31080 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 

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. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the food additive regulations 

to no longer provide for the use of 25 

plasticizers in various food contact 

applications because these uses have 

been abandoned. We are taking this 

action in response to a food additive 

petition submitted by the Flexible Vinyl 

Alliance (FVA or petitioner). 

DATES: This rule is effective May 20, 

2022. See section VIII for further 

information on the filing of objections. 

Submit either electronic or written 

objections and requests for a hearing on 

the final rule by June 21, 2022. 

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 June 21, 2022. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

June 21, 2022. 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– 

2018–F–3757 for ‘‘Indirect Food 

Additives: Adhesives and Components 

of Coatings; Paper and Paperboard 

Components; Polymers; Adjuvants, 

Production Aids, and Sanitizers.’’ 

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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Stephen DiFranco, Office of Food 

Additive Safety (HFS–255), Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740– 

3835, 240–402–2710; or Alexandra 

Jurewitz, Office of Regulations and 

Policy (HFS–024), Center for Food 

Safety and Applied Nutrition, 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), submitted by FVA, c/o 

Keller and Heckman LLP, 1001 G Street 

NW, Suite 500 West, Washington, DC 

20001. The petition proposed 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 

plasticizers that the petition identifies 

as ortho-phthalates because these food 

additive uses have been permanently 

abandoned. In some cases, these 

substances were approved for food 

additive uses more than four decades 

ago. 

One of the 26 plasticizers identified in 

the petition was diallyl phthalate 

(Chemical Abstract Services number 

(CAS No.) 131–17–9). The filing notice 

indicated that this substance may be 

used as a food additive under 

§§ 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 makes no 


khammond on DSKJM1Z7X2PROD with RULES2
Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 31081 

claims in their petition that the use of 

polymers produced with diallyl 

phthalate for food contact applications 

have been abandoned. Thus, after 

following up with the petitioner, diallyl 

phthalate is no longer subject to this 

petition, and diallyl phthalate will not 

be discussed further. In sum, there are 

25 remaining substances that are the 

subject of this petition; their 

corresponding CAS numbers (when 

available) are listed in table 1. 

TABLE 1—ORTHO-PHTHALATES AFFECTED BY THIS FINAL RULE

Food additive CAS No. 

Dimethyl phthalate (dimethyl orthophthalate) .................................................................................................................................. 131–11–3 

Diphenyl phthalate ........................................................................................................................................................................... 84–62–8 

Methyl phthalyl ethyl glycolate (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ........................................ 85–71–2 

Diethyl phthalate .............................................................................................................................................................................. 84–66–2 

Diphenylguanidine phthalate 1 ......................................................................................................................................................... 17573–13–6 

Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) .................................................................................................. 84–72–0 

Diisobutyl phthalate ......................................................................................................................................................................... 84–69–5 

Butyl benzyl phthalate 2 ................................................................................................................................................................... 85–68–7 

Di-n-butyl phthalate 3 ....................................................................................................................................................................... 84–74–2 

Butyl phthalyl butyl glycolate 4 (Butyl carbobutoxymethyl phthalate) .............................................................................................. 85–70–1 

Dihexyl phthalate (Di-n-hexyl phthalate) ......................................................................................................................................... 84–75–3 

Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate) ............................................................................................................. 117–83–9 

Dimethylcyclohexyl phthalate .......................................................................................................................................................... 1322–94–7 

Diisooctyl phthalate .......................................................................................................................................................................... 27554–26–3 

Dioctyl phthalate (Di-n-octyl phthalate) ........................................................................................................................................... 117–84–0 

Butyloctyl phthalate (n-butyl n-octyl phthalate) ............................................................................................................................... 84–78–6 

Di(2-ethylhexyl) hexahydrophthalate 1 ............................................................................................................................................. 84–71–9 

Amyl decyl phthalate (n-amyl n-decyl phthalate) ............................................................................................................................ 7493–81–4 

Butyl decyl phthalate 5 (n-butyl n-decyl phthalate) .......................................................................................................................... 89–19–0 

Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) ........................................................................................... 119–07–3 

Didecyl phthalate (Di-n-decyl phthalate) ......................................................................................................................................... 84–77–5 

Dodecyl phthalate ............................................................................................................................................................................ 21577–80–0 

Dihydroabietyl phthalate .................................................................................................................................................................. 26760–71–4 

Castor oil phthalate, hydrogenated ................................................................................................................................................. N/A 

Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol 6 ..................................................................................... 68650–73–7 

1We note that while these substances are not chemically classified as ortho-phthalates, they are included in FAP 8B4820. The FAP describes 

all of the substances as ortho-phthalates, although for these substances that characterization is incorrect. 2The petitioner refers to this substance as butyl benzyl phthalate; it is listed in §§ 176.170 and 178.3740 as butylbenzyl phthalate. These terms 

are synonymous, referring to the same chemical substance. 3The petitioner refers to this substance as di-n-butyl phthalate; it is listed in §§ 175.105, 175.300, 175.380, 176.170, 176.180, 176.300, 

177.2420, and 177.2600 as dibutyl phthalate and in § 177.1200 as dibutylphthalate. These terms are synonymous, referring to the same chemical substance. 4Substance is listed as butyl phthalate butyl glycolate in § 175.105. We believe this is a typographical error, and it should be listed as butyl 

phthalyl butyl glycolate. 5The petitioner refers to this substance as butyl decyl phthalate; it is listed in § 175.105 as butyldecyl phthalate. These terms are synonymous, 

referring to the same chemical substance. 6The petitioner refers to this substance as castor oil phthalate with adipic acid and fumaric acid-diethylene glycol; it is listed in § 177.1200 as 

castor oil phthalate with adipic acid and fumaric acid-diethylene glycol polyester. These terms are synonymous, referring to the same chemical 

substance. 

None Available. 

The petitioner asserts that the 

currently authorized uses of the 

plasticizers identified in tables 2 

through 19 have been abandoned. In 

addition to the uses of the 25 

plasticizers that are approved for food 

additive uses as described in tables 2 

through 19, certain plasticizers that are 

the subject of the petition are also 

authorized for prior sanctioned uses. 

