[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Proposed Rules]
[Pages 17142-17155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211

[Docket No. FDA-2011-N-0920]
RIN 0910-AG36


Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is correcting a 
proposed rule that published in the Federal Register of January 16, 
2013. That proposed rule would amend our regulation for current good 
manufacturing practice in manufacturing, packing, or holding human food 
(CGMPs) to modernize it and to add requirements for domestic and 
foreign facilities that are required to register under the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement 
hazard analysis and risk-based preventive controls for human food. That 
proposed rule also would revise certain definitions in our current 
regulation for registration of food facilities to clarify the scope of 
the exemption from registration requirements provided by the FD&C Act 
for ``farms.'' We proposed these actions as part of our announced 
initiative to revisit the CGMPs since they were last revised in 1986 
and to implement new statutory provisions in the FD&C Act. The document 
published with several typographical errors, stylistic errors (such as 
incorrect indentation of bulleted paragraphs and a gap in the 
sequential numbering of tables), and a mistake in the date of a 
reference. The document also published with an Appendix in which all 
references are numbered incorrectly. This document corrects those 
errors.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety 
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION: FDA is correcting the January 16, 2013 (78 
FR 3646), proposed rule entitled ``Current Good Manufacturing Practice 
and Hazard Analysis and Risk-Based Preventive Controls for Human 
Food.'' The document published with several typographical errors, 
stylistic errors (such as incorrect indentation of bulleted paragraphs 
and a gap in the sequential numbering of tables), and a mistake in the 
date of a reference. We note that there are a total of 10 numbered 
tables in the preamble. These tables are numbered as follows: Table 1 
(page 3675), table 2 (page 3679), table 3 (page 3680), table 4 (page 
3682), table 5 (page 3687), table 6 (page 3692), table 8 (page 3714), 
table 9 (page 3717), table 10 (page 3718), and table 11 (page 3728). 
There is no table numbered ``Table 7''. We are not changing the table 
numbers to adjust the gap between tables 6 and 8 because the cross-
references within the document to tables 8, 9, 10, and 11 are all 
correct, and because the gap between tables 6 and 8 is a stylistic 
error that does not affect the substantive content of the document. We 
apologize for any confusion. The document also published with an 
Appendix in which all references are numbered incorrectly. This 
document corrects those errors.
    In FR Doc. 2013-00125, beginning on page 3646, in the Federal 
Register of Wednesday, January 16, 2013, we are making the following 
corrections:
    1. On page 3650, in the first column, in the first full paragraph, 
in the last sentence, ``Pub. L. 111-533'' is corrected to read ``Public 
Law 111-353''.
    2. On page 3717, in the second column of ``Table 9--Proposed 
Revisions for Consistency of Terms,'' in the first entry, ``the phrase 
``food-production purposes (i.e., manufacturing, processing, packing, 
and holding) to consistently use the same group of terms in proposed 
part 117'' is corrected by closing the quotation after the 
parenthetical phrase to read ``the phrase ``food-production purposes 
(i.e., manufacturing, processing, packing, and holding)'' to 
consistently use the same group of terms in proposed part 117''.
    3. On page 3728, in the first column of ``Table 11--Potential 
Revisions to Establish Requirements in Place of Current Guidance,'' in 
the fifth entry, ``Sec.  117.40(a)(1)'' is corrected to read ``Sec.  
117.40(a)(3)''.
    4. On page 3728, in the second column of ``Table 11--Potential 
Revisions to Establish Requirements in Place of Current Guidance,'' in 
the fifth entry, the word ``must'' in ``All

[[Page 17143]]

equipment must be so installed'' is corrected to be italicized and read 
``must'' for emphasis.
    5. On page 3735, in the first column, in line 25 under 
``Radiological Hazards,'' the section reference ``III.D.2.e'' is 
corrected to read ``II.D.2.e''.
    6. On page 3765, in the second column, the ninth, tenth, eleventh, 
and twelfth bulleted paragraphs and in the third column, the first and 
second bulleted paragraphs are corrected by doubly indenting them to 
show that these bulleted paragraphs are all examples relevant to the 
eighth bulleted paragraph on specifying the frequency of sample 
collection.
    7. On page 3780, in the third column, in line 15, ``requirements of 
part 110'' is corrected to read ``requirements of part 117''.
    8. On page 3794, in the third column, in the third paragraph, the 
date ``2012'' in reference 194 is corrected to read ``2013''.
    9. In proposed Sec.  117.135(d)(3)(iv), on page 3806, in the third 
column, ``records review in accordance with Sec.  117.150(d)(5)(i)'' is 
corrected to read ``records review in accordance with Sec.  
117.150(d)(2)(i)''.
    10. On pages 3812 through 3821, the references to the Appendix are 
numbered incorrectly. For the convenience of the reader, a corrected 
Appendix, with the correct reference numbers, is printed below.
    The Appendix has been revised to read as follows:

Appendix

    Although the proposed rule that is the subject of this document 
does not include specific codified language regarding environmental 
monitoring or finished product testing, we believe that these 
regimes can play a critical role in a modern food safety system. In 
sections XII.J.2 and XII.J.3 of the preamble of this document, we 
request comment on when and how these types of testing are an 
appropriate means of implementing the statutory directives set out 
in section 418 of the FD&C Act. In this Appendix, we provide 
background material on these testing measures.

I. The Role of Testing as a Verification Measure in a Modern Food 
Safety System

A. Verification of Preventive Controls

    The safety of food is principally ensured by the effective 
implementation of scientifically valid preventive control measures 
throughout the food chain (Ref. 1) (Ref. 2). Prevention of hazards 
in food is much more effective than trying to differentiate safe 
from unsafe food using testing. Although testing is rarely 
considered a control measure, it plays a very important role in 
ensuring the safety of food. An important purpose of testing is to 
verify that control measures, including those related to suppliers 
and those verified through environmental monitoring, are controlling 
the hazard (Ref. 3) (Ref. 4). Testing is used in conjunction with 
other verification measures in the food safety system, such as 
audits of suppliers, observations of whether activities are being 
conducted according to the food safety plan, and reviewing records 
to determine whether process controls are meeting specified limits 
for parameters established in the food safety plan. Although testing 
may be conducted for biological, chemical, physical or radiological 
hazards, the most common testing is for microbiological hazards. 
Thus, much of the testing described below focuses on microbial 
testing, but many of the issues discussed apply to testing for other 
hazards as well. We focus more of our discussion below on 
verification testing of the environment because of the increasing 
recognition of the benefits of such testing in identifying 
conditions that could result in environmental pathogens 
contaminating food; thus such verification testing is important in 
preventing contamination in food, whereas verification testing of 
raw materials, ingredients, and finished products is used to detect 
contamination that has already occurred.
    As discussed in sections I.C, I.E, and I.F of this Appendix, 
microbial testing may include:
     Testing raw materials and ingredients to verify that 
suppliers have significantly minimized or prevented hazards 
reasonably likely to occur in the raw materials and ingredients;
     Testing the environment to verify that sanitation 
controls have significantly minimized or prevented the potential for 
environmental pathogens to contaminate RTE food; and
     Testing finished product to verify that preventive 
controls have significantly minimized or prevented hazards 
reasonably likely to occur in the food.
    Each type of testing provides information applicable to managing 
hazards in foods, depending on the food and process. For example, a 
dry blending operation, e.g., for spices and seasonings, often 
verifies its supplier controls by testing incoming ingredients 
before use (as discussed in section I.C of this Appendix) and 
periodically sampling and testing finished products. If all the 
ingredients being blended had been treated to adequately reduce 
hazards such as Salmonella spp., a dry blending operation generally 
does less testing to verify supplier controls than if this were not 
the case. (We use the term ``adequately reduce'' (which is a term 
used in some of our guidance documents) (Ref. 5) (Ref. 6) to mean 
the same as ``significantly minimize or prevent'' as described in 
section 418 of the FD&C Act or ``prevent, eliminate or reduce to an 
acceptable level'' as used in our seafood and juice HACCP 
regulations. All these terms mean to reduce a hazard to an extent 
that it is not reasonably likely to cause illness or injury.) A dry 
blending operation generally does not test incoming ingredients if 
the facility treats the blended materials to ensure adequate 
reduction of pathogens but sometimes tests finished product to 
verify preventive controls have been effective. A dry blending 
operation also sometimes uses environmental monitoring to verify 
that sanitation controls to significantly minimize or prevent the 
potential for environmental pathogens to contaminate the blended 
materials have been effective.
    For acidified canned vegetables in which a lethal process is 
delivered in the final package, microbial testing of incoming 
ingredients and of finished product provides little benefit as a 
verification activity (although it would be used in process 
validation); however, facilities producing such products sometimes 
conduct periodic testing of incoming ingredients for pesticides as 
an appropriate supplier verification activity.

B. Scientifically Valid Sampling and Testing

    Consistent with our previous discussion of the term 
``scientifically valid'' in the proposed rule to establish CGMP 
requirements for dietary ingredients and dietary supplements (68 FR 
12158 at 12198), we use the term ``scientifically valid'' with 
respect to testing to mean using an approach to both sampling and 
testing that is based on scientific information, data, or results 
published in, for example, scientific journals, references, text 
books, or proprietary research. A scientifically valid analytical 
method is one that is based on scientific data or results published 
in, for example, scientific journals, references, text books, or 
proprietary research (68 FR 12158 at 12198). Sampling and testing 
used for verification in a food safety system must be scientifically 
valid if they are to provide assurance that preventive controls are 
effective.

