USDA Regulation

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USDA Regulation Requirements on Food Safety
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Regulation 9 CFR Parts 304, 308, 310, 320, 327,
381, 416 and 417 (430) FSIS established
requirements applicable to meat and poultry
establishments

• Reduce the occurrence and numbers of pathogenic
  
• microorganisms
• Reduce the incidence of foodborne illness the
  new
• regulations
• require develop and implement written
  sanitation standard operating procedures
  (Sanitation SOPs)
• require regular microbial testing by slaughter
  establishments to verify the adequacy of the
  establishments process controls.
• establish pathogen reduction performance
  standards for Sallmonella that establishments
  must meet.
• require that all meat and poultry
  establishments develop and implement HACCP (9
  CFR Part 417)

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Microbiological Requirements

• E.coli process control testing regulation
• Effective Jan 27, 1997
• 9 CFR 310.25(a) 9 CFR 381.94(a)
• Salmonella pathogen reduction performance
  standard
• Effective Jan 26, 1998
• Jan 25, 1999
• Jan 25, 2000
• 9 CFR 310.25(b) 9 CFR 381.94(b)
• The control of Listeria monocytogenes in
  Post-lethality Exposed RTE Poultry Products.
• 9 CFR 430

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Microbiologicel Performance Criteria and
Standards.

• FSIS established
• Micro performance stds for reduction of
  Salmonella in raw products
• Qualitative assay
• DLD Est.
• Performance criteria for use with E.coli testing
• To verify the effectiveness of process control in
  SH. Est.
• Quantitative assay
• Est. DLD
• Control of L. monocytogenes
• Qualitative assay
• Est. DLD

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sample Collection Procedure for Isolation for
Salmonella sp.
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 200
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Poultry Carcass Selection

• A whole carcass.
• Select at random after chilling at the end of
• drip line or last readily accessible point
  prior to
• cut-up /packaging.
• Take on any shift.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Requirements of sample selection

• Selection of TIME
• Selection of CHILLER
• Selection of POULTRY CARCASS
• At random time, Id carcass
• Count back 5 carcasses
• Select the next carcass

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Septic Techniques / Sampling

• Area desiqnated for preparing samples.
• Stainless steel, wheeled carter table.
• Supporting sample bag.
• 500 ppm. Sodium hypochlorite solution.
• Label the sample bags before starting sampling
  procedure.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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• Materials
• 1 large (3500 ml) sterile bag
• 400 ml sterile prechilled Buffered
• Peptone Water (BPW)
• Sterile gloves
• Sodium hypochlorite (or equivalent)
• sanitizing solution
• Empty, sterile screw-cap container (jar)
• 1 small resealable bag

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (1)

• Ensure that all supplies are on hand.

• Wash, sanitize, and dry your hands.

• Carefully open the large sterile bag.

• Put on sterile gloves aseptically.

• With one gloved hand, pick up the selected
• chicken carcass by the legs and allow any
• excess fluid to drain.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (2)

• With your other hand, pick up the open sample
  bag.
• Place the bird in the sampling bag,

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (3)

• Rest the bottom of the bag on a flat surface.
  Uncap the
• pre-chilled. BPW container, pour on to the
  carcass.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (4)

• Pick up the bag by the top and, through the bag,
  
• manipulate the loose neck skin on the carcass
  to
• position it over the neck bone

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (5)

• Expel most of the air from the bag. Twist the
  top of the
• bag and fold the twist over. Firmly hold the
  bag closed.
• Rinse the entire carcass, using a repeated
  rocking
• motion to invert the bird 30 times
  (approximately 1 minute).

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (6)

• Rest the bag on a flat surface.
• Open the small resealable bag.
• Remove the lid from the empty screw-cap
• container and place the lid in the bag.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (7)

• Carefully open the bag containing the bird. With
  one
• hand, hold the chicken carcass through the
  bag by a
• leg pour the rinse fluid into the open
  container the 30 ml.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (8)

• Close the sample

• Place the sealed sample container in the small
• re-sealable bag.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection (9)

• Discard all the remaining

• Return the chicken carcass to the chill tank.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sample Shipment

• Samples must be
• Analysed ASAP.
• Analysed no later than one day after
• collection.
• Kept Shipped under refrigerated condition not
  frozen.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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• Testing Method
• USDA-FSIS method.
• AOAC validated method.
• Other method validated by well-known
  organization.
• 30 ml carcass rinse.
• 30 ml BPW

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Control Strains.
S. typhimurium (H2S ve) S. senftenberg (H2S
- ve)
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Salmonella Performance Standards
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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E.Coli Performance Criteria Testing

• Slaughterhouse
• Obligation to control SH and sanitary dressing
  process
• Prevent contamination with
• fecal material
• Intestinal content
• FSIS inspectors
• Apply zero tolerance standard for visible feces
  ingesta on dressed carcass.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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9 CFR 310.25(a) 381.94(a) Process Control
Testing Regulation.