Any such prior sanctioned use is 

beyond the scope of a food additive 

petition, which applies only to 

substances that meet the definition of 

‘‘food additive.’’ Accordingly, this final 

rule has no impact on any prior 

sanctioned uses. 

TABLE 2—ORTHO-PHTHALATES AUTHORIZED BY § 175.105 AFFECTED BY THIS FINAL RULE

[Adhesives] 

Food additive CAS No. 

Dimethyl phthalate (dimethyl orthophthalate) .................................................................................................................................. 131–11–3 

Diphenyl phthalate ........................................................................................................................................................................... 84–62–8 

Methyl phthalyl ethyl glycolate (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ........................................ 85–71–2 

Diethyl phthalate .............................................................................................................................................................................. 84–66–2 

Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) .................................................................................................. 84–72–0 

Diisobutyl phthalate ......................................................................................................................................................................... 84–69–5 

Butyl benzyl phthalate ..................................................................................................................................................................... 85–68–7 

Di-n-butyl phthalate 1 ....................................................................................................................................................................... 84–74–2 

Butyl phthalyl butyl glycolate 2 (Butyl carbobutoxymethyl phthalate) .............................................................................................. 85–70–1 

Dihexyl phthalate (Di-n-hexyl phthalate) ......................................................................................................................................... 84–75–3 

Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate) ............................................................................................................. 117–83–9 

Diisooctyl phthalate .......................................................................................................................................................................... 27554–26–3 


khammond on DSKJM1Z7X2PROD with RULES2
31082 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 

TABLE 2—ORTHO-PHTHALATES AUTHORIZED BY § 175.105 AFFECTED BY THIS FINAL RULE—Continued 

[Adhesives] 

Food additive CAS No. 

Dioctyl phthalate (Di-n-octyl phthalate) ........................................................................................................................................... 117–84–0 

Butyloctyl phthalate (n-butyl n-octyl phthalate) ............................................................................................................................... 84–78–6 

Di(2-ethylhexyl) hexahydrophthalate ............................................................................................................................................... 84–71–9 

Butyl decyl phthalate 3 (n-butyl n-decyl phthalate) .......................................................................................................................... 89–19–0 

Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) ........................................................................................... 119–07–3 

Dihydroabietyl phthalate .................................................................................................................................................................. 26760–71–4 

1The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 175.105 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 2The petitioner refers to this substance as butyl phthalyl butyl glycolate; it is listed in § 175.105 as butyl phthalate butyl glycolate. We believe 

this is a typographical error, and it should be listed as butyl phthalyl butyl glycolate. These terms are synonymous, referring to the same chemical substance. 3The petitioner refers to this substance as butyl decyl phthalate; it is listed in § 175.105 as butyldecyl phthalate. These terms are synonymous, 

referring to the same chemical substance. 

TABLE 3—ORTHO-PHTHALATES AUTHORIZED BY § 175.300 AFFECTED BY THIS FINAL RULE

[Resinous and polymeric coatings] 

Food additive CAS No. 

Diethyl phthalate .............................................................................................................................................................................. 84–66–2 

Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) .................................................................................................. 84–72–0 

Di-n-butyl phthalate 1 ....................................................................................................................................................................... 84–74–2 

Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) ................................................................................................ 85–70–1 

Diisooctyl phthalate .......................................................................................................................................................................... 27554–26–3 

1The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 175.300 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 4—ORTHO-PHTHALATES AUTHORIZED BY § 175.320 AFFECTED BY THIS FINAL RULE

[Resinous and polymeric coatings for polyolefin films]. 

Food additive CAS No. 

Diethyl phthalate .............................................................................................................................................................................. 84–66–2 

Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) .................................................................................................. 84–72–0 

Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) ................................................................................................ 85–70–1 

TABLE 5—ORTHO-PHTHALATES AUTHORIZED BY § 175.380 AFFECTED BY THIS FINAL RULE

[Xylene-formaldehyde resins condensed with 4,4′-isopropylidenediphenol-epichlorohydrin epoxy resins] 

Food additive CAS No. 

Diethyl phthalate 1 ............................................................................................................................................................................ 84–66–2 

Ethyl phthalyl ethyl glycolate 1 (Ethyl carbethoxymethyl phthalate) ................................................................................................ 84–72–0 

Di-n-butyl phthalate 1 2 ..................................................................................................................................................................... 84–74–2 

Butyl phthalyl butyl glycolate 1 (Butyl carbobutoxymethyl phthalate) .............................................................................................. 85–70–1 

Diisooctyl phthalate 1 ....................................................................................................................................................................... 27554–26–3 

1By cross-referencing § 175.300, § 175.380 authorizes use of this plasticizer. 

2The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 175.300 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 6—ORTHO-PHTHALATES AUTHORIZED BY § 175.390 AFFECTED BY THIS FINAL RULE

[Zinc-silicon dioxide matrix coatings] 

Food additive CAS No. 

Diethyl phthalate 1 ............................................................................................................................................................................ 84–66–2 

Ethyl phthalyl ethyl glycolate 1 (Ethyl carbethoxymethyl phthalate) ................................................................................................ 84–72–0 

Di-n-butyl phthalate 1 2 ..................................................................................................................................................................... 84–74–2 

Butyl phthalyl butyl glycolate 1 (Butyl carbobutoxymethyl phthalate) .............................................................................................. 85–70–1 

Diisooctyl phthalate 1 ....................................................................................................................................................................... 27554–26–3 

1By cross-referencing § 175.300, § 175.390 authorizes use of this plasticizer. 

2The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 175.300 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 


khammond on DSKJM1Z7X2PROD with RULES2
Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 31083 

TABLE 7—ORTHO-PHTHALATES AUTHORIZED BY § 176.170 AFFECTED BY THIS FINAL RULE

[Components of paper and paperboard in contact with aqueous and fatty foods] 

Food additive CAS No. 

