[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Proposed Rules]
[Pages 56750-56758]
[FR Doc No: 2018-24657]

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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]

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

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
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``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,<PHONE_NUMBER>.

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

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.

  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

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

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
------------------------------------------------------------------------

    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
------------------------------------------------------------------------

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

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


[Federal Register: October 30, 2008 (Volume 73, Number 211)]
[Proposed Rules]
[Page 64568-64571]
[DOCID:fr30oc08-17]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1118; Directorate Identifier 2007-NM-318-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-600, -700, -700C, -
800, and -900 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) that applies to all Boeing Model 737-600, -700, -700C, -
800, and -900 series airplanes. The existing AD currently requires
reviewing the airplane maintenance records to determine whether an
engine has been removed from the airplane since the airplane was
manufactured. For airplanes on which an engine has been removed, the
existing AD also requires an inspection of the aft engine mount to
determine if the center link assembly is correctly installed, and
follow-on actions if necessary. This proposed AD would require the same
actions for airplanes on which the engine has not been previously
removed. This proposed AD results from reports indicating that
operators found that the center link assembly for the aft engine mount
was reversed on several airplanes that had not had an engine removed
since delivery. We are proposing this AD to prevent increased
structural loads on the aft engine mount, which could result in failure
of the aft engine mount and consequent separation of the engine from
the airplane.

DATES: We must receive comments on this proposed AD by December 15,
2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Allen Rauschendorfer, Aerospace
Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-1118;
Directorate Identifier 2007-NM-318-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On January 21, 2003, we issued AD 2003-03-01, amendment 39-13025
(68 FR 4367, January 29, 2003), for all Boeing Model 737-600, -700, -
700C, -800, and -900 series airplanes. That AD requires reviewing the
airplane maintenance records to determine whether an engine has been
removed from the airplane since the airplane was manufactured. For
airplanes on which an engine has been removed, that AD requires an
inspection of the aft engine mount to determine if the center link
assembly is correctly installed, and follow-on actions if necessary.
That AD resulted from reports indicating that operators found that the
center link assembly for the aft engine mount was reversed on several
airplanes. We issued that AD to prevent increased structural loads on
the aft engine mount, which could result in failure of the aft engine
mount and consequent separation of the engine from the airplane.

Actions Since Existing AD Was Issued

    Since we issued AD 2003-03-01, the manufacturer informed us that it
is possible that some center links were incorrectly installed in an aft
engine mount before the airplane was delivered. In AD 2003-03-01
inspection of the aft engine mounts was required only for airplanes
that had an engine change after the airplane was delivered to the
operator. The inspection is now necessary for all airplanes, line
numbers 1 through 1277 inclusive.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin 737-71A1462,
Revision 3, dated May 20, 2004. The procedures in Revision 3 of the
service bulletin are essentially the same as those in Boeing Alert
Service Bulletin 737-71A1462, Revision 1, dated November 7, 2002. We
referred to Revision 1 of the service bulletin as the appropriate
source of service information for accomplishing the actions required by
AD 2003-03-01. However, Revision 3 of the service bulletin also
specifies inspecting to determine if the center link assembly is
installed correctly on any installed engine that has not been removed
from

the airplane since the airplane's delivery. Revision 3 of the service
bulletin also specifies repeating the inspection during each subsequent
engine change for each aft engine mount. Finally, Revision 3 also
specifies that adding permanent part marks on the center link assembly
and the hanger fitting ends the need for the repetitive inspections.
Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition.

FAA's Determination and Requirements of the Proposed AD

    We have evaluated all pertinent information and identified an
unsafe condition that is likely to develop on other airplanes of the
same type design. For this reason, we are proposing this AD, which
would supersede AD 2003-03-01 and would retain the requirements of the
existing AD. This proposed AD would also require the same actions for
airplanes on which the engine has not been previously removed. This
proposed AD would also require accomplishing the actions specified in
the service bulletin described previously, except as discussed under
``Difference Between the Proposed AD and the Service Bulletin.''

Difference Between the Proposed AD and the Service Bulletin

    Boeing Alert Service Bulletin 737-71A1462, Revision 3 specifies
contacting the part manufacturer (CFMI) for more instructions if damage
is found to the engine mounting lugs and the adjacent engine turbine
rear frame. (Damage includes cracking, yielding, buckling, and wear.)
However, this proposed AD would require repairing those conditions in
one of the following ways:
     Using a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by an Authorized Representative
for the Boeing Commercial Airplanes Delegation Option Authorization
(DOA) Organization whom we have authorized to make those findings.

Clarification of Certain Actions

    Revision 3 of the service bulletin specifies repeating the
inspection during each subsequent engine change for each aft engine
mount. This proposed AD does not specify a repetitive inspection but
instead specifies in paragraph (n), ``Parts Installation,'' that no
person may install an engine on any airplane unless the center link
assembly of the aft engine mount is found to be installed correctly.
    Revision 3 of the service bulletin also specifies that adding
permanent part marks on the center link assembly and the hanger fitting
ends the need for the repetitive inspections. As noted above, this
proposed AD would not include a repetitive inspection requirement. In
addition, because the affected parts are rotable, the repetitive
inspections referred to in the service bulletin would be terminated
only as long as the engine stays on the airplane.

