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OCR for page 152
8
Current Status of Microbiological
Criteria and Legislative Bases
INTRODUCTION
Early Programs in the United States
Some of the initial intensive efforts directed at the control of bacteria
in processing and storage were focused on fluid milk and other dairy
products because of the role these foods played in foodborne disease
transmission. The milk sanitation program is one of the oldest in the Public
Health Service; the initial ordinance was developed in 1924 as a model
regulation for voluntary adoption by state and local milk control agencies
(USPHS, 1924~. An accompanying code provided administrative and tech-
nical details on satisfactory compliance (USPHS, 19271. Microbiological
criteria were included in these original regulations.
Periodic revisions followed as improvements in technology for the pro-
duction and transport of raw milk and for the processing, packaging, and
storage of pasteurized milk products occurred. Each of the revisions was
developed with the assistance of milk sanitation and regulatory agencies
at the federal, state, and local levels and with other segments of the dairy
industry. These early efforts led to the current programs. The Grade A
Pasteurized Milk Ordinance, 1978 Recommendations, of the U.S. Public
Health Service, Food and Drug Administration (USPHS/FDA, 1978), the
most recent revision, was produced with substantial assistance from the
National Conference on Interstate Milk Shippers (NCIMS) and was im-
plemented in 1980. The chemical, bacteriological, and temperature stan-
dards in this revision are presented in Table 8-1.
Recognition of the public health problems associated with shellfish in
the United States in the early 1900s resulted in the establishment of a
152
OCR for page 153
CURRENT STATUS AND LEGISLATIVE BASES
TABLE 8-l Chemical, Bacteriological, and Temperature Standards for
Grade A Milk and Milk Products
Grade A raw milk for pasteurization (ultrapasteurization or aseptic processing):
Temperature Cooled to 45°F (7°C) or less within two hours after
milking: Provided that the blend temperature after the
first and subsequent milkings does not exceed 50°F
(10°C).
153
Bacterial limits - Individual producer milk not to exceed 100,000 per ml
prior to comingling with other producer milk.
Not to exceed 300,000 per ml as comingled milk prior to
pasteurization.
Antibiotics No zone equal to or greater than 16 mm with the Bacillus
stearothermophilus disc assay method specified by
NCIMS.
Somatic cell count Individual producer milk: Not to exceed 1,500,000 per
ml.
Grade A pasteurized milk and milk products:
Temperature Cooled to 45°F (7°C) or less and maintained thereat.
Bacterial limits* 20,000 per ml.
Coliform Not to exceed 10 per ml: Provided that, in the case of
bulk milk transport tank shipments, shall not exceed 100
per ml.
Less than 1 leg per ml by the Scharer Rapid Method or
equivalent.
No zone equal to or greater than 16 mm with the Bacillus
stearothermophilus disc assay method specified by
NCIMS.
Grade A aseptically processed milk and milk products:
Temperature None
Bacterial limits No growth by test specified in Section 6.
Antibiotics No zone equal to or greater than 16 mm with the Bacillus
stearothermophilus disc assay method specified by
NCIMS.
Phosphatase
Antibiotics
*Not applicable to cultured products.
SOURCES: USPHS/FDA, 1978; FDA, 1983e (1979 NCIMS, Aseptic Processing, and 1981
Antibiotic Testing NCIMS Changes).
National Shellfish Sanitation Program (NSSP) (USPHS, 19251. The Public
Health Service, the states, and the shellfish industry each accepted re-
sponsibilities for certain aspects of the program. The National Shellfish
Sanitation Program, Manual of Operations, was last revised in 1965 (US-
DHEW, 19651.
Current Levels of Concern and Application
Microbiologial criteria are applicable at the international, federal, state
(both health and agriculture departments), and local (city-county) levels,
OCR for page 154
154 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
as well as by the food industry. The types of criteria at each of these
levels are influenced by the mission and responsibilities of the agency or
organization involved.
