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ARTICLE 12:11 FROZEN DAIRY DESSERTS Chapter 12:11:01 12:11:02 12:11:03

Frozen dairy desserts. Requirements for plants. Pasteurization and packa in . CHAPTER 12:11:01 FROZEN DAIRY DESSERTS

!ection 12:11:01:01 12:11:01:01.01 12:11:01:01.02 12:11:01:01.03 12:11:01:01.0% 12:11:01:01.0& 12:11:01:01.0' 12:11:01:02 12:11:01:03 12:11:01:0% 12:11:01:0&

"efinitions. Frozen dairy dessert mi# defined. $ce cream mi# defined. $ce milk mi# defined. $ce milk shake mi# defined. Frozen milk shake defined. Frozen yo urt defined. !tandards of identity and la(el statements for frozen dairy desserts. )uality standards for pasteurized dairy in redients* mi#* or frozen dairy desserts. Procedures for testin compliance of product +ith standards of identity and quality. Frozen dairy dessert samplin .

12:11:01:01. Definitions. ,erms defined in !"C- 3./0/1 ha1e the same meanin +hen used in this article. $n addition* terms used in this article mean: 213 4C $ P4 or 4cleaned in place*4 the procedure (y +hich sanitary pipelines or pieces of dairy equipment are mechanically cleaned in place (y circulation5 223 4"airy plant4 or 4plant*4 a place* premise* or esta(lishment +here milk or dairy products are recei1ed or handled for the processin or manufacturin of mi# and frozen dairy desserts5 233 4"epartment*4 the secretary of a riculture or his authorized a ent5 2%3 4Frozen dairy dessert*4 any frozen or partially frozen com(ination of t+o or more of the follo+in : milk or milk products* e s or e products* su ar* +ater* fruit or fruit 6uices* candy* nut meats* or other harmless and +holesome food products such as fla1ors* color* and sta(ilizer* includin ice cream* ice milk* frozen custard* milk sher(ets* frozen milk shakes* soft/ser1e ice cream or ice milk* frozen yo urts* and lo+fat or nonfat frozen desserts5 2&3 47fficial methods*4 Officia !et"o#s of Ana $sis* 8ssociation of 7fficial 8nalytical Chemists $nternational 21...35

2'3 4!tandard methods*4 Stan#a%# !et"o#s fo% t"e E&a'ination of Dai%$ P%o#(cts * 8merican Pu(lic 9ealth 8ssociation 2200%35 2:3 43/8 sanitary standards*4 )*A Sanita%$ Stan#a%#s an# Acce+te# P%actices* 3/8 !anitary !tandards Committee 21...35 203 4"ry po+der mi#*4 the dry* unfrozen com(ination of t+o or more of the follo+in in redients or their deri1ati1es* +hich ha1e (een pasteurized accordin to su(di1ision 2&3 of !"C3./0/1 and +hich* +hen reconstituted* meet the standard of the product declared on the la(el: milk or milk products* e s or e products* su ars* fruit or fruit 6uices* candy* nut meats* other harmless and +holesome food products* fla1ors* color* and harmless sta(ilizer5 2.3 4!ecretary*4 the secretary of a riculture* includin a ents and employees of the department of a riculture to the e#tent that this article in1ol1es inspection and enforcement of administrati1e responsi(ilities. So(%ce: !- 1.:&* ch 1'* ; 15 3 !"R :1* effecti1e 8pril 1:* 1.::5 12 !"R 102* effecti1e "ecem(er 2&* 1.0&5 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 13 !"R 202* effecti1e <uly &* 1.0:5 32 !"R 203* effecti1e <une '* 200'5 3& !"R 103* effecti1e Fe(ruary 2* 200.. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. Refe%ences: Officia !et"o#s of Ana $sis* 1'th edition* 1...* 8ssociation of 7fficial 8nalytical Chemists* =aithers(ur * >". Copies may (e o(tained from the 8ssociation of 7fficial 8nalytical Chemists $nternational* Customer !er1ice* %01 ?. Frederick 81e.* !uite &00* =aithers(ur * >" 200::/2%1:. Stan#a%# !et"o#s fo% t"e E&a'ination of Dai%$ P%o#(cts* 1:th edition* 200%* 9. >ichael @ehr* Ph.".* and <oseph F. Frank* Ph.".* Aditors* 8merican Pu(lic 9ealth 8ssociation* @ashin ton* ".C. Copies may (e o(tained from the 8merican Pu(lic 9ealth 8ssociation* 101& 1&th !treet* ?. @.* @ashin ton* ". C. 2000&. )*A Sanita%$ Stan#a%#s an# Acce+te# P%actices * ?o1em(er 21* 1...* formulated (y the "airy $ndustry Committee* $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* B.! Pu(lic 9ealth !er1ice* B.!. "epartment of 8 riculture* "airy and Food $ndustries !upply 8ssociation* and Poultry and A $nstitute of 8merica. Pu(lished (y the <ournal of Food Protection. Copies may (e o(tained from the $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* Co# :01* 8mes* $o+a &0010. 12:11:01:01.01. F%o.en #ai%$ #esse%t 'i& #efine#. Frozen dairy dessert mi# is the unfrozen liquid product +hich is used in the manufacture of frozen dairy desserts* includin ice cream mi#* lo+ fat ice cream mi#* ice milk mi#* ice milk shake mi#* sher(et mi#* custard mi#* or any other mi# that contains the in redients for a frozen dairy dessert. So(%ce: 13 !"R 202* effecti1e <uly &* 1.0:5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. 12:11:01:01.02. Ice c%ea' 'i& #efine#. $ce cream mi# is the unfrozen liquid product used in the manufacture of ice cream. $ce cream mi# must contain a minimum of 10 percent milk fat and

