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177.2600 Rubber articles intended for repeated use.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.2600]

[Page 349-354]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 177_INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
 
Subpart C_Substances for Use Only as Components of Articles Intended for 
                              Repeated Use
 
Sec.  177.2600  Rubber articles intended for repeated use.

    Rubber articles intended for repeated use may be safely used in 
producing, manufacturing, packing, processing, preparing, treating, 
packaging, transporting, or holding food, subject to the provisions of 
this section.
    (a) The rubber articles are prepared from natural and/or synthetic 
polymers and adjuvant substances as described in paragraph (c) of this 
section.
    (b) The quantity of any substance employed in the production of 
rubber articles intended for repeated use shall not exceed the amount 
reasonably required to accomplish the intended effect in the rubber 
article and shall not be intended to accomplish any effect in food.
    (c) Substances employed in the preparation of rubber articles 
include the following, subject to any limitations prescribed:
    (1) Substances generally recognized as safe for use in food or food 
packaging.
    (2) Substances used in accordance with the provisions of a prior 
sanction or approval.
    (3) Substances that by regulation in parts 170 through 189 of this 
chapter may be safely used in rubber articles, subject to the provisions 
of such regulation.
    (4) Substances identified in this paragraph (c)(4), provided that 
any substance that is the subject of a regulation in parts 174, 175, 
176, 177, 178 and Sec.  179.45 of this chapter conforms with any 
specification in such regulation.
    (i) Elastomers.

Acrylonitrile-butadiene copolymer.
Brominated isobutylene-isoprene copolymers complying with Sec.  
177.1210.
Butadiene-acrylonitrile-ethylene glycol dimethacrylate copolymers 
containing not more than 5 weight percent of polymer units derived from 
ethylene glycol dimethacrylate.
Butadiene-acrylonitrile-methacrylic acid copolymer.
Butadiene-styrene-methacrylic acid copolymer.
Chloroprene polymers.
Chlorotrifluoroethylene-vinylidene fluoride copolymer.
Ethylene-propylene copolymer elastomers which may contain not more than 
5 weight-percent of total polymer units derived from 5-methylene-2-
norbornene and/or 5-ethylidine-2-norbornene.
Ethylene-propylene-dicyclopentadiene copolymer.
Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8 
weight percent of total polymer units derived from 1,4-hexadiene.
Hydrogenated butadiene/acrylonitrile copolymers (CAS Reg. No. 88254-10-
8) produced when acrylonitrile/butadiene copolymers are modified by 
hydrogenation of the olefinic unsaturation to leave either: (1) Not more 
than 10 percent trans olefinic unsaturation and no [alpha], [beta]-
olefinic unsaturation as determined by a method entitled ``Determination 
of Residual [alpha], [beta]-Olefinic and Trans Olefinic Unsaturation 
Levels in HNBR,'' developed October 1, 1991, by Polysar Rubber Corp., 
1256 South Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4 
percent to 20 percent olefinic unsaturation and Mooney viscosities 
greater than 45 (ML 1 + 4 @ 100 [deg]C), as determined by ASTM Standard 
Method D1646-92, ``Standard Test Method for Rubber--Viscosity and 
Vulcanization Characteristics (Mooney Viscometer),'' which are both 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of these methods may be obtained from the Division of 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, 
MD 20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/

[[Page 350]]

code--of--federal--regulations/ibr--locations.html. A copy of ASTM 
Standard Method D1646-92 may also be obtained from the American Society 
for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 
19428-2959.
Isobutylene-isoprene copolymer.
Polyamide/polyether block copolymers (CAS Reg. No. 77402-38-1 prepared 
by reacting a copolymer of omega-laurolactam and adipic acid with 
poly(tetramethylene ether glycol). The polyamide and polyether 
components are reacted in ratios such that the polyamide component 
constitutes a minimum of 30 weight-percent of total polymer units. The 
copolymers may be used in contact with foods of Types I, II, III, IV, V, 
VI, VII, VIII, and IX identified in table 1 of Sec.  176.170(c) of this 
chapter at temperatures not to exceed 150 [deg]F except that those 
copolymers prepared with less than 50 weight-percent of polyamide are 
limited to use in contact with such foods at temperatures not to exceed 
100 [deg]F.
Polybutadiene.
Polyester elastomers derived from the reaction of dimethyl 
terephthalate, 1,4-butanediol, and [alpha]-hydro-omega-hydroxypoly 
(oxytetramethylene). Additionally, trimethyl trimellitate may be used as 
a reactant. The polyester elastomers may be used only in contact with 
foods containing not more than 8 percent alcohol and limited to use in 
contact with food at temperatures not exceeding 150 [deg]F.
Polyisoprene.
Polyurethane resins (CAS Reg. Nos. 37383-28-1 or 9018-04-6) derived from 
the reaction of diphenylmethane diisocyanate with 1,4-butanediol and 
polytetramethylene ether glycol.
Polyurethane resins derived from reactions of diphenylmethane 
diisocyanate with adipic acid and 1,4-butanediol.
Rubber, natural.
Silicone basic polymer as described in ASTM method D1418-81, ``Standard 
Practice for Rubber and Rubber Latices--Nomenclature,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.

