facility in Maryland because Maryland originally identified this source as BART-eligible. The Commenter further noted that control technologies available in 1977 differ from those available today, so a BART analysis would be beneficial. In addition, the Commenter suggested that a permit condition to shut down the coal cleaning facility by the end of 2014 would address the Commenter's concerns because the facility indicated that it did not plan to operate beyond 2014.

Response 2: EPA disagrees with the Commenter's assertions that the identified Maryland coal cleaning facility should be subject to BART. EPA agrees with Maryland that the source was not in existence by August 7, 1977 because this source did not meet EPA's definition of “in existence” at 40 CFR 51.301. EPA did not grant approval of the coal cleaning construction application until February 23, 1978. Therefore, the coal cleaning facility was not in existence prior to 1977 and is not a BART-eligible source. Additionally, EPA disagrees that any permit requirements for shutdown are necessary or required for this particular source. The Federal regional haze program does not require existing sources to shutdown. While the facility may intend to cease operations in the near future, Maryland was not required to make such a shutdown enforceable in its Regional Haze SIP.

Comment 3: The Commenter further stated that Maryland's discussion on achievement of reasonable progress goals focused on the contribution to emission reductions of sulfur only and not NO X .

Response 3: EPA disagrees with the Commenter's assertion that Maryland was required to focus on the contribution to emission reductions of NO X in its Regional Haze SIP. As discussed in EPA's Response to Comment 2, VISTAS, MANE-VU, and Maryland determined that the key pollutant contributing to visibility impairment in the MANE-VU and VISTAS Class I areas is sulfate. Maryland accordingly focused on SO 2 emission reductions for the first planning period, an approach that EPA believes was appropriate given the technical analyses done by VISTAS and MANE-VU. As discussed in the NPR, the State of Maryland does not have a Class 1 area and is not required to establish reasonable progress goals such as NO X emission reductions.

Comment 4: The Commenter recommended two different control technologies for Unit 26 at the NewPage Luke Mill that combined would reduce NO X emissions at the Mill by 60 to 90 percent.

Response 4: Although Unit 26 at the NewPage Luke Mill is mentioned in the BART analysis done by the facility, Unit 26 is not a BART-eligible source. The owner of the NewPage Luke Mill correctly provided a BART analysis for the BART-eligible Unit 25, and Maryland determined BART for Unit 25. As discussed more fully in EPA's Response to Comments 2 and 3 above, EPA does not agree that any further controls for NO X are needed for reasonable progress at any source at the NewPage Luke Mill at this time.

Comment 5: The Commenter stated that EPA mischaracterized the Luke Paper Company's commitment in the letter dated October 31, 2007 for BART controls at the NewPage Luke Mill. The Commenter stated that EPA noted in its NPR that Luke Paper Company committed to installing either a spray dryer absorber or a circulating dry scrubber resulting in approximately 90 percent emission reductions in SO 2 and to year round operation of the existing selective non-catalytic reduction (SNCR) control at Unit 25 for NO X control as BART for the BART subject Unit 25 at the NewPage Luke Mill. The Commenter asserted that its October 31, 2007 letter committed to reduce emissions by 90 percent for SO 2 without specifying controls, to reduce NO X emissions to 0.4 pounds per million British thermal units (lb/MMbtu), and to control PM emissions to 0.07 lb/MMbtu for Unit 25 at the NewPage Luke Mill on a yearly basis.

Response 5: EPA agrees with the Commenter that Maryland's Regional Haze SIP submittal and our approval of the submittal requires the NewPage Luke Mill at Unit 25 to meet BART limits of 0.44 lb/MMbtu for SO 2 , a rolling 30-day emission rate of 0.40 lb/MMbtu for NO X , and 0.07 lb/MMbtu for PM. Although Maryland's BART determination was based on the use of certain controls, BART is an emission limit. 40 CFR 51.301. In our NPR, we inadvertently suggested that the Maryland Regional Haze SIP required the use of specific controls. We agree with the Commenter that the Maryland Regional Haze SIP requires the NewPage Luke Mill to meet the BART emission limits noted above but does not require the facility to install specific controls at Unit 25 to meet these limits.

Comment 6: The Commenter stated that Maryland failed to meet the requisite demonstration that the distribution of emission reductions will be similar to that under the source-specific BART and failed to conduct dispersion modeling to show that the Maryland HAA results in greater reasonable progress toward achieving natural baseline visibility conditions in the areas protected by the RHR.

Response 6: EPA disagrees with the Commenter. EPA discussed in the NPR how Maryland's HAA was an acceptable alternative to BART for EGUs and discussed how the HAA met the requirements for a BART alternative program in 40 CFR 51.308(e)(2). EPA finds that the distribution of emission reductions in Maryland at EGUs from the HAA is comparable to and not substantially different from emission reductions under BART at EGUs. The emission reductions from the HAA are discussed in detail in the NPR. Maryland's HAA covers all of the BART-subject EGU sources and also includes two EGUs which are not BART-subject sources. With the exception of a single unit at one EGU, the Maryland HAA covers more units at each source than just BART-eligible units as illustrated in Table 5 of Section III.B.5 of the NPR. 5 The HAA does not allow facilities to obtain out-of-state emission allowances in lieu of adding pollution controls locally. All of the emission reductions pursuant to the HAA are at EGUs in Maryland which are located in the eastern portion of Maryland around Baltimore and Washington, DC in the same physical location as BART-eligible EGUs. Table 5 of Section III.B.5 of the NPR supports the conclusion that the distribution of emissions is not substantially different under the HAA than under BART because the HAA includes all of the BART sources and all of the BART-eligible units with the exception of Chalk Point Unit 3. Because the Maryland HAA includes all the BART-subject EGU sources, the distance from HAA sources to Class I areas is identical to the distance from BART-subject EGU sources to Class I areas.