C. Verification Testing of Raw Materials and Ingredients

    Raw materials and ingredients are often tested as part of a 
supplier approval and verification program, as one of the 
verification activities when a preventive control that is adequate 
to significantly minimize or prevent the hazard is not applied at 
the receiving facility. The utility and frequency of raw material 
and ingredient testing for verification of supplier controls depend 
on many factors, including:
     The hazard and its association with the raw material or 
ingredient;
     The likelihood that the consumer would become ill if 
the hazard were present in the raw material or ingredient;
     How that raw material or ingredient will be used by the 
receiving facility (e.g., the effect of processing on the hazard); 
and
     The potential for contamination of the facility's 
environment with the hazard in the raw material or ingredient.
    Testing a raw material or ingredient occurs more frequently when 
there is a history of the hazard in the raw material or ingredient, 
e.g., from a specific supplier or from the country of origin. Once a 
facility has developed a relationship with a supplier and there is a 
history of tests negative for the hazard, the frequency is often 
reduced.
    Testing a raw material or ingredient is more useful, and a 
facility generally tests a raw material or ingredient more 
frequently, when the raw material or ingredient contains a hazard 
for which there is a reasonable

[[Page 17144]]

probability that exposure to the hazard will result in serious 
adverse health consequences or death to humans or animals. However, 
when a hazard that the receiving facility has identified as 
reasonably likely to occur in a raw material or ingredient is one 
for which the receiving facility has preventive controls that 
significantly minimize or prevent the hazard, testing generally is 
less frequent. An exception to this general paradigm is when the 
process control depends on the amount of the hazard present in the 
raw material or ingredient (e.g., when the process control is 
effective at eliminating 100 microorganisms per gram of ingredient, 
but not 1000 microorganisms per gram of ingredient) and there is a 
need to verify that the hazard is not present in amounts that would 
render the process control ineffective. A receiving facility often 
finds that testing of raw materials or ingredients is most useful, 
and generally tests more frequently, when the receiving facility 
does not have a process that would significantly minimize the hazard 
and is relying on preventive controls earlier in the supply chain to 
significantly minimize or prevent the hazard in the raw material or 
ingredient, as in a bagged salad facility or a dry-mix operation 
producing, for example, spice blends or trail mix. In such 
situations, the testing is conducted to verify the preventive 
controls used to ensure that hazards in the raw material or 
ingredient have been significantly minimized or prevented.
    The frequency of the testing conducted by a facility generally 
depends in part on the likelihood and severity of illness to the 
consumer if the hazard were present, the ability of supplier 
controls to significantly minimize or prevent the hazard in the raw 
material or ingredient, the practicality of testing to detect the 
hazard, and other factors. For example, a facility generally tests a 
raw material or ingredient more frequently from a supplier that does 
not have a kill step for Salmonella spp. in shelled nutmeats 
compared to a supplier that steam treats the nuts to kill Salmonella 
spp. As another example, if a facility tests a raw material or 
ingredient as part of its food safety program for salad greens, the 
facility is more likely to test more frequently for E. coli O157:H7 
than for other Shiga-toxin producing E. coli (pathogenic E. coli 
that produce the same toxin as E. coli O157:H7 but are less likely 
to cause severe illness (Ref. 7)), based on both the severity of the 
illness to the consumer and practical problems with testing fresh 
produce for pathogenic strains of Shiga-toxin producing E. coli. 
Where a raw material or ingredient could introduce an environmental 
pathogen such as Salmonella spp. or L. monocytogenes to the facility 
(e.g., raw nuts or soy powder for Salmonella spp.; chopped celery to 
be used in a salad for L. monocytogenes), a facility generally tests 
the raw material or ingredient more frequently to verify that 
supplier controls for the raw material or ingredient minimize to the 
extent possible the potential for a contaminated raw material or 
ingredient to introduce the environmental pathogen to the facility's 
environment.
    As discussed in section I.F of this Appendix, there are 
limitations to testing food. Thus, as with other testing, raw 
material or ingredient testing is rarely the sole basis for making a 
determination on the safety of a raw material or ingredient.

D. Verification of Sanitation Controls to Significantly Minimize or 
Prevent the Potential for an Environmental Pathogen to Contaminate 
Food

1. Environmental Pathogens in Food

    As discussed in section II.D of the preamble of this document, 
food can become contaminated with pathogenic microorganisms at many 
different steps in the farm-to-table continuum. Any time a food is 
exposed to the environment during a manufacturing, processing, 
packing, or holding activity, there is the potential for the food to 
be contaminated with pathogenic microorganisms. As discussed in 
section X.B of the preamble of this document, proposed Sec.  117.3 
would define the term ``environmental pathogen'' to mean a 
microorganism that is of public health significance and is capable 
of surviving and persisting within the manufacturing, processing, 
packing, or holding environment. The environmental pathogens most 
frequently involved in the contamination of foods leading to 
foodborne illness are Salmonella spp. and L. monocytogenes.

2. Salmonella spp. as an Environmental Pathogen

    We discuss Salmonella spp. in section II.D.2.a of the preamble 
of this document. Salmonella has been isolated from a variety of 
foods and it can get into food by a variety of mechanisms (see 
section II.D of the preamble of this document). Our focus here is on 
Salmonella contamination from the environment (discussed further in 
section I.D.2 of this Appendix), particularly as a hazard associated 
with low-moisture foods (Ref. 8) (Ref. 9). Low-moisture foods 
include cereal, peanuts, nuts, nut butters (including peanut 
butter), spices, dried herbs, milk powder, chocolate and many other 
foods. Although Salmonella outbreaks from low-moisture foods are 
less common than from foods such as eggs and produce, several such 
outbreaks in the last decade have involved hundreds of illnesses 
(Ref. 8). The low-moisture foods causing outbreaks included cereal, 
raw almonds, dried snacks, spices, and peanut butter (Ref. 8) (Ref. 
10). Chocolate also has been a source of outbreaks from Salmonella 
spp., although none in the U.S. in recent years (Ref. 8). Dried 
dairy products, such as milk and whey, also present a risk of 
contamination with Salmonella spp. from the environment (Ref. 11). A 
review of FDA recall data from 1970 to 2003 showed there were 21 
recalls of spices and herbs contaminated with Salmonella spp. (Ref. 
12). Almost half of the 86 primary RFR entries reported in the first 
RFR Annual Report due to finding Salmonella spp. were from low-
moisture foods (Ref. 13).

3. Listeria monocytogenes as an Environmental Pathogen

    We discuss L. monocytogenes in section II.D.2.a of the preamble 
of this document. As discussed in that section, the FDA/FSIS Lm RA 
shows that the risk of illness from L. monocytogenes increases with 
the number of cells ingested and that there is greater risk of 
illness from RTE foods that support growth of L. monocytogenes than 
from those that do not (Ref. 14). A key finding of the risk 
assessment released by FAO in 2004 was that the models developed 
predict that nearly all cases of listeriosis result from the 
consumption of high numbers of the pathogen (Ref. 15). Refrigerated 
foods present a greater risk from L. monocytogenes because some 
refrigerated foods that support growth may be held for an extended 
period of time, thus increasing the risk if L. monocytogenes is 
present in a food. Growth of L. monocytogenes does not occur if the 
food is frozen, but the organism may survive. If a frozen food 
contaminated with L. monocytogenes is thawed and held at 
temperatures that support growth, e.g., under refrigeration, the 
risk of illness from L. monocytogenes in that food increases. As 
discussed in section II.D.1 of the preamble of this document, 
contamination of RTE food with L. monocytogenes from the environment 
is common and, thus, targeted preventive controls to significantly 
minimize or prevent L. monocytogenes contamination of RTE foods are 
warranted.

4. Environmental Pathogens in the Plant Environment

    Environmental pathogens may be introduced into a facility 
through raw materials or ingredients, people, or objects (Ref. 8) 
(Ref. 9) (Ref. 16) (Ref. 17) (Ref. 18). Once in the facility, 
environmental pathogens can be a source of contamination of food. 
Environmental pathogens may be transient strains or resident strains 
(Ref. 8) (Ref. 9) (Ref. 16). Transient strains are environmental 
pathogens that contaminate a site in the facility where they can be 
eliminated by normal cleaning and sanitizing (Ref. 16). Transient 
strains tend to vary over time within a facility, e.g., they will be 
found in different areas and the specific strain will differ. 
Resident strains are environmental pathogens that contaminate a site 
in the facility that is difficult to clean and sanitize with normal 
cleaning and sanitizing procedures and, thus, these strains become 
established in what is referred to as a ``niche'' or harborage site 
(Ref. 8) (Ref. 9) (Ref. 16) (Ref. 17) (Ref. 18) (Ref. 19). The 
finding of the same specific strain multiple times in a facility 
often indicates a resident strain.
    If a harborage site contains nutrients (i.e., food) and water 
and is exposed to a temperature that falls within the growth range 
of the environmental pathogen, the pathogen can multiply, which 
increases the chance that it will be transferred to other sites 
(including food-contact surfaces) and to food. Transfer can occur by 
people (e.g., if a person touches the contaminated site and then 
touches other objects, or tracks the pathogen from the contamination 
site to other sites on shoes), by equipment (e.g., if the pathogen 
is picked up by the wheels of a cart or forklift and is transferred 
to other locations), by water (e.g., water that contacts the 
harborage site is splashed onto other areas, including equipment, or 
aerosols containing the pathogen transfer it to other areas) or by 
air (dissemination of contaminated dust particles by air handling 
systems) (Ref. 8) (Ref. 9) (Ref. 19) (Ref. 17).

[[Page 17145]]

Such transfer mechanisms from harborage sites can result in 
intermittent contamination of food-contact surfaces and food over 
long periods of time, often with the same strain of the pathogen 
(Ref. 8) (Ref. 16) (Ref. 19) (Ref. 20).

5. Contamination of Food With Salmonella spp. From the Plant 
Environment

    As discussed immediately below, the available data and 
information associate insanitary conditions in food facilities with 
contamination of a number of foods with the environmental pathogen 
Salmonella spp. Such contamination has led to recalls and to 
outbreaks of foodborne illness.
    In 1998, a breakfast cereal product was implicated in an 
outbreak, due to Salmonella Agona, that caused 409 illnesses and one 
death in 23 states (Ref. 20) (Ref. 21) (Ref. 22). During the 
outbreak investigation, Salmonella was isolated from various 
locations in the plant, including the floor, processing equipment, 
and the exhaust system of the implicated processing line (Ref. 20). 
In 2008, the same Salmonella Agona strain was again implicated in an 
outbreak linked to a similar cereal product from the same 
manufacturing facility (Ref. 23). In the 2008 outbreak, the same 
strain was isolated from patients, cereal and the plant environment 
(Ref. 23).
    In 2006-2007, a commercial brand peanut butter contaminated with 
Salmonella Tennessee caused 715 illnesses and 129 hospitalizations 
(Ref. 24). FDA isolated Salmonella Tennessee from 13 unopened jars 
of peanut butter with production dates ranging from August 2006 to 
January 2007 and from two plant environmental samples (Ref. 25).
    During the years 2008 through 2010, there were three large 
recalls of foods containing ingredients contaminated with Salmonella 
spp. where FDA's investigation identified insanitary conditions at 
the facility that manufactured the ingredient and detected 
Salmonella spp. in the plant environment (Ref. 26) (Ref. 27) (Ref. 
28) (Ref. 29) (Ref. 30) (Ref. 31) (Ref. 32) (Ref. 33) (Ref. 34). In 
2008-2009, an outbreak was linked to Salmonella Typhimurium in 
peanut butter and peanut paste (Ref. 28) (Ref. 29) (Ref. 32). This 
outbreak resulted in an estimated 714 illnesses, 166 
hospitalizations, and 9 deaths (Ref. 29). Implicated foods included 
contaminated peanut butter consumed at institutional settings and 
crackers made with the contaminated peanut butter as an ingredient 
(Ref. 28) (Ref. 29). Inspections conducted by FDA at the two 
implicated ingredient manufacturing facilities (which shared 
ingredients) revealed lack of controls to prevent product 
contamination from pests, from an insanitary air-circulation system, 
from insanitary food-contact surfaces, and from the processing 
environment (Ref. 26) (Ref. 30) (Ref. 31). Several strains of 
Salmonella spp. were found in multiple products and in the plant 
environment (Ref. 30). This outbreak led to the recall of more than 
3900 products containing peanut-derived ingredients (Ref. 35).
    In 2009, USDA detected Salmonella spp. in a powdered dairy shake 
and FDA began an investigation of the suppliers of ingredients used 
to manufacture the product. The inspection of the supplier of one of 
the ingredients uncovered insanitary conditions that resulted in the 
recall of multiple ingredients manufactured by that supplier, 
including instant nonfat dried milk and whey proteins, produced over 
a 2-year period (Ref. 33). During its investigation of the 
supplier's facility, FDA identified several strains of Salmonella 
spp. on food-contact and non-food-contact surfaces and in other 
areas of the plant environment, as well as a number of sanitation 
deficiencies (Ref. 34).
    In 2010, FDA received a report through the RFR of Salmonella 
contamination of hydrolyzed vegetable proteins that a company 
purchased as an ingredient. Both the company that submitted the 
report and FDA found multiple Salmonella-positive samples collected 
from the plant environment, including food-contact surfaces. FDA 
found numerous sanitation deficiencies during its inspection of the 
production facility. There were no reports of illness associated 
with the contamination, but multiple product recalls resulted (Ref. 
27).

