on farm processing maryland 6-2-10

8/12/2019 On Farm Processing Maryland 6-2-10

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GUIDELINE FOR ON-FARM AND/OR SMALL

MILK PROCESSING PLANTS

Maryland Department o !ealt" and Mental !y#$ene

Center or M$l% Control &CMC'Re() */+,

A milk plant is any place, premises or establishment where milk or milk products are collected,handled, processed, stored, pasteurized, aseptically processed, packaged, or prepared for distribution.The establishment of a dairy processing facility of any size and location is a very involvedundertaking. The Maryland Department of Health and Mental Hygiene DHMH! "enter for Milk"ontrol "M"! administers and enforces dairy laws and regulations designed to protect the generalpublic health and be of service to the dairy industry. All dairy facilities must be approved andpermitted by DHMH before sale of any milk product can be made.#t is imperative that consultation with DHMH, "enter for Milk "ontrol is necessary before any definiteplans for dairy processing are made.

Rle. or La. $rade A %asteurized Milk &rdinance, '(() *evision %M&! vm.cfsan.fda.gov+ear+p-nci.html!

"ode of Maryland *egulations http++www.dsd.state.md.us+comar+!

/(./0.(0 1 Manufacture and 2ale of 3rozen Dairy 3oods and #ces Manufactured for 2alein Maryland

/(./0.(4 1 %roduction, %rocessing, Transportation, 2torage, and Distribution of Milk/(./0.(5 1 %roduction, %rocessing, Transportation, 2torage, and Distribution of Manufacture

$rade Milk/(./0.(6 1 %ilot 3armstead "heese %rogram

Health $eneral Article, Title '/, 2ubtitle ' and 7, Annotated "ode of Maryland

http++www.dsd.state.md.us+comar+Annot8"ode8#d9+:nvir#nde9.htm;Titleuipment dealers and other on-farm processors,"ounty :nvironmental Health Department, etcC. It $. $mportant to "a(e a 0learm$..$on .tatement o yor #oal. and a t$meta1le to rea0" t"em)

3ourth 2tep 1 2ubmission of %lans 1 A copy of all construction plans, 2&%@s and e>uipment list mustbe submitted to "M" for review and approval :3&*: construction begins.*efer to the following handout E&n 3arm and+or 2mall Milk %rocessing %lants 1 %lan

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http://vm.cfsan.fda.gov/~ear/p-nci.htmlhttp://www.dsd.state.md.us/comar/Annot_Code_Idx/EnvirIndex.htm#Title%209http://www.3-a.org/http://www.ams.usda.gov/dairy/manufmlk.pdfhttp://vm.cfsan.fda.gov/~lrd/cfr110.htmlhttp://www.access.gpo.golv/nara/cfr/index.htmlhttp://vm.cfsan.fda.gov/~ear/p-nci.htmlhttp://www.dsd.state.md.us/comar/Annot_Code_Idx/EnvirIndex.htm#Title%209http://www.3-a.org/http://www.ams.usda.gov/dairy/manufmlk.pdfhttp://vm.cfsan.fda.gov/~lrd/cfr110.htmlhttp://www.access.gpo.golv/nara/cfr/index.html


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*eview 2ubmittalsFApplicant will receive a letter of approval from "M" to begin construction.

After "onstruction egins

%eriodic consultation and construction inspections are made by "enter for Milk "ontrol.

Gater sample taken after all plumbing complete.

Appro9. ' weeks before processing plant is to begin operation

Application for operating permits! is submitted and fee is paid$rade A lab certification%lant sampler certificationulk Milk 2ampler+Hauler "ertification if applicable!Milk transportation vehicle permitted if applicable!Iabel approval 1 Jeed description and e9ample of labelsA 2tandard &perating %rocedures or &perations Manual that addresses

Manufacturing practices, :mployee training, Traceback, and %lant sanitation.Approval of all single service container sources 1 Jeed a list of container sources%roduct sell by date approval%roduction 2heet approvalApplicable Iog approval ph log, bottle washer log, sanitizer log, Appendi9 J logs,

filler log, vitamin log, HKA" system filter log!Discuss monthly reports to be submitted after operation begins Drug Testing.

Kolume "ontrol, Kitamin Testing!

HA""% evaluation may be re>uired for certain facilities.

Ghen plant is ready to operate, a full inspection and e>uipment tests will be conducted by "M".