EPA provided an analysis supporting emission reductions from the HAA exceeding presumptive BART in the NPR. The factors used by Maryland to develop the HAA emission limitations incorporate criteria used in the RHR as discussed in the NPR in greater detail. As discussed in Section III.B.5 of the NPR, Maryland did a comparison of HAA emission limits for 13 of the 15 units subject to the HAA which resulted in a surplus of SO 2 and NO X reductions compared to presumptive BART because the HAA applies to more units than BART. Because the BART-subject sources are all HAA-subject sources, the distribution of emission reductions is not substantially different than under BART. As discussed in the NPR and in Maryland's Regional Haze SIP submittal, the alternative measure (i.e., the HAA) results in greater emission reductions than BART and therefore achieves greater reasonable progress. See 40 CFR 51.308(e)(3). Because the distribution of emissions is not substantially different, dispersion modeling is not required in 40 CFR 51.308(e)(3).

Comment 7: The Commenter stated that Maryland has not demonstrated how the emissions reductions resulting from the Maryland HAA are surplus to those reductions resulting from measures adopted to meet other requirements of the CAA as of the baseline date of this SIP, as required by EPA's RHR and the infrastructure requirements related to visibility protection for the 1997 8-Hour Ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS.

Response 7: Because Maryland is using the HAA as an alternative to BART for its EGU BART-eligible sources as permitted by the RHR and as discussed in the NPR, EPA agrees with Maryland's analysis that emission reductions from the 13 HAA units will result in emission reductions that are surplus to the baseline date of the SIP. In promulgating the RHR in 1999, EPA explained that the “baseline date of the SIP” in this context means “the date of the emissions inventories on which the SIP relies,” which is “defined as 2002 for regional haze purposes.” See 64 FR 35742, July 1, 1999, and 70 FR 39143, July 6, 2005. Any measure adopted after 2002 is accordingly “surplus” under 40 CFR 51.308(e)(2)(iv). As discussed in the NPR, Maryland's use of the HAA (which was adopted after 2002) as an alternative to BART for EGUs is in accordance with and satisfies the requirements in 40 CFR 51.308(e)(2) for BART alternatives, including the requirement that the emission reductions be surplus to the baseline date of the SIP. The NPR also discusses how Maryland developed the emission reductions required by the HAA. EPA is not restating that analysis here.

Also, EPA's final approval of Maryland's Regional Haze SIP herein will satisfy the infrastructure requirements of CAA section 110(a)(2)(D)(i)(II) and (a)(2)(J) for the 1997 8-hour Ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS. EPA disagrees with the Commenter's suggestion that the emission reductions from the HAA are not surplus solely because the reductions are part of Maryland's Regional Haze SIP which satisfies CAA infrastructure elements in section 110(a)(2)(D) and (J) of the CAA. Section 110(a)(2) of the CAA does not impose specific requirements on particular sources, and therefore surplus reduction is not at issue.

Comment 8: The Commenter stated that the BART analyses submitted by Constellation Energy for Wagner Unit 3 and Crane Unit 2 are deeply flawed and failed to identify correctly BART technology and BART limits for those units. The Commenter also stated that Maryland improperly compared HAA emissions to those under presumptive BART and that Maryland must redo its analysis and compare emissions reductions under the HAA to those produced by full source-specific BART analyses.

Response 8: The primary requirement, as specified in CAA section 169A, is for sources to procure, install, and operate BART. In some cases this requirement is met with an analysis of potential controls considering five factors given in EPA's RHR. EPA has interpreted this requirement to be met if an alternative set of emission limits are established which mandate greater reasonable progress toward visibility improvement than direct application of BART on a source-by-source basis. In promulgating the RHR, EPA stated that to demonstrate that emission reductions of an alternative program would result in greater emission reductions, “the State must estimate the emission reductions that would result from the use of BART-level controls. To do this, the State could undertake a source-specific review of the sources in the State subject to BART, or it could use a modified approach that simplifies the analysis.” 64 FR 35742 (July 1, 1999).

In guidance published October 13, 2006, EPA offered further clarification for states for assessing alternative strategies, in particular regarding the benchmark definition of BART to use in judging whether the alternative is better. See 71 FR 60619. In this rulemaking, EPA stated in the preamble that the presumptive BART levels given in the BART guidelines would be a suitable baseline against which to compare alternative strategies where the alternative has been designed to meet a requirement other than BART. 71 FR at 60619; see also 40 CFR 51.308(e)(2)(i)(C). Maryland's analysis is fully consistent with EPA's conclusions in this rulemaking.

While EPA recognizes that a case-by-case BART analysis may result in emission limits more stringent than the presumptive limits, the presumptive limits are reasonable and appropriate for use in assessing an alternative emissions reductions scenario such as the HAA when comparing it to the BART scenario. See 71 FR 60619 (stating “the presumptions represent a reasonable estimate of a stringent case BART * * * because * * * they would be applied across the board to a wide variety of units with varying impacts on visibility, at power plants of varying size and distance from Class I areas”).

Maryland's HAA was developed to bring Maryland into attainment with the NAAQS for ozone and PM 2.5 by CAA deadlines and to reduce atmospheric deposition of nitrogen to the Chesapeake Bay and other Maryland waters. The HAA imposes limitations on SO 2 , NO X , and mercury emissions from coal-fired EGUs in Maryland. Although Maryland is also now using the HAA as an alternative to BART for its EGU BART-eligible sources as permitted pursuant to EPA's RHR (40 CFR 51.308(e)(2)), the use of presumptive limits is appropriate. EPA agrees with Maryland's analysis that emission reductions from the thirteen HAA units will result in emission reductions that will provide greater reasonable progress than would BART alone as described more fully in the NPR.

Regarding the units at H.A. Wagner and C.P. Crane, EPA notes that H.A. Wagner Units 2 and 3 and C.P. Crane Units 1 and 2 are subject to the HAA (Maryland's alternative BART program) while only C.P. Crane Unit 2 and H.A. Wagner Unit 3 are BART-eligible units. Because these additional units (as well as units at Brandon Shores and Dickerson) are covered under the HAA, significantly more emission reductions are achieved by the HAA than through application of presumptive BART as discussed in Section III.B.5 in the NPR.

