83 FR 56750 - Flexible Vinyl Alliance; Filing of Food Additive Petition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 220 (November 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 220 (November 14, 2018)
| Page Range | 56750-56758 | |
| FR Document | 2018-24657 |
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)] [Proposed Rules] [Pages 56750-56758] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
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without prescribing multiple engineering particular crosswalk requires translation from (703) 600–0383
requirements. three performance characteristics to one [FR Doc. 2018–24697 Filed 11–13–18; 8:45 am]
product efficiency measure, and each of
C. The Combined Metric Is Easier for BILLING CODE 6450–01–P
those performance characteristic standards
Consumers To Use and Understand
are currently further divided into separate
AFUE2 is easier for consumers to product classes. It will likely be necessary to
understand. It is difficult for the average adjust the calculated baseline efficiencies to DEPARTMENT OF HEALTH AND
consumer to distinguish between the fuel ensure that the maximum permissible energy HUMAN SERVICES
efficiency of a furnace, the electric efficiency use of the furnace reflects minimally
of the furnace fans and the watts saved or lost compliant furnaces at each product class for Food and Drug Administration
during stand-by or off-mode. The average each metric.
consumer considers three separate measures For example, minimally compliant non- 21 CFR Parts 175, 176, 177, and 178
for a single product unnecessarily complex weatherized natural gas furnaces are
and unhelpful. A single metric will serve as currently rated with an AFUE of 80%. Based [Docket No. FDA–2018–F–3757]
an easy basis of comparison between all fuel on preliminary estimates, after the
furnace types. A simple label can concisely Flexible Vinyl Alliance; Filing of Food
application of the degradation factor, the
represent the single efficiency metric and Additive Petition
baseline efficiencies for the AFUE2 rating is
provide approximate costs of operation,
77%.13 The FER and stand-by loss
which is a chief concern of consumers. AGENCY: Food and Drug Administration,
regulations also specify different product
The AFUE2 test method and metric
classes for which the minimally compliant
HHS.
improves consumer utility of the efficiency ACTION: Notification of petition.
product will also have to be measured and
information. Furnace manufacturers question
the technical viability of the FER test averaged. Using this data, the baseline
minimum efficiencies can be adjusted SUMMARY: The Food and Drug
procedure and metric. A separate regulation Administration (FDA or we) is
for ventilation energy disproportionately upward to ensure all current energy use is
emphasizes the electrical consumption of a appropriately captured. More testing is announcing that we have filed a
furnace, when the fuel consumption is much required to assign values to this petition, submitted by the Flexible
more significant to consumers. A methodology. Vinyl Alliance (FVA), requesting that
representative proportion of energy use by Crosswalks can create havoc in the market we amend our food additive regulations
both parts is described by AFUE2. if not carefully executed. AHRI urges DOE to to no longer provide for the use of 26
work with stakeholders to ensure a precise ortho-phthalates in various food-contact
IV. Metric Changes Require a Crosswalk and simple transition from ‘‘AFUE + FER + applications because these uses have
AHRI requests that DOE adopt the AFUE2 Stand-by/off-mode’’ to ‘‘AFUE2.’’ For clarity,
AHRI recommends that the baseline
been permanently abandoned.
test procedure pursuant to a notice-and-
comment rulemaking. The Department has efficiency for translation is the AFUE DATES: The food additive petition was
statutory authority to amend test procedures minimum for each residential furnace filed on July 3, 2018. Submit either
under 42 U.S.C. 6293(e) of EPCA. The statute product class. Maintaining the established electronic or written comments by
prescribes steps to establish a crosswalk from product class structure for residential January 14, 2019.
the previous metric to the new metric. furnaces will have the least disruptive impact ADDRESSES: You may submit comments
Specifically, EPCA states that DOE ‘‘shall on the market. As described above, these
determine, in the rulemaking carried out
as follows. Please note that late,
baseline efficiencies can be adjusted to
with respect to prescribing such procedure, ensure that maximum energy use and
untimely filed comments will not be
to what extent, if any, the proposed test minimum efficiencies remain steady, but the considered. Electronic comments must
procedure would alter the measured energy decades-old definitions and classifications be submitted on or before January 14,
efficiency . . . of a covered product as remain constant for ease of market adoption. 2019. The https://www.regulations.gov
determined under the existing test electronic filing system will accept
procedure.’’ V. AHRI Requests a Prompt Response
comments until 11:59 p.m. Eastern Time
The transition from three independent Finally, AHRI requests that DOE act at the end of January 14, 2019.