Butyl benzyl phthalate 1 ................................................................................................................................................................... 85–68–7 

Di-n-butyl phthalate 2 ....................................................................................................................................................................... 84–74–2 

1The petitioner refers to this substance as butyl benzyl phthalate; it is listed in § 176.170 as butylbenzyl phthalate. These terms are synonymous, referring to the same chemical substance. 2The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 176.170 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 8—ORTHO-PHTHALATES AUTHORIZED BY § 176.180 AFFECTED BY THIS FINAL RULE

[Components of paper and paperboard in contact with dry food] 

Food additive CAS No. 

Butyl benzyl phthalate 1 ................................................................................................................................................................... 85–68–7 

Di-n-butyl phthalate 1 2 ..................................................................................................................................................................... 84–74–2 

Didecyl phthalate 1 (Di-n-decyl phthalate) ....................................................................................................................................... 84–77–5 

Dodecyl phthalate 1 .......................................................................................................................................................................... 21577–80–0 

1By cross-referencing § 176.170, § 176.180 authorizes use of this plasticizer. 

2The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 176.170 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 9—ORTHO-PHTHALATES AUTHORIZED BY § 176.300 AFFECTED BY THIS FINAL RULE

[Slimicides] 

Food additive CAS No. 

Butyl benzyl phthalate 1 ................................................................................................................................................................... 85–68–7 

Di-n-butyl phthalate 2 ....................................................................................................................................................................... 84–74–2 

Didecyl phthalate (Di-n-decyl phthalate) ......................................................................................................................................... 84–77–5 

Dodecyl phthalate ............................................................................................................................................................................ 21577–80–0 

1By cross-referencing §§ 176.170 and 176.180, § 176.300 authorizes use of this plasticizer. 

2The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 176.300 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 10—ORTHO-PHTHALATES AUTHORIZED BY § 177.1010 AFFECTED BY THIS FINAL RULE

[Acrylic and modified acrylic plastics, semirigid and rigid] 

Food additive CAS No. 

Dimethyl phthalate (dimethyl orthophthalate) .................................................................................................................................. 131–11–3 

TABLE 11—ORTHO-PHTHALATES AUTHORIZED BY § 177.1200 AFFECTED BY THIS FINAL RULE

[Cellophane] 

Food additive CAS No. 

Diisobutyl phthalate ......................................................................................................................................................................... 84–69–5 

Di-n-butyl phthalate 1 ....................................................................................................................................................................... 84–74–2 

Dimethylcyclohexyl phthalate .......................................................................................................................................................... 1322–94–7 

Castor oil phthalate, hydrogenated ................................................................................................................................................. N/A 

Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol 2 ..................................................................................... 68650–73–7 

1The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 177.1200 as dibutylphthalate. These terms are synonymous, referring to the same chemical substance. 2The petitioner refers to this substance as castor oil phthalate with adipic acid and fumaric acid-diethylene glycol; it is listed in § 177.1200 as 

castor oil phthalate with adipic acid and fumaric acid-diethylene glycol polyester. These terms are synonymous, referring to the same chemical 

substance. 

TABLE 12—ORTHO-PHTHALATES AUTHORIZED BY § 177.1210 AFFECTED BY THIS FINAL RULE

[Closures with sealing gaskets for food containers] 

Food additive CAS No. 

Diethyl phthalate1 2 .......................................................................................................................................................................... 84–66–2 

Ethyl phthalyl ethyl glycolate 1 (Ethyl carbethoxymethyl phthalate) ................................................................................................ 84–72–0 

Di-n-butyl phthalate 135 .............................................................................................................................................................. 84–74–2 

Butyl phthalyl butyl glycolate1 (Butyl carbobutoxymethyl phthalate) ............................................................................................... 85–70–1 


khammond on DSKJM1Z7X2PROD with RULES2
31084 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 

TABLE 12—ORTHO-PHTHALATES AUTHORIZED BY § 177.1210 AFFECTED BY THIS FINAL RULE—Continued 

[Closures with sealing gaskets for food containers] 

Food additive CAS No. 

Diisooctyl phthalate 1 ....................................................................................................................................................................... 27554–26–3 

Dimethyl phthalate1 4 (dimethyl orthophthalate) .............................................................................................................................. 131–11–3 

Diphenyl phthalate 1 2 ....................................................................................................................................................................... 84–62–8 

Methyl phthalyl ethyl glycolate 1 (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ..................................... 85–71–2 

Diphenylguanidine phthalate 4 ......................................................................................................................................................... 17573–13–6 

Diisobutyl phthalate 1 4 ..................................................................................................................................................................... 84–69–5 

Butyl benzyl phthalate 1 4 ............................................................................................................................................................ 85–68–7 

Dihexyl phthalate (Di-n-hexyl phthalate) 1 2 ..................................................................................................................................... 84–75–3 

Di(butoxyethyl) phthalate 1 (Bis(2-n-butoxyethyl) phthalate) ........................................................................................................... 117–83–9 

Dimethylcyclohexyl phthalate 4 ........................................................................................................................................................ 1322–94–7 

Dioctyl phthalate 1 4 (Di-n-octyl phthalate) ....................................................................................................................................... 117–84–0 

Butyloctyl phthalate 1 (n-butyl n-octyl phthalate) ............................................................................................................................. 84–78–6 

Di(2-ethylhexyl) hexahydrophthalate 1 ............................................................................................................................................. 84–71–9 

Amyl decyl phthalate 4 (n-amyl n-decyl phthalate) .......................................................................................................................... 7493–81–4 

Butyl decyl phthalate 1 (n-butyl n-decyl phthalate) .......................................................................................................................... 89–19–0 

Decyl octyl phthalate 1 4 (Octyldecyl phthalate/n-octyl n-decyl phthalate) ...................................................................................... 119–07–3 

Didecyl phthalate3 4 (Di-n-decyl phthalate) ...................................................................................................................................... 84–77–5 

Dodecyl phthalate 3 .......................................................................................................................................................................... 21577–80–0 

Dihydroabietyl phthalate 1 ................................................................................................................................................................ 26760–71–4 

Castor oil phthalate, hydrogenated 4 ............................................................................................................................................... N/A 

Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol 4 6 ................................................................................... 68650–73–7 

1By cross-referencing part 175, § 177.1210 authorizes use of this plasticizer. 

