Federal Register/Vol. 79, No. 247/Wednesday, December 24

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

(a) Effective Date seal, P/N 54L041, that was found to have a MA. For information on the availability of This AD is effective December 26, 2014. through-crack in the front forward fillet this material at the FAA, call 781–238–7125. radius, into any engine. (6) You may view this service information (b) Affected ADs at the National Archives and Records (g) Definitions This AD supersedes AD 2013–15–09, Administration (NARA). For information on Amendment 39–17525 (78 FR 49111, August For the purpose of this AD: the availability of this material at NARA, call 13, 2013). (1) Piece-part exposure is when the second- 202–741–6030, or go to: http:// stage HPT air seal is removed from the engine www.archives.gov/federal-register/cfr/ibr- (c) Applicability and fully disassembled. locations.html. This AD applies to all Pratt & Whitney (2) A through-crack is a crack that has propagated through the thickness of the part Issued in Burlington, Massachusetts, on Division (PW) PW4074, PW4074D, PW4077, December 22, 2014. PW4077D, PW4084D, PW4090, and PW4090– and can be seen on both the inner diameter 3 turbofan engine models with second-stage and outer diameter of the front forward fillet Colleen M. D’Alessandro, high-pressure turbine (HPT) air seal, part radius. Assistant Directorate Manager, Engine and number (P/N) 54L041, 50L960, or 50L976, Propeller Directorate, Aircraft Certification (h) Credit for Previous Actions installed. Service. (1) If you performed an ECI of the second- [FR Doc. 2014–30283 Filed 12–23–14; 8:45 am] (d) Unsafe Condition stage HPT air seal before the effective date of BILLING CODE 4910–13–P This AD was prompted by additional this AD, using PW ASB No. PW4G–112– reports of cracking in the second-stage HPT A72–330, Revision 1, dated February 14, air seal. We are issuing this AD to prevent 2013, or an earlier version, you have met the failure of the second-stage HPT air seal, requirements of paragraph (e)(2)(i) of this AD. DEPARTMENT OF HEALTH AND which could lead to uncontained engine (2) If you performed an in-shop FPI of the HUMAN SERVICES failure and damage to the airplane. second-stage HPT air seal before the effective date of this AD, you have met the Food and Drug Administration (e) Compliance requirements of paragraph (e)(2)(i) of this AD. Comply with this AD within the 21 CFR Part 172 compliance times specified, unless already (i) Alternative Methods of Compliance done. (AMOCs) [Docket No. FDA–2009–F–0303] (1) At the next piece-part exposure after the The Manager, Engine Certification Office, effective date of this AD, do the following: FAA, may approve AMOCs for this AD. Use Food Additives Permitted for Direct (i) Remove from service second-stage HPT the procedures found in 14 CFR 39.19 to Addition to Food for Human air seals, P/Ns 50L960, 50L976, and 54L041. make your request. You may email your Consumption; Advantame (ii) Perform a fluorescent-penetrant request to: [email protected]. inspection (FPI) of the second-stage HPT air AGENCY: Food and Drug Administration, seal, P/N 54L041, for a through-crack in the (j) Related Information HHS. front forward fillet radius. (1) For more information about this AD, ACTION: Final rule; response to (iii) If a through-crack in the front forward contact Jo-Ann Theriault, Aerospace objections. fillet radius is found, remove the first-stage Engineer, Engine Certification Office, FAA, HPT hub, second-stage HPT hub, and second- Engine & Propeller Directorate, 12 New SUMMARY: The Food and Drug stage HPT blade retaining plate from service. England Executive Park, Burlington, MA Administration (FDA or we) is Do not reinstall the first-stage HPT hub, 01803; phone: 781–238–7105; fax: 781–238– responding to objections we received on second-stage HPT hub, or second-stage HPT 7199; email: [email protected]. the final rule that amended the food blade retaining plate into any engine. (2) PW Service Bulletin (SB) No. PW4G– (2) For engines with second-stage HPT air 112–72–332, Revision 3, dated June 25, 2014, additive regulations to provide for the seals, P/N 54L041, installed, perform initial which is not incorporated by reference in this safe use of advantame as a non-nutritive and repetitive inspections for cracks on-wing AD, can be obtained from PW, using the sweetener and flavor enhancer in foods until the part is removed from the engine as contact information in paragraph (k)(3) of generally, except in meat and poultry. follows: this AD. This SB provides guidance on how After reviewing the objections to the (i) Perform an initial eddy current to replace the second-stage HPT air seal with final rule, we have concluded that they inspection (ECI) for cracks before reaching an air seal that is more resistant to low cycle do not provide a basis for modifying or 2,200 cycles since new, within 1,000 cycles- fatigue cracks. revoking the regulation. We are also in-service after September 17, 2013, or before (k) Material Incorporated by Reference confirming the effective date of May 21, further flight, whichever occurs later. (ii) Thereafter, repeat the ECI every 1,200 (1) The Director of the Federal Register 2014, for the final rule. cycles since last inspection, or fewer, approved the incorporation by reference DATES: The effective date of the final depending on the results of the inspection. (IBR) of