a minimum of 3&.' percent total food solids. $ce cream mi# must contain not less than 3.2 pounds of total solids to the allon and +ei h not less than . pounds to the allon. So(%ce: 13 !"R 202* effecti1e <uly &* 1.0:. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. 12:11:01:01.0). Ice 'i / 'i&0 o- fat ice c%ea' 'i& #efine#. $ce milk mi#Dlo+ fat ice cream mi# is the unfrozen liquid product used in the manufacture of soft/ser1e ice milk and frozen milk shakes. $ce milk mi#Dlo+ fat ice cream mi# must contain a minimum of 2 percent milk fat (ut not more than : percent milk fat and a minimum of 20.. percent total food solids. $ce milk mi#Dlo+ fat ice cream mi# must contain not less than 2.' pounds of total solids to the allon and +ei h not less than . pounds to the allon. So(%ce: 13 !"R 202* effecti1e <uly &* 1.0:5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. 12:11:01:01.01. Ice 'i / s"a/e 'i& #efine#. $ce milk shake mi# is the unfrozen liquid product used in the manufacture of frozen milk shakes. $ce milk shake mi# must contain a minimum of 2 percent milk fat (ut not more than : percent milk fat and a minimum of 23 percent total food solids. $ce milk shake mi# must contain not less than 2.0: pounds of total solids to the allon and +ei h not less than . pounds to the allon. So(%ce: 13 !"R 202* effecti1e <uly &* 1.0:. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. 12:11:01:01.02. F%o.en 'i / s"a/e #efine#. Frozen milk shake is the semifrozen dessert produced from ice milk mi# or ice milk shake mi#. Frozen milk shake must contain a minimum of 2 percent milk fat (ut not more than : percent milk fat and a minimum of 23 percent total solids. So(%ce: 13 !"R 202* effecti1e <uly &* 1.0:. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. 12:11:01:01.03. F%o.en $o4(%t #efine#. Frozen yo urt* lo+fat frozen yo urt* and nonfat frozen yo urt are frozen dairy products made from milk* +ith or +ithout added solids* fla1orin fruits* or seasonin * +hich has (een pasteurized and after+ards fermented (y one or more strains of lacto(acillus (ul aricus* includin yo urt strains* streptococcus thermophilus* and lacto(acillus acidophilus. So(%ce: 13 !"R 202* effecti1e <uly &* 1.0:. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. 12:11:01:02. Stan#a%#s of i#entit$ an# a5e state'ents fo% f%o.en #ai%$ #esse%ts. Frozen dairy desserts must comply +ith the follo+in standards of identity and la(el statements:

