Flexible Vinyl Alliance; Filing of Food Additive Petition, 56750-56758 [2018-24657]

Download as PDF 56750 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules without prescribing multiple engineering requirements. C. The Combined Metric Is Easier for Consumers To Use and Understand AFUE2 is easier for consumers to understand. It is difficult for the average consumer to distinguish between the fuel efficiency of a furnace, the electric efficiency of the furnace fans and the watts saved or lost during stand-by or off-mode. The average consumer considers three separate measures for a single product unnecessarily complex and unhelpful. A single metric will serve as an easy basis of comparison between all fuel furnace types. A simple label can concisely represent the single efficiency metric and provide approximate costs of operation, which is a chief concern of consumers. The AFUE2 test method and metric improves consumer utility of the efficiency information. Furnace manufacturers question the technical viability of the FER test procedure and metric. A separate regulation for ventilation energy disproportionately emphasizes the electrical consumption of a furnace, when the fuel consumption is much more significant to consumers. A representative proportion of energy use by both parts is described by AFUE2. IV. Metric Changes Require a Crosswalk AHRI requests that DOE adopt the AFUE2 test procedure pursuant to a notice-andcomment rulemaking. The Department has statutory authority to amend test procedures under 42 U.S.C. 6293(e) of EPCA. The statute prescribes steps to establish a crosswalk from the previous metric to the new metric. Specifically, EPCA states that DOE ‘‘shall determine, in the rulemaking carried out with respect to prescribing such procedure, to what extent, if any, the proposed test procedure would alter the measured energy efficiency . . . of a covered product as determined under the existing test procedure.’’ The transition from three independent metrics to one integrated product metric will demonstrably ‘‘alter the measured efficiency.’’ As such, DOE ‘‘shall amend the applicable energy conservation standard during the rulemaking carried out with respect to such test procedure. In determining the amended energy conservation standard, the Secretary shall measure, pursuant to the amended test procedure, the energy efficiency . . . of a representative sample of covered products that minimally comply with the existing standard. The average of such energy efficiency . . . determined under the amended test procedure shall constitute the amended conservation standard for the applicable covered products.’’ AHRI has begun analyzing testing data to assist in the development of the required crosswalk. A representative sample of furnaces that are ‘‘minimally compliant’’ with energy conservation minimums at each furnace product class will be tested, rated, and averaged. This average will provide a degradation factor that can be applied to all furnaces within that product class to ensure equivalence across product lines with the current AFUE metric. Uniquely, this VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 particular crosswalk requires translation from three performance characteristics to one product efficiency measure, and each of those performance characteristic standards are currently further divided into separate product classes. It will likely be necessary to adjust the calculated baseline efficiencies to ensure that the maximum permissible energy use of the furnace reflects minimally compliant furnaces at each product class for each metric. For example, minimally compliant nonweatherized natural gas furnaces are currently rated with an AFUE of 80%. Based on preliminary estimates, after the application of the degradation factor, the baseline efficiencies for the AFUE2 rating is 77%.13 The FER and stand-by loss regulations also specify different product classes for which the minimally compliant product will also have to be measured and averaged. Using this data, the baseline minimum efficiencies can be adjusted upward to ensure all current energy use is appropriately captured. More testing is required to assign values to this methodology. Crosswalks can create havoc in the market if not carefully executed. AHRI urges DOE to work with stakeholders to ensure a precise and simple transition from ‘‘AFUE + FER + Stand-by/off-mode’’ to ‘‘AFUE2.’’ For clarity, AHRI recommends that the baseline efficiency for translation is the AFUE minimum for each residential furnace product class. Maintaining the established product class structure for residential furnaces will have the least disruptive impact on the market. As described above, these baseline efficiencies can be adjusted to ensure that maximum energy use and minimum efficiencies remain steady, but the decades-old definitions and classifications remain constant for ease of market adoption. V. AHRI Requests a Prompt Response Finally, AHRI requests that DOE act promptly to initiate a notice-and-comment rulemaking to adopt the proffered test procedure and metric as soon as possible. The FER minimum efficiency standards go into effect in July of 2019, and DOE will have to expedite the release of a notice of proposed rulemaking to ensure that manufacturers do not have to comply with one metric and test procedure while preparing to comply with another. AHRI appreciates the consideration that DOE will give this petition and thanks the Department in advance for its attention to this petition. Signed, Caroline Davidson-Hood, General Counsel. Air-Conditioning, Heating, and Refrigeration Institute 2311 Wilson Boulevard, Suite 400 Arlington, Virginia 22201 CDavidson-Hood@ahrinet.org 13 The 3% degradation factor is based on preliminary findings. AHRI will provide more substantial testing to support a degradation factor as more tests are conducted. The preliminary value will likely change with more data. PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 (703) 600–0383 [FR Doc. 2018–24697 Filed 11–13–18; 8:45 am] BILLING CODE 6450–01–P 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. 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. SUMMARY: 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 E:\FR\FM\14NOP1.SGM 14NOP1 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–F–3757 for ‘‘Flexible Vinyl Alliance; Filing of Food Additive Petition.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions: To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. 56751 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 orthophthalates 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) ...................................................................................................................................... Diphenyl phthalate ............................................................................................................................................................................... Methyl phthalyl ethyl glycolate (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ............................................ Diethyl phthalate .................................................................................................................................................................................. Diphenylguanidine phthalate 1 ............................................................................................................................................................. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... Diallyl phthalate ................................................................................................................................................................................... Diisobutyl phthalate ............................................................................................................................................................................. Butyl benzyl phthalate ......................................................................................................................................................................... Di-n-butyl phthalate .............................................................................................................................................................................. Butyl phthalyl butyl glycolate 2 (Butyl carbobutoxymethyl phthalate) .................................................................................................. Dihexyl phthalate (Di-n-hexyl phthalate) ............................................................................................................................................. Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate) ................................................................................................................. Dimethylcyclohexyl phthalate .............................................................................................................................................................. Diisooctyl phthalate .............................................................................................................................................................................. Dioctyl phthalate (Di-n-octyl phthalate) ............................................................................................................................................... Butyloctyl phthalate (n-butyl n-octyl phthalate) ................................................................................................................................... Di(2-ethylhexyl) hexahydrophthalate 1 ................................................................................................................................................. Amyl decyl phthalate (n-amyl n-decyl phthalate) ................................................................................................................................ Butyl decyl phthalate (n-butyl n-decyl phthalate) ................................................................................................................................ VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\14NOP1.SGM 14NOP1 131–11–3 84–62–8 85–71–2 84–66–2 17573–13–6 84–72–0 131–17–9 84–69–5 85–68–7 84–74–2 85–70–1 84–75–3 117–83–9 1322–94–7 27554–26–3 117–84–0 84–78–6 84–71–9 7493–81–4 89–19–0 56752 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules 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) ............................................................................................... Didecyl phthalate (Di-n-decyl phthalate) ............................................................................................................................................. Dodecyl phthalate ................................................................................................................................................................................ Dihydroabietyl phthalate ...................................................................................................................................................................... Castor oil phthalate, hydrogenated ..................................................................................................................................................... Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol ............................................................................................ 119–07–3 84–77–5 21577–80–0 26760–71–4 N/A 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, ‘‘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 § 175.105 THAT WOULD BE AFFECTED BY THIS FAP [‘‘Adhesives’’] Food additive CAS No. Dimethyl phthalate (dimethyl orthophthalate) ...................................................................................................................................... Diphenyl phthalate ............................................................................................................................................................................... Methyl phthalyl ethyl glycolate (1,2Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ............................................. Diethyl phthalate .................................................................................................................................................................................. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... Diallyl phthalate ................................................................................................................................................................................... Diisobutyl phthalate ............................................................................................................................................................................. Butyl benzyl phthalate ......................................................................................................................................................................... Di-n-butyl phthalate 1 ........................................................................................................................................................................... Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) 2 .................................................................................................. Dihexyl phthalate (Di-n-hexyl phthalate) ............................................................................................................................................. Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate) ................................................................................................................. Diisooctyl phthalate .............................................................................................................................................................................. Dioctyl phthalate (Di-n-octyl phthalate) ............................................................................................................................................... Butyloctyl phthalate (n-butyl n-octyl phthalate) ................................................................................................................................... Di(2-ethylhexyl) hexahydrophthalate ................................................................................................................................................... Butyl decyl phthalate (n-butyl n-decyl phthalate) 3 .............................................................................................................................. Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) ............................................................................................... Dihydroabietyl phthalate ...................................................................................................................................................................... 131–11–3 84–62–8 85–71–2 84–66–2 84–72–0 131–17–9 84–69–5 85–68–7 84–74–2 85–70–1 84–75–3 117–83–9 27554–26–3 117–84–0 84–78–6 84–71–9 89–19–0 119–07–3 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, ‘‘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 § 175.300 THAT WOULD BE AFFECTED BY THIS FAP [‘‘Resinous and polymeric coatings’’] Food additive CAS No. Diethyl phthalate .................................................................................................................................................................................. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... Di-n-butyl phthalate 1 ........................................................................................................................................................................... Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... Diisooctyl phthalate .............................................................................................................................................................................. 84–66–2 84–72–0 84–74–2 85–70–1 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, ‘‘Resinous and polymeric coating for polyolefin films’’ (21 CFR 175.320), as VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 being impacted by the FAP. Specifically, the petition identifies the PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 use of the ortho-phthalates listed in table 4 as being impacted. E:\FR\FM\14NOP1.SGM 14NOP1 56753 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules 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 .................................................................................................................................................................................. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... The petition identifies § 175.380, ‘‘Xylene-formaldehyde resins condensed with 4,4’isopropylidenediphenolepichlorohydrin 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 § 175.380 does not directly refer to these ortho-phthalates, the regulation authorizes their use by cross- 84–66–2 84–72–0 85–70–1 referencing § 175.300(b)(3). Although use of ortho-phthalates authorized by § 175.380 would be affected by the FAP, the FAP would not require the regulatory text in § 175.380 to be 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 .................................................................................................................................................................................. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... Di-n-butyl phthalate 1 ........................................................................................................................................................................... Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) 2 .................................................................................................. Diisooctyl phthalate .............................................................................................................................................................................. 84–66–2 84–72–0 84–74–2 85–70–1 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, ‘‘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 § 175.390 does not directly refer to these ortho-phthalates, the regulation authorizes their use by cross-referencing § 175.300. Although use of orthophthalates authorized by § 175.390 would be affected by the FAP, the FAP would not require the regulatory text in § 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 .................................................................................................................................................................................. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... Di-n-butyl phthalate 1 ........................................................................................................................................................................... Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... Diisooctyl phthalate .............................................................................................................................................................................. 84–66–2 84–72–0 84–74–2 85–70–1 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, ‘‘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 § 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 ....................................................................................................................................................................... Di-n-butyl phthalate 2 ........................................................................................................................................................................... 85–68–7 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, ‘‘Components of paper and paperboard VerDate Sep<11>2014 20:31 Nov 13, 2018 Jkt 247001 in contact with dry food’’ (21 CFR 176.180) as being impacted by the FAP. PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 Specifically, the petition identifies the use of the ortho-phthalates listed in E:\FR\FM\14NOP1.SGM 14NOP1 56754 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules table 8 as being impacted. Although the regulation in § 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 crossreferencing § 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 ................................................................................................................................................................................... Butyl benzyl phthalate ......................................................................................................................................................................... Di-n-butyl phthalate 1 ........................................................................................................................................................................... Didecyl phthalate (Di-n-decyl phthalate) ............................................................................................................................................. Dodecyl phthalate ................................................................................................................................................................................ 131–17–9 85–68–7 84–74–2 84–77–5 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, ‘‘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 §§ 176.170 and 176.180. TABLE 9—ORTHO-PHTHALATES AUTHORIZED BY § 176.300 THAT WOULD BE AFFECTED BY THIS FAP [‘‘Slimicides’’] Food additive CAS No. Diallyl phthalate ................................................................................................................................................................................... Butyl benzyl phthalate ......................................................................................................................................................................... Di-n-butyl phthalate .............................................................................................................................................................................. Didecyl phthalate (Di-n-decyl phthalate) ............................................................................................................................................. Dodecyl phthalate ................................................................................................................................................................................ The petition identifies § 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 131–17–9 85–68–7 84–74–2 84–77–5 21577–80–0 use of the ortho-phthalate listed in table 10 as being impacted. 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) ...................................................................................................................................... The petition identifies § 177.1200, ‘‘Cellophane’’ (21 CFR 177.1200) as being impacted by the FAP. Specifically, the petition identifies the 131–11–3 use of the ortho-phthalates listed in 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 ............................................................................................................................................................................. Di-n-butyl phthalate 1 ........................................................................................................................................................................... Dimethylcyclohexyl phthalate .............................................................................................................................................................. Castor oil phthalate, hydrogenated ..................................................................................................................................................... Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol ............................................................................................ 84–69–5 84–74–2 1322–94–7 N/A 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, ‘‘Closures with sealing gaskets for food containers’’ (21 CFR 177.1210), as being impacted by the FAP. Specifically, the petition identifies the first five orthophthalates listed in table 12 as being impacted based on the authorization of their use in § 177.1210. Although the VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 regulation in § 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 § 179.45 (21 CFR 179.45). In addition to the first five ortho-phthalates in table 12 that the petition identifies as being authorized PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 under § 177.1210, § 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 § 177.1210 authorizes their food additive use by E:\FR\FM\14NOP1.SGM 14NOP1 56755 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules cross-referencing authorizations in parts 174–178 and § 179.45. Although use of the substances authorized by § 177.1210 that are listed in table 12 would be affected by the FAP, the FAP would not require the regulatory text in § 177.1210 to be amended. 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 .................................................................................................................................................................................. Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl phthalate) ...................................................................................................... Di-n-butyl phthalate .............................................................................................................................................................................. Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl phthalate) .................................................................................................... Diisooctyl phthalate .............................................................................................................................................................................. Dimethyl phthalate (dimethyl orthophthalate) ...................................................................................................................................... Diphenyl phthalate ............................................................................................................................................................................... Methyl phthalyl ethyl glycolate (1,2-Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-methyl ester) ............................................ Diphenylguanidine phthalate ............................................................................................................................................................... Diallyl phthalate ................................................................................................................................................................................... Diisobutyl phthalate ............................................................................................................................................................................. Butyl benzyl phthalate ......................................................................................................................................................................... Dihexyl phthalate (Di-n-hexyl phthalate) ............................................................................................................................................. Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) phthalate) ................................................................................................................. Dimethylcyclohexyl phthalate .............................................................................................................................................................. Dioctyl phthalate (Di-n-octyl phthalate) ............................................................................................................................................... Butyloctyl phthalate (n-butyl n-octyl phthalate) ................................................................................................................................... Di(2-ethylhexyl) hexahydrophthalate ................................................................................................................................................... Amyl decyl phthalate (n-amyl n-decyl phthalate) ................................................................................................................................ Butyl decyl phthalate (n-butyl n-decyl phthalate) ................................................................................................................................ Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) ............................................................................................... Didecyl phthalate (Di-n-decyl phthalate) ............................................................................................................................................. Dodecyl phthalate ................................................................................................................................................................................ Dihydroabietyl phthalate ...................................................................................................................................................................... Castor oil phthalate, hydrogenated ..................................................................................................................................................... Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol ............................................................................................ The petition identifies § 177.1400, ‘‘Hydoxyethyl cellulose film, waterinsoluble’’ (21 CFR 177.1400), as being impacted by the FAP. Specifically, the petition identifies the use of the orthophthalates listed in table 13 as being impacted. Although the regulation in § 177.1400 does not directly refer to these ortho-phthalates, the regulation authorizes their use by cross-referencing § 177.1200(c). Although use of the ortho-phthalates authorized by 84–66–2 84–72–0 84–74–2 85–70–1 27554–26–3 131–11–3 84–62–8 85–71–2 17573–13–6 131–17–9 84–69–5 85–68–7 84–75–3 117–83–9 1322–94–7 117–84–0 84–78–6 84–71–9 7493–81–4 89–19–0 119–07–3 84–77–5 21577–80–0 26760–71–4 N/A 68650–73–7 § 177.1400 would be affected by the FAP, the FAP would not require the regulatory text in § 175.1400 to be amended. 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 ............................................................................................................................................................................. Di-n-butyl phthalate 1 ........................................................................................................................................................................... Dimethylcyclohexyl phthalate .............................................................................................................................................................. Castor oil phthalate, hydrogenated ..................................................................................................................................................... Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol ............................................................................................ 84–69–5 84–74–2 1322–94–7 N/A 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, ‘‘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 § 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) ............................................................................................................................................... VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\14NOP1.SGM 14NOP1 117–84–0 56756 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules The petition identifies § 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 § 177.1590 THAT WOULD BE AFFECTED BY THIS FAP [‘‘Polyester elastomers’’] Food additive CAS No. Dimethyl phthalate (dimethyl orthophthalate) ...................................................................................................................................... The petition identifies § 177.2420, ‘‘Polyester resins, cross-linked’’ (21 CFR 177.2420), as being impacted by the FAP. Specifically, the petition identifies 131–11–3 the use of the ortho-phthalates listed in 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) ...................................................................................................................................... Butyl benzyl phthalate ......................................................................................................................................................................... Di-n-butyl phthalate .............................................................................................................................................................................. 131–11–3 85–68–7 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, ‘‘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 § 177.2600 THAT WOULD BE AFFECTED BY THIS FAP [‘‘Rubber articles intended for repeated use’’] Food additive CAS No. Diphenylguanidine phthalate ............................................................................................................................................................... Di-n-butyl phthalate 1 ........................................................................................................................................................................... Dioctyl phthalate (Di-n-octyl phthalate) ............................................................................................................................................... Amyl decyl phthalate (n-amyl n-decyl phthalate) ................................................................................................................................ Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n-decyl phthalate) ............................................................................................... Didecyl phthalate (Di-n-decyl phthalate) ............................................................................................................................................. 17573–13–6 84–74–2 117–84–0 7493–81–4 119–07–3 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, ‘‘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 § 178.3740 THAT WOULD BE AFFECTED BY THIS FAP [‘‘Plasticizers in polymeric substances’’] Food additive CAS No. Diphenyl phthalate ............................................................................................................................................................................... Butyl benzyl phthalate ......................................................................................................................................................................... Dihexyl phthalate (Di-n-hexyl phthalate) ............................................................................................................................................. The petition identifies § 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 84–62–8 85–68–7 84–75–3 the use of the ortho-phthalate listed in table 19 as being impacted. 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 .................................................................................................................................................................................. VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\14NOP1.SGM 14NOP1 84–66–2 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules 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 (§ 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 (§ 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 § 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 VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 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 orthophthalates listed in table 1 for use in food contact applications in the United States; • Currently import the orthophthalates 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 orthophthalates are being used in foodcontact applications. PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 56757 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 §§ 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 §§ 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 E:\FR\FM\14NOP1.SGM 14NOP1 56758 Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Proposed Rules 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 DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Parts 630 and 635 [FHWA Docket No. FHWA–2018–0036] RIN 2125–AF84 Construction and Maintenance— Promoting Innovation in Use of Patented and Proprietary Products Federal Highway Administration (FHWA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM); request for comments. AGENCY: This rulemaking would provide greater flexibility to States to use proprietary or patented materials in Federal-aid projects. The FHWA is SUMMARY: VerDate Sep<11>2014 18:15 Nov 13, 2018 Jkt 247001 seeking comment on two alternate coproposals to help advance this objective: First, FHWA proposes to amend and replace the requirements relating to patented and proprietary product approvals with a more flexible general requirement that enhances fairness, open competition, and transparency in the product selection process. Alternatively, the agency proposes rescinding the requirements, thereby encouraging further innovation in the development of new highway transportation technology and methods, as well as potentially reducing costs. DATES: Comments must be received on or before January 14, 2019. Late-filed comments will be considered to the extent practicable. ADDRESSES: To ensure that you do not duplicate your docket submissions, please submit them by only one of the following means: • Federal eRulemaking Portal: Go to https://www.regulations.gov and follow the online instructions for submitting comments. • Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor Room W12–140, Washington, DC 20590; • Hand Delivery: West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. 5 p.m., Monday through Friday, except Federal holidays. The telephone number is (202) 366– 9329. • Instructions: You must include the agency name and docket number or the Regulatory Identification Number (RIN) for the rulemaking at the beginning of your comments. All comments received will be posted without change to www.regulations.gov, including any personal information provided. FOR FURTHER INFORMATION CONTACT: Mr. John Huyer, Office of Preconstruction, Construction and Pavements, (651) 291– 6111 or, Mr. William Winne, Office of the Chief Counsel, (202) 366–1397, Federal Highway Administration, 1200 New Jersey Avenue SE, Washington, DC 20590. Office hours are from 8 a.m. to 4:30 p.m., e.t., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: Electronic Access and Filing This document and all comments received may be viewed online through the Federal eRulemaking portal at https://www.regulations.gov. Electronic submission and retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days a year. Please follow the PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 instructions. An electronic copy of this document may also be downloaded from the Office of the Federal Register’s home page at: https://www.archives.gov/ federal-register and the Government Publishing Office’s web page at: https:// www.gpo.gov/fdsys. Background There are differing practices across the United States on whether government entities may specify a patented material, article, or process in the letting of public works contracts through competitive bidding.1 Some jurisdictions prohibit the practice altogether on the grounds that it would inhibit competition, particularly where only one contractor can provide the specified material.2 Other jurisdictions allow the specification as long as the use of any other article equally as suitable is also allowed.3 The Federal government’s regulations on direct procurement and the uniform regulations on Federal financial assistance take the latter approach.4 In the majority of States, however, the practice of specifying a patented product in government contracts is allowed.5 The Federal-aid Road Act of 1916 (1916 Act) 6 was silent about patented and proprietary products but provided that Federal-aid funded State highway construction was ‘‘subject to the inspection and approval of the Secretary of Agriculture, and in accordance with the rules and regulation made pursuant to this Act.’’ 7 Accordingly, regulations implementing the 1916 Act were issued on September 1, 1916. Regulation 8, Section 4 of those rules provided, ‘‘No part of the money apportioned under the act shall be used, directly or indirectly, to pay, or to reimburse a State, county, or local subdivision for the payment of any premium or royalty on any patented or proprietary material, specification, process, or type of construction, unless purchased or obtained on open actual competitive bidding at the same or a less cost than 1 See generally 10 McQuillin Mun. Corp. § 29.42 (3d ed.). 2 Examples include Illinois, Indiana, Kentucky, Louisiana, Massachusetts, and Wisconsin. 3 Examples include California, Iowa, New Jersey, and New York. 4 See 48 CFR 52.211–6 and 2 CFR 200.319(a)(6). 5 Examples include Arizona, Colorado, Connecticut, Florida, Idaho, Kansas, Maryland, Michigan, Montana, Nebraska, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, and Washington. 6 1916 Act, ch. 241, 39 Stat. 355. 7 The Office of Public Roads was the predecessor agency of FHWA and was part of the Department of Agriculture in 1916. E:\FR\FM\14NOP1.SGM 14NOP1

