Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Rules and Regulations 39911 

Elimination Act sec. 1704 (44 U.S.C. 3504 

note); Energy Policy Act of 2005, Pub. L. 

109–58, 119 Stat. 594 (2005). 

Sections 150.3, 150.15, 150.15a, 150.31, 

150.32 also issued under Atomic Energy Act 

secs. 11e(2), 81, 83, 84 (42 U.S.C. 2014e(2), 

2111, 2113, 2114). Section 150.14 also issued 

under Atomic Energy Act sec. 53 (42 U.S.C. 

2073). 

Section 150.15 also issued under Nuclear 

Waste Policy Act sec. 135 (42 U.S.C. 10155, 

10161). Section 150.17a also issued under 

Atomic Energy Act sec. 122 (42 U.S.C. 2152). 

Section 150.30 also issued under Atomic 

Energy Act sec. 234 (42 U.S.C. 2282). 

PART 160—TRESPASSING ON 

COMMISSION PROPERTY 

■ 71. Revise the authority citation for 

part 160 to read as follows: 

Authority: Atomic Energy Act secs. 161, 

229, 223, 234 (42 U.S.C. 2201, 2278a, 2273, 

2282); Energy Reorganization Act sec. 201 (42 

U.S.C. 5841). 

PART 170—FEES FOR FACILITIES, 

MATERIALS IMPORT AND EXPORT 

LICENSES AND OTHER REGULATORY 

SERVICES UNDER THE ATOMIC 

ENERGY ACT OF 1954, AS AMENDED 

■ 72. Revise the authority citation for 

part 170 to read as follows: 

Authority: Independent Offices 

Appropriations Act sec. 501 (31 U.S.C. 9701); 

Atomic Energy Act sec. 161(w) (42 U.S.C. 

2201(w)); Energy Reorganization Act sec. 201 

(42 U.S.C. 5841); Chief Financial Officers Act 

sec. 205 (31 U.S.C. 901, 902); Government 

Paperwork Elimination Act sec. 1704 (44 

U.S.C. 3504 note); Energy Policy Act sec. 623, 

Energy Policy Act of 2005 sec. 651(e), Pub. 

L. 109–58,119 Stat. 783 (42 U.S.C. 2201(w), 

2014, 2021, 2021b, 2111). 

PART 171—ANNUAL FEES FOR 

REACTOR LICENSES AND FUEL 

CYCLE LICENSES AND MATERIAL 

LICENSES, INCLUDING HOLDERS OF 

CERTIFICATES OF COMPLIANCE, 

REGISTRATIONS, AND QUALITY 

ASSURANCE PROGRAM APPROVALS 

AND GOVERNMENT AGENCIES 

LICENSED BY THE NRC 

■ 73. Revise the authority citation for 

part 171 to read as follows: 

Authority: Consolidated Omnibus Budget 

Reconciliation Act sec. 6101 Pub. L. 99–272, 

as amended by sec. 5601, Pub. L. 100–203 as 

amended by sec. 3201, Pub. L. 101–239, as 

amended by sec. 6101, Pub. L. 101–508, as 

amended by sec. 2903a, Pub. L. 102–486 (42 

U.S.C. 2213, 2214), and as amended by Title 

IV, Pub. L. 109–103 (42 U.S.C. 2214); Atomic 

Energy Act sec. 161(w), 223, 234 (42 U.S.C. 

2201(w), 2273, 2282); Energy Reorganization 

Act sec. 201 (42 U.S.C. 5841); Government 

Paperwork Elimination Act sec. 1704 (44 

U.S.C. 3504 note); Energy Policy Act of 2005 

sec. 651(e), Pub. L. 109–58 (42 U.S.C. 2014, 

2021, 2021b, 2111). 

Dated at Rockville, Maryland, this 27th day 

of June 2012. 

For the Nuclear Regulatory Commission. 

Cindy Bladey, 

Chief, Rules, Announcements, and Directives 

Branch, Division of Administrative Services, 

Office of Administration. 

[FR Doc. 2012–16176 Filed 7–5–12; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 93 

[Docket No. FAA–2010–0302; Amdt. No. 93– 

97] 

RIN 2120–AJ75 

The New York North Shore Helicopter 

Route 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action requires 

helicopter pilots to use the New York 

North Shore Helicopter Route when 

operating along the north shore of Long 

Island, New York. The North Shore 

Helicopter Route was added to the New 

York Helicopter Route Chart in 2008 

and prior to this action, its use has been 

voluntary. The purpose of this rule is to 

protect and enhance public welfare by 

maximizing utilization of the existing 

route flown by helicopter traffic one 

mile off the north shore of Long Island 

and thereby reducing helicopter 

overflights and attendant noise 

disturbance over nearby communities. 

