Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Rules and Regulations 86239 

Opelousas, LA, KOPL, Takeoff Minimums 

and Obstacle DP, Amdt 1A 

Leonardtown, MD, 2W6, RNAV (GPS) RWY 

11, Amdt 3 

Leonardtown, MD, 2W6, Takeoff Minimums 

and Obstacle DP, Amdt 1 

Bellaire, MI, ACB, RNAV (GPS) RWY 2, 

Amdt 1 

Boyne City, MI, N98, RNAV (GPS) RWY 9, 

Orig-C 

Charlevoix, MI, CVX, RNAV (GPS) RWY 27, 

Orig-D 

Gaylord, MI, GLR, RNAV (GPS) RWY 9, 

Amdt 1 

Gaylord, MI, GLR, RNAV (GPS) RWY 27, 

Amdt 1 

Gaylord, MI, KGLR, Takeoff Minimums and 

Obstacle DP, Orig-A 

Ontonagon, MI, OGM, RNAV (GPS) RWY 35, 

Orig-A 

Blue Earth, MN, SBU, RNAV (GPS) RWY 34, 

Orig-A 

Hattiesburg-Laurel, MS, PIB, VOR–A, Orig-B, 

CANCELED 

Laurel, MS, LUL, VOR–A, Amdt 6, 

CANCELED 

Kinston, NC, ISO, RNAV (GPS) RWY 5, Amdt 

3C 

Falls City, NE, FNB, RNAV (GPS) RWY 33, 

Amdt 2A 

Dansville, NY, DSV, RNAV (GPS)-A, Orig-B 

Sand Springs, OK, OWP, RNAV (GPS) RWY 

17, Amdt 1 

Sand Springs, OK, OWP, RNAV (GPS) RWY 

35, Amdt 1 

Watonga, OK, KJWG, Takeoff Minimums and 

Obstacle DP, Amdt 1A 

Bradford, PA, KBFD, Takeoff Minimums and 

Obstacle DP, Orig-A 

Lancaster, PA, KLNS, Takeoff Minimums and 

Obstacle DP, Amdt 2 

Savannah, TN, KSNH, Takeoff Minimums 

and Obstacle DP, Amdt 3A 

Sevierville, TN, GKT, Takeoff Minimums and 

Obstacle DP, Amdt 4B 

Dallas, TX, DAL, ILS OR LOC RWY 13L, ILS 

RWY 13L (SA CAT I), ILS RWY 13L (SA 

CAT II), Amdt 34A 

Dallas, TX, DAL, ILS OR LOC RWY 13R, 

Amdt 6C 

Madisonville, TX, 51R, RNAV (GPS) RWY 1, 

Amdt 1 

Madisonville, TX, 51R, RNAV (GPS) RWY 

19, Amdt 1 

Madisonville, TX, 51R, Takeoff Minimums 

and Obstacle DP, Amdt 1 

Madisonville, TX, 51R, VOR RWY 19, Amdt 

3 

Manti, UT, 41U, RNAV (GPS) RWY 3, OrigC 

Quinton, VA, W96, RNAV (GPS) RWY 11, 

Amdt 3 

Quinton, VA, W96, RNAV (GPS) RWY 29, 

Amdt 3 

Saluda, VA, W75, RNAV (GPS) RWY 1, Amdt 

1 

Saluda, VA, W75, Takeoff Minimums and 

Obstacle DP, Amdt 3 

Port Angeles, WA, KCLM, WATTR NINE, 

Graphic DP 

Boscobel, WI, OVS, RNAV (GPS) RWY 7, 

Orig-C 

Boscobel, WI, OVS, RNAV (GPS) RWY 25, 

Amdt 2A 

Eau Claire, WI, EAU, Takeoff Minimums and 

Obstacle DP, Amdt 2B 

Racine, WI, RAC, Takeoff Minimums and 

Obstacle DP, Amdt 5B 

Pineville, WV, I16, RNAV (GPS) RWY 26, 

Orig-E 

[FR Doc. 2024–25210 Filed 10–29–24; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 175, 176, 177, and 178 

[Docket No. FDA–2018–F–3757] 

Indirect Food Additives: Adhesives 

and Components of Coatings; Paper 

and Paperboard Components; 

Polymers; Adjuvants, Production Aids, 

and Sanitizers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; response to 

objection; confirmation of effective date. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

responding to the objection that we 

received from the Environmental 

Defense Fund, Breast Cancer Prevention 

Partners, Environmental Protection 

Network, Environmental Working 

Group, and Healthy Babies Bright 

Futures on the final rule that amended 

the food additive regulations to no 

longer provide for the use of 25 

plasticizers that the petition identified 

as ortho-phthalates because these food 

additive uses have been permanently 

abandoned. After reviewing the 

objection, FDA has concluded that the 

objection does not provide a basis for 

modifying FDA’s final rule amending 

the food additive regulations. 