the service information listed in this rule published on May 21, 2014 (79 FR (iii) Use section 4.0 of the appendix of PW paragraph under 5 U.S.C. 552(a) and 1 CFR 29078), is confirmed: May 21, 2014. Alert Service Bulletin (ASB) No. PW4G–112– part 51. FOR FURTHER INFORMATION CONTACT: A72–330, Revision 2, dated July 11, 2013, to (2) You must use this service information Felicia M. Ellison, Center for Food as applicable to do the actions required by perform the inspection and use paragraph 8 Safety and Applied Nutrition (HFS– of the Accomplishment Instructions of PW this AD, unless the AD specifies otherwise. ASB No. PW4G–112–A72–330, Revision 2, (3) The following service information was 265), Food and Drug Administration, dated July 11, 2013, to disposition the results approved for IBR on September 17, 2013 (78 5100 Paint Branch Pkwy., College Park, of the inspection. FR 49111, August 13, 2013). MD 20740–3835, 240–402–1264. (i) Pratt & Whitney (PW) Alert Service SUPPLEMENTARY INFORMATION: (f) Installation Prohibition Bulletin No. PW4G–112–A72–330, Revision (1) After the effective date of this AD, do 2, dated July 11, 2013. I. Background not install any second-stage HPT air seal, P/ (ii) Reserved. In the Federal Register of July 21, N 54L041, P/N 50L960, or P/N 50L976, into (4) For PW service information identified 2009 (74 FR 35871), we announced that any engine. in this AD, contact Pratt & Whitney Division, (2) After the effective date of this AD, do 400 Main St., East Hartford, CT 06108; a food additive petition (FAP 9A4778), not install any spare first-stage HPT hub, phone: 860–565–8770; fax: 860–565–4503. had been filed by Ajinomoto Co., Inc., second-stage HPT hub, or second-stage HPT (5) You may view this service information c/o Ajinomoto Corporate Services LLC, blade retaining plate that was previously at FAA, Engine & Propeller Directorate, 12 1120 Connecticut Ave. NW., suite 1010, mated in service to a second-stage HPT air New England Executive Park, Burlington, Washington, DC 20036. The petition

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proposed to amend the food additive objection on which a hearing is section 409(c)(5). Specifically, NRDC regulations in part 172, Food Additives requested; failure to request a hearing states that advantame and the sweetener Permitted for Direct Addition to Food on an objection constitutes a waiver of aspartame are structurally related and for Human Consumption (21 CFR part the right to a hearing on that objection; that FDA has stated that ‘‘advantame 172), to provide for the safe use of and (5) must include a detailed actually contains a small amount of advantame as a non-nutritive sweetener description and analysis of the factual aspartame.’’ NRDC asserts that when we in tabletop applications and powdered information to be presented in support were considering potential effects of beverage mixes. Subsequently, in a of the objection if a hearing is requested; advantame, we considered the health letter dated August 24, 2012, the failure to include a description and effects of aspartame but did not consider petitioner informed us that FAP 9A4778 analysis for an objection constitutes a the potential impacts of advantame on had been transferred from Ajinomoto waiver of the right to a hearing on that the hypothalamus despite having Corporate Services LLC to Ajinomoto objection. evidence that aspartame significantly North America, Inc., One Parker Plaza, Following publication of the final rule altered that part of the brain. In support 400 Kelby St., Fort Lee, NJ 07024. permitting the use of advantame as a of their claim, NRDC cites five animal In an amended document published non-nutritive sweetener and flavor studies that they state are in FDA’s in the Federal Register of October 26, enhancer in foods generally, except possession and indicate aspartame 2012 (77 FR 65340), we announced that meat and poultry, we received 12 affects the hypothalamus. NRDC Ajinomoto Co., Inc., c/o Ajinomoto submissions with objections to the rule requests that since the brain tissues North America, Inc., One Parker Plaza, within the 30-day objection period. The from the key advantame animal studies 400 Kelby St., Fort Lee, NJ 07024, had majority of these submissions were were preserved, FDA should withdraw amended its food additive petition to letters expressing concern regarding one its approval of advantame until those provide for the safe use of advantame as or more of the following issues: (1) tissues are examined for alteration of the a non-nutritive sweetener and flavor Labeling of products containing hypothalamus and the implications on a enhancer in foods generally, except in advantame, and (2) advantame being child’s developing brain are fully meat and poultry. mistaken for aspartame. A few of the considered. In addition, NRDC claims In response to FAP 9A4778, we issued letters also expressed general opposition that we did not comply with Executive a final rule in the Federal Register on to the final rule, or objected to the rule Order 13045 regarding protection of May 21, 2014 (79 FR 29078), permitting based on adverse effects believed to children from environmental health the safe use of advantame as a non- have been caused by aspartame, and not risks and safety risks by not assessing nutritive sweetener and flavor in foods advantame. None of these letters the safety of advantame on a child’s generally, except