Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Rules and Regulations 77385 

(a) Effective Date 

This AD is effective December 26, 2014. 

(b) Affected ADs 

This AD supersedes AD 2013–15–09, 

Amendment 39–17525 (78 FR 49111, August 

13, 2013). 

(c) Applicability 

This AD applies to all Pratt & Whitney 

Division (PW) PW4074, PW4074D, PW4077, 

PW4077D, PW4084D, PW4090, and PW4090– 

3 turbofan engine models with second-stage 

high-pressure turbine (HPT) air seal, part 

number (P/N) 54L041, 50L960, or 50L976, 

installed. 

(d) Unsafe Condition 

This AD was prompted by additional 

reports of cracking in the second-stage HPT 

air seal. We are issuing this AD to prevent 

failure of the second-stage HPT air seal, 

which could lead to uncontained engine 

failure and damage to the airplane. 

(e) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(1) At the next piece-part exposure after the 

effective date of this AD, do the following: 

(i) Remove from service second-stage HPT 

air seals, P/Ns 50L960, 50L976, and 54L041. 

(ii) Perform a fluorescent-penetrant 

inspection (FPI) of the second-stage HPT air 

seal, P/N 54L041, for a through-crack in the 

front forward fillet radius. 

(iii) If a through-crack in the front forward 

fillet radius is found, remove the first-stage 

HPT hub, second-stage HPT hub, and secondstage HPT blade retaining plate from service. 

Do not reinstall the first-stage HPT hub, 

second-stage HPT hub, or second-stage HPT 

blade retaining plate into any engine. 

(2) For engines with second-stage HPT air 

seals, P/N 54L041, installed, perform initial 

and repetitive inspections for cracks on-wing 

until the part is removed from the engine as 

follows: 

(i) Perform an initial eddy current 

inspection (ECI) for cracks before reaching 

2,200 cycles since new, within 1,000 cyclesin-service after September 17, 2013, or before 

further flight, whichever occurs later. 

(ii) Thereafter, repeat the ECI every 1,200 

cycles since last inspection, or fewer, 

depending on the results of the inspection. 

(iii) Use section 4.0 of the appendix of PW 

Alert Service Bulletin (ASB) No. PW4G–112– 

A72–330, Revision 2, dated July 11, 2013, to 

perform the inspection and use paragraph 8 

of the Accomplishment Instructions of PW 

ASB No. PW4G–112–A72–330, Revision 2, 

dated July 11, 2013, to disposition the results 

of the inspection. 

(f) Installation Prohibition 

(1) After the effective date of this AD, do 

not install any second-stage HPT air seal, P/ 

N 54L041, P/N 50L960, or P/N 50L976, into 

any engine. 

(2) After the effective date of this AD, do 

not install any spare first-stage HPT hub, 

second-stage HPT hub, or second-stage HPT 

blade retaining plate that was previously 

mated in service to a second-stage HPT air 

seal, P/N 54L041, that was found to have a 

through-crack in the front forward fillet 

radius, into any engine. 

(g) Definitions 

For the purpose of this AD: 

(1) Piece-part exposure is when the secondstage HPT air seal is removed from the engine 

and fully disassembled. 

(2) A through-crack is a crack that has 

propagated through the thickness of the part 

and can be seen on both the inner diameter 

and outer diameter of the front forward fillet 

radius. 

(h) Credit for Previous Actions 

(1) If you performed an ECI of the secondstage HPT air seal before the effective date of 

this AD, using PW ASB No. PW4G–112– 

A72–330, Revision 1, dated February 14, 

2013, or an earlier version, you have met the 

requirements of paragraph (e)(2)(i) of this AD. 

(2) If you performed an in-shop FPI of the 

second-stage HPT air seal before the effective 

date of this AD, you have met the 

requirements of paragraph (e)(2)(i) of this AD. 