• Slaughterhouse
• Obligation to control SH and sanitary dressing
  process
• Prevent contamination with
• fecal material
• Intestinal content
• FSIS inspectors
• Apply zero tolerance standard for visible feces
  ingesta on dressed carcass.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Verification of Process Controlof Slaughtering
and Processing EST. by Using E. coli Biotype I
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Why Using E.Coli ?
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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E.Coli Testing (2)

• E.coli has survival and growth characteristic
  similar to enteric pathogens.
• e.g. Salmolnella
• E.coli O157 H7
• Analysis for E.coli at Est.
• Safer
• More feasible
• Wide acceptance of its use as an indicator of
  the potential presence of enteric pathogen.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Resqunsibilities Establishments on E.coli
process control

• Conduct E.coli Testing
• Establishment of sampling procedures
• Id designated employee to take sample
• Location
• How sampling randomness is achieved
• Handling of samples
• Check list
• Materials
• Record keeping
• cfu / ml
• Maintained at Est. for 12 month.
• Must be made available to inspector on request

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sampling Frequencies (1)
CHICKEN
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sampling Frequencies (2)
CHICKEN

• Est. with Total annual production
• Production lt 400,000 chicken / year
• At least 13 Tests / year
• 1 Test /week
• Conform to standardstop sampling
• Non form to standard continue sampling

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Est. Production lt 440,000 chicken
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sampling Frequencies (3)
DUCK

• Annual Production gt 60,000 ducks
• 1 test per 3,000 carcasses.
• But a minimum of 1 sample during each week of
  operation.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sampling Frequencies (3)
DUCK

• Annual Production lt 60,000 ducks
• At least 1 sample during each week of operation,
  after June 1 of each year.
• 13 samples
• lt 13 samples June 1 of the following year.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sample collection.

• gt 1 line
• Select randomly
• Whole birds
• At the end of chilling process, after dripping
  line.
• Wash with 400 ml of Butterfields Phosphate
  Diluent (BPD)

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Analytical Method.
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Values for Marginal and Unacceptable Results for
E.coli Performance Criteria
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Evaluation of E. coli Test Results
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Example of E.coli results using a control chart
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Compliance Guidelines to Control Listeria
monocytogenes in Post-Lethality exposed RTE meat
and poultry products 9 CFR 430
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Definitions(430.1) (1)

• Antimicrobial agent.
• - A substance in or added to an RTE that has the
  effect of
• Reducing or eliminating a microorganism,
  including a pathogen such as L. monocytogenes.
• Suppressing or limiting growth of L.
  monocytogenes.
• - in The product throughout the shelf life of the
  product.
• E.g. Potassium lactate and sodium diacetate.
• Antimicrobial process.
• - An operation that has the effect of suppressing
  or limiting the growth of a microorganism e.g.,
  freezing.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Definitions(430.1) (2)

• Antimicrobial process.
• - An operation that has the effect of suppressing
  or limiting the growth of a microorganism e.g.,
  freezing.

• Deli product.
• - A ready-to-eat meat or poultry product
• that is typically sliced and assembled in a
  sandwich
• for consumption.
• Hot dog product.
• - 9 CFR 319.180 and 319.181.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Definitions(430.1) (3)

• Lethality treatment.
• - A process eliminates or reduces the number of
  pathogenic microorganisms on or in a product.
• Cooking
• Antimicrobial agent or process

• Post-lethality exposed product.
• - Ready-to-eat product that comes into direct
  contact with a food contact surface after the
  lethality treatment in a post-lethality
  processing environment.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Definitions(430.1) (4)

• Post-lethality exposed product.
• - Ready-to-eat product that comes into direct
  contact with a food contact surface after the
  lethality treatment in a post-lethality
  processing environment.
• Post-lethality processing environment.
• - The area where the product is routed after
  having been subjected to an initial lethality
  treatment.

• Post-lethality treatment.
• - Lethality treatment that is applied or is
  effective after post-lethality exposure.
• Listeria spp.
• Listeria-like organism

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Verifying the Effectiveness of Sanitation program
for Listeria monocytogenes.
Alternative 1 Use of a post-lethality treatment
and an antimicrobial agent of process that
limits growth of L.monocytogenes (
Recommended) Alternative 2 Use of a post
lethality treatment or an antimicrobial agent
or process that limits growth of
L.monocytogenes. (required ) Alternative 3 Use
of sanitation control measures and testing to
prevent contamination of product with
L.monocytogenes. (required )
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Expected Frequencies of Establishment
Verification Testing of Food Contact Surfaces for
Alternatives 1, 2 and 3.
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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• Take sample at least 3h. After the start
  operation
• Composite sample
• lt 5 samples
• Similar surfaces
• Environmental samples
• Locate potential sources of contamination.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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• Sample collection for FCS
• 1 square foot area by swabbing.