DATES: The effective date of May 20, 

2022, for the final rule published on 

May 20, 2022 (87 FR 31080), is 

confirmed. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this final rule into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Stephen DiFranco, Office of Food 

Chemical Safety, Dietary Supplements, 

and Innovation (HFS–275), Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740–3835, 240– 

402–2710; or Lauren Kleinman, Human 

Foods Program, Office of Policy, 

Regulations and Information (HFS–024), 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

14, 2018 (83 FR 56750), we announced 

that we filed a food additive petition 

(FAP 8B4820) (Petition) submitted by 

The Flexible Vinyl Alliance (FVA or 

Petitioner), c/o Keller and Heckman, 

LLP, 1001 G St. NW, Suite 500 West, 

Washington, DC 20001. The Petition 

requested that we amend our food 

additive regulations in parts 175, 176, 

177, and 178 (21 CFR parts 175, 176, 

177, and 178) to no longer provide for 

the use of 26 plasticizer substances that 

the Petition identified as orthophthalates. (FAP 8B4820 submitted by 

FVA claimed that the food additive uses 

of di(2-ethylhexyl) hexahydrophthalate 

and diphenylguanidine phthalate are 

abandoned. We note that these 

substances are not chemically classified 

as ortho-phthalates and that 

characterization as such is incorrect.) 

The Petition requested that we revoke 

the approvals on the basis that the food 

additive uses have been permanently 

abandoned. 

One of the 26 plasticizers identified in 

the Petition was diallyl phthalate 

(Chemical Abstract Services number 

(CAS Reg No.) 131–17–9). The filing 

document indicated that this substance 

may be used as a food additive under 

§§ 175.105, 176.180, 176.300, and 

177.1210 (21 CFR 175.105, 176.180, 

176.300, and 177.1210) (see 83 FR 

56750). However, upon further review, 

we determined that the use of diallyl 

phthalate is only authorized for use in 

these regulations as a monomer to 

produce polymers and not as a 

plasticizer. FVA made no claims in their 

Petition that the use of polymers 

produced with diallyl phthalate for food 

contact applications have been 

abandoned. Thus, after FDA followed 

up with the Petitioner, diallyl phthalate 

was no longer subject to this Petition (87 

FR 31080). In the Federal Register of 

May 20, 2022 (87 FR 31080), FDA 

issued a final rule amending the food 

additive regulations in parts 175, 176, 

177, and 178 to no longer provide for 

the use of 25 plasticizers in various food 

contact applications (final rule). We 

gave interested persons until June 21, 

2022, to file objections and requests for 

a hearing on the final rule. 

II. Objection and Comments 

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

Drug, and Cosmetic Act (FD&C Act) (21 


ddrumheller on DSK120RN23PROD with RULES1
86240 Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Rules and Regulations 

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 relating to food 

additive regulations are governed by 21 

CFR part 12. Under § 12.22(a) (21 CFR 

12.22(a)), each objection must: (1) be 

submitted on or before the 30th day 

after the date of publication of the final 

rule; (2) be separately numbered; (3) 

specify with particularity the provision 

of the regulation or proposed order 

objected to; (4) 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) 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 the publication of the final 

rule in which we granted the Petition 

asserting abandonment of the 25 

plasticizers in various food contact uses, 

we received a submission from the 

Environmental Defense Fund, Breast 

Cancer Prevention Partners, 

Environmental Protection Network, 

Environmental Working Group, and 

Healthy Babies Bright Futures 

(Objectors) containing one objection and 

two comments (see submission from 

Tom Neltner, Senior Director for Safer 

Chemicals, Environmental Defense 

Fund, et al., submitted to the Dockets 

Management Staff, Food and Drug 

Administration, dated June 19, 2022 

(Submission) (Ref. 1). The Submission 

does not contain a request for a hearing. 

III. Analysis of Objections and 

Comments 

The Submission contains one 

numbered objection and two numbered 

comments. We address each objection 

and comment below. 

A. Objection 1 

The Submission states that ‘‘The 

agency [improperly] denied FVA’s 

request to remove approval of diallyl 

phthalate because it was used as a 

monomer to produce polymers and not 

as a plasticizer’’ (Ref. 1 at page 1). The 

Submission states that the FVA survey 

that FVA submitted to provide evidence 

of abandonment asked survey recipients 

about food contact applications for the 

listed substances, not about use of the 

listed substances as plasticizers. 

