485 Evolution and Challenges of Sustainability
antimicrobial compounds), Jenner (created the smallpox vaccine—the world’s first vaccine),
Koch (developed Koch’s postulates—the four criteria used to establish a causal relationship
between a microbe and a disease), Pasteur (introduced pasteurization and disproved the
doctrine of spontaneous generation—the idea that living organisms could arise from
nonliving materials), Lister (promoted sterilization during surgery using carbolic acid, or
phenol, as an antiseptic), Bierjinek (founded virology and environmental microbiology), and
Winogradsky (initiated and developed microbial ecology).3
The contributions by these scientists and others resulted in the rapid growth of microbiology
in the latter half of the 19th century, and the time between 1980–1900 has been referred to
as the Golden Age of Microbiology because it was a time when the role of microorganisms
in fermentation was becoming known, and the microorganisms that caused many diseases
were isolated and identified.3 The Society of American Bacteriologists was founded in 1899.
This organization was the forerunner of the American Society for Microbiology, which
currently has nearly 40,000 members.
The deplorable conditions of the meat-packing industry in Chicago at the beginning of the
20th century were brought to light in The Jungle by Upton Sinclair. This book raised a public
outcry that resulted in passage of The Pure Food &Drug Act of 1906. This Act helped
ensure the sanitary manufacture of foods and drugs, required drug ingredient labeling,
and prohibited the sale of adulterated (e.g., contaminated) and misbranded products in
interstate commerce. The Food and Drug Administration (FDA) was established in 1931
however, it was not given regulatory authority for the safety of foods and cosmetics or for
the safety and efficacy of drugs. Visible mold growth was the primary microbiological
problem of products reported around this time.4 However, it is likely that many products
were contaminated with significant numbers of bacteria that were not detected because
products may not have had preservatives, and microbiological testing probably was not
done on a regular basis.
The time from 1900–1930 was a time of consolidation in which many investigators worked
to better understand the wealth of information generated during the Golden Age of
Microbiology. In the early 1900s, The American Public Health Association published the
first edition of Standard Methods for Examination of Water and Wastewater and forerunners of
Standard Methods for Examination of Dairy Products were published. The Digestive Ferments
Company (DifcoTM) was established in 1914. DifcoTM introduced dehydrated culture media,
which provided considerable time savings for media preparation as well as uniformity of
culture media used for growing bacteria, yeasts, and molds. Research on preservatives
began, and parabens became the preservative of choice because of their antibacterial and
antifungal activity.4
In 1937, the “Elixir of Sulfonamide” incident resulted in more than 100 deaths in the
United States due to consumption of an antibiotic, sulfonamide, in diethylene glycol that
was not safety tested. This and other tragedies resulted in enactment of the Food, Drug,
and Cosmetic Act of 1938, which gave the FDA responsibility for requiring manufacturers
to ensure safety—including the microbiological safety—of their products.3
EVOLUTION OF COSMETIC MICROBIOLOGY
In 1941, Maison deNavarre published The Chemistry and Manufacture of Cosmetics to provide
scientific information about cosmetic raw materials, formulations, and product preservation.5

486 JOURNAL OF COSMETIC SCIENCE
This book helped create a more scientific approach to the development and manufacture
of cosmetics. The importance of microbiology was becoming more recognized, parabens
were the preservative of choice, and preservative testing used cultures of test bacteria. The
Society of Cosmetic Chemists was founded in 1945. Visible mold contamination was the
primary cause of recognized product defects in the 1940s.4
In the 1950s, microbiologists were involved with testing new antimicrobials to determine
their antimicrobial spectrum (i.e., which types of bacteria, yeasts, and molds they inhibited)
and concentrations needed for product preservation. In-use panel tests were conducted to
determine substantivity and antibacterial activity for product claim support. Preservation
studies included testing for incompatibility with ingredients and the effects of pH,
packaging, and storage conditions however, there were no standardized microbiological test
methods for preservative efficacy at this time.4 Curry noted that scientists were becoming
aware of the growing problem of bacterial resistance.4
In 1965, Kallings, Ernerfeldt and Silverstolpe6 reported microbial contamination of
nonsterile pharmaceuticals and selected toiletries in their report to the Royal Swedish
Medical Board.6 Kallings and coworkers identified the need to improve microbiological
controls during manufacturing and the need to improve the preservative systems of
aqueous products. The report was a “call to action” for the entire cosmetic industry because
it revealed that some marketed products were contaminated with bacteria, yeasts, and
molds. Although many companies had microbiological programs in place at the time, this
report demonstrated the need for improved microbiological controls in manufacturing and
the need for adequately preserved products. In the following years, governmental agencies
and independent testing laboratories conducted surveys to determine the type and extent
of product contamination.
In a presentation at the Toiletry Goods Scientific Conference in 1969, Wolven and Levenstein
reported that 61 out of 250 (24.4%) unopened cosmetic product samples examined were
contaminated with microorganisms.7Thisreportalarmedmanufacturersandregulatoryofficials
because bacterial contamination of products can have adverse health effects for consumers.
The Cosmetic, Toiletry, and Fragrance Association (CTFA) Microbiology Committee and
the Quality Assurance Committee developed guidelines for the cosmetic industry. Many
manufacturers incorporated these guidelines into their standard operating procedures.
In 1971, the FDA advised manufacturers that contaminated products were in violation
of the Food, Drug, and Cosmetic Act and that bacterial contamination could result in
“regulatory action” including seizure (i.e., placement of goods under quarantine by a federal
marshal), injunction (i.e., regulatory control that prevents a manufacturer from introducing
goods into interstate commerce), and/or criminal prosecution (i.e., legal proceedings that
could result in fines or imprisonment).3 Manufacturers reviewed their microbiological data
and improved product preservative systems, as needed.
Wolven and Levenstein conducted a follow-up survey in 1972 in which they found 8 out of
223 samples (3.6%) were contaminated.8 The microorganisms recovered from these samples
were Gram-negative rods (6%, including 0.5% pseudomonads), Gram-positive rods (5%),
and molds (0.4%). In addition, a CTFA survey from 1972–1975 tested 3,967 cosmetic and
toiletry products and found that 97.7% of them were “essentially free” of microorganisms
and that no Staphylococcus aureus, Escherichia coli or Pseudomonas aeruginosa were recovered in
any of the samples examined. These results showed that the industry had improved their
microbiological practices.3