6. Contamination of Food with L. monocytogenes From the Plant 
Environment

    As discussed immediately below, the available data and 
information associate insanitary conditions in food facilities with 
contamination of a number of foods with the environmental pathogen 
L. monocytogenes. Such contamination has led to recalls and to 
outbreaks of foodborne illness.
    Between October 2008 and March 2009, eight cases of listeriosis 
from five states were linked to Mexican-style cheese that was likely 
contaminated post-pasteurization (Ref. 36). The outbreak strain was 
isolated from product and from a vat gasket in a post-pasteurization 
section of the processing line.
    In October 2010, the Texas Department of State Health Services 
ordered a fresh-cut produce facility to stop processing after 
laboratory tests of chopped celery indicated the presence of L. 
monocytogenes (Ref. 37). The testing was done as part of an 
investigation of 10 cases of listeriosis, six of which were linked 
to chopped celery from the facility. Texas Department of State 
Health Services and FDA inspectors found sanitation deficiencies at 
the plant (Ref. 37) (Ref. 38) and suggested that the L. 
monocytogenes in the chopped celery may have contaminated other 
produce. FDA laboratory testing found L. monocytogenes in multiple 
locations in the plant environment, including on food-contact 
surfaces; the DNA fingerprint of the L. monocytogenes in the FDA 
samples matched the DNA fingerprint of the clinical cases reported 
by the Texas Department of State Health Services (Ref. 39).
    In 2011, an outbreak of listeriosis from cantaloupes was 
attributed to insanitary conditions at a facility that washed, 
packed, cooled, and stored intact cantaloupes (Ref. 40) (Ref. 41). 
The outbreak appears to have occurred due to a combination of 
factors, including pooled water on the floor of the facility (which 
was also difficult to clean), poorly designed equipment (not easily 
cleaned and sanitized) that was previously used for a different 
commodity, no pre-cool step, a truck parked near the packing area 
that had visited a cattle operation, and possible low level 
contamination from the growing/harvesting operation (Ref. 40).
    There have been several outbreaks in which meat or poultry 
products produced in FSIS-inspected establishments were contaminated 
with L. monocytogenes from the plant environment (Ref. 42), and much 
of our understanding of sources of L. monocytogenes in the plant 
environment, as well as appropriate ways to control this organism, 
has come from the efforts of FSIS and the meat and poultry industry 
to control this hazard in FSIS-inspected establishments (Ref. 18). 
For example, harborage sites such as hollow rollers, rubber seals, 
close-fitting metal-to-metal spaces in equipment such as slicers, 
and on-off switches of equipment were identified in meat and poultry 
establishments. The increased risk of contamination resulting from 
construction, and the importance of control of traffic and water in 
the RTE area also became widely known as a result of investigations 
at meat and poultry establishments (Ref. 17) (Ref. 18).
    Outbreaks of listeriosis resulting from environmental 
contamination have also occurred in other countries. For example, an 
outbreak of listeriosis in Finland in 1999 was associated with 
butter (Ref. 43). The outbreak strain was isolated from the 
manufacturing facility, including from the packaging machine and the 
floor (Ref. 43). An outbreak of listeriosis in 2009 in Austria and 
Germany was associated with acid curd cheese; the outbreak strain 
was found in the production facility (Ref. 44).
    Many foods without a known association with illnesses have been 
recalled due to the presence of L. monocytogenes (Ref. 45) (Ref. 46) 
(Ref. 47) (Ref. 48). There is also an extensive body of literature 
on isolation of L. monocytogenes in the food processing environment. 
Information on the environment as a source of Listeria has been 
available for many years. For example, in a 1989 study involving 6 
different types of food plants (frozen food, fluid dairy, cheese, 
ice cream, potato processing, and dry food), drains, floors, 
standing water, food residues, and food-contact surfaces were found 
to be positive (Ref. 49). No finished foods were tested, but the 
authors concluded that food production environments could be the 
source of contamination for foods that have received listericidal 
treatments and that measures should be taken to prevent survival and 
growth of these organisms in food environments (Ref. 49).
    Listeria testing in 62 dairy facilities during 1987-1988 
(including facilities producing fluid milk, frozen product, butter, 
processed cheese, natural cheese and dry products) found Listeria in 
a variety of locations, including packaging equipment, conveyors, 
coolers, drains and floors (Ref. 50). Listeria was detected more 
frequently in wet locations, including drains, conveyors and floors 
(Ref. 50). Pritchard and co-workers also examined 21 dairy 
processing environments for Listeria and found 80 of 378 sites 
positive for Listeria spp. (Ref. 51). Sites positive for L. 
monocytogenes included holding tanks, table tops, conveyor/chain 
systems, a milk filler and a brine pre-filter machine (Ref. 51).
    The packaging machine was found to be the main problem with L. 
monocytogenes

[[Page 17146]]

that persisted in an ice cream plant in Finland for several years 
and occasionally contaminated finished product (Ref. 52). A 
volumetric doser was found to be the source of L. monocytogenes in 
sauces produced in a fresh sauce production plant in Italy (Ref. 
53), and slicers and conveyor belts were found to contribute to 
contamination of sandwiches in a Swiss sandwich producing plant 
(Ref. 54). L. monocytogenes also has been found on tables, water 
hoses, air guns, floors, gloves, drains and a bread-feeding machine 
(Ref. 54).
    Some of the available data and information about the potential 
presence of the environmental pathogen L. monocytogenes comes from 
studies conducted to detect the presence of Listeria spp. in lieu of 
L. monocytogenes. Listeria spp. are ``indicators'' of the potential 
presence of L. monocytogenes. (See section I.E of this Appendix for 
a discussion of indicator organisms). A study conducted over a 4-
year time period on the prevalence of L. monocytogenes on produce 
and in the plant environment in a large produce processing plant in 
Poland demonstrated that the indicator organism Listeria spp., and 
the environmental pathogen L. monocytogenes, could be isolated from 
conveyor belts after blanching and from freezing tunnels (Ref. 55). 
Studies in a vegetable processing plant in Spain found the indicator 
organism L. innocua (commonly found when the species of Listeria 
spp. are determined) in frozen RTE vegetables and in the plant 
environment, e.g., washing tunnels, conveyor belts and floors (Ref. 
56). L. innocua was more prevalent than L. monocytogenes in the 
frozen RTE vegetables and in the plant environment. In both of these 
examples, the presence of an ``indicator organism'' (either Listeria 
spp. or L. innocua) demonstrated that insanitary conditions existed 
that were conducive to the presence and harborage of L. 
monocytogenes.

E. Role of Environmental Monitoring in Verifying the Implementation 
and Effectiveness of Sanitation Controls in Significantly 
Minimizing or Preventing the Potential for an Environmental 
Pathogen to Contaminate Food

1. Purpose of Environmental Monitoring

    Appropriate sanitation controls can minimize the presence of 
environmental pathogens in the plant and the transfer of 
environmental pathogens to food-contact surfaces and to food (Ref. 
16). The purpose of monitoring for environmental pathogens in 
facilities where food is manufactured, processed, packed or held is 
to verify the implementation and effectiveness of sanitation 
controls intended to significantly minimize or prevent the potential 
for an environmental pathogen to contaminate food. In so doing, 
environmental monitoring can find sources of environmental pathogens 
that remain in the facility after routine cleaning and sanitizing 
(particularly strains that may have become established in the 
facility as resident strains) so that the environmental pathogens 
can be eliminated by appropriate corrective actions (e.g., 
intensified cleaning and sanitizing, sometimes involving equipment 
disassembly). Pritchard et al. noted that daily cleaning and 
sanitizing appeared to be effective in eliminating transient 
contaminants from equipment and concluded that greater emphasis 
needs to be placed on cleaning and sanitizing the plant environment 
(Ref. 51). A robust environmental monitoring program for 
environmental pathogens can detect these strains and enables the 
facility to eliminate them from the environment which can prevent 
contamination of food with these pathogens and, thus, prevent 
foodborne illnesses (Ref. 57) (Ref. 17) (Ref. 18) (Ref. 58) (Ref. 
59). In the situations described in sections I.D.5 and I.D.6 of this 
Appendix, such a program for the environmental pathogens Salmonella 
spp. and L. monocytogenes might have allowed the facility to detect 
a problem before product contamination occurred, thereby preventing 
an outbreak, recall, or both, or minimizing the amount of product 
affected by a recall. Studies of environmental pathogens have 
clearly demonstrated that environmental monitoring can identify the 
presence of situations that can lead to contamination of food and 
allow actions to be taken to prevent such contamination (Ref. 51) 
(Ref. 60).