(i) Alternative Methods of Compliance 

(AMOCs) 

The Manager, Engine Certification Office, 

FAA, may approve AMOCs for this AD. Use 

the procedures found in 14 CFR 39.19 to 

make your request. You may email your 

request to: ANE-AD-AMOC@faa.gov. 

(j) Related Information 

(1) For more information about this AD, 

contact Jo-Ann Theriault, Aerospace 

Engineer, Engine Certification Office, FAA, 

Engine & Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; phone: 781–238–7105; fax: 781–238– 

7199; email: jo-ann.theriault@faa.gov. 

(2) PW Service Bulletin (SB) No. PW4G– 

112–72–332, Revision 3, dated June 25, 2014, 

which is not incorporated by reference in this 

AD, can be obtained from PW, using the 

contact information in paragraph (k)(3) of 

this AD. This SB provides guidance on how 

to replace the second-stage HPT air seal with 

an air seal that is more resistant to low cycle 

fatigue cracks. 

(k) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(3) The following service information was 

approved for IBR on September 17, 2013 (78 

FR 49111, August 13, 2013). 

(i) Pratt & Whitney (PW) Alert Service 

Bulletin No. PW4G–112–A72–330, Revision 

2, dated July 11, 2013. 

(ii) Reserved. 

(4) For PW service information identified 

in this AD, contact Pratt & Whitney Division, 

400 Main St., East Hartford, CT 06108; 

phone: 860–565–8770; fax: 860–565–4503. 

(5) You may view this service information 

at FAA, Engine & Propeller Directorate, 12 

New England Executive Park, Burlington, 

MA. For information on the availability of 

this material at the FAA, call 781–238–7125. 

(6) You may view this service information 

at the National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Burlington, Massachusetts, on 

December 22, 2014. 

Colleen M. D’Alessandro, 

Assistant Directorate Manager, Engine and 

Propeller Directorate, Aircraft Certification 

Service. 

[FR Doc. 2014–30283 Filed 12–23–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 172 

[Docket No. FDA–2009–F–0303] 

Food Additives Permitted for Direct 

Addition to Food for Human 

Consumption; Advantame 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; response to 

objections. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

responding to objections we received on 

the final rule that amended the food 

additive regulations to provide for the 

safe use of advantame as a non-nutritive 

sweetener and flavor enhancer in foods 

generally, except in meat and poultry. 

After reviewing the objections to the 

final rule, we have concluded that they 

do not provide a basis for modifying or 

revoking the regulation. We are also 

confirming the effective date of May 21, 

2014, for the final rule. 

DATES: The effective date of the final 

rule published on May 21, 2014 (79 FR 

29078), is confirmed: May 21, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Felicia M. Ellison, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 240–402–1264. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 21, 

2009 (74 FR 35871), we announced that 

a food additive petition (FAP 9A4778), 

had been filed by Ajinomoto Co., Inc., 

c/o Ajinomoto Corporate Services LLC, 

1120 Connecticut Ave. NW., suite 1010, 

Washington, DC 20036. The petition 

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77386 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Rules and Regulations 

proposed to amend the food additive 

regulations in part 172, Food Additives 

Permitted for Direct Addition to Food 

for Human Consumption (21 CFR part 

172), to provide for the safe use of 

advantame as a non-nutritive sweetener 

in tabletop applications and powdered 

beverage mixes. Subsequently, in a 

letter dated August 24, 2012, the 

petitioner informed us that FAP 9A4778 

had been transferred from Ajinomoto 

Corporate Services LLC to Ajinomoto 

North America, Inc., One Parker Plaza, 

400 Kelby St., Fort Lee, NJ 07024. 

In an amended document published 

in the Federal Register of October 26, 

2012 (77 FR 65340), we announced that 

Ajinomoto Co., Inc., c/o Ajinomoto 

North America, Inc., One Parker Plaza, 

400 Kelby St., Fort Lee, NJ 07024, had 

amended its food additive petition to 

provide for the safe use of advantame as 

a non-nutritive sweetener and flavor 

enhancer in foods generally, except in 

meat and poultry. 