Comment 9: The Commenter stated that Maryland must ensure that reasonable progress goals are set so as to put the state on the glidepath to attainment of baseline natural visibility conditions in all affected Class I areas by 2064. For at least the Dolly Sods Wilderness, the Commenter stated that it did not appear that Maryland has done so and questioned what date the Class I areas would attain.

Response 9: EPA disagrees with the Commenter. As stated in the NPR, because Maryland does not have a Class I area, it is not required to establish reasonable progress goals. However, Maryland participated in conference calls and a meeting with West Virginia during the consultation process. They discussed the sources and emissions reductions expected within the area of influence for Dolly Sods. Subsequently, based on the planned measures in neighboring states, West Virginia decided for the first planning period not to ask neighboring states for additional emissions reductions. Previously, EPA approved West Virginia's reasonable progress goals for the Dolly Sods Class I area. See 77 FR 16932 (March 23, 2012). Therefore, EPA disagrees with the Commenter and confirms that no such further analysis regarding the glidepath to attainment is needed.

Comment 10: The Commenter stated that EPA lacked CAA statutory authority to allow Maryland to use the HAA as an alternative to source-specific BART.

Response 10: EPA disagrees with the Commenter regarding EPA's clear statutory authority. EPA's authority to establish non-BART alternatives in the regional haze program and the specific methodology in 40 CFR 51.308(e)(2) for assessing such alternatives have been previously challenged and upheld by the United States Court of Appeals for the District of Columbia Circuit. In the first case challenging the provisions in the RHR allowing for states to adopt alternative programs in lieu of BART, the court affirmed our interpretation of section 169A(b)(2) of the CAA as allowing for alternatives to BART where those alternatives will result in greater reasonable progress than BART. Center for Energy and Economic Development v. EPA, 398 F.3d 653, 660 (DC Cir. 2005) (finding reasonable EPA's interpretation of CAA section 169(a)(2) as requiring BART only as necessary to make reasonable progress). In the second case, Utility Air Regulatory Group v. EPA, 471 F.3d 1333 (DC Cir. 2006), the court specifically upheld our determination that states could rely on the Clean Air Interstate Rule (CAIR) as an alternative program to BART for EGUs in the CAIR-affected states. The court concluded that EPA's two-pronged test for determining whether an alternative program achieves greater reasonable progress was a reasonable one and also agreed with EPA that nothing in the CAA required EPA to “impose a separate technology mandate for sources whose emissions affect Class I areas, rather than piggy-backing on solutions devised under other statutory categories, where such solutions meet the statutory requirements.” Id. at 1340. We do not agree, therefore, that EPA lacks statutory authority for 40 CFR 51.308(e)(2) which permits states to include in a SIP an alternative trading program that provides for greater reasonable progress than BART in place of source-specific BART.

EPA is approving a revision to the Maryland SIP submitted on February 13, 2012 by the State of Maryland through MDE that addresses regional haze for the first implementation period. In submitting the plan, Maryland also stated that the Regional Haze SIP submission meets the relevant and applicable obligations related to visibility pursuant to section 110(a)(2) of the CAA, including, but not limited to, section 110(a)(2)(D)(i)(II) and (a)(2)(J) of the CAA, for the 1997 8-Hour Ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS for Maryland. EPA has determined that the Maryland Regional Haze SIP contains the emission reductions needed to achieve Maryland's share of emission reductions agreed upon through the regional planning process. Furthermore, Maryland's Regional Haze Plan ensures that emissions from the state will not interfere with the reasonable progress goals for neighboring states' Class I areas consistent with the requirements of the visibility prong of section 110(a)(2)(D)(i)(II) of the CAA. EPA is approving this SIP revision as meeting the requirements of the regional haze program, CAA section 110(a)(2)(J), 6 and the infrastructure SIP requirements of CAA section 110(a)(2)(D)(i)(II) relating to visibility protection for the 1997 8-Hour Ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS.

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 Order 12866 (58 FR 51735, October 4, 1993);

• 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 4, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to Maryland's Regional Haze Plan for the first implementation period, through 2018 may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2) of the CAA.

Therefore, 40 CFR part 52 is amended as follows:

This supplementary information section is arranged as follows:

Illinois submitted a plan on June 24, 2011, to address the requirements of Clean Air Act section 169A and the Regional Haze Rule, as codified in Title 40 Code of Federal Regulations Part 51.308 (40 CFR 51.308).

EPA published a notice of proposed rulemaking evaluating Illinois' submittal on January 26, 2012, at 77 FR 3966. This notice described the nature of the regional haze problem and the statutory and regulatory background for EPA's review of Illinois' regional haze plan. The notice provided a lengthy delineation of the requirements that Illinois intended to meet, including requirements for mandating BART, consultation with other states in establishing goals representing reasonable progress in mitigating anthropogenic visibility impairment, and adoption of limitations as necessary to implement a long-term strategy for reducing visibility impairment.

Of particular interest were EPA's findings regarding BART. States are required to address the BART requirements for sources with significant impacts on visibility, which Illinois defined as having at least 0.5 deciview impact on a Class I area. Using modeling performed by the Lake Michigan Air Directors Consortium (LADCO), Illinois identified 10 power plants and two refineries as having sufficient impact to warrant being subject to a requirement representing BART. 1