2By cross-referencing part 178, § 177.1210 authorizes use of this plasticizer. 

3By cross-referencing part 176, § 177.1210 authorizes use of this plasticizer 

4By cross-referencing part 177, § 177.1210 authorizes use of this plasticizer. 

5The petitioner refers to this substance as di-n-butyl phthalate; it is listed in §§ 175.105, 175.300, 175.380, 176.170, 176.180, 176.300, 

177.2420, and 177.2600 as dibutyl phthalate and in § 177.1200 as dibutylphthalate. These terms are synonymous, referring to the same chemical substance. 6The petitioner refers to this substance as castor oil phthalate with adipic acid and fumaric acid-diethylene glycol; it is listed in § 177.1200 as 

castor oil phthalate with adipic acid and fumaric acid-diethylene glycol polyester. These terms are synonymous, referring to the same chemical 

substance. 

TABLE 13—ORTHO-PHTHALATES AUTHORIZED BY § 177.1400 AFFECTED BY THIS FINAL RULE

[Hydroxyethyl cellulose film, water-insoluble] 

Food additive CAS No. 

Diisobutyl phthalate 1 ....................................................................................................................................................................... 84–69–5 

Di-n-butyl phthalate 1 2 ..................................................................................................................................................................... 84–74–2 

Dimethylcyclohexyl phthalate 1 ........................................................................................................................................................ 1322–94–7 

Castor oil phthalate, hydrogenated 1 ............................................................................................................................................... N/A 

Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol 1 3 ................................................................................... 68650–73–7 

1By cross-referencing § 177.1200, § 177.1400 authorizes use of this plasticizer. 

2The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 177.1200 as dibutylphthalate. These terms are synonymous, referring to the same chemical substance. 3The petitioner refers to this substance as castor oil phthalate with adipic acid and fumaric acid-diethylene glycol; it is listed in § 177.1200 as 

castor oil phthalate with adipic acid and fumaric acid-diethylene glycol polyester. These terms are synonymous, referring to the same chemical 

substance. 

TABLE 14—ORTHO-PHTHALATES AUTHORIZED BY § 177.1460 AFFECTED BY THIS FINAL RULE

[Melamine-formaldehyde resins in molded articles] 

Food additive CAS No. 

Dioctyl phthalate (Di-n-octyl phthalate) ........................................................................................................................................... 117–84–0 

TABLE 15—ORTHO-PHTHALATES AUTHORIZED BY § 177.1590 AFFECTED BY THIS FINAL RULE

[Polyester elastomers] 

Food additive CAS No. 

Dimethyl phthalate (dimethyl orthophthalate) .......................................................................................................................................... 131–11–3 


khammond on DSKJM1Z7X2PROD with RULES2
Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 31085 

TABLE 16—ORTHO-PHTHALATES AUTHORIZED BY § 177.2420 AFFECTED BY THIS FINAL RULE

[Polyester resins, cross-linked] 

Food additive CAS No. 

Dimethyl phthalate (dimethyl orthophthalate) .................................................................................................................................. 131–11–3 

Butyl benzyl phthalate ..................................................................................................................................................................... 85–68–7 

Di-n-butyl phthalate 1 ....................................................................................................................................................................... 84–74–2 

1The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 177.2420 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 17—ORTHO-PHTHALATES AUTHORIZED BY § 177.2600 AFFECTED BY THIS FINAL RULE

[Rubber articles intended for repeated use] 

Food additive CAS No. 

Diphenylguanidine phthalate ........................................................................................................................................................... 17573–13–6 

Di-n-butyl phthalate 1 ....................................................................................................................................................................... 84–74–2 

Dioctyl phthalate (Di-n-octyl phthalate) ........................................................................................................................................... 117–84–0 

Amyl decyl phthalate (n-amyl n-decyl phthalate) ............................................................................................................................ 7493–81–4 

Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) ........................................................................................... 119–07–3 

Didecyl phthalate (Di-n-decyl phthalate) ......................................................................................................................................... 84–77–5 

1The petitioner refers to this substance as di-n-butyl phthalate; it is listed in § 177.2600 as dibutyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 18—ORTHO-PHTHALATES AUTHORIZED BY § 178.3740 AFFECTED BY THIS FINAL RULE

[Plasticizers in Polymeric Substances] 

Food additive CAS No. 

Diphenyl phthalate ........................................................................................................................................................................... 84–62–8 

Butyl benzyl phthalate 1 ................................................................................................................................................................... 85–68–7 

Dihexyl phthalate (Di-n-hexyl phthalate) ......................................................................................................................................... 84–75–3 

1The petitioner refers to this substance as Butyl benzyl phthalate; it is listed in § 178.3740 as butylbenzyl phthalate. These terms are synonymous, referring to the same chemical substance. 

TABLE 19—ORTHO-PHTHALATES AUTHORIZED BY § 178.3910 AFFECTED BY THIS FINAL RULE

[Surface lubricants used in the manufacture of metallic articles] 

Food additive CAS No. 

Diethyl phthalate .............................................................................................................................................................................. 84–66–2 

II. Evaluation of Abandonment 

Section 409(i) of the Federal Food, 

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

U.S.C. 348(i)) states that we must, by 

regulation, establish the procedure for 

amending or repealing a food additive 

regulation and that this procedure must 

conform to the procedure provided in 

section 409 of the FD&C Act for the 

promulgation of such regulations. Our 

regulations pertaining 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, under 21 CFR 

part 10, may propose the issuance of a 

regulation amending or repealing a 

regulation pertaining to a food additive 

or granting or repealing an exception for 

such additive (§ 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 

(§ 171.130(b)). New data must be 

furnished in the form specified in 

§§ 171.1 and 171.100 (21 CFR 171.1 and 

171.100) for submitting petitions 

(§ 171.130(b)). Under these regulations, 

a petitioner may propose that we amend 

a food additive regulation if the 

petitioner can demonstrate that there are 

‘‘old uses abandoned’’ for the relevant 

food additive (§ 171.130(b)). Such 

abandonment must be complete and 

permanent for any intended uses in the 

United States market. While section 409 

of the FD&C Act and § 171.130 also 

provide for amending or revoking a food 

additive regulation based on safety, an 

amendment or revocation based on 

abandonment is not based on safety but 

is based on the fact that regulatory 

authorization is no longer necessary 

because the use of that food additive has 

been completely and permanently 

abandoned. 