metrics to one integrated product metric will promptly to initiate a notice-and-comment Comments received by mail/hand
demonstrably ‘‘alter the measured rulemaking to adopt the proffered test
efficiency.’’ As such, DOE ‘‘shall amend the
delivery/courier (for written/paper
procedure and metric as soon as possible.
applicable energy conservation standard submissions) will be considered timely
The FER minimum efficiency standards go
during the rulemaking carried out with into effect in July of 2019, and DOE will have
if they are postmarked or the delivery
respect to such test procedure. In to expedite the release of a notice of service acceptance receipt is on or
determining the amended energy proposed rulemaking to ensure that before that date.
conservation standard, the Secretary shall manufacturers do not have to comply with
measure, pursuant to the amended test Electronic Submissions
one metric and test procedure while
procedure, the energy efficiency . . . of a preparing to comply with another. AHRI Submit electronic comments in the
representative sample of covered products appreciates the consideration that DOE will following way:
that minimally comply with the existing give this petition and thanks the Department • Federal eRulemaking Portal:
standard. The average of such energy in advance for its attention to this petition.
efficiency . . . determined under the
https://www.regulations.gov. Follow the
amended test procedure shall constitute the Signed, instructions for submitting comments.
amended conservation standard for the Caroline Davidson-Hood, Comments submitted electronically,
applicable covered products.’’ General Counsel. including attachments, to https://
AHRI has begun analyzing testing data to Air-Conditioning, Heating, and Refrigeration www.regulations.gov will be posted to
assist in the development of the required Institute the docket unchanged. Because your
crosswalk. A representative sample of 2311 Wilson Boulevard, Suite 400 comment will be made public, you are
furnaces that are ‘‘minimally compliant’’ Arlington, Virginia 22201 solely responsible for ensuring that your
with energy conservation minimums at each CDavidson-Hood@ahrinet.org comment does not include any
furnace product class will be tested, rated,
and averaged. This average will provide a
confidential information that you or a
13 The 3% degradation factor is based on
degradation factor that can be applied to all third party may not wish to be posted,
preliminary findings. AHRI will provide more
furnaces within that product class to ensure substantial testing to support a degradation factor
such as medical information, your or
equivalence across product lines with the as more tests are conducted. The preliminary value anyone else’s Social Security number, or
current AFUE metric. Uniquely, this will likely change with more data. confidential business information, such
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TABLE 1—ORTHO-PHTHALATES THAT WOULD BE AFFECTED BY THIS FAP—Continued
Food Additive CAS No.
Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) ............................................................................................... 119–07–3
Didecyl phthalate (Di-n-decyl phthalate) ............................................................................................................................................. 84–77–5
Dodecyl phthalate ................................................................................................................................................................................ 21577–80–0
Dihydroabietyl phthalate ...................................................................................................................................................................... 26760–71–4
Castor oil phthalate, hydrogenated ..................................................................................................................................................... N/A
Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol ............................................................................................ 68650–73–7
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 § 175.105, impacted by the FAP. Specifically, the substances listed in table 2 as being
‘‘Adhesives’’ (21 CFR 175.105) as being petition identifies the use of the impacted.
TABLE 2—ORTHO-PHTHALATES AUTHORIZED BY § 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 (1,2Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ............................................. 85–71–2
Diethyl phthalate .................................................................................................................................................................................. 84–66–2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... 84–72–0
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 phthalate) 2 .................................................................................................. 85–70–1
Dihexyl phthalate (Di-n-hexyl phthalate) ............................................................................................................................................. 84–75–3
Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate) ................................................................................................................. 117–83–9
Diisooctyl phthalate .............................................................................................................................................................................. 27554–26–3
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-decyl phthalate) ............................................................................................... 119–07–3
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 § 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 § 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 § 175.105 as Butyldecyl phthalate. These
terms are synonymous, referring to the same chemical substance.
The petition identifies § 175.300, CFR 175.300), as being impacted by the the use of the ortho-phthalates listed in
‘‘Resinous and polymeric coatings’’ (21 FAP. Specifically, the petition identifies table 3 as being impacted.