In response to FAP 9A4778, we issued 

a final rule in the Federal Register on 

May 21, 2014 (79 FR 29078), permitting 

the safe use of advantame as a nonnutritive sweetener and flavor in foods 

generally, except in meat and poultry. 

This regulation is codified at § 172.803. 

We based our decision on data 

contained in the petition and in our 

files. In the preamble to the final rule 

(79 FR 29078 at 29079–29084), we 

outlined the basis for our decision and 

stated that objections to the final rule 

and requests for a hearing were due 

within 30 days of the publication date 

(i.e., by June 20, 2014). 

II. Objections and Requests for a 

Hearing 

Section 409(f)(1) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 348(f)(1)) provides that, 

within 30 days after publication of an 

order relating to a food additive 

regulation, any person adversely 

affected by such order may file 

objections, ‘‘specifying with 

particularity the provisions of the order 

deemed objectionable, stating 

reasonable grounds therefor, and 

requesting a public hearing upon such 

objections.’’ 

Under 21 CFR 171.110, objections and 

requests for a hearing are governed by 

part 12 (21 CFR part 12) of FDA’s 

regulations. Under § 12.22(a), each 

objection must meet the following 

conditions: (1) Must be submitted on or 

before the 30th day after the date of 

publication of the final rule; (2) must be 

separately numbered; (3) must specify 

with particularity the provision of the 

regulation or proposed order objected 

to; (4) must specifically state each 

objection on which a hearing is 

requested; failure to request a hearing 

on an objection constitutes a waiver of 

the right to a hearing on that objection; 

and (5) must include a detailed 

description and analysis of the factual 

information to be presented in support 

of the objection if a hearing is requested; 

failure to include a description and 

analysis for an objection constitutes a 

waiver of the right to a hearing on that 

objection. 

Following publication of the final rule 

permitting the use of advantame as a 

non-nutritive sweetener and flavor 

enhancer in foods generally, except 

meat and poultry, we received 12 

submissions with objections to the rule 

within the 30-day objection period. The 

majority of these submissions were 

letters expressing concern regarding one 

or more of the following issues: (1) 

Labeling of products containing 

advantame, and (2) advantame being 

mistaken for aspartame. A few of the 

letters also expressed general opposition 

to the final rule, or objected to the rule 

based on adverse effects believed to 

have been caused by aspartame, and not 

advantame. None of these letters 

requested a hearing, nor provided 

evidence in support of any of these 

objections that could be considered 

factual information (§ 12.22(a)(5)). 

Therefore, these objections do not 

justify the modification or revocation of 

the regulation. We will not discuss these 

submissions further. 

There was one submission that raised 

a specific objection. The letter was from 

the Natural Resources Defense Council 

(NRDC) (letter to Docket No. FDA– 

2009–F–0303, June 20, 2014). The letter 

from NRDC did not request a hearing on 

their objection. Therefore, NRDC has 

waived its right to a hearing on their 

objection (see § 12.22(a)(4)). The only 

remaining question under § 12.24(a) is 

whether NRDC’s objection, and the 

information submitted in support of the 

objection, establish that the regulation 

authorizing the use of advantame 

should be modified or revoked. As 

discussed in detail in section III, we 

have concluded that NRDC has not 

established a basis for modification or 

revocation of the regulation authorizing 

the use of advantame. 