2. Indicator Organisms

    The term ``indicator organism'' can have different meanings, 
depending on the purpose of using an indicator organism. As 
discussed in the scientific literature, the term ``indicator 
organism'' means a microorganism or group of microorganisms that is 
indicative that (1) a food has been exposed to conditions that pose 
an increased risk for contamination of the food with a pathogen or 
(2) a food has been exposed to conditions under which a pathogen can 
increase in numbers (Ref. 61). This definition in the scientific 
literature is consistent with a definition of indicator organism 
established by NACMCF as one that indicates a state or condition and 
an index organism as one for which the concentration or frequency 
correlates with the concentration or frequency of another 
microorganism of concern (Ref. 62). FDA considers the NACMCF 
definition of an indicator organism to be an appropriate working 
definition for the purpose of this document.
    The use of ``indicator organisms'' as a verification of hygiene 
measures in facilities is common practice (Ref. 63). For example, it 
is common practice to use the presence of generic (nonpathogenic) E. 
coli in a food processing plant as an indication of whether food was 
prepared, packed, or held under insanitary conditions, without 
considering whether the insanitary conditions reflect a specific 
pathogen, such as E. coli O157:H7 or Salmonella spp. However, such 
use of an indicator organism is distinct from the use of indicator 
organisms as discussed in the remainder of this document--i.e., for 
the specific purpose of monitoring for the presence of environmental 
pathogens.
    Environmental monitoring for environmental pathogens can be 
conducted by testing for the specific pathogenic microorganism 
(e.g., Salmonella spp.) or by testing for an ``indicator organism.'' 
The presence of an indicator organism indicates conditions in which 
the environmental pathogen may be present. An organism is useful as 
an indicator organism if there is sufficient association of 
conditions that could result in the presence of the indicator 
organism and conditions that could result in the pathogen such that 
there can be confidence that the pathogen would not be present if 
the indicator is not present. Attributes that provide scientific 
support for use of an indicator organism in lieu of a specific 
pathogen include:
     Similar survival and growth characteristics;
     A shared common source for both organisms; and
     A direct relationship between the state or condition 
that contributes to the presence of pathogen and the indicator 
organism (Ref. 62).
    The presence of an indicator organism in the plant environment, 
including on a food-contact surface, does not necessarily mean that 
an environmental pathogen is in the plant or in a food produced 
using that food-contact surface--the indicator may be present but 
the pathogen may be absent. Pritchard et al., in their study on the 
presence of Listeria in dairy plant environments, concluded that, 
because the level of contamination was higher in environmental 
samples than in equipment samples, environmental contamination with 
Listeria does not necessarily translate into contamination of 
equipment in the plant (Ref. 51).
    Typically, a facility that finds an indicator organism during 
environmental monitoring conducts microbial testing of surrounding 
surfaces and areas to determine the potential source of the 
contamination, cleans and sanitizes the contaminated surfaces and 
areas, and conducts additional microbial testing to determine 
whether the contamination has been eliminated. If the indicator 
organism is found on retest, the facility generally takes more 
aggressive corrective actions (e.g., more intensified cleaning and 
sanitizing, including dismantling equipment, scrubbing surfaces, and 
heat-treating equipment parts) (Ref. 17). In general, whether a 
facility takes subsequent steps to determine an indicator organism 
detected on a food-contact surface is actually the environmental 
pathogen depends, in part, on the risk of foodborne illness if the 
food being produced on a food-contact surface that has tested 
positive for an indicator organism were to be contaminated. For 
example, the risk of listeriosis is greater if the food supports 
growth of L. monocytogenes. In some cases, a facility simply assumes 
that a food produced using a food-contact surface that is 
contaminated with an indicator organism is contaminated with the 
environmental pathogen and takes corrective action to either 
reprocess it or divert it to a use that would not present a food 
safety concern.

3. Environmental Monitoring for L. monocytogenes and the Use of an 
Indicator Organism

    Tests for the indicator organism Listeria spp. detect multiple 
species of Listeria, including the pathogen L. monocytogenes. There 
is Federal precedent for the use of Listeria spp. as an appropriate 
indicator organism for L. monocytogenes. FSIS has established 
regulations requiring FSIS-regulated establishments that produce RTE

[[Page 17147]]

meat or poultry products exposed to the processing environment after 
a lethality procedure (e.g., cooking) to prevent product 
adulteration by L. monocytogenes.
    FSIS has issued guidelines (FSIS Compliance Guideline for 
Controlling Listeria monocytogenes in Post-lethality Exposed Ready-
to-Eat Meat and Poultry Products) (hereinafter the FSIS Listeria 
Compliance Guideline) to help FSIS-regulated establishments that 
produce RTE meat or poultry products exposed to the processing 
environment after a lethality procedure comply with the requirements 
of 9 CFR part 430 (Ref. 64). Under the FSIS Listeria Compliance 
Guideline, FSIS-regulated establishments may establish an 
environmental monitoring program for Listeria spp. rather than for 
the pathogen, L. monocytogenes.
    In general, under the FSIS Listeria Compliance Guideline, an 
FSIS-regulated establishment that receives a positive test result 
for an indicator organism on a food-contact surface:
     Takes corrective action (i.e., intensify the cleaning 
and sanitizing of the affected food-contact surface);
     Retests the affected food-contact surface; and
     Takes additional corrective action (intensified each 
time the test is positive for the indicator organism) and conducts 
additional testing until the affected food-contact surface is 
negative for the indicator organism.
    Some segments of the food industry subject to regulation by FDA 
have adopted the principles, described in the FSIS Listeria 
Compliance Guideline, for corrective actions after a finding of 
Listeria spp. on food-contact surfaces in the plant. For example, in 
response to a request for comments on a draft guidance document 
directed to control of L. monocytogenes in refrigerated or frozen 
ready-to-eat foods, we received letters describing programs similar 
to the program in the FSIS Listeria Compliance Guideline, using 
Listeria spp. as an indicator organism during environmental 
monitoring for L. monocytogenes (Ref. 65) (Ref. 66) (Ref. 67) (Ref. 
68). In addition, as discussed in section II.A.1 of the preamble of 
this document, a key finding of the CGMP Working Group Report was 
the importance of updating CGMP requirements to require a written 
environmental pathogen control program for food processors that 
produce RTE foods that support the growth of L. monocytogenes. 
Written comments from the food industry supported such a control 
program (Ref. 69). Thus, the importance of controlling L. 
monocytogenes in the environment of RTE food production facilities 
and using environmental monitoring to detect the presence of L. 
monocytogenes or Listeria spp. (as an indicator organism for L. 
monocytogenes) has been well-established.
    FDA's current thinking is that Listeria spp. is an appropriate 
indicator organism for L. monocytogenes, because tests for Listeria 
spp. will detect multiple species of Listeria, including L. 
monocytogenes, and because the available information supports a 
conclusion that modern sanitation programs, which incorporate 
environmental monitoring for Listeria spp., have public health 
benefits.

4. Environmental Monitoring for Salmonella spp. and the Use of an 
Indicator Organism

    Salmonella spp. is a member of the family Enterobacteriaceae, 
and thus there is some relationship between the presence of 
Salmonella spp. and the presence of Enterobacteriaceae. There are 
few studies that have investigated the use of organisms such as 
Enterobacteriaceae or other members of the family 
Enterobacteriaceae, such as E. coli, to serve as an indicator 
organism for Salmonella spp. in the environment. The European Food 
Safety Agency (EFSA) evaluated whether environmental monitoring for 
Enterobacteriaceae as an indicator organism for Salmonella spp. (or 
for Cronobacter spp.) could be useful. Although EFSA's focus was on 
the utility of Enterobacteriaceae as an indicator organism in the 
production of a single product--i.e., powdered infant formula--their 
analysis may be relevant to the utility of Enterobacteriaceae as an 
indicator organism in other dried foods. EFSA concluded that, 
although there are insufficient data to establish a correlation 
between the presence of Enterobacteriaceae and Salmonella spp. in 
powdered infant formula because Salmonella spp. is so rarely 
present, monitoring for Enterobacteriaceae in the product 
environment can be used to confirm the application of GMPs (Ref. 
70). ICMSF also considered the utility of environmental monitoring 
for Enterobacteriaceae as an indicator organism for Salmonella spp. 
ICMSF indicates that, for powdered infant formula manufacturing, low 
levels of Enterobacteriaceae do not guarantee the absence of 
Salmonella spp. (Ref. 71) and recommends testing directly for the 
pathogen, as well as for Enterobacteriaceae. FDA agrees with EFSA 
and ICMSF that there are insufficient data to establish a 
correlation between the presence of Enterobacteriaceae and 
Salmonella spp. during the production of powdered infant formula; 
FDA is not aware of any information supporting the use of an 
indicator organism for the purpose of environmental monitoring for 
Salmonella spp. during the production of other foods, particularly 
dried foods.
    ICMSF recommends testing for Salmonella spp. in the environment 
for a number of other products, e.g., baked dough products (Ref. 
72), dry spices receiving a kill step (Ref. 73), dried cereal 
products (Ref. 74), nuts (Ref. 75), cocoa powder, chocolate and 
confectionary (Ref. 76), and dried dairy products (Ref. 77). For 
most of these products ICMSF also recommends testing the environment 
for Enterobacteriaceae as a hygiene indicator, but not in lieu of 
the environmental pathogen Salmonella spp. Likewise, food industry 
guidance for low-moisture foods recommends testing for Salmonella 
spp. in the environment (Ref. 59). FDA's current thinking is that 
there is no currently available indicator organism for Salmonella 
spp. We request data, information, and other comment bearing on 
whether there is a currently available indicator organism for 
Salmonella spp. that could be used for environmental monitoring.

5. Environmental Monitoring Procedures

    The procedures associated with an environmental monitoring 
program generally include the collection of environmental samples at 
locations within the facility and testing the samples for the 
presence of an environmental pathogen or indicator organism. One 
approach to defining sampling locations is to divide the facility 
into zones based on the risk with respect to contamination of 
product. A common industry practice is to use four zones (Ref. 16) 
(Ref. 59):
     Zone 1 consists of food-contact surfaces;
     Zone 2 consists of non-food-contact surfaces in close 
proximity to food and food-contact surfaces;
     Zone 3 consists of more remote non-food-contact 
surfaces that are in the process area and could lead to 
contamination of zones 1 and 2; and
     Zone 4 consists of non-food-contact surfaces, outside 
of the processing area, from which environmental pathogens can be 
introduced into the processing environment.
    Generally the number of samples and frequency of testing is 
higher in zones 1 and 2 because of the greater risk of food 
contamination if the environmental pathogen is detected in these 
zones. Information on appropriate locations for sampling within 
these zones can be found in the literature (Ref. 11) (Ref. 17) (Ref. 
50) (Ref. 51) (Ref. 59). Facilities should become familiar with 
locations in which environmental pathogens have been found in other 
facilities and use this information in selecting sites to sample.
    Examples of appropriate food-contact surfaces that could be 
monitored include hoppers, bins, conveyors, tables, slicers, 
blenders, knives and scrapers. Testing food-contact surfaces for 
Listeria spp. is a commonly recommended verification measure for 
facilities producing refrigerated RTE foods (Ref. 57) (Ref. 16) 
(Ref. 17). Although some literature suggests that routine 
environmental monitoring for Salmonella spp. in low-moisture food 
environments would not normally target food-contact surfaces (Ref. 
59), the data (discussed in the preamble of this document) available 
from investigations of food facilities following outbreaks, recalls, 
or reports to the RFR warrant including food-contact surfaces in a 
routine environmental testing program for Salmonella spp. However, a 
routine environmental monitoring program for Salmonella spp. may not 
contain the same level of food-contact surface testing (including 
the frequency of testing and number of samples collected) as a 
routine environmental monitoring program for Listeria, because the 
same benefits may not be achieved. For example:
     L. monocytogenes is usually the environmental pathogen 
of concern for most wet RTE food production environments. It is 
important to sample areas where the organisms are likely to be 
present in relatively high numbers. L. monocytogenes frequently 
establishes itself in a harborage site on equipment and grows 
(increases in number) there, where both food and moisture are 
available. L. monocytogenes organisms work their way out of the 
harborage site during production and contaminate food.
     Salmonella spp. is usually the environmental pathogen 
of concern for most dry (e.g., low-moisture) RTE food