Changes to Existing AD

    This proposed AD would retain the requirements of AD 2003-03-01.
Since AD 2003-03-01 was issued, the AD format has been revised, and
certain paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers have changed in this proposed AD, as listed in
the following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                          Corresponding  requirement  in
      Requirement in AD  2003-03-01              this  proposed AD
------------------------------------------------------------------------
Paragraph (a)...........................  Paragraph (f).
Paragraph (b)...........................  Paragraph (g).
Paragraph (c)...........................  Paragraph (h).
Paragraph (d)...........................  Paragraph (i).
Paragraph (e)...........................  Paragraph (m).
Paragraph (f)...........................  Paragraph (n).
------------------------------------------------------------------------

    We have also removed Note 1 of the existing AD and re-numbered
subsequent notes accordingly. We have also revised Note 2 and Note 3 of
the existing AD (Note 1 and Note 2 of this proposed AD) to provide a
more up-to-date definition of a general visual inspection and a
detailed inspection.
    Boeing Commercial Airplanes has received a DOA. We have revised
paragraph (i) of this AD (paragraph (d) of AD 2003-03-01) to delegate
the authority to approve an alternative method of compliance for any
repair required by this proposed AD to an Authorized Representative for
the Boeing Commercial Airplanes DOA rather than a Designated
Engineering Representative (DER). We have also simplified paragraph (i)
of this AD by referring to the ``Alternative Methods of Compliance
(AMOCs)'' paragraph (o) of this proposed AD for repair methods, which
includes a reference to the DOA.

Costs of Compliance

    There are about 1,277 airplanes of the affected design in the
worldwide fleet. This proposed AD would affect about 500 airplanes of
U.S. registry. The average labor rate is $80 per work hour. The
following table provides the estimated costs for U.S. operators to
comply with this proposed AD.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                           Action                              Work hours     Parts       airplane    Fleet cost
----------------------------------------------------------------------------------------------------------------
Maintenance records review (required by AD 2003-03-01)......            1           $0          $80      $40,000
Inspection for correct installation of center link assembly             1            0           80       40,000
 (new proposed action)......................................
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-13025 (68 FR 4367, January 29, 2003) and adding
the following new airworthiness directive (AD):

Boeing: Docket No. FAA-2008-1118; Directorate Identifier 2007-NM-
318-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by December
15, 2008.

Affected ADs

    (b) This AD supersedes AD 2003-03-01.

Applicability

    (c) This AD applies to all Boeing Model 737-600, -700, -700C, -
800, and -900 series airplanes, certificated in any category.

Unsafe Condition

    (d) This AD results from reports indicating that operators found
that the center link assembly for the aft engine mount was reversed
on several airplanes that had not had an engine removed since
delivery. We are issuing this AD to prevent increased structural
loads on the aft engine mount, which could result in failure of the
aft engine mount and consequent separation of the engine from the
airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of the Requirements of AD 2003-03-01

Review of Maintenance Records

    (f) Within 90 days after February 13, 2003 (the effective date
of AD 2003-03-01), review the airplane maintenance records to
determine whether either engine has been removed since the
airplane's date of manufacture. If neither engine has been removed
since the airplane's date of manufacture, no further action is
required by this paragraph; however paragraph (n) of this AD
continues to apply.

Inspection To Determine if Center Link Assembly Is Installed Correctly

    (g) For any installed engine that is found to have been removed
from the airplane since the airplane's date of manufacture: Within
90 days after February 13, 2003, do a one-time general visual
inspection to determine if the center link assembly of the aft
engine mount is installed correctly, per the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-71A1462, Revision
1, dated November 7, 2002; or Revision 3, dated May 20, 2004. If the
center link assembly is installed correctly, as specified in the
service bulletin, no further action is required by paragraph (g),
(h), or (i) of this AD for that engine; however paragraph (n) of
this AD continues to apply.

    Note 1: For the purposes of this AD, a general visual inspection
is: ``A visual examination of an interior or exterior area,
installation, or assembly to detect obvious damage, failure, or
irregularity. This level of inspection is made from within touching
distance unless otherwise specified. A mirror may be necessary to
ensure visual access to all surfaces in the inspection area. This
level of inspection is made under normally available lighting
conditions such as daylight, hangar lighting, flashlight, or
droplight and may require removal or opening of access panels or
doors. Stands, ladders, or platforms may be required to gain
proximity to the area being checked.''

Follow-on and Corrective Actions

    (h) For any center link assembly that is found installed
incorrectly during the inspection required by paragraph (g) of this
AD: Before further flight, do the actions in paragraphs (h)(1),
(h)(2), and (h)(3) of this AD, per the Accomplishment Instructions
of Boeing Alert Service Bulletin 737-71A1462, Revision 1, dated
November 7, 2002; or Revision 3, dated May 20, 2004; except that it
is not necessary to submit a report of findings to the airplane
manufacturer.
    (1) Remove the center link assembly and install it correctly.
    (2) Perform a detailed inspection of the engine mounting lugs
and engine turbine rear frame for cracking, yielding, buckling, or
wear damage.
    (3) Perform a detailed inspection of the hardware for the aft
engine mount; including the center link assembly, right link
assembly, aft mount hanger assembly, and link pins; for cracking,
yielding, buckling, or wear damage.