According to this objection, FVA 

‘‘clearly considered diallyl phthalate as 

abandoned,’’ and therefore FDA should 

have removed diallyl phthalate from its 

food additive regulations on the basis 

that its use has been abandoned. The 

Submission also states the Objectors are 

not requesting a hearing on this 

Objection. Therefore, the Objectors have 

waived any right to a hearing on their 

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

remaining question under § 12.24(a) is 

whether the Objection establishes that 

the final rule should be modified or 

revoked with respect to diallyl 

phthalate. As described below, we 

conclude that the Objectors have not 

established a basis for modifying or 

revoking the final rule. 

As FDA stated in the Federal Register 

document announcing the final rule, 

after following up with the Petitioner, 

diallyl phthalate was no longer subject 

to the Petition. In an email 

correspondence dated July 20, 2018, 

between FDA and FVA’s agent, FVA 

confirmed that diallyl phthalate is not 

within the scope of the abandonment 

request (see also 87 FR 31080 at 31080 

through 31081; Ref. 2). Thus, diallyl 

phthalate was removed from the 

Petition. Because diallyl phthalate was 

removed from the scope of the Petition, 

when FDA issued the final rule granting 

the Petition, the final rule did not cover 

diallyl phthalate. Thus, the final rule 

did not impact the regulatory 

authorizations for diallyl phthalate. 

Accordingly, FDA’s actions regarding 

diallyl phthalate were reasonable, and 

there is no need for FDA to modify or 

revoke the final rule in response to 

Objection 1. 

B. Comment 1 

The Submission asserts that FDA 

should remove the existing prior 

sanctioned uses of diethyl phthalate 

(CAS Reg. No. 84–66–2), diisooctyl 

phthalate (CAS Reg. No. 27554–26–3), 

ethylphthalyl ethyl glycolate (CAS Reg 

No. 84–72–0), and butylphthalyl butyl 

glycolate (CAS Reg. No. 85–70–1) as a 

plasticizer at § 181.27 (Ref. 1 at page 3). 

The Submission states that the survey 

that FVA used to support the request to 

remove food additive approvals for 

these substances did not differentiate 

between food additive and priorsanctioned uses of these substances, and 

so therefore the prior-sanctioned uses 

should also be considered abandoned. 

The comment states that based on this 

evidence, FDA should have either 

removed the prior-sanction approvals as 

part of the final rule ‘‘or initiated 

rulemaking to do so.’’ 

Prior-sanctioned uses are beyond the 

scope of food additive petitions, which 

apply only to substances that meet the 

definition of ‘‘food additive’’ in section 

201(s) of the FD&C Act (21 U.S.C. 

321(s)). Consequently, prior-sanctioned 

uses are not the subject of the final rule 

(87 FR 31080 at 31081). Furthermore, 

section 409(f)(1) of the FD&C Act 

permits objections and requests for a 

hearing only to orders made under 

section 409(c) and (d) of the FD&C Act. 

Because FDA has not issued any orders 

under section 409(c) or (d) of the FD&C 

Act taking action on the specified priorsanctioned-uses, the Submission’s 

request regarding prior-sanctioned uses 

is not an objection to an order under 

section 409(c)(1)(B) of the FD&C Act and 

is not subject to the objections and 

hearing procedure in section 409(f) of 

the FD&C Act. Therefore, we will not 

address requests related to priorsanctioned uses as part of this 

objections procedure under section 

409(f) of the FD&C Act. The appropriate 

procedure for requesting rulemaking 

with respect to prior-sanctioned uses is 

to submit a citizen petition in 

accordance with 21 CFR 10.30. 

C. Comment 2 

The Submission states that ‘‘we do 

not object’’ to the FVA abandonment 

claim, but states that some of the 

abandoned substances ‘‘may be present 

in food, food packaging and food 

handling equipment.’’ According to the 

Submission, there is a need for FDA to 

‘‘clearly communicate to food 

manufacturers and food packaging and 

handling equipment manufacturers that 

they are not permitted to use [the 

abandoned substances] in food uses that 

may migrate into food without a specific 

food additive use approval or a specific 

authorization[.]’’ 

With respect to the suggestion that 

FDA needs to further communicate 

about the final rule, we disagree. We 

have already adequately communicated 

the nature and the scope of this action, 

in accordance with our standard 

procedures when granting a food 

additive petition. Specifically, we 

published the final rule in the Federal 

Register, which is the standard way for 

Agencies to communicate with 

regulated parties about substantive 

matters. We also posted a constituent 

update on FDA’s website on the date the 

final rule went on display, informing 

industry and the public of the changes 

to the food additive regulations that 

resulted from the May 20, 2022, final 

rule and the circumstances around the 

action (Ref. 3). The constituent update 


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Federal Register / Vol. 89, No. 210 / Wednesday, October 30, 2024 / Rules and Regulations 86241 

remains available on FDA’s website. 