[[Page 17148]]

environments. Equipment used in the production of dry products is 
rarely wet and, thus, there is no moisture to allow growth of 
Salmonella spp. As a result, Salmonella harborage sites are less 
likely to be found on equipment and are more likely to be found in 
the environment in locations where food particles lodge and escape a 
dry cleaning process. When these locations get wet, the Salmonella 
spp. grows and contaminates other areas of the facility, eventually 
contaminating food-contact surfaces and food. Nevertheless, sampling 
food-contact surfaces (e.g., filler hoppers, conveyors, valves, 
sifter cuffs) can be useful, as can sampling residues such as sifter 
tailings and product scrapings.
    Examples of appropriate non-food-contact surfaces that could be 
monitored include exteriors of equipment, equipment supports, 
control panels, door handles, floors, drains, refrigeration units, 
ducts, overhead structures, cleaning tools, motor housings and 
vacuum canisters. Standing water in production areas and areas that 
have become wet and then have dried are also appropriate places to 
monitor. Testing non-food-contact surfaces for L. monocytogenes or 
Listeria spp. is a commonly recommended verification measure for 
facilities producing refrigerated or frozen RTE foods (Ref. 57) 
(Ref. 16) (Ref. 17) and can detect L. monocytogenes that is brought 
into the plant by people or objects. Corrective actions can prevent 
transferring the organisms to a food-contact surface (where they can 
contaminate food) or from establishing a harborage that can serve as 
a source of contamination. Recommendations for routine environmental 
monitoring for Salmonella spp. in low moisture food environments 
generally target non-food-contact surfaces because equipment used in 
the production of low-moisture foods where Salmonella spp. is the 
environmental pathogen of concern does not have the moisture to 
allow Salmonella spp. to grow and, thus, sampling non-food-contact 
surfaces for Salmonella spp. may be more effective in finding the 
organism than sampling food-contact surfaces. Scrapings or residues 
that accumulate under or above equipment are more useful samples 
than sponges or swabs of food-contact surfaces (Ref. 76).
    As discussed in section I.E.2 of this Appendix with respect to 
indicator organisms, a facility that finds an indicator organism or 
an environmental pathogen during environmental monitoring typically 
conducts microbial testing of surrounding surfaces and areas to 
determine the potential source of the contamination, cleans and 
sanitizes the contaminated surfaces and areas, and conducts 
additional microbial testing to determine whether the contamination 
has been eliminated. If the organism is found on retest, the 
facility generally takes more aggressive corrective actions (e.g., 
more intensified cleaning and sanitizing, including dismantling 
equipment, scrubbing surfaces, and heat-treating equipment parts) 
(Ref. 17).
    The adequacy of a corrective action in response to environmental 
monitoring depends in part on the following factors related to the 
risk presented in a particular situation:
     Whether the environmental contamination is on a food-
contact surface or a non-food-contact surface;
     The proximity of a contaminated non-food-contact 
surface to one or more food-contact surfaces;
     Whether there have been previous positives on the 
specific food-contact surface or non-food-contact surface or in the 
same area; and
     The environmental monitoring strategy for the type of 
food, and whether the food supports growth of the environmental 
pathogen (see the discussion of the relevance of whether a food 
supports the growth of an environmental pathogen in section I.D.4 of 
this Appendix).
    If an environmental pathogen or an appropriate indicator 
organism (the test organism) is detected in the environment, 
corrective actions are taken to eliminate the organism, including 
finding a harborage site if one exists (Ref. 17) (Ref. 18) (Ref. 
59). Otherwise, the presence of the environmental pathogen could 
result in contamination of food-contact surfaces or food. The 
presence of the indicator organism suggests that conditions exist in 
which the environmental pathogen may be present and could result in 
contamination of food-contact surfaces or food. Corrective actions 
are taken for every finding of an environmental pathogen or 
indicator organism in the environment to prevent contamination of 
food-contact surfaces or food.
    Sampling and microbial testing from surfaces surrounding the 
area where the test organism was found are necessary to determine 
whether the test organism is more widely distributed than on the 
original surface where it was found and to help find the source of 
contamination if other sites are involved. Cleaning and sanitizing 
the contaminated surfaces and surrounding areas are necessary to 
eliminate the test organism that was found there. Additional 
sampling and microbial testing are necessary to determine the 
efficacy of cleaning and sanitizing. For example, detection of the 
test organism after cleaning and sanitizing indicates that the 
initial cleaning was not effective, and additional, more intensified 
cleaning and sanitizing, or other actions may be needed, including 
dismantling equipment, scrubbing surfaces, and heat-treating 
equipment parts (Ref. 17). Examples of additional corrective actions 
that could be taken include reinforcing employee hygiene practices 
and traffic patterns; repairing damaged floors; eliminating damp 
insulation, water leaks, and sources of standing water; replacing 
equipment parts that can become harborage sites (e.g., hollow 
conveyor rollers and equipment framework), and repairing roof leaks 
(Ref. 17) (Ref. 59). The types of corrective actions would depend on 
the type of food, the facility and the environmental pathogen.
    The finding of a test organism on a food-contact surface usually 
represents transient contamination rather than a harborage site 
(Ref. 18). However, finding the test organism on multiple surfaces 
in the same area, or continuing to find the test organism after 
cleaning and sanitizing the surfaces where it was found, suggests a 
harborage site for the test organism. Mapping the location of 
contamination sites, whether the harborage site is on equipment or 
in the environment, can help locate the source of the harborage site 
or identify additional locations to sample (Ref. 59).
    The types of facilities that may conduct environmental 
monitoring and that could implement corrective actions on finding 
the test organism in the facility are quite diverse, and include 
facilities producing low-moisture products such as cereals, 
chocolate and dried milk powders and facilities producing a variety 
of RTE refrigerated products such as deli salads, cheeses and bagged 
salads. The number of sites appropriate for testing and the 
applicable cleaning and sanitizing procedures would depend on the 
facility and the equipment.
    Corrective actions may involve investigative procedures when the 
initial corrective actions have not been successful in eliminating 
the environmental pathogen or indicator organism. One example of an 
investigative procedure is taking samples from food-contact surfaces 
and/or product from the processing line at multiple times during the 
day while the equipment is operating and producing product (Ref. 
17). Another example of an investigative procedure is conducting 
molecular strain typing such as pulsed-field gel electrophoresis 
(PFGE), ribotyping, or polymerase chain reaction (PCR) analysis to 
determine if particular strains are persistent in the environment 
(Ref. 19) (Ref. 78) (Ref. 54) (Ref. 52) (Ref. 53) (Ref. 79). 
Molecular strain typing can indicate that strains isolated at 
different points in time have the same molecular ``fingerprint,'' 
suggesting a common source, and perhaps a harborage site, that has 
not been detected based on the results of routine environmental 
monitoring (Ref. 52) (Ref. 53). Molecular strain typing can also be 
used when trying to determine if a specific ingredient is the source 
of contamination (Ref. 78).
    If environmental monitoring identifies the presence of an 
environmental pathogen or appropriate indicator organism, the 
facility may conduct finished product testing. As discussed in 
section I.F of this Appendix, there are shortcomings for 
microbiological testing of food for process control purposes. 
Testing cannot ensure the absence of a hazard, particularly when the 
hazard is present at very low levels and is not uniformly 
distributed. If an environmental pathogen is detected on a food-
contact surface, finished product testing would be appropriate only 
to confirm actual contamination or assess the extent of 
contamination, because negative findings from product testing could 
not adequately assure that the environmental pathogen is not present 
in food exposed to the food-contact surface. If a facility detects 
an environmental pathogen on a food-contact surface, the facility 
should presume that the environmental pathogen is in the food.
    Finished product testing could be appropriate if an 
environmental pathogen is detected on a non-food-contact surface, 
such as on the exterior of equipment, on a floor or in a drain. The 
potential for food to be contaminated directly from contamination in

[[Page 17149]]

or on a non-food-contact surface is generally low, but transfer from 
non-food-contact surfaces to food-contact surfaces can occur. 
Finished product testing can provide useful information on the 
overall risk of a food when pathogens have been detected in the 
environment. In general, finished product testing is most 
appropriate when an indicator organism, rather than an environmental 
pathogen, is detected on a food-contact surface.
    The results of finished product testing can be used in 
combination with the results of environmental monitoring and 
corrective actions to help ensure that the food released into 
commerce is not adulterated. For example, if a facility with an 
aggressive environmental monitoring program detects an indicator 
organism on a food-contact surface, it may use information such as 
the following in determining whether to release product into 
commerce:
     The number and location of positive sample findings, 
including from the original sampling and from additional/follow-up 
testing of areas surrounding the site of the original finding;
     The root cause analysis of the source of the 
contamination;
     Information on the efficacy of the facility's 
corrective actions (including the results of additional follow-up 
sampling);
     Information obtained from any finished product testing, 
taking into consideration the statistical confidence associated with 
the results.