This rule will lapse in 2 years unless the 

FAA determines that a permanent rule 

is merited. 

DATES: Effective August 6, 2012 through 

August 6, 2014. 

ADDRESSES: For information on where to 

obtain copies of rulemaking documents 

and other information related to this 

final rule, see ‘‘How To Obtain 

Additional Information’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this rule 

contact Gary A. Norek, Airspace, 

Regulations and ATC Procedures Group, 

AJV–11, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone 202–267–8783. For legal 

questions concerning this rule contact 

Rebecca MacPherson, AGC–200, Office 

of Chief Counsel, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone 202–267–3073. 

SUPPLEMENTARY INFORMATION: 

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 * * *’’ 

I. Executive Summary 

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 


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39912 Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Rules and Regulations 

1A review of the Registry database indicated that 

approximately 90 percent of all registered 

helicopters have a single-engine. A review of the 

2010 GA survey indicated that approximately 85 

percent of the active helicopter population is singleengine. The discrepancies in the two data sets are 

a function of filters in the survey that are designed 

to focus on helicopters that are actively flown. 

2See Eastern Region Helicopter Council 

Operations Analysis—Suffolk County, Memorial 

Day Weekend 2010, June 23, 2010, Docket No. 

FAA–2010–0302–0898. 

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. 

II. Background 

A. Statement of the Problem 

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. 

Uniqueness of the Situation 

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 multiengine 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 


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3Should the FAA decide against allowing the 

rule to sunset, we may evaluate the affected fleet 

as the quieter technologies are incorporated into the 

helicopter fleet as a whole and may reevaluate the 

continued need for a mandatory route if the 

majority of affected helicopters have the quieter 

engines. 

4While the route extends to Orient Point, it is 

unlikely that many operators would stay on the 

route that long because Orient Point is located at 

the far eastern point of the island, well east of any 

significant population centers. 

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 pointto-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. 

Safety Implications 

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. 

Community Involvement 

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. 

Future Technology 

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. 

B. Summary of the NPRM 

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. 

C. General Overview of Comments 

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 


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39914 Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Rules and Regulations 

5The FAA has not been able to independently 

assess the validity or reliability of these estimates. 

In any event, the FAA continued to receive noise 

complaints after implementation of the voluntary 

route. 

6The Performance Data Analysis and Reporting 

System (PDARS) supports the collection, archiving, 

and reporting of flight plan and radar track data 

from Air Route Traffic Control Centers, Terminal 

Radar Approach Control facilities, and Air Traffic 

Control Towers to manage aviation activity within 

the National Airspace System (NAS). The PDARS 

data analyzed by the FAA for this rule represents 

visual flight rule (VFR) aircraft operating in Class 

E and G airspace along the northern shoreline of 

Long Island, New York. The data represent aircraft 

using a transponder code indicating VFR operation 

and altitude. 

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. 

III. Discussion of Public Comments and 

Final Rule 

A. Justification for the Rule 

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. 

B. Safety Issues 

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 


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Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Rules and Regulations 39915 

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 eastand 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. 

C. Route Location 

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 


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7Long Island North Shore Helicopter Route 

Environmental Study, John A. Volpe National 

Transportation Systems Center. The FAA analyzed 

data from the PDARS. The PDARS supports the 

collection, archiving, and reporting of flight plan 

and radar track data from Air Route Traffic Control 

Centers, Terminal Radar Approach Control 

facilities, and Air Traffic Control Towers to manage 

aviation activity within the National Airspace 

System (NAS). The PDARS data analyzed by the 

FAA for this rule represents visual flight rule (VFR) 

aircraft operating in Class E and Class G airspace 

in the vicinity of the northern shoreline of Long 

Island, New York. The data represent aircraft using 

a transponder code indicating VFR operation and 

altitude. The FAA’s analysis modeled noise from 

approximately 15,600 flight operations, based on an 

average of 42.8 operations per day over 11 days 

around Memorial Day and July 4, 2011. The 

resulting noise levels were below DNL 45 dB. 

