83 FR 47557 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 183 (September 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 183 (September 20, 2018)
| Page Range | 47557-47560 | |
| FR Document | 2018-20375 |
[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)] [Rules and Regulations] [Pages 47557-47560] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20375] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2017-F-3717] Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications. We are taking this action in response to a food additive petition filed by the Juice Products Association. DATES: This rule is effective September 20, 2018. Submit either electronic or written objections and requests for a hearing on the final rule by October 22, 2018. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of September 20, 2018. See the ADDRESSES section and the OBJECTIONS section IX of this document for further information on filing objections. ADDRESSES: You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before October 22, 2018. The https://www.regulations.gov electronic filing system will accept objections until midnight Eastern Time at the end of October 22, 2018. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic objections in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov. If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-F-3717 for ``Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D 3 Final Rule.'' Received objections, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.Confidential Submissions--To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1071. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 26, 2017 (82 FR 34615), amended August 22, 2017 (82 FR 39711), we announced that we filed a food additive petition (FAP 7A4818) submitted on behalf of the Juice Products Association by Hogan [[Page 47558]] Lovells US LLP, Columbia Square, 555 Thirteenth Street NW, Washington, DC 20004. The petition proposed to amend the food additive regulations in Sec. 172.380 (21 CFR 172.380), Vitamin D 3 , to replace the currently specified minimum RDI percentage values of calcium in calcium-fortified 100 percent fruit juices and fruit juice drinks with absolute values. Specifically, Sec. 172.380(c)(1) currently provides for the use of vitamin D3 at a level not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices that are fortified with greater than or equal to 33 percent of the RDI of calcium per 240 mL, excluding fruit juices that are specifically formulated or processed for infants. In addition, Sec. 172.380(c)(2) provides for the use of up to 100 IU of vitamin D3 per 240 mL in fruit juice drinks that are fortified with greater than or equal to 10 percent of the RDI of calcium per 240 mL, excluding fruit juice drinks that are specifically formulated or processed for infants. The petitioner proposed to replace the RDI percentage values of calcium in 100 percent fruit juices and fruit juice drinks in these regulations with the absolute values of added calcium of 330 milligrams (mg) and 100 mg per 240 mL, respectively. The petitioner also requested that we update the reference for specifications for vitamin D3 in Sec. 172.380(b) from the 9th edition of the Food Chemicals Codex (FCC 9) to the 10th edition (FCC 10). II. Evaluation of Petition Section 409(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(i)) states that we shall, by regulation, establish the procedure for amending or repealing a food additive regulation, and that this procedure shall conform to the procedure provided in section 409 of the FD&C Act. Our regulations specific to administrative actions for food additives provide that the Commissioner of Food and Drugs, on his own initiative or on the petition of any interested person, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive (Sec. 171.130(a) (21 CFR 171.130(a))). The regulations further provide that any such petition must include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data submitted as a food additive petition must be furnished in the form specified in 21 CFR 171.1 and 171.100 for submitting such petitions (Sec. 171.130(b)). In the Federal Register of February 27, 2003 (68 FR 9000), we issued the regulations at Sec. 172.380(c)(1) and (2) permitting the use of vitamin D3 in calcium fortified 100 percent fruit juices and fruit juice drinks. We took that action in response to a food additive petition (FAP 2A4734) from the Minute Maid Co. (Minute Maid). Minute Maid petitioned for vitamin D3 to be allowed to be added to calcium-fortified 100 percent fruit juices and fruit juice drinks so that the calcium and vitamin D levels are comparable to the levels in milk. When we issued these regulations in 2003, the RDI for calcium was 1,000 mg; however, in the Federal Register of May 27, 2016 (81 FR 33742), we issued a final rule which, among other things, redefined the RDI of calcium for adults and children 4 years of age and older to 1,300 mg (21 CFR 101.9(c)(8)(iv)). Because of the change in the RDI for calcium, the minimum level of added calcium in 100 percent fruit juice that may be fortified with vitamin D3 increased from 330 mg to 430 mg and in fruit juice drinks from 100 mg to 130 mg. The Juice Products Association stated that the proposed revision of