213 $ce cream* frozen custard* lo+ fat ice cream* ice milk* fruit sher(ets* mellorine* +ater ices* nonfruit sher(ets* and nonfruit +ater ices shall meet the standards of identity and la(el statements prescri(ed in 21 C.F.R. 13&.110 to 21 C.F.R. 13&.1'0* inclusi1e 28pril 1* 1..%35 223 -o+fat frozen dairy dessert must meet the follo+in standards: 2a3 Contain not less than 0.& percent and not more than 1.. percent milk fat (y +ei ht5 2(3 Contain not less than 12 percent total milk solids (y +ei ht5 2c3 Contain not less than 1.3 pounds of food solids per allon5 2d3 @ei h less than %.& pounds per allon5 2e3 Cear on the container the name 4-o+fat Frozen "airy "essert45 and 2f3 Comply +ith la(elin requirements set forth in 21 C.F.R. 101.1 to 21 C.F.R. 101.100* inclusi1e 28pril 1* 1..%35 233 ?onfat frozen dairy dessert must meet the follo+in standards: 2a3 >eet all the requirements of lo+fat frozen dairy dessert e#cept that milk fat content must (e less than 0.& percent milk fat (y +ei ht5 2(3 Cear on the container the name 4?onfat Frozen "airy "essert45 2c3 Cear on the container the statement* 4less than 0.& percent milk fat45 and 2d3 Comply +ith la(elin requirements set forth in 21 C.F.R. 101.1 to 21 C.F.R. 101.100* inclusi1e 28pril 1* 1..%35 2%3 Frozen yo urt* lo+fat frozen yo urt* and nonfat frozen yo urt must meet the follo+in standards: 2a3 Frozen yo urt must contain not less than 3.2& percent milk fat5 2(3 -o+fat frozen yo urt must contain not more than 2 percent milk fat5 2c3 ?onfat frozen yo urt must contain a ma#imum of 0.2& percent milk fat5 2d3 Frozen fruit yo urt must contain not less than 0 percent (y +ei ht of clean* mature* sound fruit or its equi1alent in other forms* such as puree. ,he milk fat content of frozen fruit yo urt may (e reduced to not less than 2.0 percent milk fat* and the milk fat content of lo+fat frozen fruit yo urt may (e reduced to not less than 1.3 percent milk fat5 2e3 $f offered for sale* frozen yo urt* lo+fat frozen yo urt* and nonfat frozen yo urt must (e la(eled +ith the factory num(er or factory name on the container and on the carton5 2f3 $f fruit is added to any of the frozen yo urt products* the name of the fruit must precede the name of the product on the la(el5 and 2 3 Frozen yo urt products must comply +ith the la(elin requirements set forth in 21 C.F.R. 101.1 to 21 C.F.R. 101.100* inclusi1e 28pril 1* 1..%3. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 13 !"R 202* effecti1e <uly &* 1.0:5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10.

12:11:01:0). 6(a it$ stan#a%#s fo% +aste(%i.e# #ai%$ in4%e#ients7 'i&7 o% f%o.en #ai%$ #esse%ts. 8t no time after pasteurization may frozen dairy desserts or frozen dairy dessert mi# or any product manufactured from them contain more than &0*000 (acteria per ram or shall contain more than 10 coliform or anisms per ram for plain or more than 20 coliform or anisms per ram in chocolate* fruit* nut or other fla1ors. $f t+o of the last four consecuti1e samples ha1e e#ceeded the (acterial or coliform standard* the secretary shall send a +ritten notice to the person concerned. ,he notice shall remain in effect as lon as t+o of the last four samples e#ceed the limit of the standard. 8n additional sample shall then (e taken to determine compliance* (ut not (efore the lapse of three days. $mmediate suspension of permit shall (e instituted if three of the last fi1e consecuti1e samples e#ceed the (acteria or coliform standard. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'5 3& !"R 103* effecti1e Fe(ruary 2* 200.. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10. Refe%ence: ,ene%a S+ecification fo% Dai%$ P ants A++%o8e# fo% 9SDA Ins+ection an# ,%a#in4 Se%8ice* 8u ust 20* 2002. Copies may (e o(tained from the Bnited !tates "epartment of 8 riculture* 8 ricultural >arketin !er1ice* "airy Pro rams* =radin Cranch* 1%00 $ndependence 81enue* !@* !top 0230* @ashin ton* "C 202&0/0230 at no char e. 12:11:01:01. P%oce#(%es fo% testin4 co'+ iance of +%o#(ct -it" stan#a%#s of i#entit$ an# :(a it$. ,he procedures used in testin and e#aminin frozen dairy desserts and frozen dairy dessert mi# for compliance +ith !"C- 3./0 are those prescri(ed in !tandard >ethods for the A#amination of "airy Products* 1:th edition* 200%* and 7fficial >ethods for 8nalysis* 1'th edition* 1.... So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 102* effecti1e "ecem(er 2&* 1.0&5 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/10* 3./0/11. Refe%ences: Stan#a%# !et"o#s fo% t"e E&a'ination of Dai%$ P%o#(cts * 1:th edition* 200%* 9. >ichael @ehr* Ph.". and <oseph F. Frank* Ph.".* Aditors* 8merican Pu(lic 9ealth 8ssociation* $nc.* @ashin ton* ".C. Copies may (e o(tained from the 8merican Pu(lic 9ealth 8ssociation* 101& 1&th !treet ?.@.* @ashin ton* ".C. 2000&. Officia !et"o#s of Ana $sis* 1'th edition* 1...* 8ssociation of 7fficial 8nalytical Chemists $nternational* =aithers(ur * >". Copies may (e o(tained from the 8ssociation of 7fficial 8nalytical Chemists $nternational* Customer !er1ice* %01 ?. Frederick 81e.* !uite &00* =aithers(ur * >" 200::/2%1:. 12:11:01:02. F%o.en #ai%$ #esse%t sa'+ in4. !amples of frozen dairy desserts from retail stores* food ser1ice esta(lishment* rocery stores* and other places +here frozen dairy desserts are sold shall (e e#amined as determined (y the secretary. ,he results of such e#aminations shall (e used to determine compliance +ith this chapter. Proprietors of such esta(lishments shall furnish the secretary* upon request* +ith the names of all distri(utors from +hom frozen dairy desserts are o(tained. So(%ce: 3& !"R 103* effecti1e Fe(ruary 2* 200.. ,ene%a A(t"o%it$: !"C- 3./0/10.