INTERNATIONAL ACTIVITIES
Joint FAD/WHO Food Standards Program
Microbiological criteria for foods at the international level are applied
primarily within the Joint FAD/WHO Food Standards Program as imple-
mented by the Codex Alimentarius Commission (Olson, 19781. The his-
tory of international food standards is relatively short. In 1958 the governing
bodies of the Food and Agriculture Organization (FAO) and the World
Health Organization (WHO) established a joint food standards program
having the following purposes:
protect the health of the consumers and ensure fair practices in the
food trade;
2. promote coordination of all food standards work undertaken by in-
ternational, governmental, and nongovernmental organizations;
3. determine priorities and initiate and guide the preparation of drafts
of standards through and with the aid of appropriate organizations;
4. finalize standards elaborated under (3) above and, after acceptance
by governments, publish them in a Codex Alimentarius as either regional
or worldwide standards, together with international standards already fi-
nalized by other bodies under (2) above, wherever this is practicable;
5. amend published standards, after appropriate survey in the light of
developments.
The Codex Alimentarius Commission was created to implement the
program through which international food standards for processed, semi-
processed, and raw foods are established. Membership in the commission
is voluntary and is made up of member and associate member nations of
FAO and WHO. At present, 121 nations are members (Kimbrell, 19821.
Each member government is free to adopt each standard at any one of
four levels of participation:
1. full acceptance of the standard and foods affected;
2. acceptance with specified deviations from the standard and fondest
affected;
The term standard(s) as used by Codex has a different meaning than that defined in this
report. The Codex meaning relates to requirements or provisions set forth in various documents
and codes quite apart from microbiological criteria.
OCR for page 155
CURRENT STATUS AND LEGISLATIVE BASES
155
3. target acceptance of food products in anticipation of later approval
of Codex Standard;
4. nonacceptance with free distribution of fondest conforming to Codex
Standard.
The specific objectives of the Codex program are:
1. to develop international food standards on a worldwide or regional
basis;
2. to publish these standards in a food code (Codex Alimentarius);
3. to record acceptance and implementation of these standards by gov-
ernments.
To date, 148 international standards have been adopted and 19 more
are under development (Kimbrell, 19821. These Codex standards are very
similar to standards of identity; microbiological criteria have seldom been
included as part of a standard. They contain qualitative statements about
hygiene and end-product specifications. Codex standards are intended to
be mandatory and thus require government approval. The United States
has completed action on 41 of the 148 standards; 14 more are in the rule-
making process.
Other recommendations and provisions, including the codes of practice,
are advisory in nature and do not require government approval. Subsidiary
bodies (committees and expert groups) of the commission develop the
standards and codes. Some committees deal with general subjects such as
hygiene, analysis, or sampling applicable to all foods. Others, including
the commodity committees, deal with specific foods.
The Codex Committee on Food Hygiene has the major responsibility
for all provisions of food hygiene related to standards or codes of practices
including microbiological criteria. In recent years, activities to establish
microbiological criteria for foods in international trade that may present
microbiological hazards have increased.
The First Joint PAD/WHO Expert Consultation on Microbiological Cri-
teria for Foods (FAD/WHO, 1975) gave high priority to criteria for egg
products, dried milks, precooked frozen seafoods, and frozen meat. A
specific recommendation for establishment of microbiological specifica-
tions for egg products was forwarded to the Codex Committee on Food
Hygiene. Specifications were quickly adopted; they became the first mi-
crobiological criteria for a food or food commodity group to be included
in a Code of Hygienic Practice.
A second Joint FAD/WHO Expert Consultation (FAD/WHO, 1977)
recommended that the Committee on Food Hygiene consider development
of microbiological criteria for precooked shrimps and prawns, foods for
OCR for page 156
156 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRlTERlA
Infants and children, and ice mixes and edible ices. The consultation
recommended that high priority be given to consideration of criteria for
dried milk, cheese, precooked frozen crabmeat, desiccated coconut, and
precooked frozen lobster. It assigned a lesser, yet strong, priority to con-
sideration of criteria for cooked meat and poultry, fish and fishery prod-
ucts, dried soups and broths, dried fruits, enzymes, gelatin, protein
concentrates, and low-acid salad dressing. This second expert consultation
developed the statement on "General Principles for the Establishment and
Application of Microbiological Criteria for Foods" for inclusion in the
Codex Procedural Manual (see Appendix B).
As of 1978 a Code of Practice on General Principles of Food Hygiene
onH 19 (~1PC of Mv~ri~.ni~ Practice for specific food commodities had
been completed or were in the process of being developed (Olson, 19781;
by 1982, 21 codes of hygienic or technological practice had been devel-
oped (Kimbrell, 19821. These codes apply to foods in the following com-
modity groups: canned fruit and vegetable products, dried fruits, desiccated
coconut, dehydrated fruits and vegetables including edible fungi, tree nuts,
processed poultry, egg products, molluscan shellfish, low-acid and acid-
ified low-acid canned foods, foods for infants and children, peanuts, frog
legs, dried mail, natural mineral waters, and salvaging of canned foods.