Agencies

[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Proposed Rules]
[Pages 56750-56758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24657]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175, 176, 177, and 178

[Docket No. FDA-2018-F-3757]

Flexible Vinyl Alliance; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by the Flexible Vinyl Alliance
(FVA), requesting that we amend our food additive regulations to no
longer provide for the use of 26 ortho-phthalates in various food-
contact applications because these uses have been permanently
abandoned.

DATES: The food additive petition was filed on July 3, 2018. Submit
either electronic or written comments by January 14, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 14, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such

[[Page 56751]]

as a manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-F-3757 for ``Flexible Vinyl Alliance; Filing of Food Additive
Petition.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions: To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this document into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephen DiFranco, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2710.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have
filed a food additive petition (FAP 8B4820), submitted by FVA, c/o
Keller and Heckman, LLP., 1001 G St. NW, Suite 500 West, Washington, DC
20001. The petition requests that we amend our food additive
regulations in parts 175, 176, 177, and 178 (21 CFR parts 175, 176,
177, and 178) to revoke the approvals for 26 substances that the
petition identifies as ortho-phthalates. The petition requests that we
revoke the approvals because the food additive uses have been
permanently abandoned. The substances affected by this petition and
their corresponding Chemical Abstracts Service (CAS) numbers (when
available) are listed in table 1. Some of the substances are the
subject of approvals in multiple food additive regulations for
different uses, and the petition identifies the regulations that
authorize the food additive use of the substances. Therefore, we are
also listing the regulations that would be affected by this FAP (see
tables 2-19). For each regulation that would be affected, we list the
specific ortho-phthalates that the regulation authorizes. The petition
asserts that the uses of the ortho-phthalates identified in tables 2-19
have been abandoned. If the FAP is granted in full, none of the ortho-
phthalates listed in table 1 would be authorized for food additive use
in FDA's food additive regulations. Some of the substances are the
subject of prior sanction authorizations. The FAP does not pertain to
those prior sanction uses.