La- I'+ e'ente#: !"C- 3./0/10. CHAPTER 12:11:02 RE69IRE!ENTS FOR PLANTS !ection 12:11:02:01 12:11:02:02 12:11:02:03 12:11:02:0% 12:11:02:0& 12:11:02:0' 12:11:02:0: 12:11:02:00 12:11:02:0. 12:11:02:10 12:11:02:11 12:11:02:12 12:11:02:13 12:11:02:1% 12:11:02:1& 12:11:02:1' 12:11:02:1: 12:11:02:10 12:11:02:1. 12:11:02:20 12:11:02:21 12:11:02:22 12:11:02:23 12:11:02:2%

Premises. Cuildin construction and maintenance. Protection of (uildin openin s. Processin rooms separated from other rooms. "epartment to appro1e plans for ne+ or remodelin of plant. $nterior finishin . Eentilation and li htin . @ater supply. !team. "isposal of +astes. Construction of equipment and utensils. $nstallation of equipment. Pasteurization equipment. ,hermometer accuracy. Cleanin and sanitizin . Cleanin equipment not desi ned for in/place cleanin . Cleaned/in/place method of cleanin equipment. !tora e of utensils and porta(le equipment. !tora e of nonrefri erated products. !tora e of supplies. Pasteurization and recorder charts to (e on file. Eehicles used in transportin of frozen dairy desserts. Personnel cleanliness. 9ealth of personnel.

12:11:02:01. P%e'ises. ,he plant area and surroundin shall (e kept clean* orderly* and free from refuse and ru((ish* smoke* dust and air pollution* and stron or foul odors. 8 draina e system shall (e pro1ided for rapid draina e of all +ater from plant (uildin s includin surface +ater around the plant and on the premises. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:02. ;(i #in4 const%(ction an# 'aintenance. Cuildin s shall (e of sound construction. ,he e#terior and interior shall (e kept clean and in ood repair to protect a ainst dust* dirt* and mold and to pre1ent the entrance or har(orin of insects* rodents* 1ermin* and other animals. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3.

12:11:02:0). P%otection of 5(i #in4 o+enin4s. 7utside doors* +indo+s* skyli hts* and transoms shall (e screened or other+ise co1ered. 7utside doors shall open out+ard and (e self/ closin and those leadin to processin rooms shall (e sound and ti ht/fittin . @indo+ sills on ne+ construction shall (e slopin . 7utside con1eyor openin s and other special outside openin s shall (e protected (y doors* screens* flaps* fans* or tunnels. 7utside openin s for sanitary pipelines shall (e completely cemented around the pipe openin or ha1e ti ht metal collars. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3. 12:11:02:01. P%ocessin4 %oo's se+a%ate# f%o' ot"e% %oo's. 8ll rooms* compartments* coolers* freezers* and dry stora e space in +hich any ra+ material* packa in * in redient supplies* or finished products are handled* processed* manufactured* packa ed* or stored shall (e separated from the processin (y a partition or suita(le arran ement of equipment or facilities so as to a1oid contamination of milk or dairy products. Coiler and tool rooms shall (e separated from other rooms. ,oilet and dressin rooms shall (e con1eniently located and shall not open directly into any room in +hich milk* dairy products* or in redients are handled* processed* packa ed* or stored. "oors of all toilet rooms shall (e self/closin and fi#tures shall (e kept clean and in ood repair. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3. 12:11:02:02. De+a%t'ent to a++%o8e + ans fo% ne- o% %e'o#e in4 of + ant. Plans for ne+ plant construction or ma6or remodelin of e#istin plants shall (e su(mitted to the department for appro1al prior to ne+ construction or remodelin . So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3. 12:11:02:03. Inte%io% finis"in4. ,he interior finishin includin the +alls* ceilin s* partitions* and posts of all rooms in +hich milk or dairy products are recei1ed* handled* or processed and +here mi# and frozen dairy desserts are manufactured* packa ed* or stored* e#cept dry stora e of packa in materials* or in +hich equipment or utensils are +ashed* shall (e smoothly finished +ith a +asha(le material of li ht color that is su(stantially imper1ious to moisture. ,he floors in these rooms shall (e concrete or other imper1ious material and shall (e smooth* properly raded to drain* and ha1e drains trapped. Rooms used for storin frozen dairy desserts* frozen fruits* e s* and compara(le in redients need not (e pro1ided +ith floor drains* (ut the floors shall (e kept clean. ,he plum(in shall (e installed so as to pre1ent (ackup of se+a e into the plant. 7n ne+ construction or e#tensi1e remodelin * the floors shall (e 6oined and co1ed +ith the +alls to form +aterti ht 6oints. !ound* smooth* +ood floors may (e used in packa in rooms +here the nature of the product permits. ,oilet and dressin rooms shall ha1e imper1ious floors and smooth +alls. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3.