F. The Role of Finished Product Testing in Verifying the 
Implementation and Effectiveness of Preventive Controls

    The utility of finished product testing for verification depends 
on many factors that industry currently considers in determining 
whether finished product testing is an appropriate approach to 
reducing the risk that contaminated food would reach the consumer 
and cause foodborne illness. The first such consideration is the 
nature of the hazard and whether there is evidence of adverse health 
consequences from that hazard in the food being produced or in a 
similar food. If the hazard were to be present in the food, how 
likely is it that illness will occur and how serious would the 
consequences be? The more likely and severe the illness, the greater 
the frequency of conducting verification testing. For example, 
Salmonella spp. is a hazard that if consumed could cause serious 
illness, particularly in children and the elderly. In contrast, in 
situations where unlawful pesticide residues are considered 
reasonably likely to occur, the presence of a pesticide residue that 
is not approved for a specific commodity but that is within the 
tolerance approved for other commodities, while deemed unsafe as a 
matter of law, may not actually result in illness. Thus, a firm is 
more likely to conduct finished product testing to verify Salmonella 
spp. control than to verify control of pesticides.
    Another consideration in determining whether finished product 
testing is appropriate is the intended consumer of the food. The 
greater the sensitivity of the intended consumer (as would be the 
case, for example, for a medical food provided to hospitalized 
adults), the greater the likelihood that finished product testing 
would be used as a verification activity.
    Another consideration in determining whether finished product 
testing is appropriate is the impact of the food on the contaminant. 
For example, depending on the food, pathogens may survive in food, 
increase in number, or die off. Finished product testing generally 
is not conducted if pathogens that may be in a food would die off in 
a relatively short period of time (e.g., before the food reaches the 
consumer). For example, many salad dressings have antimicrobial 
properties, including low pH, high acidity, and preservatives, that 
are lethal for pathogens such as Salmonella spp. or E. coli O157:H7. 
If a facility has validated the lethality of the formulation of the 
salad dressing, the facility is unlikely to conduct finished product 
testing for pathogens such as Salmonella spp. or E. coli O157:H7, as 
this would not be an effective use of resources, particularly if 
proper formulation of the food is verified during production. In 
contrast, verification testing is more likely in food where 
pathogens can survive in a food, particularly where pathogens may 
grow in a food.
    Another consideration in determining whether finished product 
testing is appropriate is the intended use of the food. For example, 
consumers cook many foods, e.g., dried pasta, cake mixes, and most 
frozen vegetables, thereby reducing pathogens. A facility should not 
rely on the consumer to eliminate hazards that can be prevented. 
However, there is little benefit in testing a food that is normally 
consumed following a step that can be relied on to inactivate the 
hazard. It is important to validate that the instructions provided 
to the consumer adequately reduce the pathogen of concern. It is 
also important to understand the customary use of the food, which 
may include uses that do not include the hazard reduction step. For 
example, dried soup mixes may be mixed with sour cream to make a 
dip, without the pathogen inactivation step that occurs when boiling 
the soup mix with water. If Salmonella spp. may be present in an 
ingredient for the soup mix, e.g., dried parsley or black pepper, 
and neither the supplier nor the facility treats the ingredient or 
the soup mix in a way that significantly reduces Salmonella spp., 
then finished product testing for Salmonella spp. would be 
warranted. Likewise, frozen peas and corn may be added to fresh 
salads, deli-type salads, or salsas without a pathogen inactivation 
step; finished product testing for L. monocytogenes could be 
warranted for these foods where this is a likely use.
    Another consideration in determining whether finished product 
testing is appropriate is the type of controls the supplier has 
implemented to minimize the potential for the hazard to be present, 
e.g., whether the supplier uses a kill step for a pathogen or has 
other programs in place that will adequately reduce the hazard. A 
facility generally is more likely to conduct finished product 
testing when the supplier does not have a program that can ensure 
the hazard has been adequately reduced in the ingredient supplied. 
Another consideration is the verification procedures that are in 
place at the supplier and at the receiving facility. If the supplier 
has a well-executed control program, including a supplier approval 
and verification program that has been verified through audits to 
adequately reduce the hazard, the receiving facility performs 
periodic verification testing of the ingredient provided by the 
supplier, and the supplier has a good compliance history, the 
frequency of finished product verification testing by the receiving 
facility is low, particularly if the receiving facility has a 
process that further reduces the hazard. However, if the ingredient 
is associated with a hazard and the processes used by the supplier 
and the receiving facility will not significantly minimize it, or if 
a facility is using a new supplier, the frequency of finished 
product verification testing increases.
    One of the most important considerations in determining whether 
finished product testing is appropriate is the effect of processing 
on the hazard. The frequency of finished product testing generally 
is low when a manufacturing process significantly minimize the 
hazard (e.g., a 5-log reduction of a pathogen) and procedures are in 
place to prevent recontamination after that process; the frequency 
of finished product testing increases when a manufacturing process 
does not significantly minimize the hazard (e.g., 1- or 2-log 
reduction of a pathogen). For example, testing is not common for 
bagged spinach that is irradiated to provide a 5-log reduction of 
Salmonella spp. and E. coli O157:H7; finished product verification 
testing would be more common if the only pathogen reduction step is 
washing the spinach leaves in chlorinated water. Likewise, FDA noted 
in the preamble to the juice HACCP regulation that it was not 
requiring end product verification testing for juice treated to 
achieve a 5-log reduction in a target pathogen because the post-
treatment level of microorganisms would be too low to be detected 
using reasonable sampling and analytical methods (68 FR 6138 at 
6174).
    Another important consideration in determining whether finished 
product testing is appropriate is whether a hazard can be 
reintroduced into a food that has been treated to significantly 
minimize the hazard, either through exposure to the environment or 
by the addition of an ingredient after a treatment to significantly 
minimize a hazard. For example, verification testing is not common 
if a lethal treatment for a pathogen is given to food in its final 
package (such as a marinara sauce heated in the jar or hot-filled 
into the jar) but would be more common if food exposed to the 
environment, such as a cold gazpacho filled into a container. 
Likewise, verification testing generally is more frequent for foods 
given significant handling before packaging, regardless of whether 
they have previously received a treatment that would significantly 
minimize a hazard, if they will be consumed without a treatment 
lethal for pathogens that can be introduced during handling (e.g., 
L. monocytogenes or Salmonella spp. from the environment; pathogens 
such as Staphylococcus aureus or Salmonella spp. from food 
handlers). Verification testing also

[[Page 17150]]

would be more frequent if an ingredient that has potential to be 
contaminated with a pathogen is added to a food that was previously 
treated to significantly minimize a hazard (e.g., adding seasonings 
to chips or crackers after frying or baking) than if all ingredients 
are added before the treatment.
    In assessing whether to conduct verification testing and 
determine the frequency of that testing, a facility generally 
considers the impact of all the preventive control measures applied 
in producing the food, because multiple control measures provide 
greater assurance that a hazard is being controlled. For example, 
the frequency or finished product verification testing generally 
could be lower for a food that is subject to supplier controls that 
include audits and certificates of analysis (COAs); that contains 
ingredients that have been subjected to ingredient testing; that is 
produced under well-implemented sanitation controls that are 
verified through a robust environmental monitoring program; and that 
is treated using a validated process that significantly minimizes 
the hazard than for a food that is not subject to all these 
controls. Finished product testing generally is more frequent during 
initial production cycles until there is an accumulation of 
historical data (e.g., finished product test results that are 
negative for the hazard) to confirm the adequacy of preventive 
controls. Once this history has been established, the frequency of 
testing generally is reduced to that needed to provide ongoing 
assurance that the preventive controls continue to be effective and 
to signal a possible loss of control, as discussed further 
immediately below.
    There are well-known shortcomings of product testing, especially 
microbiological testing, for process control purposes, and it is 
generally recognized that testing cannot ensure the absence of a 
hazard, particularly when the hazard is present at very low levels 
and is not uniformly distributed (Ref. 61) (Ref. 80)). Moreover, the 
number of samples used for routine testing often is statistically 
inadequate to provide confidence in the safety of an individual lot 
in the absence of additional information about adherence to 
validated control measures. This is illustrated below for Salmonella 
spp.
    FDA's Investigations Operations Manual (IOM) (Ref. 81) and 
Bacteriological Analytical Manual, BAM, (Ref. 82) provide sampling 
plans to determine the presence of Salmonella in processed foods 
intended for human consumption. The stringency of the sampling plan 
is based on the category of the food. Category III foods are those 
that would normally be subject to a process lethal to Salmonella 
spp. between the time of sampling and consumption (e.g., macaroni 
and noodle products, frozen and dried vegetables, frozen dinners, 
food chemicals). Category II foods are those that would not normally 
be subject to a process lethal to Salmonella spp. between the time 
of sampling and consumption (e.g., fluid milk products, cheeses, nut 
products, spices, chocolate, prepared salads, ready-to-eat 
sandwiches). Category I foods are Category II foods intended for 
consumption by the aged, the infirm, and infants (e.g., foods 
produced for a hospital). FDA takes 15 samples for Category III 
foods, 30 for Category II foods, and 60 for Category I foods and 
tests a 25 g subsample (analytical unit) from each sample. To reduce 
the analytical workload, the analytical units may be composited 
(Ref. 83), with the maximum size of a composite unit being 375 g (15 
analytical units). This composite is tested in its entirety for 
Salmonella spp. The probability of detecting Salmonella spp. for 
various contamination rates under the three IOM Salmonella sampling 
plans is shown in Table 1. (Probability of Detecting Salmonella.)

 Table 1--Probability of Detecting Salmonella spp. in Lots at Various Contamination Rates Under the Three Different IOM Salmonella Sampling Plans (Left)
          and the Expected Number of Positive Composite Samples Using Weekly Testing for 1 Year Under the IOM Salmonella Sampling Plans (Right)
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Probability of detecting Salmonella
                                                                                   spp. in a lot (percent)
                                                Expected  of positive composites per year
                                                                 (weekly testing)
                                                                           -----------------------------------------------------------------------------
Contamination Rate.........................  CFU/g or CFU/kg..............        N=15*        n=30*        n=60*        n=15*        n=30*        n=60*
1 in 10....................................  1/250g.......................           79           96          >99           40           81          162
1 in 30....................................  1/750g.......................           40           64           87           20           41           82
1 in 100...................................  1/2.5kg......................           14           26           45            7           15           29
1 in 300...................................  1/7.5kg......................          4.9           10           18          2.5            5           10
1 in 1000..................................  1/25kg.......................          1.5            3          5.8          0.8          1.5            3
1 in 3000..................................  1/75kg.......................          0.5            1            2          0.3          0.5            1
--------------------------------------------------------------------------------------------------------------------------------------------------------
* In the table, ``n'' is the number of subsamples (which are composited in groups of 15 for analysis).

    The probability of detecting Salmonella spp. increases as the 
defect rate increases. For example, when 15 samples are tested, the 
probability of detecting Salmonella spp. is 14 percent when the 
contamination rate is 1 in 100, but 79 percent when the 
contamination rate is 1 in 10. For a given contamination rate, the 
probability of detecting Salmonella spp. increases with the number 
of samples tested. For example, at a contamination rate of 1 in 30, 
the probability of detecting Salmonella spp. increases from 40 
percent if 15 samples are tested to 87 percent if 60 samples are 
tested.
    Table 1 shows that it is clearly not feasible to attempt to 
identify low levels of contamination in an individual lot based on 
the IOM Salmonella sampling plan. If the contamination levels are 
high and 1 in 10 products are contaminated, then Salmonella spp. 
would be detected in the lot greater than 99 percent, 96 percent, 
and 79 percent of the time using Category I, II, and III testing, 
respectively. If the frequency of contaminated units is reduced to 1 
in 300, then the contaminated lot would only be detected 18 percent, 
10 percent, and 4.9 percent of the time using Category I, II, and 
III testing, respectively. At a very low frequency of contamination 
(e.g., 1 in 1000) even with testing 60 samples the contaminated lot 
would be detected only about 6 percent of the time.
    Periodic testing for trend analysis and statistical process 
control, however, does provide information to assess whether 
processes (or the food safety system) are under control over time. 
Data collected from multiple lots of product produced over days, 
months or years are used to establish a baseline for the level of 
control that can be attained under a functioning food safety system 
and to verify the system is in control or to indicate loss of 
control. In addition to showing the probability of detecting 
contamination in a lot of product for a given contamination rate, 
Table 1 also shows the value of periodic testing when contamination 
levels are low. Even though a product with 1 in 300 contaminated 
units is unlikely to be rejected when sampling a single lot at the 
Category III sampling schedule (i.e., 4.9 percent of the time), 
testing of finished products with this level of contamination on a 
weekly basis would be expected to find 2.5 positive composite 
samples per year. Similarly, if the background contamination rate is 
thought to be near 1 in 1000 but periodic testing using the Category 
III schedule has found 3 positives in the last year, then it seems 
clear that the actual frequency of contaminated units is closer to 1 
in 300. Periodic testing according to the Category I Salmonella plan 
has the potential to detect situations where the contamination rates 
are as low as 1 in 1000. If 60 samples of a food are collected 
weekly, then 3,120 samples would be collected over the course of a 
year. Compositing these 3,120 samples into 375g analytical units 
would reduce the number of analytical tests to 208 (4 tests per 
week). If 30 samples are collected weekly, and composited, there 
would be 104 tests annually, or two each week. At the 1 in 1000 
contamination rate there would be a greater than 95 percent 
confidence in seeing one or more positive tests during the year for 
testing composites from either 60 or 30 samples weekly. At higher 
rates of contamination, more positives would be detected.