• Surface Sample Collection Procedure.
• materials
• Sterile sponge in sterile bag (Whirl-Pak) or
  sterile cloth in a sterile bag (AES) or
  equivalent.
• 10-20 ml sterile Dey-Engley(D/E) broth (Remel) or
  neutralizing agent (AES) or equivalent
• Sterile stomacher bag.
• Template for a sampling area of 1 ft2.
• Sterile gloves
• Sanitizing solution.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Collection -Open the sponge bag -Pour D/E or
neutralizing broth to the sponge or cloth in the
bag. -Close the bag. -Massage the sponge/cloth
till fully HYDRATED. -Push the sponge/cloth to
the upper end of the bag.
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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• -Open the bag.
• -Put on sterile glove.
• -Remove the sponge/cloth.
• -Put the template on the sampling area.
• -wipe sponge/cloth over the sampling area within
  the template 10 times horizontally and 10 times
  vertically.
• -Place the sponge/cloth back to the sample bag.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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• Add 10 ml. of D/E or nentralizing broth.
• -Expel excess air close the bag.
• -Keep the sample under refrigerated temperature,
  NOT FROZEN.
• -Send sample to the Lab.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
52
Testing method(1)

• FSIS Listeria monocytogenes qualitative method.
• (Recommended)
• The method used by regulatory body validated by
• recognized body (AOAC, AFNOR, ISO).
• Maybe subject to FSIS Review so FSIS methods are
  recommended.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
53
Screening method

• Must meet or exceed the following performance
• Specificity ?96
• False-negative rate 3
• False-positive rate ? 4

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
54
Testing method(2)
Add 225 ? 5 ml of UVM broth to each bagged swab
sample and stomach 2 ? 0.2 min
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Quality Control
Positive control L. monocytogenes ATCC
19111, NCTC 7973 or other Negative
control L. innocua ATCC 33090 Additional
confirmatory testing L.seeligeri, L.grayi and
L.ivanovii CAMP test Staphylococcus aureus
ATCC 25923 or ATCC 49444 and
Rhodococcus equi ATCC 6939
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
56
Sampling of FCS and Products, Interpretation of
Results, and the requirements for Hold and Test
of the Products ( see flowchart 1 also )
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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If an antimicrobial agent is used, conduct tests
of food contact surfaces for L.monocytogenes,
Listeria spp., or Listeria like organisms (1)

• Least quarterly sample at least 1 square foot
• If the FCS test is positive for L.
  Monocytogenes, the product in the sampled lot
  would be considered adulterated because of the
  high probability of transfer of the pathogen to
  the product.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
58
If an antimicrobial agent is used, conduct tests
of food contact surfaces for L.monocytogenes,
Listeria spp., or Listeria like organisms (2)

• If 3 consecutive tests of food contact surfaces
  are positive for Listeria spp. or Listeria
  like organisms
• Hold the product.
• Test product for L. monocytogenes.
• Retest the food contact surface.
• Test results for the product are positive for
• L. monocytogenes.
• Recall the product, if already shipped, and
• Destroy the product, or
• Re work the product with a process that is
• destructive of L. monocytogenes.

USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
59
Alternative 3 Use of sanitation control measures
and testing to prevent contamination of product
with L. monocytogenes (required)
Non-deli or non-hotdog products, once a month
deli and hotdog products, at least four times per
month per line for large volume establishments
two small volume once for very small 1.3 million
pounds.
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
60
FLOWCHART HOLD-AND-TEST SCENARIO FLOWCHART (1/3)
Test Food Contact Surface (FCS) FCS Listeria
spp. / Listeria like () Corrective Action
Intensified Cleaning and Sanitizing Continue
Production Test FCS FCS L.spp. / L.-like ()
FCS L.spp./ L.-like
(-) Continue Production
Test according to frequency
in sanitation program
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
61
FLOWCHART HOLD-AND-TEST SCENARIO FLOWCHART (2/3)
Corrective Action Intensified Cleaning and
Sanitizing Hold and test product lot (Day
7) Continue Production for L. monocytogenes or
Follow-up FCS test L. spp./L.-like Hold
Product (days 8, 9, 10) using sampling
plan FCS L. spp./L.-like () FCS L.
spp./L.-like (-) (Day 10) Repeat steps
from Hold Product Lots (Days 8-10) Day 7 . Hold
and test until results of Day 7 Product Test
Product lots (Days 8-10) Day 7 Product Day
7 Product Day 7 Product (Day 14) Lm () Lm
(-) or L. spp./L. like () L.
spp./l.-like (-)
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
62
FLOWCHART HOLD-AND-TEST SCENARIO FLOWCHART (3/3)
Destroy Product or Release applicable
Continue analysis to Rework product with
product lot determine if
Lm () Process destructive of Lm
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
63
Sampling plan for Products (ICMSF) (1)
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
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Sampling plan for Products (ICMSF) (2)
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007
65
http//www.fsis.usda.gov/Science/Microbiological_L
ab_Guidebook
USDA Regulation Requirements on Food Safety by
Dr.Sasitorn Kanarat Date 22 February 2007