12:11:02:0<. =enti ation an# i4"tin4. 8ll rooms and compartments* includin stora e space* toilet* and dressin rooms* shall (e 1entilated to maintain sanitary conditions* pre1ent undue condensation of +ater 1apor* and minimize or eliminate o(6ectiona(le odors. -i htin * +hether natural or artificial* shall (e of ood quality and +ell distri(uted in all rooms and compartments. 8ll rooms +here milk* dairy products mi# and frozen dairy desserts are handled* processed* manufactured* or packa ed or +here equipment or utensils are +ashed shall ha1e at least 30 footcandles of li ht intensity on all +orkin surfaces. 8reas +here dairy products are e#amined for condition and quality shall ha1e at least &0 footcandles of li ht intensity. 8ll other rooms shall ha1e at least & footcandles of li ht intensity measured 30 inches a(o1e the floor. -i ht (ul(s shall (e protected a ainst (reaka e. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3. 12:11:02:0>. ?ate% s(++ $. Coth hot and cold +ater of safe and sanitary quality shall (e a1aila(le in sufficient quantity for all plant operations and facilities. @ater from other lines* +hen officially appro1ed* may (e used for (oiler feed +ater and condenser +ater if the +ater lines are completely separated from the +ater lines carryin the sanitary +ater supply and the equipment is constructed and controlled so as to preclude contamination of any product or product contact surface. ,here shall (e no cross connections (et+een safe and unsafe +ater lines or (et+een pri1ate and pu(lic supply. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3. 12:11:02:0@. Stea'. !team shall (e supplied in sufficient 1olume and pressure for satisfactory operation of each applica(le piece of equipment. !team that may come into direct contact +ith milk or dairy products shall (e culinary steam conducted throu h a steam strainer and purifier equipped +ith a steam trap and shall (e free from any compounds that may contri(ute fla1ors or endan er health. 7nly compounds complyin +ith 21 C.F.R. 1:3.310* as amended to >arch 1* 200'* may (e used to pre1ent corrosion and scale in (oilers* or to facilitate slud e remo1al. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/3. La- I'+ e'ente#: !"C- 3./0/3. 12:11:02:10. Dis+osa of -astes. ,he plant se+a e system shall ha1e sufficient slope and capacity to remo1e readily all +aste from processin operations. @here a pu(lic se+er is not a1aila(le* +astes shall (e disposed of (y an appro1ed method. Containers for the collection and holdin of +astes shall (e constructed of metal or other equally imper1ious material* kept co1ered +ith ti ht/fittin lids and placed outside the plant on a concrete sla( or on a rack at least 12 inches a(o1e the round. !olid +astes shall (e disposed of re ularly and the containers cleaned (efore reuse. "ry +aste paper shall (e (a ed and hauled a+ay. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%.