Abandonment may be limited to 

certain authorized food additive uses for 

a substance (e.g., if a substance is no 

longer used in certain product 

categories), or abandonment may apply 

to all authorized food additive uses of 

a substance (e.g., if a substance is no 

longer being manufactured). If a petition 

seeks an amendment to a food additive 

regulation based on the abandonment of 

certain uses of the food additive, such 

uses should be adequately defined so 

that both the scope of the abandonment 

and any amendment to the food additive 

regulation are clear. 

The petition states that FVA is a 

coalition that represents the plasticizer 

and vinyl products industry. Their 


khammond on DSKJM1Z7X2PROD with RULES2
31086 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 

1The Grocery Manufacture’s Association (GMA) 

became the Consumer Brands Association (CBA) in 

January 2020. 

membership consists of 11 plasticizer 

suppliers, 5 compounders, 5 non-profit 

industry groups, 4 manufacturers, 2 

resin suppliers, 1 converter, and 11 

other firms (Ref. 1). 

As support for the claim that the 

plasticizers in table 1 are no longer 

manufactured, imported, or otherwise 

marketed for the identified food contact 

applications in the United States market 

and that the described uses are 

abandoned, the petition includes the 

results of a survey conducted on behalf 

of FVA. According to the petition, the 

survey was distributed to FVA’s 

membership as well as other industry 

stakeholders. More specifically, FVA 

asked the survey recipients to sign 

letters that verify that they do not: 

1. Currently manufacture the orthophthalates listed in table 1 for use in 

food contact applications in the United 

States; 

2. Currently import the orthophthalates listed in table 1 for use in 

food contact applications in the United 

States; 

3. Intend to manufacture or import the 

ortho-phthalates listed in table 1 for use 

in food contact applications in the 

United States in the future; 

4. Currently maintain any inventory 

of the ortho-phthalates listed in table 1 

for sale or distribution into commerce 

that is intended to be marketed for use 

in food contact applications in the 

United States; and 

5. Possess any knowledge that the 

ortho-phthalates listed in table 1 are 

used in food contact applications in the 

United States. 

There are 18 signed letters that are 

attached to the petition. These signed 

letters, some of which are directly from 

manufacturers of ortho-phthalates, 

assert that the survey recipients do not 

engage in any of the activities outlined 

in the five questions in the survey 

letters. The petition states that the 

survey letters collected include the 

substantial majority of phthalate and 

polyvinyl chloride manufacturers, as 

well as downstream compounders and 

users of these materials. 

FVA also sought confirmation from 

the Plastics Industry Association’s (PIA) 

Food, Drug and Cosmetic Packaging 

Materials Committee (FDCPMC) that no 

member company has any knowledge of 

the manufacturing or marketing of the 

plasticizers in table 1 for food contact 

applications. The FDCPMC is composed 

of PIA members with what the petition 

describes as particular interest and 

expertise in packaging for food, drugs, 

cosmetics, and related products. 

According to the petition, PIA’s 

members represent entities in each 

sequence of the plastics industry supply 

chain, including processors, machinery 

and equipment manufacturers, and raw 

material suppliers. 

The petition states that FVA also 

verified with other key industry 

stakeholders that they do not have any 

knowledge of the manufacturing or 

marketing of the substances in table 1 

for food contact applications. These 

stakeholders included members of the 

Adhesives and Sealants Council, whose 

membership includes entities involved 

in the supply, manufacture, and 

distribution of adhesives and sealants in 

North America; the American Beverage 

Association, which represents beverage 

producers, distributors, franchise 

companies and support industries; the 

American Forest and Paper Association, 

which the petition describes as having 

member companies that produce more 

than 75 percent of the pulp, paper, 

paper-based packaging, and wood 

building materials in the United States; 

the Grocery Manufacturers Association,1

which the petition describes as 

representing more than 250 food, 

beverage, and consumer product 

companies globally; and the High 

Phthalates Panel of the American 

Chemistry Council (ACC). Specifically, 

the petition states that no member 

companies of these organizations have 

any knowledge of industry reliance on 

the subject food additive approvals. In 

followup correspondence with FDA, 

FVA stated these trade associations 

either contacted their entire 

memberships or the relevant portions of 

their memberships that would have 

knowledge regarding the use of orthophthalates (Ref. 2). 

Furthermore, FDA identified the 

major manufacturers of ortho-phthalates 

in the United States (Ref. 3) and notes 

that these manufacturers are listed as 

member companies of the ACC (Ref. 4). 

FDA considers the totality of the parties 

surveyed to be representative of the 

entire supply-chain of food contact 

substances and end-use products which 

may rely on the authorizations in parts 

175, 176, 177, and 178 for the use of 

plasticizers identified in tables 2 

through 19. 

In addition, when we publish a notice 

of filing of a food additive petition, 

stakeholders have an opportunity to 

provide information regarding whether 

any of the subject food additives are still 

being used. We received no comments 

that provided evidence of current use. 

In light of the evidence submitted in 

the petition, as well as the absence of 

any evidence demonstrating lack of 

abandonment, we are granting the 

petition. We conclude that the 

plasticizers in table 1 have been 

completely and permanently abandoned 

with respect to the food additive uses 

listed in tables 2 through 19. 

Accordingly, FDA is removing the 

authorizations for the food additive use 

of these substances in parts 175, 176, 

177, and 178, as described in tables 2 

through 19. 

III. Comments on the Filing Notice 

We provided 60 days for comment on 

the filing notice. We received less than 

10 comments. No comments provided 

evidence that any of the 25 plasticizers 

that are the subject, and within the 

scope, of FVA’s petition are currently 

being used in food contact applications. 

Most comments were general in nature 

and supported granting the petition. 

These comments expressed support for 

removing listings for substances that are 

no longer in use from the food additive 

regulations. 

We summarize and respond to the 

comments in the following paragraphs. 