TABLE 3—ORTHO-PHTHALATES AUTHORIZED BY § 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 phthalate) ...................................................................................................... 84–72–0
Di-n-butyl phthalate 1 ........................................................................................................................................................................... 84–74–2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... 85–70–1
Diisooctyl phthalate .............................................................................................................................................................................. 27554–26–3
1 Although the petitioner refers to this substance as di-n-butyl phthalate in the petition, it is listed in § 175.300 as dibutyl phthalate. These terms
are synonymous, referring to the same chemical substance.
The petition identifies § 175.320, being impacted by the FAP. use of the ortho-phthalates listed in
‘‘Resinous and polymeric coating for Specifically, the petition identifies the table 4 as being impacted.
polyolefin films’’ (21 CFR 175.320), as
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TABLE 4—ORTHO-PHTHALATES AUTHORIZED BY § 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 phthalate) ...................................................................................................... 84–72–0
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... 85–70–1
The petition identifies § 175.380, Specifically, the petition identifies the referencing § 175.300(b)(3). Although
‘‘Xylene-formaldehyde resins use of the ortho-phthalates listed in use of ortho-phthalates authorized by
condensed with 4,4’- table 5 as being impacted. Although the § 175.380 would be affected by the FAP,
isopropylidenediphenol- regulation in § 175.380 does not directly the FAP would not require the
epichlorohydrin epoxy resins’’ (21 CFR refer to these ortho-phthalates, the regulatory text in § 175.380 to be
175.380), as being impacted by the FAP. regulation authorizes their use by cross- amended.
TABLE 5—ORTHO-PHTHALATES AUTHORIZED BY § 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 phthalate) ...................................................................................................... 84–72–0
Di-n-butyl phthalate 1 ........................................................................................................................................................................... 84–74–2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) 2 .................................................................................................. 85–70–1
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 § 175.300(b)(3) as dibutyl phthalate. These
terms are synonymous, referring to the same chemical substance.
The petition identifies § 175.390, listed in table 6 as being impacted by § 175.300. Although use of ortho-
‘‘Zinc-silicon dioxide matrix coatings’’ the FAP. Although the regulation in phthalates authorized by § 175.390
(21 CFR 175.390) as being impacted by § 175.390 does not directly refer to these would be affected by the FAP, the FAP
the FAP. Specifically, the petition ortho-phthalates, the regulation would not require the regulatory text in
identifies the use of the ortho-phthalates authorizes their use by cross-referencing § 175.390 to be amended.
TABLE 6—ORTHO-PHTHALATES AUTHORIZED BY § 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 phthalate) ...................................................................................................... 84–72–0
Di-n-butyl phthalate 1 ........................................................................................................................................................................... 84–74–2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... 85–70–1
Diisooctyl phthalate .............................................................................................................................................................................. 27554–26–3
1 Although the petitioner refers to this substance as di-n-butyl phthalate in the petition, it is listed in § 175.300 as dibutyl phthalate. These terms
are synonymous, referring to the same chemical substance.
The petition identifies § 176.170, (21 CFR 176.170) as being affected by identifies the use of the ortho-phthalates
‘‘Components of paper and paperboard the FAP. Specifically, the petition listed in table 7 as being impacted.
in contact with aqueous and fatty foods’’
TABLE 7—ORTHO-PHTHALATES AUTHORIZED BY § 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 § 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 § 176.170 as dibutyl phthalate. These terms
are synonymous, referring to the same chemical substance.
The petition identifies § 176.180, in contact with dry food’’ (21 CFR Specifically, the petition identifies the
‘‘Components of paper and paperboard 176.180) as being impacted by the FAP. use of the ortho-phthalates listed in
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table 8 as being impacted. Although the refer to all of these ortho-phthalates, the them either directly or by cross-
regulation in § 176.180 does not directly regulation authorizes the use of all of referencing § 176.170.
TABLE 8—ORTHO-PHTHALATES AUTHORIZED BY § 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 § 176.170 as dibutyl phthalate. These terms
are synonymous, referring to the same chemical substance.