    Silicone (Si) elastomers containing methyl groups.
    Silicone (Psi) elastomers containing methyl and phenyl groups.
    Silicone (Vsi) elastomers containing methyl and vinyl groups.
    Silicone (Fsi) elastomers containing methyl and fluorine groups.
    Silicone (PVsi) elastomers containing phenyl, methyl, and vinyl 
groups.

Styrene-butadiene copolymer.
Vinylidene fluoride-hexafluoropropylene copolymers (minimum number 
average molecular weight 70,000 as determined by osmotic pressure in 
methyl ethyl ketone).
Vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymers 
(minimum number average molecular weight 100,000 as determined by 
osmotic pressure in methyl ethyl ketone).

    (ii) Vulcanization materials--(a) Vulcanizing agents.

4,4'-Bis(aminocyclohexyl)methane carbamate for use only as cross-linking 
agent in the vulcanization of vinylidene fluoridehexafluoropropylene 
copolymer and vinylidene fluoride-hexafluoropropylene-
tetrafluoroethylene copolymer elastomers identified under paragraph 
(c)(4)(i) of this section and limited to use at levels not to exceed 2.4 
percent by weight of such copolymers.
 Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate) for use 
as a cross linking agent in the vulcanization of natural rubber, 
styrene-butadiene copolymer, acrylonitrile-butadiene copolymer, and 
ethylene-propylene terpolymers identified under paragraph (c)(4)(i) of 
this section and limited to use at levels not to exceed 2.4 percent by 
weight of such copolymers.
Hexamethylenediamine carbamate for use only as cross-linking agent in 
the vulcanization of vinylidene fluoride-hexafluoropropylene copolymer 
and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene 
copolymer elastomers identified under paragraph (c)(4)(i) of this 
section and limited to use at levels not to exceed 1.5 percent by weight 
of such copolymers.
Sulfur, ground.

    (b) Accelerators (total not to exceed 1.5 percent by weight of 
rubber product).

2-Benzothiazyl-N,N-diethylthiocarbamyl-sulfide.
Benzoyl peroxide.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
N-tert-Butyl-2-benzothiazole sulfenamide.
Butyraldehyde-aniline resin (iodine number 670-705).
Carbon disulfide-1,1'-methylenedipiperidine reaction product.
Copper dimethyldithiocarbamate.
N-Cyclohexyl-2-benzothiazole sulfenamide.

[[Page 351]]