Under federal guidelines, residential land uses are 

considered compatible with noise levels below DNL 

65 dB. 14 CFR part 150, appendix A, Table 1. 

8Presumably those airports and heliports near 

larger population centers will receive have more 

take-offs and landings than the airports and 

heliports near smaller population centers. But this 

may not actually be true. It is possible that the 

airports and heliports near relatively small, but 

more affluent population centers will handle most 

of the helicopter traffic. 

9The FAA is unable to validate the assumptions 

of ERHC because it is impossible to determine 

where operators would choose to divert from the 

route to reach their intended destinations. However, 

the FAA did evaluate what it believes would be one 

of the worst case scenarios in terms of additional 

distance by looking at the distance between the 

initial waypoint at VPLYD and the Alexanders East 

Heliport, which is the southernmost heliport on the 

far south shore of Long Island. Assuming a 100 knot 

groundspeed, the FAA calculated the direct route 

time as 23.4 minutes (39 nm) and the North Shore 

route time as 30.6 minutes (51 nm), a difference of 

7 minutes. 

several years. The FAA is not aware of 

any navigational or safety issues 

associated with the use of this route. 

D. Environmental Concerns 

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 


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10See Long Island North Shore Helicopter Route 

Environmental Study, John A. Volpe National 

Transportation Systems Center. The North Shore 

Helicopter Route is located entirely within Suffolk 

County, New York, which has been designated 

under the Clean Air Act as a nonattainment area for 

particulate matter (PM–2.5) and a moderate 

nonattainment area for ozone. See U.S. 

Environmental Protection Agency (EPA), ‘‘Currently 

Designated Nonattainment Areas for All Criteria 

Pollutants,’’ available at http://www.epa.gov/ 

oaqps001/greenbk/ancl.html. In addition, the state 

of New York is within the Ozone Transport Region 

established in section 184(a) of the Clean Air Act, 

42 U.S.C. 7511c(a). EPA has determined that for 

such nonattainment areas, emissions of less than 50 

tons per year of volatile organic compounds and 

100 tons per year of nitrogen oxides, PM–2.5, or 

sulfur dioxide are de minimis. 40 CFR 93.153(b)(1). 

Using conservative assumptions, an analysis by the 

FAA (a copy of which has been placed in the docket 

for this rulemaking), indicates that emissions of 

these pollutants from combustion of an additional 

117,000 gallons of fuel would be well below these 

de minimis levels. 

11See: 33 FR 11748; August 20, 1968 (final rule 

designating special air traffic rule for Lorain County 

Regional Airport, Lorain, Ohio to route low altitude 

terminal traffic away from the Oberlin College 

Conservatory of Music to avoid audible 

disturbances; 35 FR 5466; April 2, 1970 (final rule 

designating Prohibited Airspace (P–66) Mount 

Vernon, VA based on a concern over the danger to 

irreplaceable historic structures and the noise 

nuisance caused by the low flying aircraft, 

including helicopters, over Mount Vernon grounds); 

62 FR 1192; January 8, 1997 (final rule temporarily 

banning commercial air tour operations over Rocky 

Mountain National Park in order to prevent any 

potential adverse noise impact from these 

sightseeing aircraft). 12 5 U.S.C. 551 et seq. 

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. 

E. Procedural/Miscellaneous 

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 


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13http://www.faa.gov/about/office_org/ 

headquarters_offices/apl/aviation_forecasts/ 

aerospace_forecasts/2012–2032/. 

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. 

F. Economic Evaluation 

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. 

G. Sunset Provision 

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. 


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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. 

IV. Regulatory Notices and Analyses 

A. Regulatory Evaluation 

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. 

B. Regulatory Flexibility Determination 

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-forprofit 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 


sroberts on DSK5SPTVN1PROD with RULES
39920 Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Rules and Regulations 

14See Long Island North Shore Helicopter Route 

Environmental Study, John A. Volpe National 

Transportation Systems Center. The North Shore 

Helicopter Route is located entirely within Suffolk 

County, New York, which has been designated 

under the Clean Air Act as a nonattainment area for 

particulate matter (PM–2.5) and a moderate 

nonattainment area for ozone. See U.S. 