Seven of the power plants that were identified as being subject to the requirement for BART are addressed in one of two sets of provisions of Illinois' rules known respectively as the Combined Pollutant Standards (CPS), 35 Ill. Administrative Code 225.233, and the Multi-Pollutant Standards (MPS), 35 Illinois Administrative Code 225.293-225.299. These provisions are included in Illinois' mercury rules. These rules offer the affected utilities (Midwest Generation, Dynegy, and Ameren) a choice of limitations, either to include 1) specific mercury emission limitations effective in 2015 with no limits on emissions of sulfur dioxide (SO 2) or nitrogen oxides (NO X ) or 2) work practice requirements for installation of mercury control equipment in conjunction with limits on SO 2 and NO X emissions. Illinois' submittal includes letters from the affected companies choosing the option that includes SO 2 and NO X emission limits, which pursuant to Illinois' rules establishes these limits as enforceable limits. In the case of Midwest Generation, three of its power plants meet the criteria for being subject to BART, and six plants are governed by the SO 2 and NO X limits in the Multi-Pollutant Standards. In the case of Dynegy, one of its power plants meets the criteria for being subject to BART, and four coal-fired power plants are governed by the SO 2 and NO X limits in the (CPS). In the case of Ameren, three of its power plants meet the criteria for being subject to BART, and five coal-fired plants are governed by the SO 2 and NO X limits in the (CPS). In the notice of proposed rulemaking, EPA proposed to conclude that the emission reductions from the (MPS) and the (CPS) would be greater than the reductions that would occur with unit-specific implementation of BART on the subset of these sources that meet the criteria for being subject to BART. Therefore, EPA proposed to find that the (MPS) and the (CPS) suffice to address the BART requirement for the power plants of these three utilities.

Illinois also developed source-specific limits to mandate BART for three additional power plants. These limits are adopted into two permits, one for Kincaid Generation's Kincaid Station and one for City Water, Light, and Power's (CWLP) Dallman Station and Lakeside Station. CWLP shutdown Lakeside Station in 2009, and the CWLP permit requires that the Lakeside Station never resume operation. Finally, Illinois found that Federal consent decrees regulating emissions from the two refineries with units subject to BART (facilities owned by ExxonMobil and Citgo) mandate control at the refineries in Illinois at least as much as would be required as BART. EPA proposed to conclude that Illinois satisfied BART requirements for the affected Illinois power plants and refineries.

As stated in the notice of proposed rulemaking, Illinois did not rely on the Clean Air Interstate Rule (CAIR) for its BART determinations. Illinois is in the CAIR region. However, it used its state rules, permits, and consent decrees to achieve emission reductions that satisfy BART. This means that Illinois is not reliant on CAIR and, thus, it has avoided the issues of other CAIR region states that relied on CAIR. For similar reasons, Illinois' satisfaction of regional haze rule requirements is not contingent on the Cross-State Air Pollution Rule (CSAPR) and thus is not affected by the stay of that rule.

EPA received comments from three commenters on its proposed rulemaking on the Illinois regional haze plan. These commenters included ExxonMobil, the U.S. Forest Service, and the Environmental Law and Policy Center (ELPC).

ExxonMobil comments that section 169A(b)(2)(A) requires sources to implement BART as determined by the state (emphasis in the original), and agrees with Illinois' and EPA's conclusion that “emission limits established by the consent decrees may be relied upon by Illinois for addressing the BART requirement for these facilities.” While EPA has the responsibility to evaluate whether it believes that states have made appropriate determinations as to what restrictions constitute BART, EPA appreciates the comment supporting its position, which EPA has no reason to change, that the Federal consent decrees for ExxonMobil and Citgo adequately mandate BART for the two Illinois refineries.

The U.S. Forest Service wrote to express its appreciation to Illinois for addressing prior Forest Service comments and to express support for EPA's proposed approval of Illinois' plan.

ELPC sent extensive comments objecting that control requirements for power plants in Illinois do not suffice to meet the BART requirements and leave Illinois short of meeting reasonable progress requirements. These comments are addressed in detail in the discussion that follows.

Comment: ELPC argues that “the plain language of the Clean Air Act precludes alternatives to BART.” Since the Illinois plan establishes limits that govern the collective emissions of multiple power plants owned by pertinent utilities, the plan relies on an alternative to BART as described in 40 CFR 51.308(e)(2) rather than mandating BART on a source-specific basis. ELPC states that BART at BART-eligible sources is expressly mandated in Clean Air Act section 169A(b)(2)(A). ELPC acknowledges that the Clean Air Act authorizes limited exemptions from BART, in cases which EPA determines pursuant to section 169A(c)(1) that “the source does not either by itself or in combination with other sources `emit any air pollutant which may reasonably be anticipated to cause or contribute to a significant impairment of visibility in any mandatory class I federal area.' ” ELPC observes that “[n]owhere in Section 169A did Congress contemplate or sanction sweeping alternative programs” such as Illinois uses to address BART for many of its BART-subject power plants “in lieu of source specific BART.”

ELPC acknowledges that EPA promulgated regulations reflecting its interpretation that BART requirements may be satisfied by alternative programs, and ELPC acknowledges that “the DC Circuit Court of Appeals has upheld [these] regulations.” Nevertheless, “because these [court rulings] cannot be reconciled with the plan language of the Clean Air Act,” ELPC urges that “EPA should not rely on [this interpretation] to exempt Illinois from implementing BART.”

Response: In several previous rules, EPA has concluded that Clean Air Act section 169A may reasonably be interpreted to provide that the requirement for BART may be satisfied by an alternative program that provides greater visibility protection in lieu of limitations that directly mandate BART for individual sources determined to be subject to the BART requirement. See 40 CFR 51.308(e), 64 FR 35741-35743 (July 1, 1999), and 70 FR 39136 (July 6, 2005). As ELPC acknowledges, the Court of Appeals for the District of Columbia Circuit supports that interpretation, Center for Energy and Economic Development v. EPA, 398 F.3d 653, 660 (D.C. Cir. 2005) (“ CEED ”) (finding reasonable EPA's interpretation of CAA section 169(a)(2) as requiring BART only as necessary to make reasonable progress), as has the Ninth Circuit, Central Arizona Water Conservation District v. EPA, 990 F.2d 1531, 1543 (9th Cir. 1993) Therefore, EPA views Illinois' approach as an acceptable means of addressing the BART requirement in section 169A.