Table 1--Ortho-Phthalates That Would Be Affected by This FAP
------------------------------------------------------------------------
Food Additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
Diphenyl phthalate...................................... 84-62-8
Methyl phthalyl ethyl glycolate (1,2- 85-71-2
Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-
methyl ester)..........................................
Diethyl phthalate....................................... 84-66-2
Diphenylguanidine phthalate \1\......................... 17573-13-6
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Diallyl phthalate....................................... 131-17-9
Diisobutyl phthalate.................................... 84-69-5
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate.................................... 84-74-2
Butyl phthalyl butyl glycolate \2\ (Butyl 85-70-1
carbobutoxymethyl phthalate)...........................
Dihexyl phthalate (Di-n-hexyl phthalate)................ 84-75-3
Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) 117-83-9
phthalate).............................................
Dimethylcyclohexyl phthalate............................ 1322-94-7
Diisooctyl phthalate.................................... 27554-26-3
Dioctyl phthalate (Di-n-octyl phthalate)................ 117-84-0
Butyloctyl phthalate (n-butyl n-octyl phthalate)........ 84-78-6
Di(2-ethylhexyl) hexahydrophthalate \1\................. 84-71-9
Amyl decyl phthalate (n-amyl n-decyl phthalate)......... 7493-81-4
Butyl decyl phthalate (n-butyl n-decyl phthalate)....... 89-19-0

[[Page 56752]]

Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n- 119-07-3
decyl phthalate).......................................
Didecyl phthalate (Di-n-decyl phthalate)................ 84-77-5
Dodecyl phthalate....................................... 21577-80-0
Dihydroabietyl phthalate................................ 26760-71-4
Castor oil phthalate, hydrogenated...................... N/A
Castor oil phthalate with adipic acid and fumaric acid- 68650-73-7
diethylene glycol......................................
------------------------------------------------------------------------
\1\ We note that while these substances are not chemically classified as
ortho-phthalates, they are included in FAP 8B4820. The FAP describes
all of the substances as ortho-phthalates, although for these
substances that characterization is incorrect.
\2\ Substance is named Butyl phthalate butyl glycolate in 21 CFR
175.105. We believe this is a typographical error, and it should be
named butyl phthalyl butyl glycolate or butyl carbobutoxymethyl
phthalate.

The petition identifies Sec. 175.105, ``Adhesives'' (21 CFR
175.105) as being impacted by the FAP. Specifically, the petition
identifies the use of the substances listed in table 2 as being
impacted.

Table 2--Ortho-Phthalates Authorized by Sec. 175.105 That Would Be
Affected by This FAP
[``Adhesives'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
Diphenyl phthalate...................................... 84-62-8
Methyl phthalyl ethyl glycolate 85-71-2
(1,2Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-
methyl ester)..........................................
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Diallyl phthalate....................................... 131-17-9
Diisobutyl phthalate.................................... 84-69-5
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate \1\................................ 84-74-2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate) \2\.........................................
Dihexyl phthalate (Di-n-hexyl phthalate)................ 84-75-3
Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) 117-83-9
phthalate).............................................
Diisooctyl phthalate.................................... 27554-26-3
Dioctyl phthalate (Di-n-octyl phthalate)................ 117-84-0
Butyloctyl phthalate (n-butyl n-octyl phthalate)........ 84-78-6
Di(2-ethylhexyl) hexahydrophthalate..................... 84-71-9
Butyl decyl phthalate (n-butyl n-decyl phthalate) \3\... 89-19-0
Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n- 119-07-3
decyl phthalate).......................................
Dihydroabietyl phthalate................................ 26760-71-4
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.105 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.
\2\ Although the petitioner refers to this substance as Butyl phthalyl
butyl glycolate phthalate in the petition, it is listed in Sec.
175.105 as Butyl phthalate butyl glycolate. These terms are
synonymous, referring to the same chemical substance.
\3\ Although the petitioner refers to this substance as Butyl decyl
phthalate in the petition, it is listed in Sec. 175.105 as
Butyldecyl phthalate. These terms are synonymous, referring to the
same chemical substance.

The petition identifies Sec. 175.300, ``Resinous and polymeric
coatings'' (21 CFR 175.300), as being impacted by the FAP.
Specifically, the petition identifies the use of the ortho-phthalates
listed in table 3 as being impacted.

Table 3--Ortho-Phthalates Authorized by Sec. 175.300 That Would Be
Affected by This FAP
[``Resinous and polymeric coatings'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Di-n-butyl phthalate \1\................................ 84-74-2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate).............................................
Diisooctyl phthalate.................................... 27554-26-3
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.300 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.

The petition identifies Sec. 175.320, ``Resinous and polymeric
coating for polyolefin films'' (21 CFR 175.320), as being impacted by
the FAP. Specifically, the petition identifies the use of the ortho-
phthalates listed in table 4 as being impacted.

[[Page 56753]]

Table 4--Ortho-phthalates Authorized by Sec. 175.320 That Would Be
Affected by This FAP
[``Resinous and polymeric coatings for polyolefin films'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate).............................................
------------------------------------------------------------------------

The petition identifies Sec. 175.380, ``Xylene-formaldehyde resins
condensed with 4,4'-isopropylidenediphenol-epichlorohydrin epoxy
resins'' (21 CFR 175.380), as being impacted by the FAP. Specifically,
the petition identifies the use of the ortho-phthalates listed in table
5 as being impacted. Although the regulation in Sec. 175.380 does not
directly refer to these ortho-phthalates, the regulation authorizes
their use by cross-referencing Sec. 175.300(b)(3). Although use of
ortho-phthalates authorized by Sec. 175.380 would be affected by the
FAP, the FAP would not require the regulatory text in Sec. 175.380 to
be amended.

Table 5--Ortho-Phthalates Authorized by Sec. 175.380 That Would Be
Affected by This FAP
[``Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenol-
epichlorohydrin epoxy resins'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Di-n-butyl phthalate \1\................................ 84-74-2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate) \2\.........................................
Diisooctyl phthalate.................................... 27554-26-3
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.300(b)(3) as
dibutyl phthalate. These terms are synonymous, referring to the same
chemical substance.

The petition identifies Sec. 175.390, ``Zinc-silicon dioxide
matrix coatings'' (21 CFR 175.390) as being impacted by the FAP.
Specifically, the petition identifies the use of the ortho-phthalates
listed in table 6 as being impacted by the FAP. Although the regulation
in Sec. 175.390 does not directly refer to these ortho-phthalates, the
regulation authorizes their use by cross-referencing Sec. 175.300.
Although use of ortho-phthalates authorized by Sec. 175.390 would be
affected by the FAP, the FAP would not require the regulatory text in
Sec. 175.390 to be amended.