Lo0at$on

A number of issues should be addressed when choosing a location for a processing plant. A dairy plant

on a dairy farm in close pro9imity to livestock presents special problems. /. Boning T"e $r.t .tep1 check with your "ounty %lanning and Boning Department if yourproperty is properly zoned for an on-farm processing plant. "M" will not review plans until%lanning and Boning approval is obtained.

'. Accessibility with trucks for delivery of supplies and shipping of product.=. %revailing winds , i.e. the processing areas should not be downwind from strong odors from

cattle housing and feed or manure storage.7. %ro9imity to livestock Kisitors to your facility may enLoy seeing your cattle, unfortunately it is

difficult to maintain a sense of absolute cleanliness in a milk processing plant when animals areLust outside the entrance. #nsect control alone can be an insurmountable task when cattle andthe manure they produce are close by. "attle odors and dust created by feeding and bedding

can also be problematic.0. Gaste water from the dairy plant #n Maryland the "ounty :nvironmental Health Departmentmust be contacted to determine the proper method of disposal of the plant waste water.

4. Drainage Ghen there are heavy rains will manure from the cattle housing run down the driveor area by the plant. #s the area prone to flooding

Per.onnel Tra$0 Into and T"ro#" t"e Pro0e..$n# Plant

Iivestock workers as well as other farm employees cannot be allowed to enter the processing plantwithout showering and a complete change of clothes. #t is necessary to maintain this strictpolicy in order to prevent the spread of pathogenic bacteria commonly found on a farm from

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getting into the plant. These bacteria listeria monocytogenes, salmonella, coliform,camphylobacter, and others! are serious public health threats and every effort must be taken tominimize the entrance of such pathogens into a plant. #t is strongly recommended thatsanitizing foot baths be provided at each entrance to the plant.

Ade>uate hair and beard covering and clean clothes and footwear are re>uired for anyone workingor present in the plant.

Hands shall be thoroughly washed before commencing plant functions and as often as may bere>uired to remove soil and contamination. Jo person shall resume work after visiting thetoilet room without thoroughly washing his hands. 2ignage of washing hands is re>uired in alltoilet facilities.

?se of tobacco in the dairy facility is prohibited.

%ersons working in the plant must maintain good clean working habits and conduct themselves insuch a manner as to not contaminate the milk products or e>uipment.

L$0en.$n#2 Cert$$0at$on. 3 Fee.

Karious licensing, certifications and fees will apply depending on the type of dairy processing facility.DHMH, Division of Milk "ontrol issues these licenses and certifications.

Milk %rocessor $rade A or Manufactured $rade! N/((+annually

Milk %rocessor - 3armstead "heese %roducer N/((+annually

3rozen Dessert

(-'0,((( gallons N/(+annuallyO'0,(((-/((,((( gallons N0(+annuallyO/((,(((-'0(,((( gallons N/((+annually

"ertification for Appendi9 J Animal Drug Testing N(.(((Haryeann Lambert, Laboratory Evaluation Officer 410.767.6513

Milk ulk+Hauler 2ampler N0(.(( Milk Transportation "ompany N0.((+company and N0.((+truck

"ertified %lant 2ampler N(.((

Milk ulk Truck "leaning 3acility N'0.((

#nterstate Milk 2hippers #M2! "ertification N(.((

(!f you "ill be #$i%%in& %ro'uct acro## #tate line# t$en your facility nee'# to be in#%ecte' by

one of t$e ) *atin& Officer# for com%liance "it$ !+

La1el$n#

Iabel design needs to be started as early as possible, since all labels must be submitted to andapproved by "M" prior to selling the product. A E3ood Iabeling 3act 2heetFhttp++www.mda.state.mn.us+dairyfood+labeling.pdfis available from MDA, Dairy, 3ood Meat Division.#n addition to this fact sheet, the following statements apply specifically to milk products

All bottles, containers and packages enclosing milk or milk products shall be labeled in accordancewith the applicable re>uirements of thee'eral oo', )ru&, an' -o#metic ct, the/utritionLabelin& an' E'ucation ct of 10 (/LE,the -o'e of e'eral *e&ulation# (-*,Maryland 2tatutes and $n add$t$on, shall comply with applicable ra'e 2a#teurie' ilOr'inance (2O re>uirements.

%M& *e>uirements

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/. The identity of the plant where pasteurized, ultra-pasteurized or aseptically processed3acility #D or 3acility name address!

'. #ngredients, in order of predominance.=. Jame of product7. The words Pkeep refrigerated after openingP in the case of aseptically processed milk and

milk products.

0. The word P$oatP or P2heepP shall precede the name of the milk or milk product when theproduct is or is made from goat or sheep milk respectively.