Sec. 172.380 to specify absolute values of calcium on a mg/mL basis rather than a percentage of RDI is needed to maintain the relative parity between fortified 100 percent fruit juices and fruit juice drinks and many dairy products. Without this change, the petitioner stated that 100 percent fruit juices with vitamin D3 would have higher calcium levels than milk. The petitioner also stated that the higher levels of calcium resulting from the redefined RDI for calcium present formulation challenges and may adversely impact the taste of the juice or juice drink, which could deter consumers from selecting calcium and vitamin D fortified juices. Therefore, the petitioner proposed that Sec. 172.380 be amended to express the allowable added calcium levels on a mg basis consistent with the calcium levels before the revision of the RDI for calcium. In doing so, the allowable levels of calcium and vitamin D in 100 percent fruit juices and juice drinks would again be comparable to the levels in milk. Because the petitioner sought to revise the existing regulation to restore the amount of calcium fortification required to levels on par with milk, without introducing new uses for vitamin D3 or changing the levels of vitamin D3 and calcium that were considered when the regulations were established, there is no increase in dietary exposure to vitamin D3 or to calcium. Therefore, we have determined that there are no safety concerns as a result of the proposed amendment. Additionally, the current regulation for the use of vitamin D3 in food (Sec. 172.380) indicates that the additive must meet the specifications in the 9th edition of the Food Chemicals Codex (FCC 9). The petitioner requested that we update the specifications for vitamin D3 in Sec. 172.380 by replacing the existing FCC 9 reference with the 10th edition of the Food Chemicals Codex (FCC 10), the most recent edition at the time the petition was submitted. The specifications for vitamin D3 in FCC 10 are identical to those in FCC 9. However, since we received the petition, FCC has been updated to the 11th edition (FCC 11). The specifications for vitamin D3 in FCC 11 are identical to those in FCC 10. Therefore, we are amending Sec. 172.380 by adopting the specifications for vitamin D3 in FCC 11 in place of FCC 9, because FCC 11 is the most current version. III. Incorporation by Reference FDA is incorporating by reference the monograph from Food Chemicals Codex, 11th ed., 2018, pp. 1243-1244 (vitamin D3 ), which is approved by the Director of the Office of the Federal Register. You may purchase a copy of the material from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, http://www.usp.org/. Copies also may be examined at FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039. The FCC monograph establishes the standard for purity and identity for vitamin D3 . The monograph provides specifications and analytical methodologies used to identify the substance and establish acceptable purity criteria. To ensure that only food grade vitamin D3 is used in foods listed in Sec. 172.380, the additive must meet the specifications and identity in the FCC monograph. IV. Conclusion Based on data and information in the petition, we conclude that amending the food additive regulations in the regulation for vitamin D3 to replace the current RDI percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values is safe and appropriate. Thus, the RDI percentage values of calcium in 100 percent fruit juices and fruit juice drinks in these regulations are replaced with the absolute values of added calcium of [[Page 47559]] 330 mg and 100 mg per 240 mL, respectively. Consequently, we are amending the food additive regulations as set forth in this document. Additionally, the current regulation for the use of vitamin D3 in food (Sec. 172.380) indicates that the additive must meet the specifications in FCC 9. The more current version is FCC 11, which contains specifications for vitamin D3 that are identical to those in FCC 9. We are amending Sec. 172.380 by adopting the specifications for vitamin D3 in FCC 11 in place of FCC 9. V. Public Disclosure In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 171.1(h), we will delete from the documents any materials that are not available for public disclosure. VI. Analysis of Environmental Impact We previously considered the environmental effects of this rule, as stated in the July 26, 2017, Federal Register notice of filing (82 FR 34615). We stated in the notice of filing that we had determined, under 21 CFR 25.30(i), that this action ``is of a type that does not individually or cumulatively have a significant effect on the human environment because the amendments are administrative in nature'' such that neither an environmental assessment nor an environmental impact statement is required. Upon further consideration, we determined that FAP 7A4818 is not solely administrative in nature as this revision has the potential to lead to manufacturing changes. Consequently, the action being requested is neither a correction nor technical change and the original categorical exclusion (21 CFR 25.30(i)) is not appropriate. Therefore, we have determined under 21 CFR 25.32(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment because the added vitamin D3 and calcium will remain in the fruit juice and fruit juice drinks through ingestion by consumers and neither food additive is intended to replace macronutrients. Therefore, neither an environmental assessment nor an environmental impact statement is required. VII. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. VIII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act Our review of this petition was limited to section 409 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies. IX. Objections If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection. Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. List of Subjects in 21 CFR Part 172 Food additives, Incorporation by reference, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 172 is amended as follows: PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 0 1. The authority citation for part 172 continues to read as follows: Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e. 0 2. Amend Sec. 172.380 by revising paragraphs (b) and (c)(1) through (2) to read as follows: Sec. 172.380 Vitamin D3. * * * * * (b) Vitamin D3 meets the specifications of ``Vitamin D3 ,'', Food Chemicals Codex, 11th ed., copyright 2018, pp. 1243-1244, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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/ibr-locations.html. (c) * * * (1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under Sec. 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants. (2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under Sec. 170.3(n)(35) of this chapter) that [[Page 47560]] are fortified with greater than or equal to 100 mg of calcium per 240 mL, excluding fruit juice drinks that are specially formulated or processed for infants. * * * * * Dated: September 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20375 Filed 9-19-18; 8:45 am] BILLING CODE 4164-01-P
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■ 4. In appendix H to part 25, section objections will not be considered. and, except for those submitted as
H25.4, add new paragraph (a)(5) to read Electronic objections must be submitted ‘‘Confidential Submissions,’’ publicly
as follows: on or before October 22, 2018. The viewable at https://www.regulations.gov
https://www.regulations.gov electronic or at the Dockets Management Staff
Appendix H to Part 25—Instructions for
filing system will accept objections until between 9 a.m. and 4 p.m., Monday
Continued Airworthiness
midnight Eastern Time at the end of through Friday.
* * * * * October 22, 2018. Objections received • Confidential Submissions—To
H25.4 Airworthiness Limitations section. by mail/hand delivery/courier (for submit an objection with confidential
(a) * * * written/paper submissions) will be information that you do not wish to be
(5) Each mandatory replacement time, considered timely if they are made publicly available, submit your
inspection interval, and related inspection postmarked or the delivery service objections only as a written/paper
and test procedure, and each critical design acceptance receipt is on or before that submission. You should submit two
configuration control limitation for each date. copies total. One copy will include the
lightning protection feature approved under information you claim to be confidential
§ 25.954. Electronic Submissions
with a heading or cover note that states
* * * * * Submit electronic objections in the ‘‘THIS DOCUMENT CONTAINS
Issued under authority provided by 49
following way: CONFIDENTIAL INFORMATION.’’ We
U.S.C. 106(f), 44701(a), and 44703 in • Federal eRulemaking Portal: will review this copy, including the
Washington, DC, on September 6, 2018. https://www.regulations.gov. Follow the claimed confidential information, in our
Carl Burleson, instructions for submitting comments. consideration of comments. The second
Objections submitted electronically, copy, which will have the claimed
Acting Deputy Administrator.
including attachments, to https:// confidential information redacted/
[FR Doc. 2018–20174 Filed 9–19–18; 8:45 am]
www.regulations.gov will be posted to blacked out, will be available for public
BILLING CODE 4910–13–P
the docket unchanged. Because your viewing and posted on https://
objection will be made public, you are www.regulations.gov. Submit both
solely responsible for ensuring that your copies to the Dockets Management Staff.
DEPARTMENT OF HEALTH AND objection does not include any If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
21 CFR Part 172 confidential business information, such must identify this information as
[Docket No. FDA–2017–F–3717] as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Food Additives Permitted for Direct information, or other information that except in accordance with 21 CFR 10.20
Addition to Food for Human identifies you in the body of your and other applicable disclosure law. For
Consumption; Vitamin D3 objection, that information will be more information about FDA’s posting
AGENCY: Food and Drug Administration, posted on https://www.regulations.gov. of comments to public dockets, see 80
HHS. • If you want to submit an objection FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
ACTION: Final rule. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
SUMMARY: The Food and Drug public, submit the objection as a 23389.pdf.