Comment: ELPC comments that “Illinois was required, but failed, to make a BART determination for each source subject to BART in the state.” ELPC lists the elements of a BART analysis that a state “ must submit ” (emphasis in original) pursuant to 40 CFR 51.308(e)(2), and ELPC states that Illinois has failed to make the BART determination based on source-specific information that EPA's regulations require. “Rather than make a BART determination for each individual source subject to BART that would be covered by Illinois' proposed alternative,” ELPC objects that the state “simply compared projected emissions reductions [from the adopted restrictions] to presumptive BART emissions.” ELPC comments that “[b]ecause Illinois entirely failed to use source-specific information or undertake a comprehensive five factor analysis to determine BART, its proposed Regional Haze State Implementation Plan (SIP) may not be approved.

Response: The primary requirement, as specified in Clean Air Act section 169A, is for sources to procure, install, and operate BART. In some cases this requirement is met with an analysis of potential controls considering five factors set out in EPA's regional haze rule (a “five-factor analysis”). 40 CFR 51.308(e)(1)(ii)(A). As noted above, EPA has determined that this requirement can be met by a state establishing an alternative set of emission limits which mandate greater reasonable progress toward visibility improvement than direct application of BART on a source-by-source basis.

In promulgating the 1999 regional haze regulations, EPA stated that to demonstrate that emission reductions of an alternative program would result in greater emission reductions, “the State must estimate the emission reductions that would result from the use of BART-level controls. To do this, the State could undertake a source-specific review of the sources in the State subject to BART, or it could use a modified approach that simplifies the analysis.” 64 FR 35742 (July 1, 1999).

In guidance published on October 13, 2006, EPA offered further clarification for states for assessing alternative strategies, in particular regarding the benchmark definition of BART to use in judging whether the alternative is better. See 71 FR 60612. In this rulemaking, EPA stated in the preamble that the presumptive BART levels given in the BART guidelines would be a suitable baseline against which to compare alternative strategies where the alternative has been designed to meet a requirement other than BART. 71 FR at 60619; see also 40 CFR 51.308(e)(2)(i)(C). Illinois' analysis is fully consistent with EPA's conclusions in this rulemaking.

Nevertheless, EPA undertook further analysis comparing Illinois' strategy against more stringent definitions of BART. In brief, EPA found that the alternative restrictions imposed by Illinois can be demonstrated to provide greater emission reductions and greater visibility improvement than even very conservative definitions of BART, even without a full analysis of the emission levels that constitute BART. The demonstration is discussed below, in the context of response to comments addressing the magnitude of controls at Illinois power plants.

Comment: ELPC believes that the pertinent requirements in Illinois' plan “will not achieve greater reasonable progress toward natural visibility conditions than BART.” Furthermore, “the MPS/CPS contains absolutely no requirements for specific control equipment to be installed or operated at any source subject to BART in Illinois.” ELPC identifies several examples of BART units that are expected to comply with the MPS or CPS with controls that are less effective than BART-level controls. ELPC also finds it problematic that “requirements for 2017 for Ameren exceed presumptive BART requirements for NO X at one of the three plants subject to BART, and far exceed presumptive SO 2 BART limits at all three (emphasis in original) Ameren plants subject to BART.” ELPC raises similar concerns in relation to specified Midwest Generation (MWG) plants. For this reason, “and because Ameren and MWG need not meet even those weak requirements at their plants subject to BART, the MPS/CPS is not `better' than presumptive BART limits.”

Response: ELPC appears to misunderstand the applicable test for alternate strategies for addressing BART. In particular, ELPC appears to believe that under the alternative approach, Illinois must require BART-level controls at each unit subject to BART. In fact, the underlying principle of EPA's guidance on alternative measures is to offer states the flexibility to require less control at BART units than BART-level control, provided the states provide additional control at non-BART units that more than compensates for any degree to which control at BART units falls short of BART. Illinois is using precisely this flexibility. Irrespective of the degree to which control at individual power plant BART units may be less stringent than the limits that for those particular units would be defined as BART, Illinois is requiring control across a universe of sources that includes many sources that are not subject to BART, thereby providing reductions that under EPA's rules and BART guidelines on alternative measures can compensate for any shortfall in control at BART units.

In response to these comments, EPA conducted further analysis of whether Illinois' requirements, addressing a substantial number of sources, can be expected to provide greater reasonable progress toward visibility protection than application of BART to the more limited number of units subject to a requirement for BART. EPA's analysis did not rely on a full five-factor analysis of BART at each BART-subject unit. Instead of using presumptive limits, EPA used emission limits described in EPA's RACT/BACT/LAER Clearinghouse as being applied to new sources. These limits, namely 0.06 pounds per million British Thermal Units (#/MMBTU) for NO X and also 0.06 #/MMBTU for SO 2 , are as stringent and are probably more stringent than would generally be expected to be met at existing power plants, due to the design constraints that are sometimes inherent in controlling emissions at an existing facility.

A more complete description of EPA's analysis is provided in the technical support document being placed in the docket for this rule. Table 1 provides a summary of the results of this analysis.

This table shows that the reductions from Illinois' plan, including reductions from the MPS, the CPS, and the permits for CWLP and Kincaid Generation, provide significantly greater emission reductions, especially for SO 2 but also for NO X , than even very conservative definitions of BART for the BART-subject units. While Illinois' limits for the CWLP and Kincaid facilities viewed individually are subject to limits at approximately presumptive levels, and thus mandate less reduction than would be mandated by conservative definitions of BART, this analysis indicates that the collective emission reductions from Illinois power plants are greater than those that would be achieved by requiring achievement of even very conservative limits at the units that are subject to a BART requirement.