For ease of reading, we preface each 

comment discussion with a numbered 

‘‘Comment,’’ and the word ‘‘Response’’ 

appears before FDA’s response. The 

number assigned is for organizational 

purposes only and does not signify any 

individual comment’s value, 

importance, or order in which it was 

received. 

(Comment 1) One comment expressed 

concern regarding the safety of diethyl 

phthalate. 

(Response 1) Diethyl phthalate (CAS 

No. 84–66–2) is included in table 1 as 

a substance that has been abandoned as 

a food additive in food contact uses. As 

stated in the filing notice (83 FR 56750 

at 56758), information on safety is not 

relevant to abandonment. To the extent 

that the comment suggests that FDA 

must make a safety determination as 

part of the review process for this 

abandonment petition, we disagree. 

Each year, we respond to hundreds of 

submissions under the various petition 

and notification programs we 

administer. Therefore, if use of a food 

additive is no longer authorized in 

response to an abandonment petition, 

we may determine that it is neither 

necessary nor an efficient use of our 

limited resources to address safety 

arguments related to an abandoned use. 

(Comment 2) One comment 

encouraged FDA to abide by statutory 

timelines and suggested that we 

improperly delayed posting the filing 

notice in the Federal Register. 

(Response 2) We acknowledge that 

there was a delay in the publication of 

the filing notice. We filed FVA’s 


khammond on DSKJM1Z7X2PROD with RULES2
Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 31087 

petition on July 3, 2018, and published 

the filing notice in the Federal Register 

on November 14, 2018. However, this 

delay did not affect the length of the 60- 

day comment period for the petition or 

the outcome of FDA’s review of the 

petition. 

(Comment 3) One comment sought 

clarity as to whether certain orthophthalates that were not the subject of 

this petition remain authorized for food 

contact use. 

(Response 3) This final rule impacts 

only the specific ortho-phthalates that 

are the subject of the petition, for the 

uses identified in the petition. We 

acknowledge that some ortho-phthalates 

continue to be permitted for use in food 

contact applications, either as prior 

sanctioned ingredients or through food 

additive regulations. 

(Comment 4) One comment stated 

that FDA did not explain how the 

petition affects installed food handling 

equipment containing ‘‘abandoned’’ 

ortho-phthalates. The comment 

expressed concern that the survey 

questions offered in support of the 

abandonment claim do not clearly 

capture the use of these substances in 

repeat use food contact substances such 

as conveyors, tubing, and other 

equipment currently installed in food 

manufacturing facilities. The comment 

asserted that for these uses to be 

abandoned, industry must not only 

cease to manufacture or sell items 

containing these plasticizers, but any 

remaining equipment containing the 26 

plasticizers must not be used. The 

comment also requested that, if the 

petition is granted, we state that 

continued use of installed equipment 

containing the abandoned substances/ 

plasticizers that come into contact with 

food is unlawful and that the food 

would be adulterated. 

(Response 4) We disagree with the 

assertion that FVA’s survey fails to 

address repeat-use items. Questions 1, 2, 

and 4 of FVA’s survey encompass broad 

types of intended use. Specifically, 

these questions ask about current 

manufacturing, importing, and 

distribution of the subject orthophthalates for ‘‘food-contact 

applications,’’ a broad term that 

arguably includes any food-contact use 

of the subject ortho-phthalates. Question 

3 has the same scope but is specific to 

the survey recipients’ future plans. 

Regarding installed food processing 

equipment that may contain any of the 

substances in table 1, the comment did 

not provide any evidence showing that 

there is use of the subject substances in 

repeat-use food contact applications. We 

note that repeated-use food handling 

equipment typically has a finite 

lifetime. The petitioner provided 

information concerning the typical 

useful lifetime of some food handling 

equipment and noted that these 

lifetimes vary based on the operating 

conditions but are roughly 300 to 500 

days for food handling conveyer belts, 

flexible tubing, and gaskets. This 

information is contained in Food 

Additive Master File No. 954, which 

was incorporated by reference into FAP 

8B4820 by the petitioner. The petitioner 

characterized the approximate lifetimes 

provided as conservative estimates of 

the usable lifetimes of repeat-use 

articles subject to these regulations (Ref. 

2). 

In assessing other food additive uses, 

FDA has compiled representative 

exposure scenarios of repeat use food 

handling articles based on data 

collected through the Food Contact 

Notification Program (Ref. 5). We note 

that the estimated standardized 

lifetimes (i.e., the amount of time an 

article such as a conveyor belt can 

function before needing replacement) in 

these scenarios are 365 days for polymer 

conveyor belts (Ref. 6), flexible polymer 

tubing (Ref. 7), and polymer o-rings 

(Ref. 8). Likewise, estimates of dietary 

exposure from the use of lubricants, 

which may contain a plasticizer, used 

on food handling equipment (e.g., 

bearings, surfaces) assume that 

relubrication is required between 600 to 

4000 machine operating hours. This is 

approximately 25 to 167 days, assuming 

nonstop operation (Ref. 8). Thus, 

lubricants are replaced on a relatively 

frequent basis. 

As such, any of these types of repeatuse items that may have been in use as 

of July 2018, at the time this petition 

was filed, would be expected to be past 

the end of their usable life. Considering 

these estimated lifetimes and the 

evidence suggesting that there would 

not be replacement products containing 

the abandoned substances, we do not 

agree that there is reason to question the 

evidence supporting abandonment in 

the context of repeat-use food handling 

equipment. 

With respect to the request that FDA 

state that continued use of installed 

equipment containing the abandoned 

substances/plasticizers that come into 

contact with food is unlawful and that 

the food would be adulterated, we 

decline. It would be premature for FDA 

to comment on the legal status of 

substances in response to an unproven 

concern that certain uses are not, in fact, 

abandoned. 

(Comment 5) One comment stated 

that it is not clear what parts of industry 

were omitted from the petitioner’s 

survey and questions whether the 

survey recipients possessed sufficient 

knowledge to accurately answer the 

survey in instances of repeat-use items. 