[[Page 17151]]

    There can be significant benefits to a facility testing finished 
products over time for process control. First, if a lot of product 
tests positive for a hazard, that lot of product can be disposed of 
such that the consumer is not exposed to the hazard (i.e., the 
product can be destroyed, reprocessed, or diverted to another use, 
as appropriate). If the testing involves enumeration of an indicator 
organism, it may even be possible to detect a trend toward loss of 
control before exceeding the criterion that separates acceptable 
from unacceptable. The process can be adjusted before there is a 
need to dispose of product. Second, the detection of loss of 
control, or potential loss of control, e.g., an unusual number of 
positives in a given period of time, allows a facility to evaluate 
and modify its processes, procedures, and food safety plan as 
appropriate to prevent loss of control in the future. In fact, the 
nature of the trends can provide information useful in determining 
the root cause of the problem (Ref. 61). A third benefit to ongoing 
verification testing is the accumulation of data that can help 
bracket any problem that occurs. For products in which there are 
large production runs without intervening sanitation cycles, this 
may provide data that can be used in conjunction with other 
information to limit the scope of a recall. A fourth benefit may be 
in detection of a problem associated with an ingredient supplier 
that results in changes to a supplier's processes, procedures, or 
food safety plan. For example, a positive in finished product due to 
routine verification testing was responsible for determining that 
hydrolyzed vegetable protein was contaminated with Salmonella spp., 
resulting in over 177 products being recalled (Ref. 84) and a 
recognition of the need for enhanced preventive controls for the 
production of this ingredient (Ref. 27). Industry commonly uses 
finished product testing to verify preventive controls used by the 
facility and by the facility's suppliers. Additionally, it is common 
for customers to require suppliers to conduct testing of products 
and ingredients being provided.

G. Metrics for Microbiological Risk Management

    Recently there has been much attention paid to microbiological 
risk management metrics for verifying that food safety systems 
achieve a specified level of public health control, e.g., the 
Appropriate Level of Protection (ALOP), for microbial hazards. 
Microbiological risk management metrics are fully discussed in Annex 
II of the Codex ``Principles and Guidelines for the Conduct of 
Microbiological Risk Management (MRM)'' (Ref. 85). These metrics 
include traditional metrics such as microbiological criteria, 
process criteria, and product criteria and emerging metrics such as 
food safety objectives (FSO), performance objectives and performance 
criteria. Of particular relevance are performance objectives and 
performance criteria. A performance objective is the maximum 
frequency and/or concentration of a microbiological hazard in a food 
at a specified step in the food chain before the time of consumption 
that provides or contributes to an FSO or ALOP, as applicable (Ref. 
86). A performance criterion is the effect in frequency and/or 
concentration of a hazard in a food that must be achieved by the 
application of one or more control measures to provide or contribute 
to a performance objective or an FSO (Ref. 86). FDA established a 
performance criterion (or performance standard) when we required 
that processors of juice products apply a control measure that will 
consistently produce, at a minimum, a 5-log reduction for the most 
resistant microorganism of public health significance (Sec.  
120.24). Section 104 of FSMA (Performance Standards) requires the 
Secretary to determine the most significant foodborne contaminants 
and issue contaminant-specific and science-based guidance documents, 
including guidance documents regarding action levels, or regulations 
for products or product classes. The proposed rule that is the 
subject of this document would not establish criteria or metrics for 
verifying that preventive controls in food safety plans achieve a 
specified level of public health control in this proposed rule. 
However, FDA will give consideration to appropriate microbiological 
risk management metrics in the future.

II. The Role of Supplier Approval and Verification Programs in a Food 
Safety System

    A food can become contaminated through the use of contaminated 
raw materials or ingredients. In the past several years, thousands 
of food products have been recalled as a result of contamination of 
raw materials or ingredients with pathogens such as Salmonella spp. 
and E. coli O157:H7. The ingredients included peanut-derived 
ingredients (Ref. 26) (Ref. 35), pistachio-derived ingredients (Ref. 
87), instant nonfat dried milk, whey protein, fruit stabilizers 
(Ref. 88) (Ref. 89) (Ref. 33) and hydrolyzed vegetable protein (Ref. 
90).
    The incident involving Salmonella spp. in hydrolyzed vegetable 
protein illustrates the impact one supplier can have on the food 
industry (Ref. 13). A receiving facility (manufacturer) detected 
Salmonella spp. in verification testing of finished product. In 
determining the source of the contamination, the manufacturer 
detected Salmonella spp. in samples of a hydrolyzed vegetable 
protein ingredient and reported the finding through FDA's RFR. After 
FDA determined that the ingredient was a reportable food, FDA 
requested that the supplier notify the immediate subsequent 
recipients of the reported hydrolyzed vegetable protein ingredient. 
Over one thousand reportable food reports were submitted to FDA from 
numerous companies concerning the potentially contaminated 
hydrolyzed vegetable protein or products made with the hydrolyzed 
vegetable protein. The hydrolyzed vegetable protein recall involved 
at least eleven different commodity categories and 177 products, 
showing the magnitude of this contamination event originating from 
one supplier (Ref. 13).
    FDA recently reviewed CGMP-related food recall information from 
2008-2009 to assess potential root causes for the contamination 
events. We determined that 36.9 percent of the 960 Class I and Class 
II recalls were directly linked to lack of supplier controls (Ref. 
91). The recent large recalls of foods containing contaminated or 
potentially contaminated ingredients have focused attention on 
supplier approval and verification programs intended to help a 
manufacturer/processor prevent the introduction of a contaminated 
raw material or other ingredient into another product (Ref. 35) 
(Ref. 84) (Ref. 89). The application of preventive approaches by the 
entire supply chain (including ingredient vendors, brokers and other 
suppliers and, ultimately, the manufacturer of a food product) is 
recognized as essential to effective food safety management (Ref. 
92).
    The development of a supplier approval and verification program 
is part of a preventive approach. Because many facilities acting as 
suppliers procure their raw materials and ingredients from other 
suppliers, there is often a chain of suppliers before a raw material 
or other ingredient reaches the manufacturer/processor. To ensure 
safe food and minimize the potential for contaminated food to reach 
the consumer, each supplier in the chain must implement preventive 
controls appropriate to the food and operation for hazards 
reasonably likely to occur in the raw material or other ingredient. 
A facility receiving raw materials or ingredients from a supplier 
must ensure that the supplier (or a supplier to the supplier) has 
implemented preventive controls to significantly minimize or prevent 
hazards that the receiving facility has identified as reasonably 
likely to occur in that raw material or other ingredient unless the 
receiving facility will itself control the identified hazard.
    A supplier approval and verification program is a means of 
ensuring that raw materials and ingredients are procured from those 
suppliers that can meet company specifications and have appropriate 
programs in place, including those related to the safety of the raw 
materials and ingredients. A supplier approval program can ensure a 
methodical approach to identifying such suppliers. A supplier 
verification program provides initial and ongoing assurance that 
suppliers are complying with practices to achieve adequate control 
of hazards in raw materials or ingredients.
    Supplier approval and verification is widely accepted in the 
domestic and international food safety community. The NACMCF HACCP 
guidelines describe Supplier Control as one of the common 
prerequisite programs for the safe production of food products and 
recommend that each facility should ensure that its suppliers have 
in place effective GMP and food safety programs (Ref. 1). The 
American Spice Trade Association advocates that spice manufacturers 
establish robust supplier prerequisite programs to evaluate and 
approve suppliers (Ref. 93). The Grocery Manufacturers Association's 
(GMA's) Food Supply Chain Handbook, developed for ingredient 
suppliers to the food industry, recommends that all suppliers in the 
food chain consider approval programs for their own suppliers; such 
supplier approval programs consist of a collection of appropriate 
programs, specifications,

[[Page 17152]]