III. Analysis of Objection 

The objection raised by NRDC asserts 

that FDA did not comply with section 

409 of the FD&C Act in our evaluation 

of the advantame petition because, they 

claim, we did not conduct a fair 

evaluation of the data before the Agency 

as required by section 409(c)(3) of the 

FD&C Act and did not consider the 

relevant safety factors as required by 

section 409(c)(5). Specifically, NRDC 

states that advantame and the sweetener 

aspartame are structurally related and 

that FDA has stated that ‘‘advantame 

actually contains a small amount of 

aspartame.’’ NRDC asserts that when we 

were considering potential effects of 

advantame, we considered the health 

effects of aspartame but did not consider 

the potential impacts of advantame on 

the hypothalamus despite having 

evidence that aspartame significantly 

altered that part of the brain. In support 

of their claim, NRDC cites five animal 

studies that they state are in FDA’s 

possession and indicate aspartame 

affects the hypothalamus. NRDC 

requests that since the brain tissues 

from the key advantame animal studies 

were preserved, FDA should withdraw 

its approval of advantame until those 

tissues are examined for alteration of the 

hypothalamus and the implications on a 

child’s developing brain are fully 

considered. In addition, NRDC claims 

that we did not comply with Executive 

Order 13045 regarding protection of 

children from environmental health 

risks and safety risks by not assessing 

the safety of advantame on a child’s 

brain development. 

The issue of whether aspartame poses 

a risk of hypothalamic adverse effects, 

including endocrine dysfunction, was 

thoroughly addressed in the 

Commissioner’s final decision on 

aspartame published in the Federal 

Register on July 24, 1981 (46 FR 38285). 

In that decision, the Commissioner 

affirmed the safety of aspartame as a 

nutritive sweetener and concluded that 

there is a reasonable certainty that 

human consumption of aspartame at 

projected consumption levels will not 

pose a risk to the brain, including 

endocrine function. We are not aware of 

any new relevant evidence to the 

contrary. NRDC has not provided any 

evidence that the effects on the 

hypothalamus in the aspartame studies 

they cited are toxicologically significant 

at the expected levels of intake of 

aspartame and, further, they have not 

provided evidence of the relevancy of 

this information to the safety of 

advantame. 

We disagree with NRDC’s 

characterization of the relationship 

between advantame and aspartame. 

While advantame is structurally related 

to aspartame, and aspartame is used as 

one of the starting chemicals in the 

manufacture of advantame, which is 

what FDA was referring to in the 

language quoted by NRDC, the two 

sweeteners are chemically different and 

are metabolized differently in the 

human body. When aspartame is 

consumed, it is metabolized into its two 

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Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Rules and Regulations 77387 

constituent amino acids, phenylalanine 

and aspartic acid, and a small amount 

of methanol. By contrast, the primary 

metabolite of advantame is the deesterified form of advantame, namely N- 

[N-[3-(3-hydroxy-4- 

methoxyphenyl)propyl]-a-aspartyl]-Lphenylalanine. Because chemically 

these two sweeteners are different 

compounds, FDA’s safety decision on 

advantame was based solely on studies 

conducted on advantame. Therefore, we 

did not consider the health effects of 

aspartame in our safety decision on 

advantame. 

Regarding concerns about possible 

effects of advantame on the 

hypothalamus, the hypothalamus is 

involved with endocrine control via the 

pituitary gland. Therefore, any longlasting hypothalamic changes would 

affect the pituitary gland. For this 

reason, we recommend in our guidance 

‘‘Toxicological Principles for the Safety 

Assessment of Direct Food Additives 

and Color Additives Used in Food’’ that 

the pituitary gland from subchronic and 

long-term animal studies be assessed for 

treatment-related changes. Consistent 

with our guidance, the pituitary gland 

was one of the organs evaluated in the 

animal studies on advantame that were 

considered in the final rule, and there 

was no evidence of toxicologically 

significant changes. 