Microbiological criteria are included in the codes of hygienic practice for
egg products, food for infants and children, dried milk, and natural mineral
waters. Other international microbiological specifications are listed in
Appendix C.
~ 1 1 ~ 1 ~ _ ~ ~ _ V ~ ^ ~ ~ d O ~ I_
European Economic Community
The interests of the European Economic Community (EEC) in micro-
biological criteria are based on the creation of a single common market
for foods and feeds. The Common Market's attempts to eliminate technical
barriers to trade include the consideration of the application of micro-
biological criteria to foods and feeds in order to protect the health of the
consumer. A proposal based on the Codex Alimentarius General Principles
for the Establishment and Application of Microbiological Criteria for Foods
was developed by the Commission of the European Communities and
submitted to the European Council of Ministers in September 1981 (B.
Simonsen, Danish Ministry of Agriculture, 1982. Personal communica-
tion). A revised proposal was approved by the European Parliament in
April 1982.
The EEC is a circumscribed version of Codex; it has fewer members,
covers a much smaller geographic area, and encompasses less diverse
cultures. Both groups depend on voluntary membership, but as the rulings
OCR for page 157
CURRENT STATUS AND LEGISLATIVE BASES
157
of the EEC are binding, the compliance may ultimately be more stringent
with EEC criteria than with Codex criteria.
International Commission on Microbiological
Specifications for Foods (ICMSF)
The ICMSF (Clark, 1978) is a voluntary advisory body which was
formed to:
1. assemble and evaluate evidence about the microbiologial quality of
foods;
2. consider whether criteria are necessary for any particular food;
3. propose suitable criteria where necessary;
4. suggest appropriate methods of examination.
Functionally, the commission seeks to:
1. provide the bases for comparable standards for microbiological judg-
ment of foods between countries;
2. foster safe movement of foods in international commerce;
3. overcome difficulties caused by differing microbiological standards
and methods of analysis.
The ICMSF activities focus on microbiological methods for examination
of food, comparative studies on suitability of media, sampling plans and
acceptance criteria, interpretation of microbiological data, and control of
food operations to assure safety and quality. Cooperative work on methods
has been carried out with the International Dairy Federation, the Inter-
national Standards Organization, and the Association of Official Analytical
Chemists.
Classic work on sampling plans as related to foods has been published
in the commission's book, Microorganisms in Foods 2, first published in
1974 and now in revision (ICMSF, 1974, 1985; see also Chapter 61.
Canadian Microbiological Standards for Foods
The Canadian regulations (Pivnick, 1978) apply to microbiological cri-
teria at a national level where the production and processing conditions
closely resemble those in the United States. The microbiological quality
of food in Canada is governed by federal, provincial, and municipal
jurisdictions. Provincial and municipal regulations may be more stringent
than federal regulations. The Food and Drugs Act and Regulations cover
all food sold in Canada regardless of place of production. The Canadian
.
OCR for page 158
158 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
Food and Drugs Act is similar to the U.S. Federal Food, Drug and Cos-
metic Act. Sections 4, 5 and 7 are pertinent:
(4) No person shall sell an article of food that
(a) has in or upon it any poisonous or harmful substance;
(b) is unfit for human consumption;
(c) consists in whole or in part of any filthy, putrid, disgusting,
rotten, decomposed or diseased animal or vegetable substance;
(d) is adulterated; or
(e) was manufactured, prepared, preserved, packaged or stored
under unsanitary conditions.
(5) No person shall label, package, treat, process, sell or advertise any
food in a manner that is false, misleading or deceptive or is likely to create
an erroneous impression regarding its character, value, quantity, com-
position, merit or safety.
(7) No person shall manufacture, prepare, preserve, package or store
for sale any food under unsanitary conditions.
To avoid the possibility of misinterpretation, numerous standards that
include microbial limits have been established under the act.
However, differences do exist between the acts of the two nations.
Whereas in the United States microbiological standards are usually estab-
lished by a proposal, response, and hearing process, the Canadian law
allows direct establishment of standards, with any product in violation of
the standards being automatically illegal. The microbiological standards
currently incorporated as regulations pursuant to the Canadian Food and
Drugs Act are summarized in Appendix D. Sampling plans associated
with each food or food commodity are included.