The petition identifies § 176.300, petition identifies the ortho-phthalates of which are permitted as a result of
‘‘Slimicides’’ (21 CFR 176.300), as being listed in table 9 as being impacted, some being listed in §§ 176.170 and 176.180.
impacted by the FAP. Specifically, the
TABLE 9—ORTHO-PHTHALATES AUTHORIZED BY § 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 § 177.1010, as being impacted by the FAP. use of the ortho-phthalate listed in table
‘‘Acrylic and modified acrylic plastics, Specifically, the petition identifies the 10 as being impacted.
semirigid and rigid’’ (21 CFR 177.1010)
TABLE 10—ORTHO-PHTHALATES AUTHORIZED BY § 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 § 177.1200, being impacted by the FAP. use of the ortho-phthalates listed in
‘‘Cellophane’’ (21 CFR 177.1200) as Specifically, the petition identifies the table 11 as being impacted.
TABLE 11—ORTHO-PHTHALATES AUTHORIZED BY § 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-diethylene glycol ............................................................................................ 68650–73–7
1 Although the petitioner refers to this substance as di-n-butyl phthalate in the petition, it is listed in § 177.1200 as dibutylphthalate. These
terms are synonymous, referring to the same chemical substance.
The petition identifies § 177.1210, regulation in § 177.1210 does not under § 177.1210, § 177.1210 also
‘‘Closures with sealing gaskets for food directly refer to these ortho-phthalates, authorizes the use of the remaining
containers’’ (21 CFR 177.1210), as being the regulation authorizes their use by substances that are listed in table 12. We
impacted by the FAP. Specifically, the cross-referencing authorizations in 21 have listed these remaining substances
petition identifies the first five ortho- CFR parts 174–178 and § 179.45 (21 CFR in table 12 because the petition seeks to
phthalates listed in table 12 as being 179.45). In addition to the first five revoke the food additive approvals for
impacted based on the authorization of ortho-phthalates in table 12 that the these substances, and § 177.1210
their use in § 177.1210. Although the petition identifies as being authorized authorizes their food additive use by
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cross-referencing authorizations in parts that are listed in table 12 would be require the regulatory text in § 177.1210
174–178 and § 179.45. Although use of affected by the FAP, the FAP would not to be amended.
the substances authorized by § 177.1210
TABLE 12—ORTHO-PHTHALATES AUTHORIZED BY § 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 phthalate) ...................................................................................................... 84–72–0
Di-n-butyl phthalate .............................................................................................................................................................................. 84–74–2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... 85–70–1
Diisooctyl phthalate .............................................................................................................................................................................. 27554–26–3
Dimethyl phthalate (dimethyl orthophthalate) ...................................................................................................................................... 131–11–3
Diphenyl phthalate ............................................................................................................................................................................... 84–62–8
Methyl phthalyl ethyl glycolate (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ............................................ 85–71–2
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) phthalate) ................................................................................................................. 117–83–9
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-decyl phthalate) ............................................................................................... 119–07–3
Didecyl phthalate (Di-n-decyl phthalate) ............................................................................................................................................. 84–77–5
Dodecyl phthalate ................................................................................................................................................................................ 21577–80–0
Dihydroabietyl phthalate ...................................................................................................................................................................... 26760–71–4
Castor oil phthalate, hydrogenated ..................................................................................................................................................... N/A
Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol ............................................................................................ 68650–73–7
The petition identifies § 177.1400, impacted. Although the regulation in § 177.1400 would be affected by the
‘‘Hydoxyethyl cellulose film, water- § 177.1400 does not directly refer to FAP, the FAP would not require the
insoluble’’ (21 CFR 177.1400), as being these ortho-phthalates, the regulation regulatory text in § 175.1400 to be
impacted by the FAP. Specifically, the authorizes their use by cross-referencing amended.
petition identifies the use of the ortho- § 177.1200(c). Although use of the
phthalates listed in table 13 as being ortho-phthalates authorized by
TABLE 13—ORTHO-PHTHALATES AUTHORIZED BY § 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-diethylene glycol ............................................................................................ 68650–73–7
1 Although the petitioner refers to this substance as di-n-butyl phthalate in the petition, it is listed in § 177.1200 as dibutylphthalate. These
terms are synonymous, referring to the same chemical substance.