Environmental Protection Agency (EPA), ‘‘Currently 

Designated Nonattainment Areas for All Criteria 

Pollutants,’’ available at http://www.epa.gov/ 

oaqps001/greenbk/ancl.html. In addition, the state 

of New York is within the Ozone Transport Region 

established in section 184(a) of the Clean Air Act, 

42 U.S.C. 7511c(a). EPA has determined that for 

such nonattainment areas, emissions of less than 50 

tons per year of volatile organic compounds and 

100 tons per year of nitrogen oxides, PM–2.5, or 

sulfur dioxide are de minimis. 40 CFR 93.153(b)(1). 

Using conservative assumptions, an analysis by the 

FAA (a copy of which has been placed in the docket 

for this rulemaking), indicates that emissions of 

these pollutants from combustion of an additional 

117,000 gallons of fuel would be well below these 

de minimis levels. 

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. 

C. Unfunded Mandates Assessment 

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. 

D. Paperwork Reduction Act 

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. 

E. International Compatibility 

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. 

F. Environmental Analysis 

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. 

V. Executive Order Determinations 

A. Executive Order 13132, Federalism 

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. 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

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. 

VI. How To Obtain Additional 

Information 

A. Rulemaking Documents 

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. 

B. Comments Submitted to the Docket 

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.). 

C. Small Business Regulatory 

Enforcement Fairness Act 

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 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 130 / Friday, July 6, 2012 / Rules and Regulations 39921 

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/. 

VII. The Amendment 

List of Subjects in 14 CFR Part 93 

Air traffic control, Airspace, 

Navigation (air). 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends chapter I of title 14, Code of 

Federal Regulations as follows: 

PART 93—SPECIAL AIR TRAFFIC 

RULES 

■ 1. The authority citation for part 93 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40109, 40113, 44502, 44514, 44701, 44715, 

44719, 46301. 

■ 2. Add subpart H to part 93 to read as 

follows: 

Subpart H—Mandatory Use of the New York 

North Shore Helicopter Route 

Sec. 

93.101 Applicability. 

93.103 Helicopter operations. 

Subpart H—Mandatory Use of the New 

York North Shore Helicopter Route 

§ 93.101 Applicability. 

This subpart prescribes a special air 

traffic rule for civil helicopters 

operating VFR along the North Shore, 

Long Island, New York, between August 

6, 2012 and August 6, 2014. 

§ 93.103 Helicopter operations. 

(a) Unless otherwise authorized, each 

person piloting a helicopter along Long 

Island, New York’s northern shoreline 

between the VPLYD waypoint and 

Orient Point, shall utilize the North 

Shore Helicopter route and altitude, as 

published. 

(b) Pilots may deviate from the route 

and altitude requirements of paragraph 

(a) of this section when necessary for 

safety, weather conditions or 

transitioning to or from a destination or 

point of landing. 

Issued in Washington, DC, on July 2, 2012. 

Ray LaHood, 

Secretary of Transportation. 

Michael P. Huerta, 

Acting Administrator. 

[FR Doc. 2012–16667 Filed 7–3–12; 4:15 pm] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 74 

[Docket No. FDA–2011–C–0050] 

D&C Red No. 6 and D&C Red No. 7; 

Change in Specification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

revising its requirements for D&C Red 

No. 6 and D&C Red No. 7 by replacing 

the current specification for ‘‘Ethersoluble matter’’ with a maximum limit 

of 0.015 percent for the recently 

identified impurity 1-[(4- 

methylphenyl)azo]-2-naphthalenol. This 

action is in response to a petition filed 

by Sun Chemical Corp. 

DATES: This rule is effective August 7, 

2012, except as to any provisions that 

may be stayed by the filing of proper 

objections. Submit either electronic or 

written objections and requests for a 

hearing by August 6, 2012. See section 

XI of this document for information on 

the filing of objections. 

ADDRESSES: You may submit objections 

and requests for a hearing, identified by 

Docket No. FDA–2011–C–0050, by any 

of the following methods: 

Electronic Submissions: Submit 

electronic objections in the following 

way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions: Submit written 

objections in the following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2011–C–0050 for this 

rulemaking. All objections received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

detailed instructions on submitting 

objections, see section XI of this 

document. 

Docket: For access to the docket to 

read background documents or 

objections received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Teresa A. Croce, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 240–402–1281. 

SUPPLEMENTARY INFORMATION: 

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. 

II. Regulatory History 

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 etherVerDate Mar<15>2010 15:44 Jul 05, 2012 Jkt 226001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\06JYR1.SGM 06JYR1

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