An additional point to be addressed is whether Illinois' plan, achieving greater emission reductions overall than application of BART on BART-subject units, can be expected also to achieve greater visibility protection than application of BART on BART-subject units. In general, Illinois' power plants are substantial distances from any Class I area. The least distance from any BART-subject Illinois power plant to any Class I area is from Dynegy's Baldwin power plant to the Mingo Wilderness Area, a distance of about 140 kilometers. The CWLP and Kincaid facilities are in the middle of the State; for example, Kincaid Station is about 300 kilometers from the Mingo Wilderness Area. Given these distances, and given that the averaging in Illinois' plan (averaging among Illinois plants of an individual company) is only authorized within the somewhat limited region within which each utility's plants are located, a reallocation of emission reductions from one plant to another is unlikely to change the impact of those emission reductions significantly. Consequently, in these circumstances, EPA is confident that the significantly greater emission reductions that Illinois mandates will yield greater progress toward visibility protection as compared to the benefits of a conservative estimate of BART.

Comment: ELPC comments that the “MPS/CPS does not require that all necessary emissions reductions take place during the first long-term strategy for regional haze.”

Response: EPA does not prohibit reductions after the BART compliance deadline (in 2017); Illinois is only required to mandate at least measures that will achieve greater reasonable progress by the BART compliance deadline. While the MPS and the CPS establish a series of progressively more stringent limits extending to 2017 and beyond, both Illinois' analysis and the EPA analysis discussed above (summarized in Table 1) evaluate satisfaction of BART requirements by considering the emission limits in effect in 2017. The conclusion of that analysis is that the reductions necessary to meet BART requirements occur by the deadline for such reductions to occur. The fact that Illinois' plan requires additional reductions after 2017 is not a shortcoming of Illinois' plan.

Comment: ELPC expects the affected utilities to use the reductions mandated here to comply with CSAPR. ELPC concludes that these reductions cannot be considered surplus and thus are not creditable for meeting BART requirements.

Response: Under 40 CFR 51.308(e)(2), the alternative measures need only be surplus to reductions from measures adopted to meet requirements of the Clean Air Act as of the baseline date of the SIP, i.e. 2002. (See 40 CFR 51.308(e)(2)(iv).) In addition, 40 CFR 51.308(e) expressly provides that the BART requirements may be met by compliance with a trading program of adequate stringency even without establishment of state-specific limits. Therefore, the existence of a trading program, and influence that the state limits have on a utility's strategy for complying with the trading program requirements, cannot be grounds for disapproving a state plan that satisfies alternative BART requirements without reliance on the trading program.

Comment: ELPC expresses a number of concerns about the BART analysis for Kincaid Station. ELPC particularly expresses concern that the company analyzes wet flue gas desulfurization for a scenario based on a relatively high sulfur Illinois coal but analyzes dry sorbent injection based on a low sulfur western coal, biasing the comparison toward a conclusion that use of the control that is least effective at removing SO 2 nevertheless achieves the lowest emissions of SO 2.

Response: EPA agrees that use of higher sulfur coal in the scenario of wet flue gas desulfurization creates a mismatch in comparing this control to the other control options. However, ELPC does not demonstrate that a more appropriate comparison would yield a different result. Indeed, given how much more expensive wet flue gas desulfurization has been estimated to be for this facility as compared to dry sorbent injection (company estimates of annualized costs of $125 million versus $25 million), EPA believes that a revised BART analysis that used the same fuel for all scenarios, and thus achieved lower emissions with wet flue gas desulfurization, would still show that wet flue gas desulfurization is not cost-effective for this facility. Therefore, EPA continues to believe that Illinois made the appropriate BART determination for this facility.

Comment: ELPC objects to the use of annual average limits, expressing concern that annual average limits allow individual days of concern to have excessive visibility impairment.

Response: EPA's BART guidance establishes presumptive averaging times of 30 days or shorter, but EPA also finds Illinois' limits to be approvable. While a limit expressed as an annual average is inherently less stringent than the same limit expressed as a 30-day average, EPA believes that Illinois provides adequate compensation in part by setting some limits below presumptive levels and in part by limiting several units that are not subject to a BART requirement.

A useful perspective is to examine the metrics by which regional haze is evaluated. These metrics are averages of visibility across 20 percent of the days of the year, in particular across the 20 percent of days with the worst visibility and across the 20 percent of days with the best visibility. (See 64 FR 35734) Twenty percent of 365 days in a year is 73 days. Furthermore, the days that have better or worse visibility are distributed throughout the year, so that allowance of greater variability in daily or monthly emissions would not necessarily yield worse (or better) visibility. Thus, while a 30-day average limit would be better suited to assuring appropriate mitigation of visibility impairment, EPA finds Illinois' annual average limitations to be adequately commensurate with the averaging time inherent in the visibility metrics being addressed.

Another facet of the use of annual rather than 30-day or shorter averages is stringency. Given normal variability in emissions, an annual average limitation is by definition less stringent than a 30-day or shorter average limitation set at the same level. In some contexts, especially those involving short-term air quality standards, EPA would not accept an annual average limitation without a demonstration that the limitation suffices to mandate that short-term average emission levels must remain below some definable, adequate level. However, different criteria are warranted in the context of regional haze, for which the relevant emissions are the emissions on the 20 percent of days with worst visibility and the 20 percent of days with best visibility. Examining the stringency of the particular limitations that Illinois has adopted, and considering degree of variability in 73-day average emissions that might be expected with an annual average emission limit, EPA finds that Illinois' annual average limitations are sufficiently stringent to conclude that emissions on a 30-day average basis can be expected to provide the visibility improvement that Illinois is required to provide.

Comment: ELPC comments that Illinois' long-term strategy must be disapproved. ELPC expresses particular concern that Illinois' plan does not mandate emission reductions for two power plants, specifically Ameren's Joppa plant and Southern Illinois Power Company's Marion plant, which ELPC believes must be mandated “to achieve the reasonable progress goals for Class I areas affected by the state.” ELPC notes that “Illinois claimed that existing or soon-to-be-implemented regulatory program”—in particular, the MPS/CPS and CSAPR—“would require sufficient emissions reductions on the 15 most significant sources so as to ensure achievement of reasonable progress goals in impacted Class I areas.” ELPC acknowledges that the Joppa Plant is addressed to the extent that Ameren's plants are collectively limited under the MPS, but ELPC observes that Ameren has the choice to comply with the MPS “without making any reductions at Joppa,” even though the plant has “a Q/D ratio” (dividing emissions by distance to the nearest Class I area) that is “nearly three times larger than any other evaluated source.” ELPC also objects that CSAPR “also does not ensure emission reductions at either Joppa or Marion, because (1) the rule is under legal challenge, is currently stayed, and may never go into effect, (2) “does not require emission reductions at particular plants,” and (3) by restricting annual emissions does not necessarily limit emissions in seasons when the most degradation in visibility may occur.