The petition identifies § 177.1460, being impacted by the FAP. use of the ortho-phthalate listed in table
‘‘Melamine-formaldehyde resins in Specifically, the petition identifies the 14 as being impacted.
molded articles’’ (21 CFR 177.1460), as
TABLE 14—ORTHO-PHTHALATES AUTHORIZED BY § 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
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The petition identifies § 177.1590, 177.1590), as being impacted by the the use of the ortho-phthalate listed in
‘‘Polyester elastomers’’ (21 CFR FAP. Specifically, the petition identifies table 15 as being impacted.
TABLE 15—ORTHO-PHTHALATES AUTHORIZED BY § 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 § 177.2420, 177.2420), as being impacted by the the use of the ortho-phthalates listed in
‘‘Polyester resins, cross-linked’’ (21 CFR FAP. Specifically, the petition identifies table 16 as being impacted.
TABLE 16—ORTHO-PHTHALATES AUTHORIZED BY § 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 § 177.2420 as dibutyl phthalate. These
terms are synonymous, referring to the same chemical substance.
The petition identifies § 177.2600, CFR 177.2600), as being impacted by the the use of the substances listed in table
‘‘Rubber articles for repeated use’’ (21 FAP. Specifically, the petition identifies 17 as being impacted.
TABLE 17—ORTHO-PHTHALATES AUTHORIZED BY § 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-decyl phthalate) ............................................................................................... 119–07–3
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 § 177.1200 as dibutyl phthalate. These
terms are synonymous, referring to the same chemical substance.
The petition identifies § 178.3740, (21 CFR 178.3740), as being impacted by identifies the use of the ortho-phthalates
‘‘Plasticizers in polymeric substances’’ the FAP. Specifically, the petition listed in table 18 as being impacted.
TABLE 18—ORTHO-PHTHALATES AUTHORIZED BY § 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 § 178.3910, CFR 178.3910), as being impacted by the the use of the ortho-phthalate listed in
‘‘Surface lubricants used in the FAP. Specifically, the petition identifies table 19 as being impacted.
manufacture of metallic articles’’ (21
TABLE 19—ORTHO-PHTHALATES AUTHORIZED BY § 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
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inclusion in the public version of the seeking comment on two alternate co- instructions. An electronic copy of this
official record. Information not marked proposals to help advance this objective: document may also be downloaded
confidential will be included in the First, FHWA proposes to amend and from the Office of the Federal Register’s
public version of the official record replace the requirements relating to home page at: http://www.archives.gov/
without prior notice. patented and proprietary product federal-register and the Government
We are not requesting comments on approvals with a more flexible general Publishing Office’s web page at: http://
the safety of these uses of the substances requirement that enhances fairness, www.gpo.gov/fdsys.
in table 1 because such information is open competition, and transparency in
Background
not relevant to abandonment, which is the product selection process.
the basis of the proposed action. We Alternatively, the agency proposes There are differing practices across
will not consider any comments rescinding the requirements, thereby the United States on whether
addressing safety in our evaluation of encouraging further innovation in the government entities may specify a
this FAP. In addition to our development of new highway patented material, article, or process in
consideration of this petition, we are transportation technology and methods, the letting of public works contracts
considering information on the safety of as well as potentially reducing costs. through competitive bidding.1 Some
many of the ortho-phthalates listed in DATES: Comments must be received on jurisdictions prohibit the practice
table 1 as part of our consideration of a or before January 14, 2019. Late-filed altogether on the grounds that it would
petition designated for reference as FAP comments will be considered to the inhibit competition, particularly where
6B4815 (see 81 FR 31877, May 20, extent practicable. only one contractor can provide the
2016). specified material.2 Other jurisdictions
ADDRESSES: To ensure that you do not
The petitioner has claimed that this allow the specification as long as the
duplicate your docket submissions,
action is categorically excluded under use of any other article equally as
please submit them by only one of the
21 CFR 25.32(m) because the petition suitable is also allowed.3 The Federal
following means:
requests an action that would prohibit • Federal eRulemaking Portal: Go to government’s regulations on direct
or otherwise restrict or reduce the use http://www.regulations.gov and follow procurement and the uniform
of a substance in food, food packaging, the online instructions for submitting regulations on Federal financial
or cosmetics. In addition, the petitioner comments. assistance take the latter approach.4 In
has stated that, to petitioner’s • Mail: Docket Management Facility, the majority of States, however, the
knowledge, no extraordinary U.S. Department of Transportation, 1200 practice of specifying a patented
circumstances exist. If FDA determines New Jersey Avenue SE, West Building product in government contracts is
a categorical exclusion applies, neither Ground Floor Room W12–140, allowed.5
an environmental assessment nor an Washington, DC 20590; The Federal-aid Road Act of 1916
environmental impact statement is • Hand Delivery: West Building (1916 Act) 6 was silent about patented
required. If FDA determines a Ground Floor, Room W12–140, 1200 and proprietary products but provided
categorical exclusion does not apply, we New Jersey Avenue SE, Washington, DC that Federal-aid funded State highway
will request an environmental 20590, between 9 a.m. 5 p.m., Monday construction was ‘‘subject to the
assessment and make it available for through Friday, except Federal holidays. inspection and approval of the Secretary
public inspection. The telephone number is (202) 366– of Agriculture, and in accordance with
9329. the rules and regulation made pursuant
Dated: November 6, 2018.