U.S. FEDERAL AGENCIES
Food and Drug Administration (FDA)
The basic mission of FDA is to protect the health and welfare of the
consumer. The principal responsibility relative to foods is to ensure that
they are safe and wholesome and are honestly and informatively labeled.
The legislative basis for the legal authority to act is the Federal Food,
Drug and Cosmetic Act, as Amended January 1980 (U. S. Congress, 19801.
Various sections of the act are applicable: Section 301, Prohibited Acts;
Section 401, Standards; Section 402, Adulteration; Section 403, Mis-
branding; and Section 801, Imports and Exports.
Specific objectives of the act related to food include provisions to:
OCR for page 159
CURRENT STATUS AND LEGISLATIVE BASES
159
1. prohibit adulteration of food Section 301 (b);
2. prevent food from containing any filthy, putrid, or decomposed
substances Section 402 (a) (31;
3. prohibit preparation, packing, or storage under unsanitary conditions
whereby it may become contaminated or be rendered injurious to health-
Section 402 (a) (41;
4. prohibit misbranding of foods- Section 301 (b);
5. set reasonable definitions and standards of identity and reasonable
standards of quality to promote honesty and fair dealing in the interests
of consumers Section 401;
6. prohibit the importation of any adulterated or mishandled food-
Section 801 (a).
The operational program of FDA may specify microbiological criteria.
In addition to the presence of foodborne pathogens and/or their toxins,
these criteria may include indicator organisms that reflect contamination
at harvest, poor manufacturing practices, and/or inadequate storage con-
ditions. (For a discussion of criteria for foodborne pathogens, see Chapter 1,
page 52, note 3.)
Compliance Policy Guides
Compliance Policy Guides (FDA, 1982a), where established, describe
FDA's official policy on compliance matters and set forth specific criteria
that must be met before the agency initiates legal actions. FDA has es-
tablished microbiological criteria for certain foods susceptible to micro-
biological contamination. These criteria may be used as the bases for legal
actions. Compliance Policy Guides containing microbiological criteria
applicable to foods and feeds are listed in Table 8-2. Contaminants covered
by these guides include foodborne pathogens, bacterial toxins, mycotox-
ins, and bacterial indicators such as aerobic plate counts (APC), Esche-
richia colt, coliform, and coagulase-positive staphylococci.
The testing of imported shrimp and frog legs for the presence of sal-
monellae and the development of block lists involving compulsory testing
for such commodities after finding repeated violations are carried out under
the authority of Section 801 of the act.
Food Defect Action Levels
Criteria used in food ingredient and finished food product evaluations
are identified in the Food Defect Action Levels first published in 1972
by the FDA (see FDA, 1982b). These levels for natural or unavoidable
OCR for page 160
160
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OCR for page 174
174 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
at the processing level. Its publication in the Federal Register, however,
has been indefinitely postponed.
National Marine Fisheries Service (NMFS)
The U.S. Department of Commerce-National Marine Fisheries Service
(USDC-NMFS) fishery products inspection program is a voluntary, fee-
for-service program involving inspection and grading of fisheries products.
A principal objective is to provide certification that fisheries products have
passed federal inspection, which in this case consists mainly of physical
examination of facilities and organoleptic evaluation of products.
A recent update has been provided on the USDC-NMFS involvement
with microbiological criteria (E. S. Garrett, USDC-NMFS. 1983. Personal
communication). The NTMFS does not establish microbiological criteria
for foods, but rather examines fishery products or causes them to be
examined for conformance with the microbiological criteria of other or-
ganizations including the Food and Drug Administration, the Department
of Defense, private manufacturing firms, and/or institutional purchasers
of seafoods. The USDC-NMFS inspection program recognizes and de-
termines conformance to microbiological standards, specifications, and
guidelines where such are either mandatory through codification in the
Federal Regulations or included in a purchasing specification on product
destined for either domestic or international trade. Microbiological food
examination is used primarily to evaluate a product's safety status as
opposed to its quality factors. Determinations of microbiological food
safety are generally focused toward fully cooked, ready-to-eat items or
the identification of process-induced hazards.
History
The NMFS had its origin in the Agricultural Marketing Act, as Amended
(U.S. Congress, 1946), which provided for establishment of a system for
distributing and marketing agricultural products based on the authority to
inspect, certify, and identify agricultural products moving in interstate
commerce. Fish and shellfish as well as processed products thereof were
included as agricultural products. Some of the present commodity pro-
grams in the USDA are based in this program; however, early efforts did
not include fish and shellfish.