Table 6--Ortho-Phthalates Authorized by Sec. 175.390 That Would Be
Affected by This FAP
[``Zinc-silicon dioxide matrix coatings'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Di-n-butyl phthalate \1\................................ 84-74-2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate).............................................
Diisooctyl phthalate.................................... 27554-26-3
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 175.300 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.

The petition identifies Sec. 176.170, ``Components of paper and
paperboard in contact with aqueous and fatty foods'' (21 CFR 176.170)
as being affected by the FAP. Specifically, the petition identifies the
use of the ortho-phthalates listed in table 7 as being impacted.

Table 7--Ortho-Phthalates Authorized by Sec. 176.170 That Would Be
Affected By This FAP
[``Components of paper and paperboard in contact with aqueous and fatty
foods'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Butyl benzyl phthalate \1\.............................. 85-68-7
Di-n-butyl phthalate \2\................................ 84-74-2
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as Butyl benzyl
phthalate in the petition, it is listed in Sec. 176.170 as
Butylbenzyl phthalate. These terms are synonymous, referring to the
same chemical substance.
\2\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 176.170 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.

The petition identifies Sec. 176.180, ``Components of paper and
paperboard in contact with dry food'' (21 CFR 176.180) as being
impacted by the FAP. Specifically, the petition identifies the use of
the ortho-phthalates listed in

[[Page 56754]]

table 8 as being impacted. Although the regulation in Sec. 176.180
does not directly refer to all of these ortho-phthalates, the
regulation authorizes the use of all of them either directly or by
cross-referencing Sec. 176.170.

Table 8--Ortho-Phthalates Authorized by Sec. 176.180 That Would Be
Affected by This FAP
[``Components of paper and paperboard in contact with dry food'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diallyl phthalate....................................... 131-17-9
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate \1\................................ 84-74-2
Didecyl phthalate (Di-n-decyl phthalate)................ 84-77-5
Dodecyl phthalate....................................... 21577-80-0
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 176.170 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.

The petition identifies Sec. 176.300, ``Slimicides'' (21 CFR
176.300), as being impacted by the FAP. Specifically, the petition
identifies the ortho-phthalates listed in table 9 as being impacted,
some of which are permitted as a result of being listed in Sec. Sec.
176.170 and 176.180.

Table 9--Ortho-Phthalates Authorized by Sec. 176.300 That Would Be
Affected by This FAP
[``Slimicides'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diallyl phthalate....................................... 131-17-9
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate.................................... 84-74-2
Didecyl phthalate (Di-n-decyl phthalate)................ 84-77-5
Dodecyl phthalate....................................... 21577-80-0
------------------------------------------------------------------------

The petition identifies Sec. 177.1010, ``Acrylic and modified
acrylic plastics, semirigid and rigid'' (21 CFR 177.1010) as being
impacted by the FAP. Specifically, the petition identifies the use of
the ortho-phthalate listed in table 10 as being impacted.

Table 10--Ortho-Phthalates Authorized by Sec. 177.1010 That Would Be
Affected by This FAP
[``Acrylic and modified acrylic plastics, semirigid and rigid'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
------------------------------------------------------------------------

The petition identifies Sec. 177.1200, ``Cellophane'' (21 CFR
177.1200) as being impacted by the FAP. Specifically, the petition
identifies the use of the ortho-phthalates listed in table 11 as being
impacted.

Table 11--Ortho-Phthalates Authorized by Sec. 177.1200 That Would Be
Affected by This FAP
[``Cellophane'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diisobutyl phthalate.................................... 84-69-5
Di-n-butyl phthalate \1\................................ 84-74-2
Dimethylcyclohexyl phthalate............................ 1322-94-7
Castor oil phthalate, hydrogenated...................... N/A
Castor oil phthalate with adipic acid and fumaric acid- 68650-73-7
diethylene glycol......................................
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.1200 as
dibutylphthalate. These terms are synonymous, referring to the same
chemical substance.

The petition identifies Sec. 177.1210, ``Closures with sealing
gaskets for food containers'' (21 CFR 177.1210), as being impacted by
the FAP. Specifically, the petition identifies the first five ortho-
phthalates listed in table 12 as being impacted based on the
authorization of their use in Sec. 177.1210. Although the regulation
in Sec. 177.1210 does not directly refer to these ortho-phthalates,
the regulation authorizes their use by cross-referencing authorizations
in 21 CFR parts 174-178 and Sec. 179.45 (21 CFR 179.45). In addition
to the first five ortho-phthalates in table 12 that the petition
identifies as being authorized under Sec. 177.1210, Sec. 177.1210
also authorizes the use of the remaining substances that are listed in
table 12. We have listed these remaining substances in table 12 because
the petition seeks to revoke the food additive approvals for these
substances, and Sec. 177.1210 authorizes their food additive use by

[[Page 56755]]

cross-referencing authorizations in parts 174-178 and Sec. 179.45.
Although use of the substances authorized by Sec. 177.1210 that are
listed in table 12 would be affected by the FAP, the FAP would not
require the regulatory text in Sec. 177.1210 to be amended.

Table 12--Ortho-Phthalates Authorized by Sec. 177.1210 That Would Be
Affected by This FAP
[``Closures with sealing gaskets for food containers'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
Ethyl phthalyl ethyl glycolate (Ethyl carbethoxymethyl 84-72-0
phthalate).............................................
Di-n-butyl phthalate.................................... 84-74-2
Butyl phthalyl butyl glycolate (Butyl carbobutoxymethyl 85-70-1
phthalate).............................................
Diisooctyl phthalate.................................... 27554-26-3
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
Diphenyl phthalate...................................... 84-62-8
Methyl phthalyl ethyl glycolate (1,2- 85-71-2
Benzenedicarboxylicacid, 1-(2-ethoxy-2-oxoethyl) 2-
methyl ester)..........................................
Diphenylguanidine phthalate............................. 17573-13-6
Diallyl phthalate....................................... 131-17-9
Diisobutyl phthalate.................................... 84-69-5
Butyl benzyl phthalate.................................. 85-68-7
Dihexyl phthalate (Di-n-hexyl phthalate)................ 84-75-3
Di(butoxyethyl) phthalate (Bis(2-n-butoxyethyl) 117-83-9
phthalate).............................................
Dimethylcyclohexyl phthalate............................ 1322-94-7
Dioctyl phthalate (Di-n-octyl phthalate)................ 117-84-0
Butyloctyl phthalate (n-butyl n-octyl phthalate)........ 84-78-6
Di(2-ethylhexyl) hexahydrophthalate..................... 84-71-9
Amyl decyl phthalate (n-amyl n-decyl phthalate)......... 7493-81-4
Butyl decyl phthalate (n-butyl n-decyl phthalate)....... 89-19-0
Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n- 119-07-3
decyl phthalate).......................................
Didecyl phthalate (Di-n-decyl phthalate)................ 84-77-5
Dodecyl phthalate....................................... 21577-80-0
Dihydroabietyl phthalate................................ 26760-71-4
Castor oil phthalate, hydrogenated...................... N/A
Castor oil phthalate with adipic acid and fumaric acid- 68650-73-7
diethylene glycol......................................
------------------------------------------------------------------------