Administration (FDA or we) is written/paper submission and in the Docket: For access to the docket to
amending the food additive regulation manner detailed (see ‘‘Written/Paper read background documents or the
for vitamin D3 to replace the current Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Reference Daily Intake (RDI) percentage Written/Paper Submissions received, go to https://
values of calcium in 100 percent fruit www.regulations.gov and insert the
Submit written/paper submissions as
juices and fruit juice drinks with docket number, found in brackets in the
follows:
absolute values and to update the heading of this document, into the
• Mail/Hand Delivery/Courier (for
reference for vitamin D3 specifications. ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets
We are taking this action in response to and/or go to the Dockets Management
Management Staff (HFA–305), Food and
a food additive petition filed by the Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers
Juice Products Association. Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
DATES: This rule is effective September • For written/paper objections FOR FURTHER INFORMATION CONTACT:
20, 2018. Submit either electronic or submitted to the Dockets Management Judith Kidwell, Center for Food Safety
written objections and requests for a Staff, FDA will post your objection, as and Applied Nutrition (HFS–265), Food
hearing on the final rule by October 22, well as any attachments, except for and Drug Administration, 5001 Campus
2018. The Director of the Federal information submitted, marked and Dr., College Park, MD 20740–3835, 240–
Register approves the incorporation by identified, as confidential, if submitted 402–1071.
reference of certain publications listed as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
in the rule as of September 20, 2018. See Instructions: All submissions received
the ADDRESSES section and the must include the Docket No. FDA– I. Background
tkelley on DSKBCP9HB2PROD with RULES2
OBJECTIONS section IX of this 2017–F–3717 for ‘‘Food Additives In the Federal Register of July 26,
document for further information on Permitted for Direct Addition to Food 2017 (82 FR 34615), amended August
filing objections. for Human Consumption; Vitamin D3 22, 2017 (82 FR 39711), we announced
ADDRESSES: You may submit objections Final Rule.’’ Received objections, those that we filed a food additive petition
and requests for a hearing as follows. filed in a timely manner (see (FAP 7A4818) submitted on behalf of
Please note that late, untimely filed ADDRESSES), will be placed in the docket the Juice Products Association by Hogan
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![47560 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Rules and Regulations
are fortified with greater than or equal I. Table of Abbreviations leaf bascule bridge that has a vertical
to 100 mg of calcium per 240 mL, CFR Code of Federal Regulations clearance of 21 feet at mean high water
excluding fruit juice drinks that are DHS Department of Homeland Security in the closed position. The Southern
specially formulated or processed for FR Federal Register Boulevard (SR 700/80) Bridge, mile
infants. OMB Office of Management and Budget 1024.7, across the AICW (Lake Worth
* * * * * NPRM Notice of proposed rulemaking Lagoon) at West Palm Beach, Florida is
(Advance, Supplemental) under construction, a temporary lift
Dated: September 13, 2018. § Section bridge is in place that has a vertical
Leslie Kux, U.S.C. United States Code
FL Florida
clearance of 14 feet at mean high water
Associate Commissioner for Policy.
FDOT Florida Department of in the closed position and a 65 foot
[FR Doc. 2018–20375 Filed 9–19–18; 8:45 am] vertical clearance in the open position.
Transportation
BILLING CODE 4164–01–P
AICW Atlantic Intracoastal Waterway The existing regulations are published
in 33 CFR 117.261(u), Flagler Memorial
II. Background Information and
Bridge, § 117.261(v) Royal Park Bridge,
DEPARTMENT OF HOMELAND Regulatory History
and § 117.261(w) Southern Boulevard
SECURITY On August 17, 2017, the Coast Guard Bridge.
published a notice of deviation from The bridge owner, Florida Department
Coast Guard drawbridge regulation with request for of Transportation, requested changes to
comments in the Federal Register (82 the drawbridge operating schedules to
33 CFR Part 117 FR 39019) to test proposed changes. better facilitate orderly vehicle traffic
[Docket No. USCG–2017–0273] Three comments were received. Due to flow across the Flagler Memorial, Royal
delays in processing this proposed Park and Southern Boulevard bridges
RIN 1625–AA09 regulatory change, on March 6, 2018, when the President of the United States,
the Coast Guard published a notice of members of the First Family, or other
Drawbridge Operation Regulation;
deviation from regulations with request persons under the protection of the
Atlantic Intracoastal Waterway, Palm
for comments extension in the Federal Secret Service visit Mar-a-Lago. The
Beach, FL
Register (82 FR 9431) to allow for increase in traffic congestion occurs
AGENCY: Coast Guard, DHS. additional time for the public to when the Presidential Security Zone (82
ACTION: Final rule. comment. One comment was received. FR 17295) is enforced which closes the
On May 21, 2018, the Coast Guard Southern Boulevard Bridge when the
SUMMARY: The Coast Guard is modifying published a notice of proposed
the operating schedule that governs the presidential motorcade is in transit.