C%oss*Refe%ence: Pri1ate se+a e disposal systems* ch :%:&3:01. 12:11:02:11. Const%(ction of e:(i+'ent an# (tensi s. Aquipment and utensils comin in contact +ith milk* dairy products* mi#* or frozen dairy desserts* includin sanitary pumps* pipin * fittin s* and connections* shall (e constructed of stainless steel or equally corrosion resistant material* e#cept that if the use of stainless steel is not practica(le* or in old equipment* other tinned metals may (e appro1ed. ?onmetallic parts +ith product contact surfaces shall (e of material that meets of the 3/8 sanitary standards for multiple use ru((er and ru((er/like materials. Culk stora e and distri(ution equipment for handlin liquid s+eetenin a ents shall consist of metals* alloys* or other materials that +ill +ithstand corrosi1e action (y the in redients* and such equipment and in redients shall (e protected from contamination. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 102* effecti1e "ecem(er 2&* 1.0&5 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. Refe%ence: )*A Sanita%$ Stan#a%#s an# Acce+te# P%actices * ?o1em(er 21* 1...* formulated (y the "airy $ndustry Committee* $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* B.!. Pu(lic 9ealth !er1ice* B.!. "epartment of 8 riculture* "airy and Food $ndustries !upply 8ssociation* and Poultry and A $nstitute of 8merica. Pu(lished (y the <ournal of Food Protection. Copies may (e o(tained from the $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* Co# :01* 8mes* $o+a &0010. 12:11:02:12. Insta ation of e:(i+'ent. 8ll equipment and pipin shall (e desi ned and installed so as to (e easily accessi(le for cleanin and shall (e kept in ood repair and free from cracks and corroded surfaces. >ilk pumps shall (e of a sanitary type and easily dismantled for cleanin . ?e+ or rearran ed equipment shall (e set out appro#imately 2% inches from any +all or spaced at least 2% inches (et+een pieces of equipment that measure more than %0 inches on the parallel sides. ,his requirement does not apply (et+een tanks if the face of the tanks e#tend throu h a +all into a processin room. 8ll parts or interior surfaces of equipment* pipes* e#cept certain pipin cleaned in place* or fittin s* includin 1al1es and connections* shall (e accessi(le for inspection. Cleaned/in/place sanitary pipin and +elded sanitary pipeline systems* if used* are accepta(le if en ineered and installed accordin to the 3/8 sanitary standards for permanently installed sanitary product pipelines and cleanin systems. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 102* effecti1e "ecem(er 2&* 1.0&5 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. Refe%ence: )*A Sanita%$ Stan#a%#s an# Acce+te# P%actices * ?o1em(er 21* 1...* formulated (y the "airy $ndustry Committee* $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* B.!. Pu(lic 9ealth !er1ice* B.!. "epartment of 8 riculture* "airy and Food $ndustries !upply 8ssociation* and Poultry and A $nstitute of 8merica. Pu(lished (y the <ournal of Food Protection. Copies may (e o(tained from the $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* Co# :01* 8mes* $o+a &0010. 12:11:02:1). Paste(%i.ation e:(i+'ent. 9i h temperature short time pasteurizers shall (e equipped +ith an automatic flo+ di1ersion 1al1e* timin pump or de1ice* temperature recorder and

holdin tu(e or its equi1alent to assure complete pasteurization. Aquipment and operation shall meet requirements of and installed in accordance +ith the 3/8 sanitary standards for the sanitary construction* installation* testin and operation of hi h/temperature short/time pasteurizers. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 102* effecti1e "ecem(er 2&* 1.0&5 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. Refe%ence: )*A Sanita%$ Stan#a%#s an# Acce+te# P%actices * ?o1em(er 21* 1...* formulated (y the "airy $ndustry Committee* $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* B.!. Pu(lic 9ealth !er1ice* B.!. "epartment of 8 riculture* "airy and Food $ndustries !upply 8ssociation* and Poultry and A $nstitute of 8merica. Pu(lished (y the <ournal of Food Protection. Copies may (e o(tained from the $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* Co# :01* 8mes* $o+a &0010. 12:11:02:11. T"e%'o'ete% acc(%ac$. -on /stem indicatin thermometers that are accurate +ithin 0.& de rees Fahrenheit plus or minus for the applica(le temperature ran e shall (e pro1ided for determinin temperatures of pasteurization of products in 1ats and for 1erifyin the accuracy of recordin thermometers. !hort/stem indicatin thermometers that are accurate +ithin 0.& de rees Fahrenheit plus or minus for the applica(le temperature ran e shall (e installed in the proper stationary position in all hi h/temperature short/time and dome/type pasteurizers and all stora e tanks +here temperature readin s are required. Recordin thermometers that are accurate +ithin one de ree Fahrenheit plus or minus shall (e used on each pasteurizer to record pasteurization temperature. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:12. C eanin4 an# saniti.in4. Aquipment* sanitary pipin s* and utensils used in the recei1in * storin * processin * manufacturin * packa in * and handlin of milk* dairy products* mi#* or frozen dairy desserts and all product contact surfaces of homo enizers* hi h pressure pumps* and hi h pressure lines shall (e kept clean and sanitary. !tacks* ele1ators* con1eyors* and the packin lands on all a itators* pumps* and 1ats shall (e inspected at re ular inter1als and kept clean. Aquipment comin in contact +ith milk* dairy products* mi#* or frozen dairy dessert shall ha1e (actericidal or sanitizin treatment immediately (efore use. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:13. C eanin4 e:(i+'ent not #esi4ne# fo% in*+ ace c eanin4. Aquipment not desi ned for cleaned/in/place cleanin shall (e disassem(led daily and thorou hly cleaned. "airy cleansers* +ettin a ents* deter ents* sanitizin a ents* or other similar material may (e used that +ill not contaminate or ad1ersely affect dairy products. !teel +ool or metal spon es shall not (e used in the cleanin of any dairy equipment or utensils. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%.