in meat and poultry. requested a hearing, nor provided brain development. This regulation is codified at § 172.803. evidence in support of any of these The issue of whether aspartame poses We based our decision on data objections that could be considered a risk of hypothalamic adverse effects, contained in the petition and in our factual information (§ 12.22(a)(5)). including endocrine dysfunction, was files. In the preamble to the final rule Therefore, these objections do not thoroughly addressed in the (79 FR 29078 at 29079–29084), we justify the modification or revocation of Commissioner’s final decision on outlined the basis for our decision and the regulation. We will not discuss these aspartame published in the Federal stated that objections to the final rule submissions further. Register on July 24, 1981 (46 FR 38285). and requests for a hearing were due There was one submission that raised In that decision, the Commissioner within 30 days of the publication date a specific objection. The letter was from affirmed the safety of aspartame as a (i.e., by June 20, 2014). the Natural Resources Defense Council nutritive sweetener and concluded that (NRDC) (letter to Docket No. FDA– II. Objections and Requests for a there is a reasonable certainty that 2009–F–0303, June 20, 2014). The letter human consumption of aspartame at Hearing from NRDC did not request a hearing on projected consumption levels will not Section 409(f)(1) of the Federal Food, their objection. Therefore, NRDC has pose a risk to the brain, including Drug, and Cosmetic Act (the FD&C Act) waived its right to a hearing on their endocrine function. We are not aware of (21 U.S.C. 348(f)(1)) provides that, objection (see § 12.22(a)(4)). The only any new relevant evidence to the within 30 days after publication of an remaining question under § 12.24(a) is contrary. NRDC has not provided any order relating to a food additive whether NRDC’s objection, and the evidence that the effects on the regulation, any person adversely information submitted in support of the hypothalamus in the aspartame studies affected by such order may file objection, establish that the regulation they cited are toxicologically significant objections, ‘‘specifying with authorizing the use of advantame at the expected levels of intake of particularity the provisions of the order should be modified or revoked. As aspartame and, further, they have not deemed objectionable, stating discussed in detail in section III, we provided evidence of the relevancy of reasonable grounds therefor, and have concluded that NRDC has not this information to the safety of requesting a public hearing upon such established a basis for modification or advantame. objections.’’ revocation of the regulation authorizing We disagree with NRDC’s Under 21 CFR 171.110, objections and the use of advantame. characterization of the relationship requests for a hearing are governed by between advantame and aspartame. part 12 (21 CFR part 12) of FDA’s III. Analysis of Objection While advantame is structurally related regulations. Under § 12.22(a), each The objection raised by NRDC asserts to aspartame, and aspartame is used as objection must meet the following that FDA did not comply with section one of the starting chemicals in the conditions: (1) Must be submitted on or 409 of the FD&C Act in our evaluation manufacture of advantame, which is before the 30th day after the date of of the advantame petition because, they what FDA was referring to in the publication of the final rule; (2) must be claim, we did not conduct a fair language quoted by NRDC, the two separately numbered; (3) must specify evaluation of the data before the Agency sweeteners are chemically different and with particularity the provision of the as required by section 409(c)(3) of the are metabolized differently in the regulation or proposed order objected FD&C Act and did not consider the human body. When aspartame is to; (4) must specifically state each relevant safety factors as required by consumed, it is metabolized into its two

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constituent amino acids, phenylalanine advantame at both the mean and 90th Dated: December 18, 2014. and aspartic acid, and a small amount percentile of consumption for various Leslie Kux, of methanol. By contrast, the primary age groups, including children. Based Associate Commissioner for Policy. metabolite of advantame is the de- on this exposure and toxicological [FR Doc. 2014–30144 Filed 12–23–14; 8:45 am] esterified form of advantame, namely N- information, the estimated levels of BILLING CODE 4164–01–P [N-[3-(3-hydroxy-4- daily intake for even high consumers of methoxyphenyl)propyl]-a-aspartyl]-L- advantame were far below phenylalanine. Because chemically (approximately 200 times) the DEPARTMENT OF HEALTH AND these two sweeteners are different acceptable daily intake level, HUMAN SERVICES compounds, FDA’s safety decision on establishing that advantame is safe for advantame was based solely on studies the general population, including Food and Drug Administration conducted on advantame. Therefore, we children. did not consider the health effects of 21 CFR Part 860 NRDC’s objection to the advantame aspartame in our safety decision on [Docket No. FDA–2013–N–1529] advantame. final rule does not provide any new Regarding concerns about possible evidence or identify any evidence that Medical