The petition identifies Sec. 177.1400, ``Hydoxyethyl cellulose
film, water-insoluble'' (21 CFR 177.1400), as being impacted by the
FAP. Specifically, the petition identifies the use of the ortho-
phthalates listed in table 13 as being impacted. Although the
regulation in Sec. 177.1400 does not directly refer to these ortho-
phthalates, the regulation authorizes their use by cross-referencing
Sec. 177.1200(c). Although use of the ortho-phthalates authorized by
Sec. 177.1400 would be affected by the FAP, the FAP would not require
the regulatory text in Sec. 175.1400 to be amended.

Table 13--Ortho-Phthalates Authorized by Sec. 177.1400 That Would Be
Affected by This FAP
[``Hydroxyethyl cellulose film, water-insoluble'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diisobutyl phthalate.................................... 84-69-5
Di-n-butyl phthalate \1\................................ 84-74-2
Dimethylcyclohexyl phthalate............................ 1322-94-7
Castor oil phthalate, hydrogenated...................... N/A
Castor oil phthalate with adipic acid and fumaric acid- 68650-73-7
diethylene glycol......................................
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.1200 as
dibutylphthalate. These terms are synonymous, referring to the same
chemical substance.

The petition identifies Sec. 177.1460, ``Melamine-formaldehyde
resins in molded articles'' (21 CFR 177.1460), as being impacted by the
FAP. Specifically, the petition identifies the use of the ortho-
phthalate listed in table 14 as being impacted.

Table 14--Ortho-Phthalates Authorized by Sec. 177.1460 That Would Be
Affected by This FAP
[``Melamine-formaldehyde resins in molded articles'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dioctyl phthalate (Di-n-octyl phthalate)................ 117-84-0
------------------------------------------------------------------------

[[Page 56756]]

The petition identifies Sec. 177.1590, ``Polyester elastomers''
(21 CFR 177.1590), as being impacted by the FAP. Specifically, the
petition identifies the use of the ortho-phthalate listed in table 15
as being impacted.

Table 15--Ortho-Phthalates Authorized by Sec. 177.1590 That Would Be
Affected by This FAP
[``Polyester elastomers'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
------------------------------------------------------------------------

The petition identifies Sec. 177.2420, ``Polyester resins, cross-
linked'' (21 CFR 177.2420), as being impacted by the FAP. Specifically,
the petition identifies the use of the ortho-phthalates listed in table
16 as being impacted.

Table 16--Ortho-Phthalates Authorized by Sec. 177.2420 That Would Be
Affected by This FAP
[``Polyester resins, cross-linked'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Dimethyl phthalate (dimethyl orthophthalate)............ 131-11-3
Butyl benzyl phthalate.................................. 85-68-7
Di-n-butyl phthalate.................................... 84-74-2
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.2420 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.

The petition identifies Sec. 177.2600, ``Rubber articles for
repeated use'' (21 CFR 177.2600), as being impacted by the FAP.
Specifically, the petition identifies the use of the substances listed
in table 17 as being impacted.

Table 17--Ortho-Phthalates Authorized by Sec. 177.2600 That Would Be
Affected by This FAP
[``Rubber articles intended for repeated use'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diphenylguanidine phthalate............................. 17573-13-6
Di-n-butyl phthalate \1\................................ 84-74-2
Dioctyl phthalate (Di-n-octyl phthalate)................ 117-84-0
Amyl decyl phthalate (n-amyl n-decyl phthalate)......... 7493-81-4
Decyl octyl phthalate (Octyldecyl phthalate/n-octyl n- 119-07-3
decyl phthalate).......................................
Didecyl phthalate (Di-n-decyl phthalate)................ 84-77-5
------------------------------------------------------------------------
\1\ Although the petitioner refers to this substance as di-n-butyl
phthalate in the petition, it is listed in Sec. 177.1200 as dibutyl
phthalate. These terms are synonymous, referring to the same chemical
substance.

The petition identifies Sec. 178.3740, ``Plasticizers in polymeric
substances'' (21 CFR 178.3740), as being impacted by the FAP.
Specifically, the petition identifies the use of the ortho-phthalates
listed in table 18 as being impacted.

Table 18--Ortho-Phthalates Authorized by Sec. 178.3740 That Would Be
Affected by This FAP
[``Plasticizers in polymeric substances'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diphenyl phthalate...................................... 84-62-8
Butyl benzyl phthalate.................................. 85-68-7
Dihexyl phthalate (Di-n-hexyl phthalate)................ 84-75-3
------------------------------------------------------------------------

The petition identifies Sec. 178.3910, ``Surface lubricants used
in the manufacture of metallic articles'' (21 CFR 178.3910), as being
impacted by the FAP. Specifically, the petition identifies the use of
the ortho-phthalate listed in table 19 as being impacted.