12:11:02:1<. C eane#*in*+ ace 'et"o# of c eanin4 e:(i+'ent. Cleaned/in/place cleanin may (e used only on equipment and pipeline systems that are desi ned and en ineered for that purpose. $nstallation and cleanin procedures shall (e in accordance +ith the 3/8 sanitary standards for permanently installed sanitary product pipelines and cleanin systems. 8n outline of the cleanin procedures to (e follo+ed shall (e posted near the cleaned in place equipment. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 102* effecti1e "ecem(er 2&* 1.0&5 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. Refe%ence: )*A Sanita%$ Stan#a%#s an# Acce+te# P%actices * ?o1em(er 21* 1...* formulated (y the "airy $ndustry Committee* $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* B.!. Pu(lic 9ealth !er1ice* B.!. "epartment of 8 riculture* "airy and Food $ndustries !upply 8ssociation* and Poultry and A $nstitute of 8merica. Pu(lished (y the <ournal of Food Protection. Copies may (e o(tained from the $nternational 8ssociation of >ilk* Food and An1ironmental !anitarians* Co# :01* 8mes* $o+a &0010. 12:11:02:1>. Sto%a4e of (tensi s an# +o%ta5 e e:(i+'ent. Btensils and porta(le equipment used in processin operations shall (e stored a(o1e the floor in clean* dry locations and in self/drainin positions on racks constructed of imper1ious* corrosion/resistant material. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:1@. Sto%a4e of non%ef%i4e%ate# +%o#(cts. "airy products* or frozen dairy dessert in redients in dry stora e shall (e arran ed in aisles* ro+s* sections* or lots or in such a manner as to (e orderly and easily accessi(le for inspection and to permit adequate cleanin of the room. "unna e or pallets shall (e used +hen applica(le. "airy products* mi#* or frozen dairy dessert in redients shall not (e stored +ith any product that +ould dama e them or impair their quality. 7pen containers shall (e carefully protected from contamination. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:20. Sto%a4e of s(++ ies. $tems in supply rooms shall (e kept clean and protected and shall (e arran ed so as to permit inspection of supplies and cleanin and sprayin of the room. $nsecticides and rodenticides shall (e properly la(eled* se re ated* and stored in a separate room or ca(inet a+ay from milk or dairy products or packa in supplies. Caps* parchment papers* +rappers* liners* askets* sin le/ser1ice sticks* spoons* co1ers* and containers for frozen dairy desserts* mi#* or their in redients* shall (e purchased and stored only in sanitary tu(es* +rappin s* or cartons and shall (e kept in them in a clean* dry place until used. ,hey shall (e handled in a sanitary manner. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%.

12:11:02:21. Paste(%i.ation an# %eco%#e% c"a%ts to 5e on fi e. Recorder charts sho+in the pasteurization record for each day shall (e marked +ith the name of the product* date* and si nature of the operator. ,he charts shall (e kept on file at the plant for at least ' months. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'l5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:22. =e"ic es (se# in t%ans+o%tin4 of f%o.en #ai%$ #esse%ts. 8ll 1ehicles used for the transportation of mi#* frozen dairy desserts* cream* milk. and dairy products shall (e constructed and operated so as to protect their contents from the sun and contamination. ,emperatures of 1ehicles used in the transportin of such products shall ha1e coolin facilities to maintain temperatures of liquid products at %& de rees Fahrenheit or less and frozen products at zero de rees Fahrenheit or less. !uch 1ehicles shall (e kept clean and no su(stance capa(le of contaminatin mi#* frozen dairy desserts* cream* milk* and dairy products shall (e transported in them. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:2). Pe%sonne c ean iness. Plant employees shall +ash their hands (efore (e innin +ork and upon returnin to +ork after usin toilet facilities* eatin * smokin * or other+ise soilin their hands. ,hey shall keep their hands clean and follo+ ood hy ienic practices +hile on duty. A#pectoratin or use of to(acco in any form is prohi(ited in rooms and compartments +here milk* dairy products* mi#* or frozen dairy desserts are unpacked or e#posed. Clean +hite or li ht colored +asha(le outer arments and caps shall (e +orn (y all persons en a ed in handlin milk* dairy products* mi#* or frozen dairy desserts. Paper caps or hairnets are accepta(le. $n addition* employees en a ed in manual moldin * +rappin * and touchin any productFs contact surface shall treat their clean hands +ith a (actericide of appro1ed stren th (efore (e innin such +ork and after each interruption. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:02:21. Hea t" of +e%sonne . ?o person affected +ith a disease in a communica(le form or +hile a carrier of such a disease may +ork in a dairy plant in a capacity +hich (rin s him into contact +ith the production* handlin * stora e* or transportation of frozen dairy desserts or frozen dairy dessert mi#* containers* equipment* and utensils. ?o person or firm may employ in such a capacity a person +ho has or is suspected of ha1in a communica(le disease or +ho is or is suspected of (ein a carrier of such a disease. @hen a reasona(le cause e#ists to suspect the possi(ility of transmission of infection from a person concerned +ith the handlin of frozen dairy desserts or frozen mi#* the secretary shall require any or all of the follo+in measures: 213 ,he immediate e#clusion of that person from the premises5 223 ,he immediate e#clusion of the frozen dairy desserts or frozen dairy dessert mi# from distri(ution and use5 and 233 ,he medical and (acteriolo ical e#amination of the person* of his associates* and of his and their (ody dischar es as considered appropriate.