(Response 5) As stated in section II of 

this final rule, we consider the totality 

of the parties surveyed in the FVA 

petition to be comprehensive and 

sufficient to determine that these uses 

are abandoned. FDA also considers 

question 5 of the survey, which asked 

about the recipients’ general knowledge 

of the use of the substances in food 

contact applications in the United 

States, to encompass not only the 

activities of the survey recipients 

themselves, but also other firms which 

supply, purchase from, or otherwise 

interact with the survey recipients. 

In their petition, FVA provided data 

from committees, panels, and industry 

associations composed of scientific and 

regulatory experts in the field of food 

contact materials, plasticizers, orthophthalates, and the plastics, paper and 

paperboard, and food industries in 

general. Individual companies that 

responded to the surveys were made 

aware of FVA’s food additive petition 

based on abandonment and were 

notified that the scope of this petition 

included repeat-use items via 

publication in the Federal Register at 83 

FR 56750. 

(Comment 6) One comment stated 

that FDA should clarify that for any 

abandoned uses, all prior and future 

uses that have been or will be deemed 

‘‘generally recognized as safe’’ (GRAS) 

are invalid. The comment asserted that 

if we decide to revoke food additive 

regulations in response to this petition, 

a company may seek to rely on a selfGRAS determination without agency 

knowledge to conclude that the use of 

one or more of these substances are 

GRAS. 

(Response 6) With regard to the 

comment’s concern that a manufacturer 

may conclude that use of one or more 

of these substances is GRAS without 

notifying us, we note that, for a 

substance to be GRAS based on 

scientific procedures, the scientific data 

and information about the use of a 

substance must be generally available 

and there must be general recognition 

among qualified experts that those data 

and information establish that the 

substance is safe under the conditions of 

its intended use (21 CFR 170.30). Prior 

approval as a food additive for one use 

does not mean that another use of the 

substance is GRAS (see 81 FR 54960 at 

54976, August 17, 2016). FDA 

encourages firms to seek our evaluation 

of any conclusion of GRAS status before 

they introduce the substance into the 

market. In the future, if a manufacturer 

wishes to establish safe conditions of 


khammond on DSKJM1Z7X2PROD with RULES2
31088 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 

use for one or more of these substances 

in food contact applications, we expect 

the manufacturer to submit either a food 

additive petition or a food contact 

substance notification prior to market 

entry because these intended uses were 

previously authorized under section 409 

of the FD&C Act. 

IV. Conclusion 

FDA reviewed the data and 

information in the petition and other 

available relevant material to evaluate 

whether the food contact uses listed in 

tables 2 through 19 have been 

permanently and completely 

abandoned. Based on the available 

information, we have determined that 

these food contact uses have been 

abandoned. Therefore, we are amending 

§§ 175.105, 175.300, 175.320, 176.170, 

176.180, 176.300, 177.1010, 177.1200, 

177.1460, 177.1590, 177.2420, 177.2600, 

178.3740, and 178.3910 of the food 

additive regulations to no longer 

provide for the food additive uses of the 

substances listed in tables 2 through 19 

because these uses have been 

abandoned. Although the regulatory text 

in §§ 175.380, 175.390, 177.1210, and 

179.1400 will not be amended, these 

regulations are also affected because 

they authorize certain uses of 

substances listed in table 1 by crossreferencing other regulations. 

V. Public Disclosure 

In accordance with § 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 § 171.1(h), we will 

delete from the documents any 

materials that are not available for 

public disclosure. 

VI. Environmental Impact 

We have determined under 21 CFR 

25.32(m) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. 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. 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 factual 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. 

IX. References 

The following references marked with 

an asterisk (*) 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 also are available 

electronically at https:// 

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

* 1. FVA 2017 Value Chain Survey Results. 

https://www.surveymonkey.com/results/ 

SM-QMSNRGQQ8/ (last accessed 

December 17, 2021). 

* 2. Email correspondence between D. Hill, 

Keller and Heckman LLP and S. 

DiFranco, Division of Food Ingredients, 

Office of Food Additive Safety (OFAS), 

Center for Food Safety and Applied 

Nutrition (CFSAN), FDA, October 30, 

2019. 

3. Malveda, Michael P; Liu, Shirley; 

Passararat, Suchada; Sesto, Barbara. 

Chemical Economics Handbook: 

Plasticizers. IHS Chemical, 2015. 

* 4. American Chemistry Council Member 

Companies. https:// 

www.americanchemistry.com/ 

Membership/MemberCompanies/ (last 

accessed December 17, 2021.) 

* 5. Memorandum from A. Gonzalez-Bonet, 

Chemistry Review Group I, Division of 

Food Contact Notifications (DFCN), 

OFAS, CFSAN, to the file, November 8, 

2017. 

* 6. Memorandum for FAP 8B4089 from L. 

Borodinsky, Food and Color Additives 

Review Section, OFAS, CFSAN, FDA to 

A. Laumbach, Indirect Additives Branch, 

OFAS, CFSAN, FDA, November 23, 

1988. 

* 7. Memorandum for FCN 000109 from K. 

Arvidson, Chemistry Review Group I, 

Division of Product Manufacture and 

Use, Chemistry and Exposure 

Assessment Team, OFAS, CFSAN, FDA 

to H. Macon, Division of Product Policy, 

OFAS, CFSAN, FDA, December 20, 2000. 

* 8. Memorandum for FAP 9B4644 from R. 

Costnatino, Special Project Team, 

Chemistry Review Team, Division of 

Manufacture and Use, OFAS, CFSAN, 

FDA to the file, April 21, 1999. 

* 9. Memorandum for FCN 001617 from A. 

Gonzalez-Bonet, Chemistry Review 

Group I, DFCN, OFAS, CFSAN, FDA to 

K. McAdams, DFCN, OFAS, CFSAN, 

FDA, February 23, 2016. 

List of Subjects 

21 CFR Part 175 

Adhesives, Food additives, Food 

packaging. 

21 CFR Parts 176, 177, and 178 

Food additives, Food packaging. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 175, 

176, 177, and 178 are amended as 

follows: 

PART 175—INDIRECT FOOD 

ADDITIVES: ADHESIVES AND 

COMPONENTS OF COATINGS 

■ 1. The authority citation for part 175 

continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348, 379e. 