Dibenzoyl-p-quinone dioxime.
Dibenzylamine.
 Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate).
Di(4-methylbenzoyl) peroxide (CAS Reg. No. 895-85-2) for use only as a 
crosslinking agent in silicone polymers and elastomers identified under 
paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by 
weight of such polymers and elastomers where the total of all 
accelerators does not exceed 1.5 percent by weight of rubber product.
Di-tert-butyl peroxide.
Dibutyl xanthogen disulfide.
2,4-Dichlorobenzoyl peroxide.
Dicumyl peroxide.
N,N-Dimethylcyclohexylamine salt of dibutyldithiocarbamic acid.
2,6-Dimethylmorpholine thiobenzothiazol.
Dipentamethylenethiuram hexasulfide (CAS Reg. No. 971-15-3).
Diphenylguanidine.
Diphenylguanidine phthalate.
1,3-Diphenyl-2-thiourea.
2,2'-Dithiobis[benzothiazole].
4,4'-Dithiodimorpholine.
N,N'-Di-o-tolylguanidine.
Di-o-tolylguanidine salt of pyrocatecholborate.
Ethylenediamine carbamate.
Heptaldehyde-aniline resin (iodine number 430-445).
Hexamethylenetetramine.
2-Mercaptobenzothiazole.
2-Mercaptothiazoline.
N-Oxydiethylene-benzothiazole-2-sulfenamide.
Piperidinium pentamethylenedithiocarba-mate.
Potassium pentamethylenedithiocarbamate.
p-Quinone dioxime.
Sodium dibutyldithiocarbamate.
Sodium dimethyldithiocarbamate.
Stannous oleate for use only as an accelerator for silicone elastomers.
Tetrabutylthiuram monosulfide.
Tetraethylthiuram disulfide.
(1,1,4,4-Tetramethyltetramethylene)bis [tert-butyl peroxide].
Tetramethylthiuram monosulfide.
Thiram (tetramethylthiuram disulfide).
Triallyl cyanurate.
Triethylenetetramine.
1,3,5-Triethyl-hexahydro-s-triazine (triethyltrimethylenetriamine).
Triphenylguanidine.
Zinc butyl xanathate.
Zinc dibenzyl dithiocarbamate.
Zinc dibutyldithiocarbamate.
Zinc diethyldithiocarbamate.
Zinc 2-mercaptobenzothiazole.
Ziram (zinc dimethyldithiocarbamate).

    (c) Retarders (total not to exceed 10 percent of weight of rubber 
product).

Cyanoguanidine.
Phthalic anhydride.
Salicylic acid.

    (d) Activators (total not to exceed 5 percent by weight of rubber 
product except magnesium oxide may be used at higher levels).

Diethylamine.
Fatty acid amines, mixed.
Fatty acids.
Magnesium carbonate.
Magnesium oxide, light and heavy.
Oleic acid, dibutylamine salt (dibutylammonium oleate).
Stannous chloride.
Tall oil fatty acids.
Tetrachloro-p-benzoquinone.
Triethanolamine.
Zinc salts of fatty acids.

    (iii) Antioxidants and antiozonants (total not to exceed 5 percent 
by weight of rubber product).

Aldol-a-naphthylamine.
Alkylated (C4 and/or C8) phenols.
BHT (butylated hydroxytoluene).
4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-butylphenol 
(CAS Reg. No. 991-84-4) for use only as a stabilizer at levels not to 
exceed 0.5 percent by weight of the finished rubber product.
Butylated reaction product of p-cresol and dicyclopentadiene as 
identified in Sec.  178.2010(b) of this chapter.
Butylated, styrenated cresols identified in Sec.  178.2010(b) of this 
chapter.
4,4'-Butylidinebis(6-tert-butyl-m-cresol).
N-Cyclohexyl-N'-phenylphenylenediamine.
p,p'-Diaminodiphenylmethane.
2,5-Di-tert-amylhydroquinone.
Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or 
xylyl.
2,6-Di-tert-butyl-p-phenylphenol.
1,2-Dihydro-2,2,4-trimethyl-6-dodecylquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-ethoxyquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-phenylquinoline.
4,4'-Dimethoxydiphenylamine.
4,6-Dinonyl-o-cresol.
N,N'-Dioctyl-p-phenylenediamine.
Diphenylamine-acetone resin.
Diphenylamine-acetone-formaldehyde resin.
N,N'-Diphenylethylenediamine.
N,N'-Disalicylalpropylenediamine.
N,N'-Di-o-tolylethylenediamine.
Hydroquinone monobenzyl ether.
Isopropoxydiphenylamine.
N-Isopropyl-N'-phenyl-p-phenylenediamine.
2,2'-Methylenebis(6-tert-butyl-4-ethylphenol).

[[Page 352]]