So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. CHAPTER 12:11:0) PASTE9RIZATION AND PACAA,IN, !ection 12:11:03:01 12:11:03:02 12:11:03:03 12:11:03:0% 12:11:03:0&

Pasteurization of frozen dairy dessert mi#. Coolin . Container and packa in materials. -a(elin . Contents of (roken or opened containers not reusa(le.

12:11:0):01. Paste(%i.ation of f%o.en #ai%$ #esse%t 'i&. 8fter formulation of an entire mi#* e#cept for fla1orin in redients* the mi# shall (e pasteurized. ,his pasteurization requirement does not apply to dry po+der mi# as defined (y su(di1ision 12:11:01:01203* +hich requires only the addition of appro1ed drinkin +ater. Pasteurized mi# or frozen dairy desserts may not come in contact +ith equipment or containers +ith +hich unpasteurized mi#* frozen dairy desserts* milk* or milk products ha1e (een in contact unless such equipment has first (een +ashed and su(6ected to a (actericidal treatment. So(%ce: !- 1.:&* ch 1'* ; 15 3 !"R :1* effecti1e 8pril 1:* 1.::5 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:0):02. Coo in4. Processed fluid milk products includin mi#* e#cept sterilized mi# in hermetically sealed containers* shall (e cooled immediately after pasteurization to %& de rees Fahrenheit or lo+er and maintained at that temperature until used. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%. 12:11:0):0). Containe% an# +ac/a4in4 'ate%ia s. Frozen dairy desserts and mi# shall (e packa ed in containers and packa in material that +ill protect the quality of the contents in re ular channels of trade. Prior to use* closures* co1ers* +rappers* and containers shall (e protected a ainst dust* mold* and other possi(le contamination. ,he packa in * cuttin * moldin * dispensin * and other handlin or preparation of mi#es or frozen dairy desserts and their in redients shall (e done in a sanitary manner. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%.

12:11:0):01. La5e in4. Frozen dairy desserts re ulated under !"C- 3./0 shall (e la(eled and packa ed in accordance +ith 21 C.F.R. 1.1 to 21 C.F.R. 1.2%* inclusi1e 28pril 1* 1..%3. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'5 13 !"R 202* effecti1e <uly &* 1.0:5 32 !"R 203* effecti1e <une '* 200'. ,ene%a A(t"o%it$: !"C- 3./0/10. La- I'+ e'ente#: !"C- 3./0/&* 3./0/0* 3./0/10. 12:11:0):02. Contents of 5%o/en o% o+ene# containe%s not %e(sa5 e. "isposition of returned frozen dairy dessert containers and contents to plant is as follo+s: 213 >i# or frozen dairy desserts in (roken* opened or partially full containers may* after deli1ery* (e returned to the plant for inspection (ut shall not (e sold or used for makin mi# or frozen dairy desserts5 223 >ultiuse containers ha1in (een used in the transportin of frozen dairy dessert mi# shall (e +ashed (y the purchaser of the mi# (efore their return to the distri(utor or manufacturer5 233 !in le ser1ice paper(oard containers used to enclose plastic (a s in the transportin of frozen dairy dessert mi# shall not (e returned for further use. So(%ce: !- 1.:&* ch 1'* ; 15 12 !"R 120* 12 !"R 1&%* effecti1e <uly 1* 1.0'. ,ene%a A(t"o%it$: !"C- 3./0/%. La- I'+ e'ente#: !"C- 3./0/%.

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