The Fish and Wildlife Act (U.S. Congress, 1956) transferred all of the
commercial fisheries activities from the USDA to the Bureau of Com-
mercial Fisheries in the newly established Fish and Wildlife Service of
the U.S. Department of the Interior. It was here in 1958 that the Fish and
OCR for page 175
CURRENT STATUS AND LEGlSLATlVE BASES
175
Fisheries Products Inspection Program originated with a commitment to
promote better health standards and sanitation. This program and some
other commercial fishery activities were transferred in 1970 to the newly
established National Marine Fisheries Service of the National Oceanic and
Atmospheric Administration (NOAA) of the U.S. Department of Com-
merce (USDC). The NMFS unit with the greatest involvement in the
establishment and use of microbiological criteria is the Division of Seafood
Research, Inspection and Consumer Services, which houses the USDC
quality-inspection activities (Sackett, 19821.
Current Cooperative Agreements
In addition to the above basic legislative authorities, the USDC fisheries
inspection service through NMFS is a participant in six Memorandums of
Understanding with other federal agencies to ensure cooperation and co-
ordination in seafood inspective activities (E. S. Garrett, ~JSDC-NMFS.
1983. Personal communication). The four Memorandums of Understand-
ing concerned with microbiological criteria are listed in Table 8-6.
The agency also participates in 11 formal federal/state agreements deal-
ing with fishery product inspective activities. The agreements are with
Alabama, Alaska, Arkansas, Florida, Hawaii, Louisiana, Maine, Missis-
sippi, New Jersey, Oregon, and Tennessee.
TABLE 8-6 U. S. Department of Commerce
Memorandums of Understanding with Other Federal
Agencies Concerned with Microbiological Criteria
Participating
Agencies Date
Purpose
FDA/USDC January 17, 1975
FDA/USDA/USDC April 2, 1975
DOD/USDC May 14, 1980
USDC/FDA May 22, 1981
To define respective roles in food
. . . . .
Inspection activities.
To transfer USDA's fish-meal
salmonella control program
to NMFS.
To transfer from DOD to USDC
. . . . .
logistics agency origin ln-
spection responsibility for
DOD procurement.
To improve research coordina-
tion and cooperation and min-
imize duplication of research
effort.
SOURCE: E. S. Garrett, National Marine Fisheries Service, 1983.
OCR for page 176
176 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
Activities Under Memorandums of Understanding. The FDA has es-
tablished several microbiological standards that are enforced in the USDC
inspection program. These microbiological standards are the "commer-
cially sterile" requirement contained in the Code of Federal Regulations
for Low-Acid Canned Food GMP (FDA, 1983c) and the microbiological
criteria for whole fish protein concentrate (FDA, 1983d). Additionally,
FDA may enforce a requirement for imported fishery products such as
shrimp from Asia to be free of Salmonella; NMFS then examines the
product for this pathogen. FDA also has Compliance Policy Guidelines
for crabmeat and cooked langostinos (FDA, 1982a).
The Department of Defense (DOD) purchases fresh and frozen oysters
under a Federal Purchasing Document (DOD, 1976) that contains micro-
biological specifications. The USDC inspection program routinely em-
ploys the microbiological specifications when inspecting oysters for military
procurement.
Activities With Industry. The USDC seafood inspection program also
determines conformance with a limited number of corporate quality as-
surance or quality control microbiological standards, specifications, or
guidelines. Each firm has its own set of specifications and contracts with
NMFS to do the inspection and analyses. Firms using microbiological
criteria specified in these programs are either large, sophisticated fishery
product processors or institutional purchasers.
Research
The USDC inspection program routinely uses microbiological evalua-
tions to determine safe and suitable processing operations for use in pro-
ducing fully cooked, ready-to-eat product. In addition, applied research
is conducted to assess potential process-induced hazards, such as con-
trolled atmosphere packaging of fishery products. Raw materials entering
USDC-inspected plants are surveyed when there is concern, for instance,
that polluted glaze water may have been used on a frozen product. When
deemed appropriate, a product safety analysis is carried out by actions
such as toxin assays of product suspected of contamination with Clostri-
dium botulinum.
U.S. Army Natick Research and Development Center
One of the objectives of this center is to provide safe and nutritionally
adequate food products in support of existing and future service concepts.