Device Classification effects of advantame on the we overlooked in our evaluation that Procedures; Reclassification Petition: hypothalamus, the hypothalamus is would call into question FDA’s Content and Form; Technical involved with endocrine control via the determination of safety for advantame. Amendment pituitary gland. Therefore, any long- Moreover, NRDC has not provided a lasting hypothalamic changes would basis for concluding that the AGENCY: Food and Drug Administration, affect the pituitary gland. For this information we evaluated is inadequate HHS. reason, we recommend in our guidance to support a finding that the use of ACTION: Final rule; technical ‘‘Toxicological Principles for the Safety advantame as a non-nutritive sweetener amendments. Assessment of Direct Food Additives in food is safe. Therefore, this objection SUMMARY: The Food and Drug and Color Additives Used in Food’’ that does not provide a basis for us to the pituitary gland from subchronic and Administration (FDA) is amending its reconsider our decision to issue the regulations for petitioning for device long-term animal studies be assessed for final rule on advantame. treatment-related changes. Consistent reclassification to update mailing with our guidance, the pituitary gland IV. Summary and Conclusion addresses for the petitions. This action was one of the organs evaluated in the is being taken to improve the accuracy Section 409 of the FD&C Act requires animal studies on advantame that were of the regulations. that a food additive be shown to be safe considered in the final rule, and there DATES: This rule is effective December was no evidence of toxicologically before marketing. Under 21 CFR 24, 2014. significant changes. 170.3(i), a food additive is ‘‘safe’’ if FOR FURTHER INFORMATION CONTACT: As previously noted, NRDC has ‘‘there is a reasonable certainty in the Nancy Pirt, Center for Devices and requested that we withdraw our minds of competent scientists that the Radiological Health, Food and Drug approval of advantame until we substance is not harmful under the Administration, 10903 New Hampshire examine the brain tissues from the key intended conditions of use.’’ In our May Ave., Bldg. 66, Rm. 4438, Silver Spring, advantame animal studies that were 21, 2014, final rule approving the use of MD 20993–0002, 301–796–6254. preserved for alteration of the advantame, we concluded that the data SUPPLEMENTARY INFORMATION: FDA is hypothalamus and fully consider the presented by the petitioner to establish updating mailing addresses for device implications on a child’s developing safety of the additive demonstrate that reclassification petitions (21 CFR brain. NRDC has claimed that several advantame is safe for its intended use in 860.123). For devices regulated by the studies on a different substance showed food. Center for Devices and Radiological effects on the hypothalamus, but has not The petitioner has the burden to Health, the room number is now 4438. provided any information to support its demonstrate the safety of the additive to In addition, the Center for Biologics view that additional histopathological gain FDA approval. However, once we Evaluation and Research has moved to examination of brain tissue samples is make a finding of safety, the burden a new location at FDA’s White Oak necessary to establish the safety of shifts to an objector, who must come Campus. The address remains the same advantame. During our evaluation of the forward with evidence that calls into for the Center for Drug Evaluation and advantame petition, we thoroughly question our conclusion (see section Research. The regulations are being reviewed all of the data provided by the 409(f)(1) of the FD&C Act). After amended to ensure clarity and to petitioner on the safety of advantame, evaluating the objection from NRDC, we improve the accuracy and readability of including the results from a two- have concluded that the objection does the regulations. Publication of this document generation study in rats, a chronic (52- not provide any basis for us to week) dog study, a 104-week mouse constitutes final action on these changes reconsider our decision to issue the carcinogenicity study, and a combined under the Administrative Procedure Act final rule permitting the use of 104-week rat carcinogenicity feeding (5 U.S.C. 553). FDA has determined that advantame as a non-nutritive sweetener study with in utero and chronic (52- notice and public comment and a and flavor enhancer in foods generally, week) phases, which included extensive delayed effective date are unnecessary except meat and poultry. Accordingly, histological evaluations of the brain, because these corrections are we are not making any changes in including the hypothalamus. In nonsubstantive. evaluating these studies, we applied the response to the objection. List of Subjects in 21 CFR Part 860 appropriate safety factors to extrapolate Therefore, we have determined that the findings from these animal studies the final rule should not be modified or Administrative practice and to humans as required by section revoked based on the objections. Thus, procedure, Medical devices. 409(c)(5) of the FD&C Act. We also we are confirming May 21, 2014, as the Therefore, under the Federal Food, considered the potential intake of effective date of the regulation. Drug, and Cosmetic Act and under

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