Response: Achievement of the applicable reasonable progress goals is not contingent on Illinois limiting emissions from the Joppa or Marion plants in particular. Given the distances of the sources in Illinois from affected Class I areas, the least of which is about 120 kilometers from the Joppa plant to Mingo Wilderness Area, the impact on visibility is primarily dependent on the total emission reductions and not on the geographical distribution of those reductions. That is, even if Ameren for example were to opt to control its Coffeen plant (about 240 kilometers from Mingo Wilderness Area) more than its Joppa plant, the net effect on visibility would likely be similar.

EPA recognizes that CSAPR is under challenge and is currently stayed. However, Illinois is not relying on additional reductions from CSAPR to provide its appropriate contribution toward achieving reasonable progress in visibility protection. Therefore, the litigation status of CSAPR is not germane to the approvability of Illinois' regional haze plan.

EPA is approving Illinois' regional haze plan as satisfying the applicable requirements in 40 CFR 51.308. Most notably, EPA concludes that Illinois has satisfied the requirements for BART in 40 CFR 51.308(e) and has adopted a long-term strategy that reduces emissions in Illinois that, in combination with similar reductions elsewhere, EPA expects to suffice to achieve the reasonable progress goals at Class I areas affected by Illinois.

In this action, EPA is also approving a set of rules and two permits for incorporation into the state implementation plan. Specifically, EPA is approving the following rules: Title 35 of Illinois Administrative Code Rules 225.233 (paragraphs a, b, e, and g), 225.291, 225.292, 225.293, 225.295, 225.296 (except paragraph d), and 225 Appendix A. While the rules provide the SO 2 and NO X limits as one of two options that the affected utilities may choose between, EPA is incorporating into the SIP Illinois' submittal of letters from the affected utilities choosing the option including the SO 2 and NO X limits, which under the approved rules makes these limits permanently enforceable. Therefore, these SO 2 and NO X limits are state enforceable and, with this SIP approval, now become federally enforceable as well. EPA also considers the limits of the state permits and the refinery consent decrees to be enforceable. While Illinois adopted the above rules as part of a state rulemaking which mostly addressed mercury emissions, the mercury provisions are not germane to this rulemaking, Illinois did not submit the mercury-related rules, and the limited set of rules that Illinois submitted suffice to mandate the SO 2 and NO X emission controls that are pertinent to this action.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act 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 Clean Air Act. 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 Order 12866 (58 FR 51735, October 4, 1993);

• 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 Clean Air Act; 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 4, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Citizens concerned with water quality in Florida may be interested in this rulemaking. Entities discharging nitrogen or phosphorus to lakes and flowing waters of Florida could be indirectly affected by this rulemaking because water quality standards (WQS) are used in determining National Pollutant Discharge Elimination System (NPDES) permit limits. Categories and entities that may ultimately be affected include:

This table is not intended to be exhaustive, but rather provides a guide for entities that may be directly or indirectly affected by this action. This table lists the types of entities of which EPA is now aware that potentially could be affected by this action. Other types of entities not listed in the table, such as nonpoint source contributors to nitrogen/phosphorus pollution in Florida's waters may be indirectly affected through implementation of Florida's water quality standards program (i.e., through Basin Management Action Plans (BMAPs)). Any parties or entities conducting activities within watersheds of the Florida waters covered by this rule, or who rely on, depend upon, influence, or contribute to the water quality of the lakes and flowing waters of Florida, may be indirectly affected by this rule. To determine whether your facility or activities may be affected by this action, you should carefully examine the language in 40 CFR 131.43, which is the final rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

On December 6, 2010, EPA's final inland waters rule, entitled “Water Quality Standards for the State of Florida's Lakes and Flowing Waters; Final Rule,” was published in the Federal Register at 75 FR 75762, and codified at 40 CFR 131.43. The final inland waters rule established numeric nutrient criteria in the form of total nitrogen, total phosphorus, nitrate+nitrite, and chlorophyll a for the different types of Florida's inland waters to assure attainment of the State's applicable water quality designated uses. More specifically, the numeric nutrient criteria translated Florida's narrative nutrient provision at Subsection 62-302.530(47)(b), Florida Administrative Code (F.A.C.), into numeric values that apply to lakes and springs throughout Florida and flowing waters outside of the South Florida Region. (EPA has distinguished the South Florida Region as those areas south of Lake Okeechobee and the Caloosahatchee River watershed to the west of Lake Okeechobee and the St. Lucie watershed to the east of Lake Okeechobee.) This final inland waters rule seeks to improve water quality, protect public health and aquatic life, and achieve the long-term recreational uses of Florida's waters, which are a critical part of the State's economy.

As stated in the rule itself (75 FR 75762, December 6, 2010), the inland waters rule was originally scheduled to take effect on March 6, 2012, except for the site-specific alternative criteria (SSAC) provision at 40 CFR 131.43(e), which took effect on February 4, 2011. On March 7, 2012, EPA published an extension of the effective date of the rule for four months to July 6, 2012 (77 FR 13497). On May 17, 2012 (77 FR 29271) EPA proposed a shorter-term extension of the July 6, 2012, effective date in order to avoid the confusion and inefficiency that could occur should Federal criteria become effective while EPA reviews State standards for approval or disapproval under CWA section 303(c). On June 7, 2012, the State of Florida Division of Administrative Hearings ruled in favor of the State's rule, enabling the State to officially submit its package to EPA on June 13, 2012.