The problems of food procurement for military purposes are somewhat
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CURRENT STATUS AND LEGISLATIVE BASES
177
different from those for civilian purposes. While garrison (base) feeding
may resemble civilian food service in terms of the degree of misuse and
abuse to which foods may be subjected, field rations may be subject to
additional abuse. The rations may be stored for extended periods of time
and considerable delays may be encountered between preparation and
consumption.
The legislative base for activities relative to microbiological criteria is
the Defense Cataloging and Standardization Act, P.L. 10 USC, 2451-56
(U.S. Congress, 1976), implemented by Department of Defense (DOD)
directive 4120.3, "Defense Standardization and Specification Program
(DSSP)" (DOD, 19781. The DSSP includes approximately 400 Military
and Federal Food Specifications. Of these, about 35 contain microbio-
logical criteria, most of which apply to finished foods.
Microbiological criteria used for monitoring foods for the military as
described in military and federal specifications were listed by Powers
(19761. A summary of the current status of these microbiological criteria
for foods purchased for the military (including pertinent Military and
Federal Specification Numbers and Sampling Plans) prepared specifically
for this subcommittee report (G. Silverman, U.S. Army Natick Research
and Development Center. 1984. Personal communication.) is presented
in Appendix E.
An increasing number of items are now purchased under a Commercial
Item Description (CID) to save on inspection and analytical costs. A CID
document is applied only to commercially available products for which
there is already a civilian market. The company's sales to the government
must be less than 50% of its total sales and the company must certify that
the product meets certain requirements. Microbiological criteria are in-
cluded in CIDs only if problems had been encountered with similar prod-
ucts already being procured.
Agencies other than DOD may carry out some of the inspection activities
associated with military food purchases. The USDA inspects food plants
except where USDA specifications are in disagreement with those of DOD.
The NMFS is responsible for assuring that the microbiological criteria are
being met in the case of shucked oysters. The military has no specifications
on other fresh products.
The input of the Natick Microbiology Branch into specifications is made
during the ration developmental stages and modified, if necessary, after
initial procurement from commercial processors. The microbiology branch
is presently concentrating on updating their criteria to make them uniform
for given classes of foods and to benefit from current analytical techniques
and concepts. For this reason the microbiological requirements listed in
Table 1 of Appendix E are illustrative of those proposed for this class of
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178 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
rations. The criteria are derived from data obtained from analyzing actual
production samples. Those listed in other Appendix E tables are current
criteria. Critical processing parameters for achieving commercially ster-
ilized or microbiologically stabilized foods are also established but are
not listed in the tables in Appendix E. These parameters include minimal
Fo values as well as water activity (prefried, canned bacon; cakes) and
pH (rice).
Federal and Regional Level Cooperation
State Level
Grade a Milk Products. The cooperation between FDA and the states
relative to grading of milk products is discussed in the section above on
cooperative programs and in Chapter 9, Part A. The chemical, bacterio-
logical, and temperature standards of this program are listed in Table
8-1 .
Changes have been introduced since the adoption of the Pasteurized
Milk Ordinance (PMO), 1978 Recommendations (Table 8-11. Some ma-
terial has been added on standards for ultrapasteurized and aseptically
processed milk and milk products. Testing for antibiotic residuals in milk
and milk products using a Bacillus stearothermophilus disc assay method
has also been approved.
Manufactured Milk Products. Grade B raw milk or raw milk for
manufacturing purposes may be regulated by USDA recommended re-
quirements (USDA, 1972) if they are adopted by the states or by require-
ments established by the individual states. The products may be subject
to the microbiological criteria established in the Standards for Grades of
Dairy Products (USDA, 1975) or to criteria established by the individual
state. For further comments, see Tables 8-3 and 8-4 and Chapter 9, Part A.
Shellfish and Seafood Sanitation Programs. The federal and state mi-
crobiological criteria for shellfish and other seafoods are listed in the
National Fisheries Institute Handbook (Martin and Pitts, 19821. Standards
and/or guidelines, advisory and mandatory, as in use in 48 states are
included. The states with criteria for shellfish use NSSP regulations for
harvest, processing, and distribution of shellfish and also use NSSP pro-
cedures for growing area surveys and plant inspections. (See discussion
above of the National Shellfish Sanitation Program and the Interstate
Shellfish Sanitation Program.) Additional monitoring and laboratory test-
ing may also be applied by state authorities.