4. The words P$rade EAFP on the e9terior surface. Acceptable locations shall include theprincipal display panel, the secondary or informational panel, or the cap+cover.

). The word PreconstitutedP or PrecombinedP if the product is made by reconstitution orrecombination.

Misleading Iabels Misleading remarks, words or endorsements are not allowed.The regulatory agency shall not permit the use of any misleading remarks, words or

endorsements upon the label. They may permit the use of registered trade designs or

similar terms on the bottle cap or label when, in their opinion, are not misleading and arenot so used as to obscure the labeling re>uired by the &rdinance.The use of super grade designations shall not be permitted. $rade designations such as

P$rade A %asteurizedP, P2elected $rade A %asteurizedP, P2pecial $rade A %asteurizedP,P%remiumP, etc., give the consumer the impression that such a grade is significantly saferthan $rade EAF.

This product does not contain any growth hormones 1 misleading. All milk contains naturalgrowth hormones. %ermit to state, Eno growth hormones addedF.

All vehicles and milk tank trucks containing milk or milk products shall be legibly marked withthe name and address of the milk plant or hauler in possession of the contents.

4ater Spply

Gater for milk plant purposes shall be from a supply properly located, protected and operated andshall be easily accessible, ade>uate and of a safe, sanitary >uality.

Kery likely you will be able to use the same well that serves your dairy farm for the processingplant. #f a new water supply is needed, all distances from sources of contamination must bestrictly followed as outlined by the %M& and Maryland Department of the :nvironment,"&MA* '4.(7.(7

This water supply must be sampled by "enter for Milk "ontrol every si9 months.The water supply must be protected from unsafe water i.e. submerged inlets! and the possibility

of negative line pressure i.e. pressure-washers!. The water supply must not be directly

connected with a non-potable water supply system by which non-potable water can be drawnor discharged into the potable water supply system.

Capt$(e 4ater Sppl$e.

This list would include water used for heating or cooling. A boiler, water heater or other steamheating system is necessary. 3or cooling, some type of chilled water or glycol cooling system isneeded. These systems do have special re>uirements that you need to meet. &nly approvedchemicals can be added to these systems. $lycol or 2weet Gater need to be sampled by "M" every4 months.

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M$l% 5al$ty and Te.t$n# %M& 2ection 4 )!

Milk and milk products are sampled and tested on a regular basis to assure >uality, safety, andlabeling compliance of the product. "M" will also sample raw milk and finished products on amonthly basis on the processing side.

Milk sample results are kept as part of the farm and plant official record. Ghenever ' of the last 7

consecutive >uality counts e9ceed the limit of the standard for that product, a written EJotice of#ntent to 2uspendF letter will be issued. Githin '/ days of the letter, but not before the lapse of =days, an additional sample will be taken. #mmediate suspension of permit or product will beinstituted whenever the standard is violated by = of the last 0 >uality counts.

+) Ra M$l%

Dairy 3arm - &nce each month a sample must be taken from the farm bulk tank and submitted toan approved laboratoryifor >uality testing to include the following acteria, 2omatic "ell"ount, Temperature, and Drug *esidues. These results must be sent to "M". A licensedHauler+2ampler must collect this sample at the farm.

2tandards for *aw Milk $rade A Manufacturing $rade

acteria 2tandard %lant "ount! Q/((,((( Q0((,(((2omatic "ell "ount 2""! Q)0(,(((R Q)0(,(((RTemperature Q70S 3 Q70S 3Drug *esidue 1 Jot 3ound 1 Jot 3ound

R$oat milk 2"" Q/,(((,(((!

All milk that is used for processing must be tested for Animal Drug *esidues eta Iactams-antibiotics! as per the re>uirements of Appendi9 J of the %M&. %roper certification isre>uired in order to run this test in a processing plant setting. *esults of these tests arerecorded and kept by the plant for review by the inspector.

%rocessing %lant - A raw milk sample will be taken by "M" each month from the raw milkstorage tank at the processing plant $rade A and Manufacturing $rade!. A facility alongwith the finished product samples for routine analysis.

6) 7F$n$."ed8 M$l% Prod0t. 9 Pa.ter$:ed2 A#ed2 Pro0e..ed

There are many types of finished milk products. "M" will collect samples for routine analysiseach month.

Testing includes acteria, drug residue, coliform, phosphatase, temperature.*ecalls of product may become necessary when it is determined it is a public safety hazard.