As previously noted, NRDC has 

requested that we withdraw our 

approval of advantame until we 

examine the brain tissues from the key 

advantame animal studies that were 

preserved for alteration of the 

hypothalamus and fully consider the 

implications on a child’s developing 

brain. NRDC has claimed that several 

studies on a different substance showed 

effects on the hypothalamus, but has not 

provided any information to support its 

view that additional histopathological 

examination of brain tissue samples is 

necessary to establish the safety of 

advantame. During our evaluation of the 

advantame petition, we thoroughly 

reviewed all of the data provided by the 

petitioner on the safety of advantame, 

including the results from a twogeneration study in rats, a chronic (52- 

week) dog study, a 104-week mouse 

carcinogenicity study, and a combined 

104-week rat carcinogenicity feeding 

study with in utero and chronic (52- 

week) phases, which included extensive 

histological evaluations of the brain, 

including the hypothalamus. In 

evaluating these studies, we applied the 

appropriate safety factors to extrapolate 

the findings from these animal studies 

to humans as required by section 

409(c)(5) of the FD&C Act. We also 

considered the potential intake of 

advantame at both the mean and 90th 

percentile of consumption for various 

age groups, including children. Based 

on this exposure and toxicological 

information, the estimated levels of 

daily intake for even high consumers of 

advantame were far below 

(approximately 200 times) the 

acceptable daily intake level, 

establishing that advantame is safe for 

the general population, including 

children. 

NRDC’s objection to the advantame 

final rule does not provide any new 

evidence or identify any evidence that 

we overlooked in our evaluation that 

would call into question FDA’s 

determination of safety for advantame. 

Moreover, NRDC has not provided a 

basis for concluding that the 

information we evaluated is inadequate 

to support a finding that the use of 

advantame as a non-nutritive sweetener 

in food is safe. Therefore, this objection 

does not provide a basis for us to 

reconsider our decision to issue the 

final rule on advantame. 

IV. Summary and Conclusion 

Section 409 of the FD&C Act requires 

that a food additive be shown to be safe 

before marketing. Under 21 CFR 

170.3(i), a food additive is ‘‘safe’’ if 

‘‘there is a reasonable certainty in the 

minds of competent scientists that the 

substance is not harmful under the 

intended conditions of use.’’ In our May 

21, 2014, final rule approving the use of 

advantame, we concluded that the data 

presented by the petitioner to establish 

safety of the additive demonstrate that 

advantame is safe for its intended use in 

food. 

The petitioner has the burden to 

demonstrate the safety of the additive to 

gain FDA approval. However, once we 

make a finding of safety, the burden 

shifts to an objector, who must come 

forward with evidence that calls into 

question our conclusion (see section 

409(f)(1) of the FD&C Act). After 

evaluating the objection from NRDC, we 

have concluded that the objection does 

not provide any basis for us to 

reconsider our decision to issue the 

final rule permitting the use of 

advantame as a non-nutritive sweetener 

and flavor enhancer in foods generally, 

except meat and poultry. Accordingly, 

we are not making any changes in 

response to the objection. 

Therefore, we have determined that 

the final rule should not be modified or 

revoked based on the objections. Thus, 

we are confirming May 21, 2014, as the 

effective date of the regulation. 

Dated: December 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30144 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 860 

[Docket No. FDA–2013–N–1529] 

Medical Device Classification 

Procedures; Reclassification Petition: 

Content and Form; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations for petitioning for device 

reclassification to update mailing 

addresses for the petitions. This action 

is being taken to improve the accuracy 

of the regulations. 

DATES: This rule is effective December 

24, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Pirt, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4438, Silver Spring, 

MD 20993–0002, 301–796–6254. 

SUPPLEMENTARY INFORMATION: FDA is 

updating mailing addresses for device 

reclassification petitions (21 CFR 

860.123). For devices regulated by the 

Center for Devices and Radiological 

Health, the room number is now 4438. 

In addition, the Center for Biologics 

Evaluation and Research has moved to 

a new location at FDA’s White Oak 

Campus. The address remains the same 

for the Center for Drug Evaluation and 

Research. The regulations are being 

amended to ensure clarity and to 

improve the accuracy and readability of 

the regulations. 

Publication of this document 

constitutes final action on these changes 

under the Administrative Procedure Act 

(5 U.S.C. 553). FDA has determined that 

notice and public comment and a 

delayed effective date are unnecessary 

because these corrections are 

nonsubstantive. 

List of Subjects in 21 CFR Part 860 

Administrative practice and 

procedure, Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

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