rulemaking (NPRM) entitled Drawbridge This action requires through traffic to
operation of the Flagler Memorial (SR Operation Regulation; Atlantic
A1A) Bridge, mile 1021.8, the Royal use the Flagler Memorial and Royal Park
Intracoastal Waterway, Palm Beach, FL
Park (SR 704) Bridge, mile 1022.6, and Bridges.
in the Federal Register (83 FR 23398).
the Southern Boulevard (SR 700/80) No comments were received. Due to IV. Discussion of Comments, Changes
Bridge, mile 1024.7, across the Atlantic delays in processing this regulatory and the Final Rule
Intracoastal Waterway, at West Palm change, on June 25, 2018, the Coast
Beach, Florida. This modification As noted above, we received four
Guard published a notice of deviation
allows the Flagler Memorial, Royal Park from regulations with request for comments total on the two notices of
and Southern Boulevard Bridges to comments extension in the Federal deviation published on August 17, 2017
operate on alternative schedules when Register (83 FR 29438) to allow and March 6, 2018, respectively. Of the
the President of the United States, additional time for public comment and four comments received, one was a
members of the First Family, or other to evaluate the changes to the operating political statement with no relevance on
persons under the protection of the schedules with the establishment of the the proposed regulation. Three of the
Secret Service visit Mar-a-Lago. The Presidential Security Zone (82 FR four comments received were in favor of
modifications are necessary to 17295). No comments were received. the regulation. Two of the comments in
accommodate the increase in vehicular We are issuing rule under 5 U.S.C. favor of the regulation suggested the
traffic when the presidential motorcade 553(d)(3), the Coast Guard finds that changes be made permanent regardless
is in transit. good cause exists for making this rule of presidential visits. The Coast Guard
effective in less than 30 days after has considered this recommendation,
DATES: This rule is effective on
publication in the Federal Register. The however, making the modified operating
September 20, 2018.
notice of deviation published in the schedule permanent would place an
ADDRESSES: To view documents
Federal Register (83 FR 29438) expires unreasonable burden on navigation and
mentioned in this preamble as being potentially have a negative impact on
available in the docket, go to http:// on August 29, 2018 and this rule must
be in effect immediately thereafter. safe navigation. The modified schedule
www.regulations.gov. Type USCG– is only in effect when uninterrupted
2017–0273 in the ‘‘SEARCH’’ box and III. Legal Authority and Need for Rule transit of dignitaries are crossing the
click ‘‘SEARCH.’’ Click on Open Docket The Coast Guard is issuing this rule Southern Boulevard Bridge. While
Folder on the line associated with this under authority 33 U.S.C. 499. The vessels may have to wait up to an hour,
rulemaking. Flagler Memorial (SR A1A) Bridge, mile it is only during the weekdays and for
FOR FURTHER INFORMATION CONTACT: If 1021.8, across the AICW (Lake Worth a short period.
you have questions on this rule, call or Lagoon) at West Palm Beach, Florida is
tkelley on DSKBCP9HB2PROD with RULES2
email CWO4 Robert Wooten, Coast V. Regulatory Analyses
a double-leaf bascule bridge that has a
Guard Sector Miami, FL, Waterways vertical clearance of 22 feet at mean We developed this rule after
Management Division, telephone 305– high water in the closed position. The considering numerous statutes and
535–4311, email robert.a.wooten@ Royal Park (SR 704) Bridge, mile 1022.6, Executive Orders related to rulemaking.
uscg.mil. across the AICW (Lake Worth Lagoon) at Below we summarize our analyses
SUPPLEMENTARY INFORMATION: West Palm Beach, Florida is a double- based on a number of these statutes and
VerDate Sep<11>2014 16:15 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\20SER1.SGM 20SER1](https://thefederalregister.org/doc/83_FR_47740/page/4.svg)
Document Created: 2018-09-20 02:09:38
Document Modified: 2018-09-20 02:09:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective September 20, 2018. Submit either electronic or written objections and requests for a hearing on the final rule by October 22, 2018. The Director of the Federal Register approves the incorporation by reference of certain publications listed | |
| Contact | Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1071. | |
| FR Citation | 83 FR 47557 | |
| CFR Associated | Food Additives; Incorporation by Reference and Reporting and Recordkeeping Requirements |
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