Table 19--Ortho-Phthalates Authorized by Sec. 178.3910 That Would Be
Affected by This FAP
[``Surface lubricants used in the manufacture of metallic articles'']
------------------------------------------------------------------------
Food additive CAS No.
------------------------------------------------------------------------
Diethyl phthalate....................................... 84-66-2
------------------------------------------------------------------------

[[Page 56757]]

II. Abandonment

Under section 409(i) of the FD&C Act, we shall by regulation
prescribe the procedure by which regulations under the foregoing
provisions of this section may be amended or repealed, and such
procedure shall conform to the procedure provided in this section for
the promulgation of such regulations. Our regulations specific to
administrative actions for food additives provide that the Commissioner
of Food and Drugs, on his own initiative or on the petition of any
interested person, under 21 CFR part 10, may propose the issuance of a
regulation amending or repealing a regulation pertaining to a food
additive or granting or repealing an exception for such additive (Sec.
171.130(a) (21 CFR 171.130(a))). These regulations further provide that
any such petition shall include an assertion of facts, supported by
data, showing that new information exists with respect to the food
additive or that new uses have been developed or old uses abandoned,
that new data are available as to toxicity of the chemical, or that
experience with the existing regulation or exemption may justify its
amendment or appeal (Sec. 171.130(b)). New data must be furnished in
the form specified in 21 CFR 171.1 and 171.100 for submitting petitions
(id.). Under these regulations, a petitioner may propose that we amend
a food additive regulation if the petitioner can demonstrate that there
are ``old uses abandoned'' for the relevant food additive (id.). Such
abandonment must be complete for any intended uses in the U.S. market.
While section 409 of the FD&C Act and Sec. 171.130 also provide for
amending or revoking a food additive regulation based on safety, an
amendment or revocation based on abandonment is not based on safety but
is based on the fact that regulatory authorization is no longer
necessary because the use of that food additive has been abandoned.
Abandonment may be based on the abandonment of certain authorized
food additive uses for a substance (e.g., if a substance is no longer
used in certain product categories), or on the abandonment of all
authorized food additive uses of a substance (e.g., if a substance is
no longer being manufactured). If a FAP seeks an amendment to a food
additive regulation based on the abandonment of certain uses of the
food additive, such uses must be adequately defined so that both the
scope of the abandonment and any amendment to the food additive
regulation are clear.
As support for the assertion that the food-contact use of the
ortho-phthalates listed in the petition has been abandoned, the FAP
includes the results of a survey petitioner sent to its members and
other firms. The petitioner asked the recipients to verify that they do
not:
Currently manufacture the ortho-phthalates listed in table
1 for use in food contact applications in the United States;
Currently import the ortho-phthalates listed in table 1
for use in food contact applications in the United States;
Intend to manufacture or import the ortho-phthalates
listed in table 1 for use in food contact applications in the United
States in the future;
Currently maintain any inventory of the ortho-phthalates
listed in table 1 for sale or distribution into commerce that is
intended to be marketed for use in food contact applications in the
United States; or
Possess any knowledge that the ortho-phthalates listed in
table 1 are used in food contact applications in the United States.
The FAP describes the petitioner's members as including plasticizer
manufacturers, compounders, formulators, molders and fabricators of
polyvinyl chloride (PVC). The petition states that the surveys
collected include the substantial majority of phthalate and PVC
manufacturers, as well as the downstream compounders and users of the
materials.
In addition, the FAP states that petitioner has confirmed with
other industry stakeholders that no entities appear to be using or
marketing the ortho-phthalates listed in table 1 in the food-contact
applications referenced in tables 2-19. The petition states that other
industry stakeholders include members of: (1) The Plastics Industry
Association's (PIA's) Food, Drug and Cosmetic Packaging Materials
Committee, (2) the Adhesives and Sealants Council, (3) the American
Beverage Association, (4) the American Forest and Paper Association,
(5) the Grocery Manufacturers Association, and (6) the High Phthalates
Panel of the American Chemistry Council. The petition states that no
member companies from the organizations indicated that they had any
knowledge that the regulatory clearances in tables 2-19 are relied upon
for use of the ortho-phthalates listed in table 1. With regard to PIA,
the petition states that PIA asked its member companies to advise
whether they have any knowledge that the subject ortho-phthalates are
being used in food-contact applications.
The FAP states that the petition captures the substantial majority
of domestic and international phthalate manufacturers and users.
We expressly request comments on FVA's request that we amend
Sec. Sec. 175.105, 175.300, 175.320, 176.170, 176.180, 176.300,
177.1010, 177.1200, 177.1460, 177.1590, 177.2420, 177.2600, 178.3740,
and 178.3910 of the food additive regulations to no longer permit the
food additive use of the substances listed in table 1 because these
uses have been abandoned. Although the regulatory text in Sec. Sec.
175.380, 175.390, 177.1210, and 179.1400 would not be amended, these
regulations would be affected because they authorize certain uses of
substances listed in table 1 by cross-referencing other regulations.
Accordingly, we request comments that address whether the use of the
substances in table 1 (as authorized in the regulations identified in
tables 2-19) have been completely abandoned. For example, we request
information on whether food contact materials containing these
substances are currently being introduced or delivered for introduction
into the U.S. market. Any comments indicating that the specified uses
of one or more of the 26 substances have not been abandoned should
specify the ortho-phthalate(s) (or substances identified in the
petition as ortho-phthalates). We also recommend including information
about the use, any relevant regulation(s) authorizing the use, and a
description of the product that contains the substance(s).
We are currently unaware of information demonstrating the continued
use of these substances in the food contact applications listed. We are
providing the public 60 days to submit comments. We anticipate that
some interested persons may wish to provide us with certain information
they consider to be trade secret or confidential commercial information
(CCI) under Exemption 4 of the Freedom of Information Act (5 U.S.C.
552). Interested persons may claim information that is submitted to us
as CCI or trade secret by clearly marking both the document and the
specific information as ``confidential.'' Information so marked will
not be disclosed except in accordance with the Freedom of Information
Act and our disclosure regulations (21 CFR part 20). For electronic
submissions to https://www.regulations.gov, indicate in the
``comments'' box of the appropriate docket that your submission
contains confidential information. Interested persons must also submit
a copy of the comment that does not contain the information claimed as
confidential for

[[Page 56758]]

inclusion in the public version of the official record. Information not
marked confidential will be included in the public version of the
official record without prior notice.
We are not requesting comments on the safety of these uses of the
substances in table 1 because such information is not relevant to
abandonment, which is the basis of the proposed action. We will not
consider any comments addressing safety in our evaluation of this FAP.
In addition to our consideration of this petition, we are considering
information on the safety of many of the ortho-phthalates listed in
table 1 as part of our consideration of a petition designated for
reference as FAP 6B4815 (see 81 FR 31877, May 20, 2016).
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(m) because the petition requests an action
that would prohibit or otherwise restrict or reduce the use of a
substance in food, food packaging, or cosmetics. In addition, the
petitioner has stated that, to petitioner's knowledge, no extraordinary
circumstances exist. If FDA determines a categorical exclusion applies,
neither an environmental assessment nor an environmental impact
statement is required. If FDA determines a categorical exclusion does
not apply, we will request an environmental assessment and make it
available for public inspection.

Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24657 Filed 11-13-18; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.