    Note 2: For the purposes of this AD, a detailed inspection is:
``An intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirror, magnifying lenses, etc., may be necessary. Surface cleaning
and elaborate procedures may be required.''

Repair

    (i) If any cracking, yielding, buckling, or wear damage is found
during the inspections required by paragraphs (h)(2) and (h)(3) of
this AD: Before further flight, replace the discrepant part with a
new or serviceable part, or repair in accordance with a method
approved by the Manager, Seattle Aircraft Certification Office
(ACO), FAA; or using a method approved in accordance with the
procedures specified in paragraph (o) of this AD.

New Requirements of This AD

Inspection of Engines That Have Not Been Removed

    (j) For all airplanes identified in Boeing Alert Service
Bulletin 737-71A1462, Revision 3, dated May 20, 2004: For any
installed engine that has not been removed from the airplane since
the airplane's date of manufacture, within 90 days after the
effective date of this AD, do a detailed inspection to determine if
the center link assembly of the aft engine mount is installed
correctly, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-71A1462, Revision 3, dated May 20,
2004.

Follow-on and Corrective Actions

    (k) For any center link assembly that is found installed
incorrectly during any inspection required by paragraph (j) of this
AD: Before further flight, do the actions required by paragraphs
(k)(1), (k)(2), and (k)(3) of this AD, per the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-71A1462, Revision
3, dated May 20, 2004, except that it is not necessary to submit a
report of findings to the airplane manufacturer.
    (1) Remove the center link assembly and install it correctly.
    (2) Perform a detailed inspection of the engine mounting lugs
and engine turbine rear frame for cracking, yielding, buckling, or
wear damage.
    (3) Perform a detailed inspection of the hardware for the aft
engine mount; including the center link assembly, right link
assembly, aft mount hanger assembly, and link pins; for cracking,
yielding, buckling, or wear damage.

Repair

    (l) If any cracking, yielding, buckling, or wear damage is found
during the inspections required by paragraphs (k)(2) and (k)(3) of
this AD, and Boeing Alert Service Bulletin 737-71A1462, Revision 3,
dated May 20, 2004, specifies to contact Boeing or the part

manufacturer: Before further flight, replace the discrepant part
(e.g., parts with cracking, yielding, buckling, and wear damage)
with a new or serviceable part, or repair using a method approved in
accordance with the procedures specified in paragraph (o) of this
AD.

Credit for Actions Done Using Previous Service Information

    (m) Inspections and corrective actions done before the effective
date of this AD in accordance with a service bulletin listed in
Table 1 of this AD are acceptable for compliance with the
corresponding requirements of this AD.

                   Table 1--Previous Service Bulletins
------------------------------------------------------------------------
 Boeing Alert Service  Bulletin       Revision              Date
------------------------------------------------------------------------
737-71A1462.....................  Original.......  Aug. 29, 2002.
737-71A1462.....................  1..............  Nov. 7, 2002.
737-71A1462.....................  2..............  May 29, 2003.
------------------------------------------------------------------------

Parts Installation

    (n) As of the effective date of this AD, no person may install
an engine on any airplane unless the inspections specified in
paragraph (g) or (j) of this AD are accomplished and the center link
assembly of the aft engine mount is found to be installed correctly.

Alternative Methods of Compliance (AMOCs)

    (o)(1) The Manager, Seattle Aircraft Certification Office (ACO)
FAA, ATTN: Allen Rauschendorfer, Aerospace Engineer, Airframe
Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601
Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6432; fax<PHONE_NUMBER>; has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

    Issued in Renton, Washington, on October 10, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-25903 Filed 10-29-08; 8:45 am]

BILLING CODE 4910-13-P


Comment Info: =================

General Comment: Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I am a mother of 3, and I also hold a job out side of the home. My daily time is limited and while I have already spent many hours researching and dissecting these issues, they do take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback. Imagine if your employees only had 75 days to produce the document in question while working ANOTHER job and the impact that would have on their family. In 75 day commenting period I have my oldest child getting a drivers license, which in the State of Maryland requires 60 hours behind the wheel with a parent. He is also working while going to college, which I provide transportation for. My 15 year old is getting a learners permit(Another 60 hours of drive time) and is also going through AP testing while preparing to go to junior police academy in June, and the all important softball season. My youngest being prepared for entering middle school, with extra homeschooling in areas she is weak in at school. Those are just a few of my personal daily challenges. This doesn't include making dinner, paying the bills, grocery shopping, laundry,the children's extra curricular activities, getting my garden in, as we supplement our large food bill with home grown salads and other vegetable goods as well as a flock of chickens that require daily care. Add to that my full time employment. Even having time to read a paper can be a challenge. This issue is important to me. I would just like more time to prepare my comment, and right now I do not feel prepared.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.