policies, and procedures (Ref. 92). GMA recommends a number of 
verification activities that suppliers can take in its Food Supply 
Chain Handbook, including self-auditing, third-party auditing and 
product testing. GMA's handbook also references verification 
activities that a supplier's customers might take, including second-
party audits (done by an employee of the customer) or third-party 
(independent) audits (conducted by persons who do not work for 
either the supplier or the customer). Codex specifies that no raw 
material or ingredient should be accepted by an establishment if it 
is known to contain parasites, undesirable microorganisms, 
pesticides, veterinary drugs or toxic, decomposed or extraneous 
substances which would not be reduced to an acceptable level by 
normal sorting and/or processing (Ref. 94). Codex also specifies 
that, where appropriate, specifications for raw materials should be 
identified and applied and that, where necessary, laboratory tests 
should be made to establish fitness for use (Ref. 94).
    Supplier verification activities include auditing a supplier to 
ensure the supplier is complying with applicable food safety 
requirements, such as CGMP requirements of current part 110. Audit 
activities may include a range of activities, such as on-site 
examinations of establishments, review of records, review of quality 
assurance systems, and examination or laboratory testing of product 
samples (Ref. 95). Other supplier verification activities include 
conducting testing or requiring supplier COAs, review of food safety 
plans and records, or combinations of activities such as audits and 
periodic testing.
    An increasing number of establishments that sell foods to the 
public, such as retailers and food service providers, are 
independently requiring, as a condition of doing business, that 
their suppliers, both foreign and domestic, become certified as 
meeting safety (as well as other) standards. In addition, domestic 
and foreign suppliers (such as producers, co-manufacturers, or re-
packers) are increasingly looking to third-party certification 
programs to assist them in meeting U.S. regulatory requirements 
(Ref. 95). There are many established third-party certification 
programs designed for various reasons that are currently being used 
by industry. Many third party audit schemes used to assess the 
industry's food safety management systems incorporate requirements 
for manufacturers and processors to establish supplier approval 
programs.
    The GFSI was established in 2000 to drive continuous improvement 
in food safety management systems to ensure confidence in the 
delivery of safe food to consumers worldwide. Their objectives 
include reducing risk by delivering equivalence and convergence 
between effective food safety management systems and managing cost 
in the global food system by eliminating redundancy and improving 
operational efficiency (Ref. 96). GFSI has developed a guidance 
document as a tool that fulfills the GFSI objectives of determining 
equivalency between food safety management systems (Ref. 96). The 
document is not a food safety standard, but rather specifies a 
process by which food safety schemes may gain recognition, the 
requirements to be put in place for a food safety scheme seeking 
recognition by GFSI, and the key elements for production of safe 
food or feed, or for service provision (e.g., contract sanitation 
services or food transportation) in relation to food safety (Ref. 
96). This benchmark document has provisions relevant to supplier 
approval and verification programs. For example, it specifies that a 
food safety standard must require that the organization control 
purchasing processes to ensure that all externally sourced materials 
and services that have an effect on food safety conform to 
requirements. It also specifies that a food safety standard must 
require that the organization establish, implement, and maintain 
procedures for the evaluation, approval and continued monitoring of 
suppliers that have an effect on food safety. Thus, all current 
GFSI-recognized schemes require supplier controls to ensure that the 
raw materials and ingredients that have an impact on food safety 
conform to specified requirements. The GFSI guidance document also 
requires audit scheme owners to have a clearly defined and 
documented audit frequency program, which must ensure a minimum 
audit frequency of one audit per year of an organization's facility 
(Ref. 96).
    Because GFSI is a document that outlines elements of a food 
safety management system for benchmarking a variety of standards, it 
does not have details about how facilities should comply with the 
elements. This type of information is found in the food safety 
schemes that are the basis for certification programs. For example, 
the Safe Quality Food (SQF) 2000 Code, a HACCP-based supplier 
assurance code for the food industry, specifies that raw materials 
and services that impact on finished product safety be supplied by 
an Approved Supplier. SQF 2000 specifies that the responsibility and 
methods for selecting, evaluating, approving and monitoring an 
Approved Supplier be documented and implemented, and that a register 
of Approved Suppliers and records of inspections and audits of 
Approved Suppliers be maintained. SQF 2000 requires that the 
Approved Supplier Program contain, among other items, agreed 
specifications; methods for granting Approved Supplier status; 
methods and frequency of monitoring Approved Suppliers; and details 
of certificates of analysis if required.
    According to SQF, the monitoring of Approved Suppliers is to be 
based on the prior good performance of a supplier and the risk level 
of the raw materials supplied. The monitoring and assessment of 
Approved Suppliers can include:
     The inspection of raw materials received;
     The provision of certificates of analysis;
     Third party certification of an Approved Supplier; or
     The completion of 2nd party supplier audits.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
1. National Advisory Committee on Microbiological Criteria for 
Foods, ``Hazard Analysis and Critical Control Point Principles and 
Application Guidelines,'' Journal of Food Protection, 61:1246-1259, 
1998.
2. Codex Alimentarius Commission, ``Principles for the Establishment 
and Application of Microbiological Criteria for Foods, CAC/GL 21--
1997,'' 1997.
3. International Commission on Microbiological Specifications for 
Foods, ``Microbiological Hazards and Their Control,'' In: 
Microorganisms in Foods 7. Microbiological Testing in Food Safety 
Management, edited by R. B. Tompkin, L. Gram, T. A. Roberts, R. L. 
Buchanan, M. van Schothorst, S. Dahms, and M. B. Cole, New York, 
Chapter 1, pp. 1-21, Kluwer Academic/Plenum Publishers, 2002.
4. International Commission on Microbiological Specifications for 
Foods, ``Selection and Use of Acceptance Criteria,'' In: 
Microorganisms in Foods 7. Microbiological Testing in Food Safety 
Management, edited by R. B. Tompkin, L. Gram, T. A. Roberts, R. L. 
Buchanan, M. van Schothorst, S. Dahms, and M. B. Cole, New York, 
Chapter 4, pp. 79-97, Kluwer Academic/Plenum Publishers, 2002.
5. FDA, ``Guidance for Industry: Measures to Address the Risk for 
Contamination by Salmonella Species in Food Containing a Peanut-
Derived Product as an Ingredient,'' 2009.
6. FDA, ``Guidance for Industry: Measures to Address the Risk for 
Contamination by Salmonella Species in Food Containing a Pistachio-
Derived Product as an Ingredient,'' 2011.
7. CDC, ``General Information. Escherichia coli (E. coli),'' (http://www.cdc.gov/ecoli/general/index.html), July 17, 2012. Accessed and 
printed on July 27, 2012.
8. Scott, V. N., C. Yuhuan, T. A. Freier, J. Kuehm, M. Moorman, J. 
Meyer, T. Morille-Hinds, L. Post, L. Smoot, S. Hood, J. Shebuski, 
and J. Banks, ``Control of Salmonella in Low-Moisture Foods I: 
Minimizing Entry of Salmonella into a Processing Facility,'' Food 
Protection Trends, 29:342-353, 2009.
9. Chen, Y., V. N. Scott, T. A. Freier, J. Kuehm, M. Moorman, J. 
Meyer, T. Morille-Hinds, L. Post, L. Smoot, S. Hood, J. Shebuski, 
and J. Banks, ``Control of Salmonella in Low-Moisture Foods II: 
Hygiene Practices to Minimize Salmonella Contamination and Growth,'' 
Food Protection Trends, 29:435-445, 2009.
10. California Department of Public Health, ``Union International 
Food Company Recall Widened Again,'' (http://www.cdph.ca.gov/Pages/NR2009-23.aspx), April 4, 2009. Accessed and printed on September 6, 
2011.
11. Gabis, D. A., R. S. Flowers, D. Evanson, and R. E. Faust, ``A 
Survey of 18 Dry

[[Page 17153]]

Product Processing Plant Environments for Salmonella, Listeria and 
Yersinia,'' Journal of Food Protection, 52:122-124, 1989.
12. Vij, V., E. Ailes, C. Wolyniak, F. J. Angulo, and K. C. Klontz, 
``Recalls of Spices Due to Bacterial Contamination Monitored by the 
U.S. Food and Drug Administration: The Predominance of 
Salmonellae,'' Journal of Food Protection, 69:233-237, 2006.
13. FDA, ``FDA Foods Program, The Reportable Food Registry: A New 
Approach to Targeting Inspection Resources and Identifying Patterns 
of Adulteration. First Annual Report: September 8, 2009-September 7, 
2010,'' (http://www.fda.gov/downloads/Food/FoodSafety/FoodSafetyPrograms/RFR/UCM240647.pdf), January, 2011. Accessed and 
printed on August 29, 2011.
14. FDA and USDA, ``Listeria monocytogenes Risk Assessment: VII. 
Interpretation and Conclusions,'' (http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/ucm185289.htm), September, 2003. Accessed and printed on October 17, 
2011.
15. Food and Agriculture Organization and World Health Organization, 
``Risk Assessment of Listeria monocytogenes in Ready-to-Eat Foods, 
Technical Report,'' 2004.
16. International Commission on Microbiological Specifications for 
Foods, ``Sampling to Assess Control of the Environment,'' In: 
Microorganisms in Foods 7. Microbiological Testing in Food Safety 
Management, edited by R. B. Tompkin, L. Gram, T. A. Roberts, R. L. 
Buchanan, M. van Schothorst, S. Dahms, and M. B. Cole, New York, 
Chapter 11, pp. 199-224, Kluwer Academic/Plenum Publishers, 2002.
17. Tompkin, R. B., V. N. Scott, D. T. Bernard, W. H. Sveum, and K. 
Sullivan Gombas, ``Guidelines to Prevent Post-Processing 
Contamination from Listeria monocytogenes,'' Dairy, Food and 
Environmental Sanitation, 19:551-562, 1999.
18. Tompkin, R. B., ``Control of Listeria monocytogenes in the Food-
Processing Environment,'' Journal of Food Protection, 65:709-725, 
2002.
19. Carpentier, B., and O. Cerf, ``Review: Persistence of Listeria 
monocytogenes in Food Industry Equipment and Premises,'' 
International Journal of Food Microbiology, 145:1-8, 2011.
20. Breuer, T., ``CDC Investigations: The May 1998 Outbreak of 
Salmonella Agona Linked to Cereal,'' Cereal Foods World, 44:185-186, 
1999.
21. CDC, ``EPI-AID 98-60 Trip-Report: Multistate Outbreak of 
Salmonella Agona Infection Linked to Consumption of Oat Cereal, 
April-June 1997,'' 1999.
22. CDC, ``Foodborne Outbreak Online Database (FOOD). Search Results 
Highlighted for 1998 Salmonella Agona Outbreak in Dry Cereal,'' 
2011. Accessed and printed on October 21, 2011.
23. CDC, ``Investigation of Outbreak of Infections Caused by 
Salmonella Agona,'' (http://www.cdc.gov/salmonella/agona/), May 13, 
2008. Accessed and printed on September 9, 2011.
24. CDC, ``Foodborne Outbreak Online Database (FOOD). Search Results 
Highlighted for 2006-2007 Salmonella Tennessee Outbreak in Peanut 
Butter,'' 2011. Accessed and printed on October 18, 2011.
25. CDC, ``Multistate Outbreak of Salmonella Serotype Tennessee 
Infections Associated with Peanut Butter--United States, 2006-
2007,'' MMWR, 56:521-524, 2007.
26. FDA, ``Peanut Products Recall,'' (http://www.fda.gov/Safety/Recalls/MajorProductRecalls/Peanut/default.htm), June 18, 2009. 
Accessed and printed on September 9, 2011.
27. FDA, ``Hydrolyzed Vegetable Protein Product Recalls,'' (http://www.fda.gov/Safety/Recalls/MajorProductRecalls/HVP/default.htm), 
December 21, 2011. Accessed and printed on July 27, 2012.
28. CDC, ``Multistate Outbreak of Salmonella Infections Associated 
with Peanut Butter and Peanut Butter-Containing Products--United 
States, 2008-2009,'' MMWR, 58:85-90, 2009.
29. Cavallaro, E., K. Date, C. Medus, S. Meyer, B. Miller, C. Kim, 
S. Nowicki, S. Cosgrove, D. Sweat, P. Quyen, J. Flint, E. R. Daly, 
J. Adams, E. Hyytia-Trees, P. Gerner-Smidt, R. M. Hoekstra, C. 
Schwensohn, A. Langer, S. V. Sodha, M. C. Rogers, F. J. Angulo, R. 
V. Tauxe, I. T. Williams, and C. Barton Behravesh, ``Salmonella 
Typhimurium Infections Associated with Peanut Products,'' New 
England Journal of Medicine, 365:601-610, 2011.
30. FDA, ``Amended Form 483 (Inspectional Observations) for Peanut 
Corporation of America, Blakely, GA, 02/05/2009,'' (http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM109834.pdf), February 5, 2009. Accessed 
and printed on October 19, 2011.
31. FDA, ``Form 483 (Inspectional Observations) for Peanut 
Corporation of America, Plainview, TX, 02/26/2009,'' (http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM114852.pdf), February 26, 2009. Accessed 
and printed on October 17, 2011.
32. CDC, ``Foodborne Outbreak Online Database (FOOD). Search Results 
Highlighted for 2008 Salmonella Typhimurium Outbreak in Peanut 
Butter and Peanut Paste,'' 2011. Accessed and printed on November 
23, 2011.
33. FDA, ``Company Recalls Various Products Due to Potential 
Salmonella Contamination. FDA, USDA, CDC Investigating; No Link to 
Human Illnesses at This Time,'' (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169471.htm), June 28, 2009. Accessed 
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October 17, 2011.

    Dated: March 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.

[FR Doc. 2013-06356 Filed 3-19-13; 8:45 am]
BILLING CODE 4160-01-P