2,2'-Methylenebis(4-methyl-6-tert-butylphenol).
2,2'-Methylenebis(4-methyl-6-nonylphenol).
2,2'-Methylenebis(4-methyl-6-tert-octylphenol).
Monooctyl- and dioctyldiphenylamine.
N,N'-Di-[beta]-naphthyl-p-phenylenediamine.
Phenyl-a-naphthylamine.
Phenyl-[beta]-naphthylamine.
Phenyl-[beta]-naphthylamine-acetone aromatic amine resin (average 
molecular weight 600; nitrogen content 5.3 percent).
o- and p-Phenylphenol.
Polybutylated (mixture) 4,4'-isopropylidenediphenol.
Sodium pentachlorophenate.
Styrenated cresols produced when 2 moles of styrene are made to react 
with 1 mole of a mixture of phenol and o-, m-, and p-cresols so that the 
final product has a Brookfield viscosity at 25 [deg]C of 1400 to 1700 
centipoises.
Styrenated phenol.
4,4'-Thiobis (6-tert-butyl-m-cresol).
Toluene-2,4-diamine.
N-o-Tolyl-N'-phenyl-p-phenylenediamine.
p(p-Tolylsufanilamide) diphenylamine.
Tri(mixed mono- and dinonylphenyl) phosphite.
Tri(nonylphenyl) phosphite-formaldehyde resins produced when 1 mole of 
tri(nonylphenyl) phosphite is made to react with 1.4 moles of 
formaldehyde or produced when 1 mole of nonylphenol is made to react 
with 0.36 mole of formaldehyde and the reaction product is then further 
reacted with 0.33 mole of phosphorus trichloride. The finished resins 
have a minimum viscosity of 20,000 centipoises at 25 [deg]C, as 
determined by LV-series Brookfield viscometer (or equivalent) using a 
No. 4 spindle at 12 r.p.m., and have an organic phosphorus content of 
4.05 to 4.15 percent by weight.

    (iv) Plasticizers (total not to exceed 30 percent by weight of 
rubber product unless otherwise specified).

n-Amyl n-decyl phthalate.
Butylacetyl ricinoleate.
n-Butyl ester of tall oil fatty acids.
Butyl laurate.
Butyl oleate.
Butyl stearate.
Calcium stearate.
Castor oil.
Coumarone-indene resins.
2,2'-Dibenzamidodiphenyl disulfide.
Dibenzyl adipate.
Dibutoxyethoxyethyl adipate.
Dibutyl phthalate.
Dibutyl sebacate.
Didecyl adipate.
Didecyl phthalate.
Diisodecyl adipate.
Diisodecyl phthalate.
Diisooctyl adipate.
Diisooctyl sebacate.
Dioctyl adipate.
Dioctyl phthalate.
Dioctyl sebacate.
Dipentene resin.
Diphenyl ketone.
Fatty acids.
Fatty acids, hydrogenated.
Isooctyl ester of tall oil fatty acids.
Lanolin.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a-
methylstyrene to 3 vinyltoluene).
Mineral oil; (1) In rubber articles complying with this section, not to 
exceed 30 percent by weight; (2) Alone or in combination with waxes, 
petroleum, total not to exceed 45 percent by weight of rubber articles 
that contain at least 20 percent by weight of ethylene-propylene 
copolymer elastomer complying with paragraph (c)(4)(i) of this section, 
in contact with foods of Types I, II, III, IV, VI, VII, VIII, and IX 
idenified in table 1 of Sec.  176.170(c) of this chapter.
Montan wax.
n-Octyl n-decyl adipate.
n-Octyl n-decyl phthalate.
Petrolatum.
Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced by the homo- and copolymerization 
of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid 
arylalkene types from distillates of cracked petroleum stocks).
Petroleum hydrocarbon resin (produced by the catalytic polymerization 
and subsequent hydrogenation of styrene, vinyltoluene, and indene types 
from distillates of cracked petroleum stocks).
Petroleum oil, sulfonated.
Phenol-formaldehyde resin.
Pine tar.
Polybutene.
Polystyrene.
Propylene glycol.
n-Propyl ester of tall oil fatty acids.
Rapeseed oil vulcanized with rubber maker's sulfur.
Rosins and rosin derivatives identified in Sec.  175.105(c)(5) of this 
chapter.
Soybean oil vulcanized with rubber maker's sulfur.
Styrene-acrylonitrile copolymer.
Terpene resins.
Triethylene glycol dicaprate.
Triethylene glycol dicaprylate.
Waxes, petroleum.
Xylene (or toluene) alkylated with dicyclopentadiene.
Zinc 2-benzamidothiophenate.

    (v) Fillers.

Aluminum hydroxide.
Aluminum silicate.
Asbestos fiber, chrysotile or crocidolite.
Barium sulfate.

[[Page 353]]

Carbon black (channel process or furnace combustion process; total 
carbon black not to exceed 50 percent by weight of rubber product; 
furnace combustion black content not to exceed 10 percent by weight of 
rubber products intended for use in contact with milk or edible oils).
Cork.
Cotton (floc, fibers, fabric).
Mica.
Nylon (floc, fibers, fabric).
Silica.
Titanium dioxide.
Zinc carbonate.
Zinc sulfide.

