Document ID: FDA-2018-F-3757-0017
Agency: fda
Document Type: Rule
Title: Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers
Posted Date: 2022-05-20T04:00Z

[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Rules and Regulations]
[Pages 31080-31089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10531]

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

[[Page 31080]]

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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 Sec. Sec.  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

[[Page 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-                            85-71-2
 Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-
 methyl ester)........................................
Diethyl phthalate.....................................           84-66-2
Diphenylguanidine phthalate \1\.......................        17573-13-6
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl           84-72-0
 phthalate)...........................................
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                        85-70-1
 carbobutoxymethyl phthalate).........................
Dihexyl phthalate (Di-n-hexyl phthalate)..............           84-75-3
Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl)                 117-83-9
 phthalate)...........................................
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-          119-07-3
 decyl phthalate).....................................
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-       68650-73-7
 diethylene glycol \6\................................
------------------------------------------------------------------------
\1\ We 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.
\2\ The petitioner refers to this substance as butyl benzyl phthalate;
  it is listed in Sec.  Sec.   176.170 and 178.3740 as butylbenzyl
  phthalate. These terms are synonymous, referring to the same chemical
  substance.
\3\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.  Sec.   175.105, 175.300, 175.380, 176.170, 176.180,
  176.300, 177.2420, and 177.2600 as dibutyl phthalate and in Sec.
  177.1200 as dibutylphthalate. These terms are synonymous, referring to
  the same chemical substance.
\4\ Substance is listed as butyl phthalate butyl glycolate in Sec.
  175.105. We believe this is a typographical error, and it should be
  listed as butyl phthalyl butyl glycolate.
\5\ The petitioner refers to this substance as butyl decyl phthalate; it
  is listed in Sec.   175.105 as butyldecyl phthalate. These terms are
  synonymous, referring to the same chemical substance.
\6\ The petitioner refers to this substance as castor oil phthalate with
  adipic acid and fumaric acid-diethylene glycol; it is listed in Sec.
  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 Sec.   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-                            85-71-2
 Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-
 methyl ester)........................................
Diethyl phthalate.....................................           84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl           84-72-0
 phthalate)...........................................
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                        85-70-1
 carbobutoxymethyl phthalate).........................
Dihexyl phthalate (Di-n-hexyl phthalate)..............           84-75-3
Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl)                 117-83-9
 phthalate)...........................................
Diisooctyl phthalate..................................        27554-26-3

[[Page 31082]]

 
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-          119-07-3
 decyl phthalate).....................................
Dihydroabietyl phthalate..............................        26760-71-4
------------------------------------------------------------------------
\1\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   175.105 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.
\2\ The petitioner refers to this substance as butyl phthalyl butyl
  glycolate; it is listed in Sec.   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.
\3\ The petitioner refers to this substance as butyl decyl phthalate; it
  is listed in Sec.   175.105 as butyldecyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

 Table 3--Ortho-Phthalates Authorized by Sec.   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           84-72-0
 phthalate)...........................................
Di-n-butyl phthalate \1\..............................           84-74-2
Butyl phthalyl butyl glycolate (Butyl                            85-70-1
 carbobutoxymethyl phthalate).........................
Diisooctyl phthalate..................................        27554-26-3
------------------------------------------------------------------------
\1\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   175.300 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

 Table 4--Ortho-Phthalates Authorized by Sec.   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           84-72-0
 phthalate)...........................................
Butyl phthalyl butyl glycolate (Butyl                            85-70-1
 carbobutoxymethyl phthalate).........................
------------------------------------------------------------------------

 Table 5--Ortho-Phthalates Authorized by Sec.   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                        84-72-0
 carbethoxymethyl phthalate)..........................
Di-n-butyl phthalate \1\ \2\..........................           84-74-2
Butyl phthalyl butyl glycolate \1\ (Butyl                        85-70-1
 carbobutoxymethyl phthalate).........................
Diisooctyl phthalate \1\..............................        27554-26-3
------------------------------------------------------------------------
\1\ By cross-referencing Sec.   175.300, Sec.   175.380 authorizes use
  of this plasticizer.
\2\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   175.300 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

 Table 6--Ortho-Phthalates Authorized by Sec.   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                        84-72-0
 carbethoxymethyl phthalate)..........................
Di-n-butyl phthalate \1\ \2\..........................           84-74-2
Butyl phthalyl butyl glycolate \1\ (Butyl                        85-70-1
 carbobutoxymethyl phthalate).........................
Diisooctyl phthalate \1\..............................        27554-26-3
------------------------------------------------------------------------
\1\ By cross-referencing Sec.   175.300, Sec.   175.390 authorizes use
  of this plasticizer.
\2\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   175.300 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

[[Page 31083]]

 Table 7--Ortho-Phthalates Authorized by Sec.   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
------------------------------------------------------------------------
\1\ The petitioner refers to this substance as butyl benzyl phthalate;
  it is listed in Sec.   176.170 as butylbenzyl phthalate. These terms
  are synonymous, referring to the same chemical substance.
\2\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   176.170 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

 Table 8--Ortho-Phthalates Authorized by Sec.   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
------------------------------------------------------------------------
\1\ By cross-referencing Sec.   176.170, Sec.   176.180 authorizes use
  of this plasticizer.
\2\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   176.170 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

 Table 9--Ortho-Phthalates Authorized by Sec.   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
------------------------------------------------------------------------
\1\ By cross-referencing Sec.  Sec.   176.170 and 176.180, Sec.
  176.300 authorizes use of this plasticizer.
\2\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   176.300 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

  Table 10--Ortho-Phthalates Authorized by Sec.   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 Sec.   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-       68650-73-7
 diethylene glycol \2\................................
------------------------------------------------------------------------
\1\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   177.1200 as dibutylphthalate. These terms are
  synonymous, referring to the same chemical substance.
\2\ The petitioner refers to this substance as castor oil phthalate with
  adipic acid and fumaric acid-diethylene glycol; it is listed in Sec.
  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 Sec.   177.1210 Affected by
                             This Final Rule
           [Closures with sealing gaskets for food containers]
------------------------------------------------------------------------
                     Food additive                           CAS No.
------------------------------------------------------------------------
Diethyl phthalate\1\ \2\..............................           84-66-2
Ethyl phthalyl ethyl glycolate \1\ (Ethyl                        84-72-0
 carbethoxymethyl phthalate)..........................
Di-n-butyl phthalate \1\ \3-5\........................           84-74-2
Butyl phthalyl butyl glycolate\1\ (Butyl                         85-70-1
 carbobutoxymethyl phthalate).........................

[[Page 31084]]

 
Diisooctyl phthalate \1\..............................        27554-26-3
Dimethyl phthalate\1\ \4\ (dimethyl orthophthalate)...          131-11-3
Diphenyl phthalate \1\ \2\............................           84-62-8
Methyl phthalyl ethyl glycolate \1\ (1,2-                        85-71-2
 Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-
 methyl ester)........................................
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)             117-83-9
 phthalate)...........................................
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-          119-07-3
 octyl n-decyl phthalate).............................
Didecyl phthalate\3\ \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-       68650-73-7
 diethylene glycol \4\ \6\............................
------------------------------------------------------------------------
\1\ By cross-referencing part 175, Sec.   177.1210 authorizes use of
  this plasticizer.
\2\ By cross-referencing part 178, Sec.   177.1210 authorizes use of
  this plasticizer.
\3\ By cross-referencing part 176, Sec.   177.1210 authorizes use of
  this plasticizer
\4\ By cross-referencing part 177, Sec.   177.1210 authorizes use of
  this plasticizer.
\5\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.  Sec.   175.105, 175.300, 175.380, 176.170, 176.180,
  176.300, 177.2420, and 177.2600 as dibutyl phthalate and in Sec.
  177.1200 as dibutylphthalate. These terms are synonymous, referring to
  the same chemical substance.
\6\ The petitioner refers to this substance as castor oil phthalate with
  adipic acid and fumaric acid-diethylene glycol; it is listed in Sec.
  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 Sec.   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-       68650-73-7
 diethylene glycol \1\ \3\............................
------------------------------------------------------------------------
\1\ By cross-referencing Sec.   177.1200, Sec.   177.1400 authorizes use
  of this plasticizer.
\2\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   177.1200 as dibutylphthalate. These terms are
  synonymous, referring to the same chemical substance.
\3\ The petitioner refers to this substance as castor oil phthalate with
  adipic acid and fumaric acid-diethylene glycol; it is listed in Sec.
  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 Sec.   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 Sec.   177.1590 Affected by
                             This Final Rule
                         [Polyester elastomers]
------------------------------------------------------------------------
                       Food additive                           CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)...............     131-11-3
------------------------------------------------------------------------

[[Page 31085]]

  Table 16--Ortho-Phthalates Authorized by Sec.   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
------------------------------------------------------------------------
\1\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   177.2420 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

  Table 17--Ortho-Phthalates Authorized by Sec.   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-          119-07-3
 decyl phthalate).....................................
Didecyl phthalate (Di-n-decyl phthalate)..............           84-77-5
------------------------------------------------------------------------
\1\ The petitioner refers to this substance as di-n-butyl phthalate; it
  is listed in Sec.   177.2600 as dibutyl phthalate. These terms are
  synonymous, referring to the same chemical substance.

  Table 18--Ortho-Phthalates Authorized by Sec.   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
------------------------------------------------------------------------
\1\ The petitioner refers to this substance as Butyl benzyl phthalate;
  it is listed in Sec.   178.3740 as butylbenzyl phthalate. These terms
  are synonymous, referring to the same chemical substance.

  Table 19--Ortho-Phthalates Authorized by Sec.   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 (Sec.  171.130(a) (21 CFR 171.130(a))). The regulations 
further provide that any such petition must include an assertion of 
facts, supported by data, showing that new information exists with 
respect to the food additive or that new uses have been developed or 
old uses abandoned, that new data are available as to toxicity of the 
chemical, or that experience with the existing regulation or exemption 
may justify its amendment or repeal (Sec.  171.130(b)). New data must 
be furnished in the form specified in Sec. Sec.  171.1 and 171.100 (21 
CFR 171.1 and 171.100) for submitting petitions (Sec.  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 (Sec.  
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 Sec.  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

[[Page 31086]]

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 ortho-phthalates listed in table 1 for 
use in food contact applications in the United States;
    2. Currently import the ortho-phthalates 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 ortho-phthalates (Ref. 2).
---------------------------------------------------------------------------

    \1\ The Grocery Manufacture's Association (GMA) became the 
Consumer Brands Association (CBA) in January 2020.
---------------------------------------------------------------------------

    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

[[Page 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 ortho-
phthalates 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 ortho-phthalates 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 repeat-use 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, ortho-phthalates, 
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 self-GRAS 
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

[[Page 31088]]

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 
Sec. Sec.  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 
Sec. Sec.  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 cross-referencing other 
regulations.

V. Public Disclosure

    In accordance with Sec.  171.1(h), the petition and the documents 
that we considered and relied upon in reaching our decision to approve 
the petition will be made available for public disclosure (see FOR 
FURTHER INFORMATION CONTACT). As provided in Sec.  171.1(h), we will 
delete from the documents any materials that are not available for 
public disclosure.

VI. 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

0
1. The authority citation for part 175 continues to read as follows:

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

Sec.  175.105   [Amended]

0
2. Amend Sec.  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''.

[[Page 31089]]

Sec.  175.300  [Amended]

0
3. Amend Sec.  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.''.

Sec.  175.320  [Amended]

0
4. Amend Sec.  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

0
5. The authority citation for part 176 continues to read as follows:

    Authority: 21 U.S.C. 321, 342, 346, 348, 379e.

Sec.  176.170  [Amended]

0
6. Amend Sec.  176.170 in the table in paragraph (b)(2) by removing the 
entries for ``Butylbenzyl phthalate'' and ``Dibutyl phthalate''.

Sec.  176.180  [Amended]

0
7. Amend Sec.  176.180 in the table in paragraph (b)(2) by removing in 
paragraph (b)(2) the entry for ``Butyl benzyl phthalate''.

Sec.  176.300   [Amended]

0
8. Amend Sec.  176.300 in paragraph (d) by removing the entries for 
``Dibutyl phthalate.'', ``Didecyl phthalate.'', and ``Dodecyl 
phthalate.''.

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

0
9. The authority citation for part 177 continues to read as follows:

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

Sec.  177.1010   [Amended]

0
10. Amend Sec.  177.1010 in paragraph (a)(8) by removing the entry for 
``Dimethyl phthalate.''.

Sec.  177.1200   [Amended]

0
11. Amend Sec.  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''.

Sec.  177.1460  [Amended]

0
12. Amend Sec.  177.1460 in paragraph (b) by removing the entry for 
``Dioctyl phthalate''.

Sec.  177.1590  [Amended]

0
13. Amend Sec.  177.1590 in paragraph (a) by removing the entry for 
``Dimethyl orthophthalate,''.

Sec.  177.2420  [Amended]

0
14. Amend Sec.  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''.

Sec.  177.2600  [Amended]

0
15. Amend Sec.  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

0
16. The authority citation for part 178 continues to read as follows:

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

Sec.  178.3740  [Amended]

0
17. Amend Sec.  178.3740 in paragraph (b) by removing the entries for 
``Butylbenzyl phthalate'', ``Dihexyl phthalate'', and ``Diphenyl 
phthalate''.

Sec.  178.3910  [Amended]

0
18. Amend Sec.  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