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CURRENT STATUS AND LEGISLATIVE BASES
179
Other Foods. A number of guidelines have been promulgated by the
states (Wehr, 19821. Twenty-nine agencies had microbiological guidelines
or standards in effect as of November 1981. The number of criteria for a
single agency varied from 1 to as many as 40. There is little agreement
on foods singled out and the criteria proposed.
The major portion of the criteria are applicable to shellfish, meat and
meat products, and delicatessen items. However, criteria are applied nar-
rowly to single items such as pecans or gelatin by some agencies and
broadly to "products and levels unspecified" or "non-packaged foods,
general" by other agencies. Sampling plans are random or unstated. The
bases for the criteria developed by each agency may be existing criteria
from another agency, internally generated data, externally generated data,
some combination of the three, experience, or opinion. Criteria for a single
food, hamburger or ground meat for example, may be implemented at the
retail level by one agency, at the distribution and retail levels by another,
at the processing and retail levels by a third, and at all three levels by a
fourth.
City-county (Local) Level
The objective of local agencies in regard to food surveillance generally
is to respond to and solve local problems relating to public health and
nuisance abatement. The agencies have a broad interface with small op-
erators involved in food processing or preparation of often very sensitive
foods as well as with some aspects of food service.
The local agency may monitor the safety and quality of locally produced
and/or consumed food products, principally delicatessen and other spe-
cialty food-processing operations and food service establishments. The
agency may follow up on local reports of alleged foodborne disease in-
cidents, poor quality products showing evidence of spoilage, insanitary
and unsightly facilities, and similar complaints. The scope and depth of
food surveillance, the qualifications of the field and laboratory personnel
involved, and the adequacy of laboratory facilities and procedures are
influenced by the population and area served by the local unit. Some city-
county units where food safety and quality are perceived to be a problem
may be very well structured and equipped to engage in food surveillance.
In addition, the personnel in these units may be adequately trained and
experienced to make appropriate interpretations of data. The nature of
local food-processing surveillance may be quite formal and well organized.
Frequently, however, local units have neither criteria of record nor ex-
perience in evaluating the results of microbiological analyses carried out
during routine inspection or in the course of an investigation of alleged
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180 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
foodborne disease. These conditions could lead to inappropriate setting
of criteria or regulatory actions by the local authority and could result in
unnecessary financial burden to industry with no reduction of risk to the
public.
The legislative bases for activities of local agencies are local ordinances.
The data bases may be meager or nonexistent. The basic information often
comes from other agencies or laboratories, and the criteria may have been
intended for other uses with other foods. At times there may be little
critical evaluation of the pertinence or validity of the application, e.g.,
applying criteria developed for highly processed foods to unprocessed or
fermented foods.
INDUSTRY
Microbiological guidelines and specifications are used by industry in
the sale and purchase of raw materials and ingredients for further pro-
cessing. They are used by industry to:
1. assure safety and wholesomeness of raw material and ingredients
and determine their suitability for further processing;
2. establish evidence of adequate processing and assess sanitation;
3. identify and monitor critical control points;
4. determine conformance tq finished product microbial limits;
5. assure safety and wholesomeness of finished products;
6. assure compliance with regulatory requirements.
The use of microbiological criteria by food processors varies greatly.
Sophisticated companies establish microbiological specifications over a
wide variety of critical raw materials and in many cases not only monitor
incoming raw materials, but also inspect the facilities in which these
products are produced. Such companies, in addition, have established
Hazard Analysis Critical Control Point programs (see Chapter 10) to mon-
itor critical control points and where appropriate to utilize microbiological
criteria in such monitoring. In addition, finished product testing through
microbiological analysis and guidelines is common in the food industry.
At the other end of the spectrum there are processors who make no use
of microbiological criteria. Hazards presented by their products are iden-
tified as a result of regulatory inspections, consumer complaints, rejection
by other processors using their products, or as a result of an outbreak of
foodborne disease.
Unfortunately, purchase specifications are frequently written by a pur-
chasing agent whose knowledge of the relevance of such specifications
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CURRENT STATUS AND LEGISLATIVE BASES
181
to the microbiological acceptability of the finished product concerned is
insufficient for selection of appropriate specifications.
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182 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA
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CURRENT STATUS AND LEGISLATIVE BASES
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Regulations 7 CFR, Subpart M. 58.2553.
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CFR, Subpart Q. 58.2655.
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Representative terms from entire chapter:
microbiological standards