    (vi) Colorants. Colorants used in accordance with Sec.  178.3297 of 
this chapter.
    (vii) Lubricants (total not to exceed 2 percent by weight of rubber 
product).

Polyethylene.
Sodium stearate.

    (viii) Emulsifiers.

Fatty acid salts, sodium or potassium.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.
Rosins and rosin-derivatives identified in Sec.  175.105(c)(5) of this 
chapter.
Sodium decylbenzenesulfonate
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
Tall oil mixed soap (calcium, potassium, and sodium).

    (ix) Miscellaneous (total not to exceed 5 percent by weight of 
rubber product).

Animal glue as described in Sec.  178.3120 of this chapter.
Azodicarbonamide as chemical blowing agent.
2-Anthraquinone sulfonic acid sodium salt for use only as polymerization 
inhibitor in chloroprene polymers and not to exceed 0.03 percent by 
weight of the chloroprene polymers.
1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5) for use as a biocide 
in uncured liquid rubber latex not to exceed 0.02 percent by weight of 
the latex solids, where the total of all items listed in paragraph 
(c)(4)(ix) of this section does not exceed 5 percent of the rubber 
product.
n-Butyllithium for use only as polymerization catalyst for 
polybutadiene.
4-tert-Butyl-o-thiocresol as peptizing agent.
tert-Butyl peracetate.
p-tert-Butylpyrocatechol.
Dialkyl (C8-C18
Di- and triethanolamine.
Diethyl xanthogen disulfide.
4-(Diiodomethylsulfonyl) toluene, Chemical Abstracts Service Registry 
No. 20018-09-01, for use as an antifungal preservative at levels not to 
exceed 0.3 percent by weight of the sealants and caulking materials.
Dodecyl mercaptan isomers, single or mixed.
2-Ethoxyethanol.
Iodoform.
p-Menthane hydroperoxide.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen 
phosphate and monohydrogen phosphate esters, barium salt; the nonyl 
group is a propylene trimer isomer and the poly (oxyethylene) content 
averages 9 moles; for use only as residual polymerization emulsifier at 
levels not to exceed 0.7 percent by weight of ethylene-propylene-1,4-
hexadiene copolymers identified under paragraph (c)(4)(i) of this 
section.
4,4'-Oxybis (benzenesulfonhydrazide) as chemical blowing agent.
Phenothiazine.
Potassium persulfate.
Sodium formaldehyde sulfoxylate.
Sodium polysulfide.
Sodium nitrite.
Sodium salt of ethylenediamine tetraacetic acid and glycine.
Sodium sulfide.
Styrene monomer.
Tall oil.
Thioxylenois as peptizing agents.
Tridecyl mercaptan.
Zinc 4-tert-butylthiophenate as peptizing agent.

    (d) Rubber articles intended for use with dry food are so formulated 
and cured under conditions of good manufacturing practice as to be 
suitable for repeated use.
    (e) Rubber articles intended for repeated use in contact with 
aqueous food shall meet the following specifications: The food-contact 
surface of the rubber article in the finished form in which it is to 
contact food, when extracted with distilled water at reflux temperature, 
shall yield total extractives not to exceed 20 milligrams per square 
inch during the first 7 hours of extraction, nor to exceed 1 milligram 
per square inch during the succeeding 2 hours of extraction.
    (f) Rubber articles intended for repeated use in contact with fatty 
foods shall meet the following specifications: The food-contact surface 
of the rubber article in the finished form in which it is to contact 
food, when extracted with n-hexane at reflux temperature, shall yield 
total extractives not to exceed 175 milligrams per square inch during 
the first 7 hours of extraction, nor to exceed 4 milligrams per square 
inch during the succeeding 2 hours of extraction.

[[Page 354]]

    (g) In accordance with good manufacturing practice finished rubber 
articles intended for repeated use in contact with food shall be 
thoroughly cleansed prior to their first use in contact with food.
    (h) The provisions of this section are not applicable to rubber 
nursing-bottle nipples.
    (i) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec.  180.22 of this chapter.

[42 FR 14572, Mar. 15, 1977]

    Editorial Note: ForFederal Register citations affecting Sec.  
177.2600, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 2600


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