Extending the July 6, 2012, effective date of EPA's inland waters rule to January 6, 2013, would avoid the confusion and inefficiency that may occur should Federal criteria become effective while EPA is reviewing Florida's rule. This six-month extension will provide EPA time to review and approve or disapprove Florida's rule under CWA section 303(c). If EPA approves Florida's rule, this six-month extension will also allow EPA to request permission from the Court to finalize a further extension of the January 6, 2013, effective date for a period of time for EPA to withdraw the Federal criteria corresponding to those State criteria approved by EPA. Finally, if the Court grants EPA permission to finalize a further extension of the January 6, 2013, effective date, this six-month extension will allow EPA to actually finalize such further extension of the January 6, 2013, effective date to allow EPA to withdraw Federal criteria corresponding to those State standards approved by EPA. If EPA does not approve Florida's standards, EPA expects that its inland waters rule would become effective January 6, 2013.

Note that regarding two portions of EPA's original inland waters rule—streams and default downstream protection values (DPVs) for unimpaired lakes—the U.S. District Court for the Northern District of Florida invalidated and remanded those two portions of the inland waters rule to EPA on February 18, 2012 ( FWF v. Jackson, 4:08-cv-00324-RH-WCS). EPA is preparing to propose in a separate rulemaking process numeric nutrient criteria for such streams and default DPVs.

EPA received twelve comments on the proposed extension of the July 6, 2012, effective date. One commenter noted that any extension of the inland waters rule effective date does not prevent Florida from developing protective numeric nutrient standards. This commenter provided information showing that Florida continues to experience nitrogen and phosphorus-fueled algae blooms. This commenter asserted that the sooner numeric criteria are put in place, the sooner Florida waters will be on the path to being fishable, swimmable, and drinkable. EPA agrees with the commenter that control of excess nitrogen and phosphorus is important, however, EPA is finalizing this six-month extension of the effective date to allow EPA time to review the submitted State standards (discussed earlier) for approval or disapproval under CWA section 303(c). As mentioned earlier, having EPA's criteria take effect while EPA is reviewing the State standards could cause confusion and administrative inefficiency for the State and regulated entities, something the EPA wants to avoid. The commenter also argued against granting the longer extension of one year that was discussed in the proposed rule. EPA agrees with the commenter and has finalized a six-month extension. The commenter also provided input on the submitted Florida numeric nutrient standards. Those comments are outside the scope of this rule.

The other eleven commenters supported the proposal to extend the effective date, arguing that the additional time would avoid the confusion and inefficiency that may occur should Federal criteria become effective prior to allowing full consideration of the Florida Department of Environmental Protection's (FDEP's) nutrient standards and withdrawal of Federal numeric nutrient criteria rulemakings in Florida. The commenters supported extension of the effective date by one year as discussed in the proposal rather than the proposed three-month extension. Some of these commenters also proposed that EPA extend the effective date beyond one year in case more time is needed to withdraw its Federal nutrient criteria.

EPA agrees that a longer extension than three months is warranted, but that six months is appropriate in order to provide sufficient time to allow EPA to take the actions described earlier. Therefore, based on public comment as well as the June 13, 2012, submission by Florida of its nutrient standards, EPA believes that a six-month extension is warranted.

EPA received several comments urging actions related to an EPA rulemaking under development (i.e., not the inland waters rule). These comments are outside the scope of this action and therefore EPA is not addressing them.

Section 553(d)(3) of the Administrative Procedure Act, 5 U.S.C. 553(d)(3), provides that “[t]he required publication or service of a substantive rule shall be made not less than 30 days before its effective date, except * * * (3) as otherwise provided by the agency for good cause found and published with the rule.” Today's final rule is a rule that relieves a restriction, i.e., that delays the effective date of a Federal rule. Today's rule does not establish any requirements but rather merely extends the effective date of already-promulgated requirements. On this basis, EPA has determined that there is “good cause” for having this rule take effect upon publication in the Federal Register . EPA thus finds that this constitutes “good cause” under 5 U.S.C. 553(d)(3).

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993), since it merely extends the effective date of an already promulgated rule, and is therefore not subject to review under Executive Order 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). This action does not impose any information collection burden, reporting or record keeping requirements on anyone.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this action on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for- profit enterprise which is independently owned and operated and is not dominant in its field.

This final rule does not establish any requirements that are applicable to small entities, but rather merely extends the date of already promulgated requirements. Thus, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

This final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. This final rule merely extends the effective date of an already promulgated regulation.

This final rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This final rule does not establish any requirements that are applicable to small entities, but rather merely extends the date of already promulgated requirements.

This action does not have Federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action merely extends the effective date of an already promulgated regulation.

Subject to the Executive Order 13175 (65 FR 67249, November 9, 2000) EPA may not issue a regulation that has Tribal implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by Tribal governments, or EPA consults with Tribal officials early in the process of developing the proposed regulation and develops a Tribal summary impact statement. However, the rule will neither impose substantial direct compliance costs on Tribal governments, nor preempt Tribal law.

In the State of Florida, there are two Indian Tribes, the Seminole Tribe of Florida and the Miccosukee Tribe of Indians of Florida, with lakes and flowing waters. Both Tribes have been approved for treatment in the same manner as a State (TAS) status for CWA sections 303 and 401 and have federally approved WQS in their respective jurisdictions. These Tribes are not subject to this final rule. This rule will not impact the Tribes because it merely extends the date of already promulgated requirements.

This action is not subject to E.O. 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in E.O. 12866 and because the Agency does not believe this action includes environmental health risks or safety risks that would present a risk to children.

This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This rulemaking does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order (E.O.) 12898 (59 FR 7629, Feb. 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. This action is not subject to E.O. 12898 because this action merely extends the effective date for already promulgated requirements.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefore, and established an effective date of July 6, 2012. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons set out in the preamble, 40 CFR part 131 is amended as follows: