[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Proposed Rules]
[Pages 56750-56758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24657]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 175, 176, 177, and 178
[Docket No. FDA-2018-F-3757]
Flexible Vinyl Alliance; Filing of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of petition.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by the Flexible Vinyl Alliance
(FVA), requesting that we amend our food additive regulations to no
longer provide for the use of 26 ortho-phthalates in various food-
contact applications because these uses have been permanently
abandoned.
DATES: The food additive petition was filed on July 3, 2018. Submit
either electronic or written comments by January 14, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 14, 2019. Comments
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 comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
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
[[Page 56751]]
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 comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment 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 comments submitted to the Dockets
Management Staff, FDA will post your comment, 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 ``Flexible Vinyl Alliance; Filing of Food Additive
Petition.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions: To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this document into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Stephen DiFranco, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2710.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have
filed a food additive petition (FAP 8B4820), submitted by FVA, c/o
Keller and Heckman, LLP., 1001 G St. NW, Suite 500 West, Washington, DC
20001. The petition requests that we amend our food additive
regulations in parts 175, 176, 177, and 178 (21 CFR parts 175, 176,
177, and 178) to revoke the approvals for 26 substances that the
petition identifies as ortho-phthalates. The petition requests that we
revoke the approvals because the food additive uses have been
permanently abandoned. The substances affected by this petition and
their corresponding Chemical Abstracts Service (CAS) numbers (when
available) are listed in table 1. Some of the substances are the
subject of approvals in multiple food additive regulations for
different uses, and the petition identifies the regulations that
authorize the food additive use of the substances. Therefore, we are
also listing the regulations that would be affected by this FAP (see
tables 2-19). For each regulation that would be affected, we list the
specific ortho-phthalates that the regulation authorizes. The petition
asserts that the uses of the ortho-phthalates identified in tables 2-19
have been abandoned. If the FAP is granted in full, none of the ortho-
phthalates listed in table 1 would be authorized for food additive use
in FDA's food additive regulations. Some of the substances are the
subject of prior sanction authorizations. The FAP does not pertain to
those prior sanction uses.
Table 1--Ortho-Phthalates That Would Be Affected by This FAP
------------------------------------------------------------------------
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).............................................
Diallyl phthalate....................................... 131-17-9
Diisobutyl phthalate.................................... 84-69-5
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate.................................... 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).............................................
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 (n-butyl n-decyl phthalate)....... 89-19-0
[[Page 56752]]
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......................................
------------------------------------------------------------------------
\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\ Substance is named Butyl phthalate butyl glycolate in 21 CFR
175.105. We believe this is a typographical error, and it should be
named butyl phthalyl butyl glycolate or butyl carbobutoxymethyl
phthalate.
The petition identifies Sec. 175.105, ``Adhesives'' (21 CFR
175.105) as being impacted by the FAP. Specifically, the petition
identifies the use of the substances listed in table 2 as being
impacted.
Table 2--Ortho-Phthalates Authorized by Sec. 175.105 That Would Be
Affected by This FAP
[``Adhesives'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
Diphenyl phthalate...................................... 84-62-8
Methyl phthalyl ethyl glycolate 85-71-2
(1,2Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-
methyl ester)..........................................
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Diallyl phthalate....................................... 131-17-9
Diisobutyl phthalate.................................... 84-69-5
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate \1\................................ 84-74-2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate) \2\.........................................
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
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 (n-butyl n-decyl phthalate) \3\... 89-19-0
Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n- 119-07-3
decyl phthalate).......................................
Dihydroabietyl phthalate................................ 26760-71-4
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.105 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
\2\ Although the petitioner refers to this substance as Butyl phthalyl
butyl glycolate phthalate in the petition, it is listed in Sec.
175.105 as Butyl phthalate butyl glycolate. These terms are
synonymous, referring to the same chemical substance.
\3\ Although the petitioner refers to this substance as Butyl decyl
phthalate in the petition, it is listed in Sec. 175.105 as
Butyldecyl phthalate. These terms are synonymous, referring to the
same chemical substance.
The petition identifies Sec. 175.300, ``Resinous and polymeric
coatings'' (21 CFR 175.300), as being impacted by the FAP.
Specifically, the petition identifies the use of the ortho-phthalates
listed in table 3 as being impacted.
Table 3--Ortho-Phthalates Authorized by Sec. 175.300 That Would Be
Affected by This FAP
[``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 carbobutoxymethyl 85-70-1
phthalate).............................................
Diisooctyl phthalate.................................... 27554-26-3
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.300 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
The petition identifies Sec. 175.320, ``Resinous and polymeric
coating for polyolefin films'' (21 CFR 175.320), as being impacted by
the FAP. Specifically, the petition identifies the use of the ortho-
phthalates listed in table 4 as being impacted.
[[Page 56753]]
Table 4--Ortho-phthalates Authorized by Sec. 175.320 That Would Be
Affected by This FAP
[``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 carbobutoxymethyl 85-70-1
phthalate).............................................
------------------------------------------------------------------------
The petition identifies Sec. 175.380, ``Xylene-formaldehyde resins
condensed with 4,4'-isopropylidenediphenol-epichlorohydrin epoxy
resins'' (21 CFR 175.380), as being impacted by the FAP. Specifically,
the petition identifies the use of the ortho-phthalates listed in table
5 as being impacted. Although the regulation in Sec. 175.380 does not
directly refer to these ortho-phthalates, the regulation authorizes
their use by cross-referencing Sec. 175.300(b)(3). Although use of
ortho-phthalates authorized by Sec. 175.380 would be affected by the
FAP, the FAP would not require the regulatory text in Sec. 175.380 to
be amended.
Table 5--Ortho-Phthalates Authorized by Sec. 175.380 That Would Be
Affected by This FAP
[``Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenol-
epichlorohydrin epoxy resins'']
------------------------------------------------------------------------
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 carbobutoxymethyl 85-70-1
phthalate) \2\.........................................
Diisooctyl phthalate.................................... 27554-26-3
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.300(b)(3) as
dibutyl phthalate. These terms are synonymous, referring to the same
chemical substance.
The petition identifies Sec. 175.390, ``Zinc-silicon dioxide
matrix coatings'' (21 CFR 175.390) as being impacted by the FAP.
Specifically, the petition identifies the use of the ortho-phthalates
listed in table 6 as being impacted by the FAP. Although the regulation
in Sec. 175.390 does not directly refer to these ortho-phthalates, the
regulation authorizes their use by cross-referencing Sec. 175.300.
Although use of ortho-phthalates authorized by Sec. 175.390 would be
affected by the FAP, the FAP would not require the regulatory text in
Sec. 175.390 to be amended.
Table 6--Ortho-Phthalates Authorized by Sec. 175.390 That Would Be
Affected by This FAP
[``Zinc-silicon dioxide matrix 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 carbobutoxymethyl 85-70-1
phthalate).............................................
Diisooctyl phthalate.................................... 27554-26-3
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.300 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
The petition identifies Sec. 176.170, ``Components of paper and
paperboard in contact with aqueous and fatty foods'' (21 CFR 176.170)
as being affected by the FAP. Specifically, the petition identifies the
use of the ortho-phthalates listed in table 7 as being impacted.
Table 7--Ortho-Phthalates Authorized by Sec. 176.170 That Would Be
Affected By This FAP
[``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\ Although the petitioner refers to this substance as Butyl benzyl
phthalate in the petition, it is listed in Sec. 176.170 as
Butylbenzyl phthalate. These terms are synonymous, referring to the
same chemical substance.
\2\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 176.170 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
The petition identifies Sec. 176.180, ``Components of paper and
paperboard in contact with dry food'' (21 CFR 176.180) as being
impacted by the FAP. Specifically, the petition identifies the use of
the ortho-phthalates listed in
[[Page 56754]]
table 8 as being impacted. Although the regulation in Sec. 176.180
does not directly refer to all of these ortho-phthalates, the
regulation authorizes the use of all of them either directly or by
cross-referencing Sec. 176.170.
Table 8--Ortho-Phthalates Authorized by Sec. 176.180 That Would Be
Affected by This FAP
[``Components of paper and paperboard in contact with dry food'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diallyl phthalate....................................... 131-17-9
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate \1\................................ 84-74-2
Didecyl phthalate (Di-n-decyl phthalate)................ 84-77-5
Dodecyl phthalate....................................... 21577-80-0
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 176.170 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
The petition identifies Sec. 176.300, ``Slimicides'' (21 CFR
176.300), as being impacted by the FAP. Specifically, the petition
identifies the ortho-phthalates listed in table 9 as being impacted,
some of which are permitted as a result of being listed in Sec. Sec.
176.170 and 176.180.
Table 9--Ortho-Phthalates Authorized by Sec. 176.300 That Would Be
Affected by This FAP
[``Slimicides'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diallyl phthalate....................................... 131-17-9
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate.................................... 84-74-2
Didecyl phthalate (Di-n-decyl phthalate)................ 84-77-5
Dodecyl phthalate....................................... 21577-80-0
------------------------------------------------------------------------
The petition identifies Sec. 177.1010, ``Acrylic and modified
acrylic plastics, semirigid and rigid'' (21 CFR 177.1010) as being
impacted by the FAP. Specifically, the petition identifies the use of
the ortho-phthalate listed in table 10 as being impacted.
Table 10--Ortho-Phthalates Authorized by Sec. 177.1010 That Would Be
Affected by This FAP
[``Acrylic and modified acrylic plastics, semirigid and rigid'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
------------------------------------------------------------------------
The petition identifies Sec. 177.1200, ``Cellophane'' (21 CFR
177.1200) as being impacted by the FAP. Specifically, the petition
identifies the use of the ortho-phthalates listed in table 11 as being
impacted.
Table 11--Ortho-Phthalates Authorized by Sec. 177.1200 That Would Be
Affected by This FAP
[``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......................................
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.1200 as
dibutylphthalate. These terms are synonymous, referring to the same
chemical substance.
The petition identifies Sec. 177.1210, ``Closures with sealing
gaskets for food containers'' (21 CFR 177.1210), as being impacted by
the FAP. Specifically, the petition identifies the first five ortho-
phthalates listed in table 12 as being impacted based on the
authorization of their use in Sec. 177.1210. Although the regulation
in Sec. 177.1210 does not directly refer to these ortho-phthalates,
the regulation authorizes their use by cross-referencing authorizations
in 21 CFR parts 174-178 and Sec. 179.45 (21 CFR 179.45). In addition
to the first five ortho-phthalates in table 12 that the petition
identifies as being authorized under Sec. 177.1210, Sec. 177.1210
also authorizes the use of the remaining substances that are listed in
table 12. We have listed these remaining substances in table 12 because
the petition seeks to revoke the food additive approvals for these
substances, and Sec. 177.1210 authorizes their food additive use by
[[Page 56755]]
cross-referencing authorizations in parts 174-178 and Sec. 179.45.
Although use of the substances authorized by Sec. 177.1210 that are
listed in table 12 would be affected by the FAP, the FAP would not
require the regulatory text in Sec. 177.1210 to be amended.
Table 12--Ortho-Phthalates Authorized by Sec. 177.1210 That Would Be
Affected by This FAP
[``Closures with sealing gaskets for food containers'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Di-n-butyl phthalate.................................... 84-74-2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate).............................................
Diisooctyl phthalate.................................... 27554-26-3
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)..........................................
Diphenylguanidine phthalate............................. 17573-13-6
Diallyl phthalate....................................... 131-17-9
Diisobutyl phthalate.................................... 84-69-5
Butyl benzyl phthalate.................................. 85-68-7
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
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
Amyl decyl phthalate (n-amyl n-decyl phthalate)......... 7493-81-4
Butyl decyl phthalate (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......................................
------------------------------------------------------------------------
The petition identifies Sec. 177.1400, ``Hydoxyethyl cellulose
film, water-insoluble'' (21 CFR 177.1400), as being impacted by the
FAP. Specifically, the petition identifies the use of the ortho-
phthalates listed in table 13 as being impacted. Although the
regulation in Sec. 177.1400 does not directly refer to these ortho-
phthalates, the regulation authorizes their use by cross-referencing
Sec. 177.1200(c). Although use of the ortho-phthalates authorized by
Sec. 177.1400 would be affected by the FAP, the FAP would not require
the regulatory text in Sec. 175.1400 to be amended.
Table 13--Ortho-Phthalates Authorized by Sec. 177.1400 That Would Be
Affected by This FAP
[``Hydroxyethyl cellulose film, water-insoluble'']
------------------------------------------------------------------------
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......................................
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.1200 as
dibutylphthalate. These terms are synonymous, referring to the same
chemical substance.