*ecall costs are the plant@s responsibility.Standard. or F$n$."ed M$l% Prod0t. are atta0"ed)

;$tam$n Add$t$on

*egulations do re>uire that you add vitamins to any reduced fat dairy products.2ome reasons for the need for addition

Kitamin A is fat soluble. #t will dissolve when mi9ed with fat and will not dissolve in water. 3orthis reason Kitamin A is found in whole milk and to a lesser degree in low fat and absent innon-fat milk, unless these products are fortified.

Kitamin D is the maLor regulator of calcium absorption in the intestine. 3ortification of freshmilk with Kitamin D is acknowledged to have virtually eliminated rickets in milk drinkingchildren. 2ince normal levels of Kitamin D are necessary for optimal calcium absorption in

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children, it is also known that these levels are re>uired as one increases in age. #t has beenassociated with reducing the incidence of osteoporosis in premenopausal women.

The following items on vitamin addition need to be considered.How will the vitamins be addedGhen in the processing procedure will they be addedGhat are the minimum and ma9imum levels re>uired*ecord keeping re>uirements to assure the proper addition of vitamins, vitamin inventory.

Annual vitamin testing is re>uired 1 at the cost of the processor.

In#red$ent.

All ingredients added to milk and milk products must be of an approved source and listed on the labelas re>uired. All ingredients must be stored properly.

Pa.ter$:at$on

All milk must be pasteurized at the place of processing and packaging. %asteurizing is the process ofheating every particle of milk in properly designed and operated e>uipment for the re>uired time andtemperature. HT2T is High Temperature 2hort Time or a continuous flow system and Kat or atch

pasteurization is heating one batch at a time in an approved tank.The most common times and temperatures are as follow

/70 degrees 3ahrenheit for =( minutes KAT/4/ degrees 3ahrenheit for /0 seconds HT2T

There are no temperatures in between these standards that comply. #f you add sweeteners or if the fatcontent is /( percent or more then higher temperatures are re>uired as follows

/00 degrees 3ahrenheit for =( minutes KAT/)0 degrees 3ahrenheit for '0 seconds HT2T

All raw products must be added before the pasteurization process begins. There is to be no cross-connections between raw and pasteurized products. Kalve separation is not allowed.

:>uipment used for pasteurization must be approved and tested by "M" on a routine basis. Testingprocedures and fre>uencies are dictated by the %M& for all $rade A products and EMilk forManufacturing %urposes and its %roduction and %rocessingF states the fre>uency of testing e>uipmentfor manufacturing grade products. Karious controls on the pasteurization units are sealed by the"M" so temperatures, timing, and pressures cannot be changed once they are tested."M" will conduct e>uipment testing every 5( days at both a $rade A plant and a Manufactured$rade plant.

Cool$n#

All raw milk and milk products shall be maintained at 703 or less until processed.

All milk e9cept when being pasteurized or further processed must be at or below 703. 2o after

pasteurizing a cooling medium must be used to cool the milk as soon as possible before it is bottled

or stored. &nce bottled it must be maintained below 70at all times in an approved cooler with a

properly operating thermometer.:very room or tank in which milk or milk products are stored shall be e>uipped with an accuratethermometer.

Delivery trucks must also maintain temperatures below 70at all times.

-oolin& of culture' %ro'uct# ll %a#teurie' mil an' mil %ro'uct#, ece%t t$e follo"in&, #$allbe coole' imme'iately %rior to fillin& or %aca&in& to 45 . or le##8

-ulture' #our cream

ci'ifie' #our cream

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9o&urt

-ulture' buttermil

-on'en#e' "$ey an' "$ey %ro'uct#:$e %ro'uct# li#te' above #$all be coole' accor'in& to 2O %roce'ure# !tem 17%. -oolin& of

il an' il 2ro'uct#.

Pa0%a#$n# and Capp$n#

All bottling and packaging of $rade A milk and milk products must be done at the place ofpasteurization in a sanitary manner with approved mechanical e>uipment. "apping and+orclosure of the container must be done in a sanitary manner by approved mechanical cappingand+or closing e>uipment. The cap or closure shall be designed and applied in such a mannerthat the pouring lip is protected to at least its largest diameter and, with regard to fluid productcontainers, removal cannot be made without detection.

Manufactured $rade products maybe manually packaged and capped. This must be done in asanitary manner and approved by "M".

%ackaging material and containers must be made of food grade materials and from approvedsources. A list of packaging materials and sources must be submitted to "M".

4are"o.$n#2torage of finished product, ingredients, packaging materials, containers, single service items, filters,

and chemicals and other items is important. All items must be stored so as to not becomecontaminated by other substances. Most products need to be stored in a clean dry place abovethe ground, away from wet walls.