§ 175.105 [Amended] 

■ 2. Amend § 175.105 in the table in 

paragraph (c)(5) by removing the entries 

for ‘‘Butyl benzyl phthalate’’, 

‘‘Butyldecyl phthalate’’, ‘‘Butyloctyl 

phthalate’’, ‘‘Butyl phthalate butyl 

glycolate’’, ‘‘Di(butoxyethyl) phthalate’’ 

‘‘Dibutyl phthalate’’, ‘‘Di(2-ethylhexyl) 

hexahydrophthalate’’, ‘‘Diethyl 

phthalate’’, ‘‘Dihexyl phthalate’’ 

‘‘Dihydroabietylphthalate’’, ‘‘Diisobutyl 

phthalate’’, ‘‘Diisooctyl phthalate’’, 

‘‘Dimethyl phthalate’’, 

‘‘Dioctylphthalate’’, ‘‘Diphenyl 

phthalate’’, ‘‘Ethyl phthalyl ethyl 

glycolate’’, ‘‘Methyl phthalyl ethyl 

glycolate’’, and ‘‘Octyldecyl phthalate’’. 


khammond on DSKJM1Z7X2PROD with RULES2
Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 31089 

§ 175.300 [Amended] 

■ 3. Amend § 175.300 in paragraph 

(b)(3)(viii)(b) by removing the entry for 

‘‘Dibutyl phthalate, for use only in 

coatings for containers having a capacity 

of 1,000 gallons or more when such 

containers are intended for repeated use 

in contact with alcoholic beverages 

containing up to 8 percent of alcohol by 

volume.’’ and in paragraph (b)(3)(xxiv) 

by removing the entries for ‘‘Butyl 

phthalyl butyl glycolate.’’, ‘‘Diethyl 

phthalate.’’, ‘‘Diisooctyl phthalate.’’, and 

‘‘Ethyl phthalyl ethyl glycolate.’’. 

§ 175.320 [Amended] 

■ 4. Amend § 175.320 in paragraph 

(b)(3)(ii) by removing the entries for 

‘‘Butyl phthalyl butyl glycolate’’, 

‘‘Diethyl phthalate’’, and ‘‘Ethyl 

phthalyl ethyl glycolate’’. 

PART 176—INDIRECT FOOD 

ADDITIVES: PAPER AND 

PAPERBOARD COMPONENTS 

■ 5. The authority citation for part 176 

continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 346, 348, 

379e. 

§ 176.170 [Amended] 

■ 6. Amend § 176.170 in the table in 

paragraph (b)(2) by removing the entries 

for ‘‘Butylbenzyl phthalate’’ and 

‘‘Dibutyl phthalate’’. 

§ 176.180 [Amended] 

■ 7. Amend § 176.180 in the table in 

paragraph (b)(2) by removing in 

paragraph (b)(2) the entry for ‘‘Butyl 

benzyl phthalate’’. 

§ 176.300 [Amended] 

■ 8. Amend § 176.300 in paragraph (d) 

by removing the entries for ‘‘Dibutyl 

phthalate.’’, ‘‘Didecyl phthalate.’’, and 

‘‘Dodecyl phthalate.’’. 

PART 177—INDIRECT FOOD 

ADDITIVES: POLYMERS 

■ 9. The authority citation for part 177 

continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348, 379e. 

§ 177.1010 [Amended] 

■ 10. Amend § 177.1010 in paragraph 

(a)(8) by removing the entry for 

‘‘Dimethyl phthalate.’’. 

§ 177.1200 [Amended] 

■ 11. Amend § 177.1200 in paragraph 

(c) by removing the entries for ‘‘Castor 

oil phthalate with adipic acid and 

fumaric acid-diethylene glycol 

polyester’’, ‘‘Castor oil phthalate, 

hydrogenated’’, ‘‘Dibutylphthalate’’, 

‘‘Diisobutyl phthalate’’, and 

‘‘Dimethylcyclohexyl phthalate’’. 

§ 177.1460 [Amended] 

■ 12. Amend § 177.1460 in paragraph 

(b) by removing the entry for ‘‘Dioctyl 

phthalate’’. 

§ 177.1590 [Amended] 

■ 13. Amend § 177.1590 in paragraph 

(a) by removing the entry for ‘‘Dimethyl 

orthophthalate,’’. 

§ 177.2420 [Amended] 

■ 14. Amend § 177.2420 in paragraph 

(b) by removing the entries for ‘‘Butyl 

benzyl phthalate (containing not more 

than 1.0 percent by weight of dibenzyl 

phthalate)’’, ‘‘dibutyl phthalate’’, and 

‘‘Dimethyl phthalate’’. 

§ 177.2600 [Amended] 

■ 15. Amend § 177.2600 in paragraph 

(c)(4)(ii)(b) by removing the entry for 

‘‘Diphenylguanidine phthalate.’’ and I n 

paragraph (c)(4)(iv) by removing the 

entries for ‘‘n-Amyl n-decyl phthalate.’’, 

‘‘Dibutyl phthalate.’’, ‘‘Didecyl 

phthalate.’’, ‘‘Dioctyl phthalate.’’, and 

‘‘n-Octyl n-decyl phthalate.’’ 

PART 178—INDIRECT FOOD 

ADDITIVES: ADJUVANTS, 

PRODUCTION AIDS, AND SANITIZERS 

■ 16. The authority citation for part 178 

continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348, 379e. 

§ 178.3740 [Amended] 

■ 17. Amend § 178.3740 in paragraph 

(b) by removing the entries for 

‘‘Butylbenzyl phthalate’’, ‘‘Dihexyl 

phthalate’’, and ‘‘Diphenyl phthalate’’. 

§ 178.3910 [Amended] 

■ 18. Amend § 178.3910 in paragraph 

(a)(2) by removing the entry for ‘‘Diethyl 

phthalate’’. 

Dated: May 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10531 Filed 5–19–22; 8:45 am] 

BILLING CODE 4164–01–P 


khammond on DSKJM1Z7X2PROD with RULES2