The petition identifies Sec. 177.1460, ``Melamine-formaldehyde
resins in molded articles'' (21 CFR 177.1460), as being impacted by the
FAP. Specifically, the petition identifies the use of the ortho-
phthalate listed in table 14 as being impacted.
Table 14--Ortho-Phthalates Authorized by Sec. 177.1460 That Would Be
Affected by This FAP
[``Melamine-formaldehyde resins in molded articles'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dioctyl phthalate (Di-n-octyl phthalate)................ 117-84-0
------------------------------------------------------------------------
[[Page 56756]]
The petition identifies Sec. 177.1590, ``Polyester elastomers''
(21 CFR 177.1590), as being impacted by the FAP. Specifically, the
petition identifies the use of the ortho-phthalate listed in table 15
as being impacted.
Table 15--Ortho-Phthalates Authorized by Sec. 177.1590 That Would Be
Affected by This FAP
[``Polyester elastomers'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
------------------------------------------------------------------------
The petition identifies Sec. 177.2420, ``Polyester resins, cross-
linked'' (21 CFR 177.2420), as being impacted by the FAP. Specifically,
the petition identifies the use of the ortho-phthalates listed in table
16 as being impacted.
Table 16--Ortho-Phthalates Authorized by Sec. 177.2420 That Would Be
Affected by This FAP
[``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.................................... 84-74-2
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.2420 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
The petition identifies Sec. 177.2600, ``Rubber articles for
repeated use'' (21 CFR 177.2600), as being impacted by the FAP.
Specifically, the petition identifies the use of the substances listed
in table 17 as being impacted.
Table 17--Ortho-Phthalates Authorized by Sec. 177.2600 That Would Be
Affected by This FAP
[``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\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.1200 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
The petition identifies Sec. 178.3740, ``Plasticizers in polymeric
substances'' (21 CFR 178.3740), as being impacted by the FAP.
Specifically, the petition identifies the use of the ortho-phthalates
listed in table 18 as being impacted.
Table 18--Ortho-Phthalates Authorized by Sec. 178.3740 That Would Be
Affected by This FAP
[``Plasticizers in polymeric substances'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diphenyl phthalate...................................... 84-62-8
Butyl benzyl phthalate.................................. 85-68-7
Dihexyl phthalate (Di-n-hexyl phthalate)................ 84-75-3
------------------------------------------------------------------------
The petition identifies Sec. 178.3910, ``Surface lubricants used
in the manufacture of metallic articles'' (21 CFR 178.3910), as being
impacted by the FAP. Specifically, the petition identifies the use of
the ortho-phthalate listed in table 19 as being impacted.
Table 19--Ortho-Phthalates Authorized by Sec. 178.3910 That Would Be
Affected by This FAP
[``Surface lubricants used in the manufacture of metallic articles'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
------------------------------------------------------------------------
[[Page 56757]]
II. Abandonment
Under section 409(i) of the FD&C Act, we shall by regulation
prescribe the procedure by which regulations under the foregoing
provisions of this section may be amended or repealed, and such
procedure shall conform to the procedure provided in this section for
the promulgation of such regulations. Our regulations specific to
administrative actions for food additives provide that the Commissioner
of Food and Drugs, on his own initiative or on the petition of any
interested person, 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))). These regulations further provide that
any such petition shall 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 appeal (Sec. 171.130(b)). New data must be furnished in
the form specified in 21 CFR 171.1 and 171.100 for submitting petitions
(id.). 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 (id.). Such
abandonment must be complete for any intended uses in the U.S. 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 abandoned.
Abandonment may be based on the abandonment of certain authorized
food additive uses for a substance (e.g., if a substance is no longer
used in certain product categories), or on the abandonment of all
authorized food additive uses of a substance (e.g., if a substance is
no longer being manufactured). If a FAP seeks an amendment to a food
additive regulation based on the abandonment of certain uses of the
food additive, such uses must be adequately defined so that both the
scope of the abandonment and any amendment to the food additive
regulation are clear.
As support for the assertion that the food-contact use of the
ortho-phthalates listed in the petition has been abandoned, the FAP
includes the results of a survey petitioner sent to its members and
other firms. The petitioner asked the recipients to verify that they do
not:
Currently manufacture the ortho-phthalates listed in table
1 for use in food contact applications in the United States;
Currently import the ortho-phthalates listed in table 1
for use in food contact applications in the United States;
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;
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; or
Possess any knowledge that the ortho-phthalates listed in
table 1 are used in food contact applications in the United States.