Furthermore, in the Federal Register of 

May 20, 2022 (87 FR 31090), we issued 

a notice requesting information on the 

use of some ortho-phthalates still 

authorized for food contact uses. The 

notice also discusses FAP 8B4820 and 

provides a citation to the final rule (see 

87 FR 31090 at 31091). 

IV. Summary and Conclusions 

After evaluating the Submission, for 

the reasons above, we conclude that the 

objection does not provide any basis for 

us to modify our regulations. 

V. References 

The following references are on 

display at the Dockets Management Staff 

(see ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they are also available 

electronically at https://

www.regulations.gov. Although FDA 

verified the website addresses in this 

document, please note that websites are 

subject to change over time. 

1. Neltner, T., Environmental Defense Fund 

et. al., to the Dockets Management Staff, 

Food and Drug Administration, dated 

June 19, 2022. 

2. Email from D.W. Hill, Keller and Heckman 

LLP to S. DiFranco, DPR, OFAS, CFSAN, 

FDA July 20, 2018. 

3. ‘‘Phthalates in Food Packaging and Food 

Contact Applications.’’ Available at: 

https://www.fda.gov/food/foodingredients-packaging/phthalates-foodpackaging-and-food-contactapplications. 

Dated: October 22, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25122 Filed 10–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2024–0392] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Dutch Kills, Queens County, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary interim rule and 

request for comments. 

SUMMARY: The Coast Guard is 

temporarily modifying the operating 

schedule that governs the Hunters Point 

Ave Bridge across Dutch Kills, mile 1.4, 

at Queens County, NY. NYCDOT 

installed a temporary work platform at 

Hunters Point Ave Bridge on May 6, 

2024 to perform blasting and painting 

operations. The work platform prevents 

the bridge from opening to marine 

traffic. Until the bridge operations are 

complete the bridge must remain in the 

closed position. 

DATES: This temporary interim rule is 

effective October 30, 2024 through 12:01 

a.m. on July 1, 2025. Comments and 

related material must reach the Coast 

Guard on or before November 29, 2024. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov. Type the docket 

number (USCG–2024–0392) in the 

‘‘SEARCH’’ box and click ‘‘SEARCH’’. In 

the Document Type column, select 

‘‘Supporting & Related Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

interim rule, call or email, Stephanie E. 

Lopez, Coast Guard; telephone 212– 

514–4335, email Stephanie.E.Lopez@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

Pub. L. Public Law 

§ Section 

U.S.C. United States Code 

NYCDOT New York City Department of 

Transportation 

TIR Temporary Interim Rule 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary interim rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b), the Coast Guard finds that good 

cause exists for not publishing a notice 

of proposed rulemaking (NPRM) with 

respect to this rule because it is 

impracticable. This bridge has a work 

platform installed which keeps the 

bridge in the closed to navigation 

position. 

On May 6, 2024, the Coast Guard 

issued a general deviation which 

allowed the bridge owner, NYCDOT, to 

deviate from the current operating 

schedule in 33 CFR 117.801(d) to 

conduct bridge blasting and painting 

operations. Due to additional work that 

has been discovered, the bridge owner 

has requested an extension of closure 

that will take the project past the 

allowable 180 days for a deviation. 

Since the bridge cannot be brought back 

to operating condition until the 

completion of the mechanical 

rehabilitation there is insufficient time 

to provide a reasonable comment period 

and then consider those comments 

before issuing the modification. 

However, we will be soliciting 

comments on this rulemaking during 

the first 30 days while this rule is in 

effect. If the Coast Guard determines 

that changes to the temporary interim 

rule are necessary, we will publish a 

temporary final rule or other 

appropriate document. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making it effective in less than 30 days 

after publication in the Federal 

Register. For reasons presented above, 

delaying the effective date of this rule 

would be impracticable and contrary to 

the public interest because the bridge is 

currently incapable of normal 

operations and will not be back into full 

operation until the rehabilitation work 

can be completed. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 33 U.S.C. 499. 

Hunters Point Ave Bridge across Dutch 

Kills is a bascule bridge with a vertical 

clearance of 5.3 feet mean high water in 

the closed position and unlimited 

vertical clearance in the open position. 

The existing drawbridge regulation, 

33 CFR 117.801(d), states that the draw 

of the Hunters Point Ave Bridge, mile 

1.4, shall open on signal if at least twohour advance notice is given. NYCDOT, 

the bridge owner, has requested to keep 

the bridge in the closed position during 

the remainder of the work. 

IV. Discussion of the Rule 

The Coast Guard is issuing this rule 

to allow the bridge owner of the Hunters 

Point Ave Bridge across Dutch Kills, 

mile 1.4, Queens, New York, to keep the 

bridge in the closed to navigation 

position until July 1, 2025. The rule is 

necessary to accommodate the 

completion of the blasting and painting 

operations. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive Orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive Orders. 


ddrumheller on DSK120RN23PROD with RULES1