• Instructions: You must include the to this Act.’’ 7
Leslie Kux, Accordingly, regulations
agency name and docket number or the
Associate Commissioner for Policy. implementing the 1916 Act were issued
Regulatory Identification Number (RIN)
[FR Doc. 2018–24657 Filed 11–13–18; 8:45 am]
for the rulemaking at the beginning of on September 1, 1916. Regulation 8,
BILLING CODE 4164–01–P
your comments. All comments received Section 4 of those rules provided, ‘‘No
will be posted without change to part of the money apportioned under
www.regulations.gov, including any the act shall be used, directly or
DEPARTMENT OF TRANSPORTATION personal information provided. indirectly, to pay, or to reimburse a
State, county, or local subdivision for
FOR FURTHER INFORMATION CONTACT: Mr.
Federal Highway Administration the payment of any premium or royalty
John Huyer, Office of Preconstruction, on any patented or proprietary material,
Construction and Pavements, (651) 291– specification, process, or type of
23 CFR Parts 630 and 635
6111 or, Mr. William Winne, Office of construction, unless purchased or
[FHWA Docket No. FHWA–2018–0036] the Chief Counsel, (202) 366–1397, obtained on open actual competitive
Federal Highway Administration, 1200 bidding at the same or a less cost than
RIN 2125–AF84 New Jersey Avenue SE, Washington, DC
20590. Office hours are from 8 a.m. to
Construction and Maintenance— 1 See generally 10 McQuillin Mun. Corp. § 29.42
4:30 p.m., e.t., Monday through Friday, (3d ed.).
Promoting Innovation in Use of
except Federal holidays. 2 Examples include Illinois, Indiana, Kentucky,
Patented and Proprietary Products Louisiana, Massachusetts, and Wisconsin.
SUPPLEMENTARY INFORMATION:
3 Examples include California, Iowa, New Jersey,
AGENCY: Federal Highway
Administration (FHWA), Department of Electronic Access and Filing and New York.
4 See 48 CFR 52.211–6 and 2 CFR 200.319(a)(6).
Transportation (DOT). This document and all comments 5 Examples include Arizona, Colorado,
ACTION: Notice of proposed rulemaking received may be viewed online through Connecticut, Florida, Idaho, Kansas, Maryland,
(NPRM); request for comments. the Federal eRulemaking portal at Michigan, Montana, Nebraska, Ohio, Oklahoma,
http://www.regulations.gov. Electronic Oregon, Pennsylvania, South Carolina, Texas, and
Washington.
SUMMARY: This rulemaking would submission and retrieval help and 6 1916 Act, ch. 241, 39 Stat. 355.
provide greater flexibility to States to guidelines are available on the website. 7 The Office of Public Roads was the predecessor
use proprietary or patented materials in It is available 24 hours each day, 365 agency of FHWA and was part of the Department
Federal-aid projects. The FHWA is days a year. Please follow the of Agriculture in 1916.
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Document Created: 2018-11-14 03:32:15
Document Modified: 2018-11-14 03:32:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of petition. | |
| Dates | The food additive petition was filed on July 3, 2018. Submit either electronic or written comments by January 14, 2019. | |
| Contact | Stephen DiFranco, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710. | |
| FR Citation | 83 FR 56750 | |
| CFR Citation | 21
CFR
175 21 CFR 176 21 CFR 177 21 CFR 178 |
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