The FAP describes the petitioner's members as including plasticizer
manufacturers, compounders, formulators, molders and fabricators of
polyvinyl chloride (PVC). The petition states that the surveys
collected include the substantial majority of phthalate and PVC
manufacturers, as well as the downstream compounders and users of the
materials.
In addition, the FAP states that petitioner has confirmed with
other industry stakeholders that no entities appear to be using or
marketing the ortho-phthalates listed in table 1 in the food-contact
applications referenced in tables 2-19. The petition states that other
industry stakeholders include members of: (1) The Plastics Industry
Association's (PIA's) Food, Drug and Cosmetic Packaging Materials
Committee, (2) the Adhesives and Sealants Council, (3) the American
Beverage Association, (4) the American Forest and Paper Association,
(5) the Grocery Manufacturers Association, and (6) the High Phthalates
Panel of the American Chemistry Council. The petition states that no
member companies from the organizations indicated that they had any
knowledge that the regulatory clearances in tables 2-19 are relied upon
for use of the ortho-phthalates listed in table 1. With regard to PIA,
the petition states that PIA asked its member companies to advise
whether they have any knowledge that the subject ortho-phthalates are
being used in food-contact applications.
The FAP states that the petition captures the substantial majority
of domestic and international phthalate manufacturers and users.
We expressly request comments on FVA's request that we amend
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 permit the
food additive use of the substances listed in table 1 because these
uses have been abandoned. Although the regulatory text in Sec. Sec.
175.380, 175.390, 177.1210, and 179.1400 would not be amended, these
regulations would be affected because they authorize certain uses of
substances listed in table 1 by cross-referencing other regulations.
Accordingly, we request comments that address whether the use of the
substances in table 1 (as authorized in the regulations identified in
tables 2-19) have been completely abandoned. For example, we request
information on whether food contact materials containing these
substances are currently being introduced or delivered for introduction
into the U.S. market. Any comments indicating that the specified uses
of one or more of the 26 substances have not been abandoned should
specify the ortho-phthalate(s) (or substances identified in the
petition as ortho-phthalates). We also recommend including information
about the use, any relevant regulation(s) authorizing the use, and a
description of the product that contains the substance(s).
We are currently unaware of information demonstrating the continued
use of these substances in the food contact applications listed. We are
providing the public 60 days to submit comments. We anticipate that
some interested persons may wish to provide us with certain information
they consider to be trade secret or confidential commercial information
(CCI) under Exemption 4 of the Freedom of Information Act (5 U.S.C.
552). Interested persons may claim information that is submitted to us
as CCI or trade secret by clearly marking both the document and the
specific information as ``confidential.'' Information so marked will
not be disclosed except in accordance with the Freedom of Information
Act and our disclosure regulations (21 CFR part 20). For electronic
submissions to https://www.regulations.gov, indicate in the
``comments'' box of the appropriate docket that your submission
contains confidential information. Interested persons must also submit
a copy of the comment that does not contain the information claimed as
confidential for
[[Page 56758]]
inclusion in the public version of the official record. Information not
marked confidential will be included in the public version of the
official record without prior notice.
We are not requesting comments on the safety of these uses of the
substances in table 1 because such information is not relevant to
abandonment, which is the basis of the proposed action. We will not
consider any comments addressing safety in our evaluation of this FAP.
In addition to our consideration of this petition, we are considering
information on the safety of many of the ortho-phthalates listed in
table 1 as part of our consideration of a petition designated for
reference as FAP 6B4815 (see 81 FR 31877, May 20, 2016).
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(m) because the petition requests an action
that would prohibit or otherwise restrict or reduce the use of a
substance in food, food packaging, or cosmetics. In addition, the
petitioner has stated that, to petitioner's knowledge, no extraordinary
circumstances exist. If FDA determines a categorical exclusion applies,
neither an environmental assessment nor an environmental impact
statement is required. If FDA determines a categorical exclusion does
not apply, we will request an environmental assessment and make it
available for public inspection.
Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24657 Filed 11-13-18; 8:45 am]
BILLING CODE 4164-01-P