5al$ty A..ran0e Pro#ram.

#t is highly recommended, but not re>uired that you have a >uality assurance program in place, tomonitor the effectiveness of your pasteurization and processing procedures. This may beaccomplished on site or you may contract with an independent laboratory. 3ollowing is a list ofthings to employ in a >uality assurance program. R2tarred items are re>uired!- uirements such as butterfat- Gill you monitor products to make sure they are still wholesome when they reach the end of the

code date- Gill you be able to respond to consumer complaints about your products

These can include the followingo Ghy is the te9ture of my dairy product strange

o Ghy does my milk have an off odor

o Ghy did my milk spoil before the code date run out

o My milk tastes funny.

o My milk tastes sour.

o 2omeone got sick after drinking my milk.

o My milk tastes like vitamins.

- RDo you have an effective insect and rodent control program- RDoes your processing procedures eliminate the possibilities of contaminating product with

aller#en.- RDo you have the ability to re0allall products if a problem is found

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- RGhat type of e>uipment cleaning program are you using #t is imperative that all e>uipment beproperly cleaned and sanitized before use, in order to maintain the highest >uality of product forthe consumer. #t is recommended to use the services of a professional cleaning company toadvise you in the selection of the proper chemicals and concentrations to use.

- RAn$mal Dr# S0reen$n#o All milk needs to be screened for beta lactam drug residues with an approved test before

processing.o 2creening test must be performed by a certified industry analyst.

- !ACCPEHazard Analysis of "ritical "ontrol %ointsF %rogramo A HA""% program identifies potential hazards of a food product in all levels of the food

processing system 1 from the farm to the consumer.2ample >uestions when possible hazards

Ghat systems are in place to prevent antibiotics from getting into the milk

How is the consumer going to handle my product Gill it be left on the table forany length of time Gill this cause bacterial growth that could be harmful

o HA""% is a new directive in the food industry. This program has become mandated in

food industries such as the fish seafood and meat poultry due to outbreaks.o HA""% is a voluntary program for the dairy industry because the dairy inspection

program currently in place has been very effective.o Hazards are identified as

iological 1 listeria, salmonella, staph, e-coli, and others"hemical 1 antibiotics, sanitizers, pesticides, microto9ins molds!%hysical 1 metal, glass, other foreign material

In.pe0t$on>The facility will need to be approved by a "M" Dairy #nspector before it can begin processing

milk. efore and during construction the dairy inspector will work closely with the processor,making visits to the facility when needed.

#nspections are made at least every = months on a $rade A plant and at a Manufacturing $radeplant. These inspections are generally unannounced. 3acility is open to inspection at anytime during normal working hours.

Kiolations noted on a plant inspection need to be corrected as soon as possible. "ritical "ontrol%oint items may be a cause for recall of product or closing of a plant facility. Ghen violationsare not corrected by the ne9t inspection, the inspector may order a reinspection or a regulatoryhearing.

%asteurization e>uipment tests are performed every 5( days on a $rade A facility and on aManufacturing $rade facility. 2ince pasteurization is a critical control point of safe milk, anyviolations found during testing need to be corrected immediately to continue processing milk.#f the violation is serious enough, the inspector may order a recall of products processed in a

determined span of time.Another vital part of the inspection is chart and record reviews

%asteurization "harts are the legal record that the milk was pasteurized. All informationas noted in the %M& needs to be present on these charts.

Appendi9 J Antibiotic 2creening records need to be kept and properly documented.%rocessing dates of various products may be re>uired on the product labels.#f milk is held for more than '7 hours in a plant tank, a recording chart must be provided

to insure the proper cooling and washing of the tank."#% P"lean-in-placeP! charts need to be maintained on mechanically cleaned systems.

"#% temperature recording charts must be located on the return line of the system.

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Milk, milk product, and ingredient sales and purchasing records will also be reviewed.The dairy plant inspection form covers most of the inspection items observed during an

inspection. :ach item is e9plained in more detail in the %M&.

*evised uly '(/(

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i Approved Milk Iaboratories are listed in the E#M2 Iist of 2anitation "ompliance and :nforcement *atings of#nterstate Milk 2hippersF published >uarterly by the ?2 Dept of Health and Human 2ervices, 3ood andDrug Administration, Milk 2afety ranch, H32-4'4, '(( " 2treet 2G, Gashington D" '('(7-5556

on farm processing maryland 6-2-10

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