Fort Environmental Laboratories (PDF) by c40e083630b38297


									Rapid Progestin-Based Endocrine Disruption Screening Assay

Fort Environmental Laboratories                          determine whether certain substances have an            tems for screening EDCs, FEL will provide the scien-
                                                         endocrine effect. Conventional toxicology and prod-     tific community, chemical and pharmaceutical
515 South Duncan Street                                  uct safety testing is expensive and time-consuming;     industries, appropriate regulatory agencies, and ulti-
Stillwater, OK 74074                                     with increasing concerns regarding the presence of      mately the public with a versatile short-term pre-
Telephone: 405-624-6771                                  EDCs in the environment, the need for rapid and         screening assay. Further, this model will enhance
                                                         efficient standardized assays and other screening       understanding of the significance of the effects of                                  tests has dramatically increased.                       EDCs on the reproductive systems of amphibians.

Environmental Problem                                                                                            The technical feasibility of these models for screen-
                                                         SBIR Technology Solution
                                                                                                                 ing potential EDCs is high. Although more work will
The endocrine system is a complex network of                                                                     be required to validate the models, it appears to fit
                                                         With support from EPA’s SBIR Program, Fort En-
glands and hormones that regulates many of the                                                                   the criteria established for emerging assays that cur-
                                                         vironmental Laboratories (FEL) modified, devel-
body’s functions, including growth, development,                                                                 rently are being sought for the EDSP .
                                                         oped, and standardized assays to test substances
and maturation, as well as the way various organs
                                                         that might disturb reproductive and developmental
operate. In recent years, concerns have been grow-
                                                         processes in animals by interfering with the endo-
ing that certain chemicals in food, water, and other
                                                         crine system. A modified Xenopus laevis oocyte
environmental media may be inadvertently disrupt-
                                                         maturation germinal vesicle breakdown (GVBD)
ing the endocrine systems of humans and wildlife. A
                                                         model based on the work of Pickford and Morris
variety of endocrine-disrupting chemicals (EDCs)
                                                         (Environ. Health Perspect., 107:285-292, 1999) for
already has been discovered, and there is strong evi-    rapid evaluation of EDCs was developed as a possi-
dence that chemical exposure has been associated         ble Endocrine Disruptor Screening Program (EDSP)
with adverse developmental and reproductive ef-          assay for EPA. An amphibian lifecycle (XLCA) model
fects on fish and wildlife in particular locations.      using Xenopus tropicalis to evaluate EDCs that affect
Many of these potential EDCs are present in the          the development of the reproductive tract also was
marketplace, where approximately 100,000-                developed and evaluated for commercialization.
150,000 chemicals currently are available as med-
ications, fertilizers, pesticides, and other products;   The 24-hour GVBD assay was designed to evaluate
approximately 2,500 new chemicals are released           environmental progestins and androgens in vitro.
each year.                                               The chronic exposure model using X. Tropicalis was
                                                         designed to specifically evaluate the impact of EDCs
Passage of the Food Quality Protection Act in 1996       on sexual differentiation and reproductive fitness.
as well as amendments to the Safe Drinking Water         The assays were standardized and evaluated by
Act reflect the concerns that some of these chemi-       conducting a preliminary validation study with a          Fort Environmental Laboratories developed
cals may pose significant risks to the endocrine sys-    series of known EDCs, compounds found to be               models for rapid evaluation of endocrine-
tems of humans and animals. To address these con-        inactive, and chemicals with unknown activity.            disrupting chemicals on reproduction and devel-
cerns, EPA has developed a screening program to          By standardizing and validating these model sys-          opment.

28                      SBIR Success Stories
Commercialization Information                            located in Stillwater, Oklahoma, FEL occupies a        Award from the State of Oklahoma for “National
                                                         unique market niche because of the significant         Small Business Research Excellence” and was a
FEL’s assay is relatively straightforward and could be   increase in interest in the use of these animals, as   finalist for the “Most Promising New Business”
commercialized following method standardization          well as many others, as indicators of environmental    award from Oklahoma City’s Oklahoma Venture
and validation. The models are capable of broadly        health. FEL won the sole 2002 National Tibbett’s       Forum in 2002 and 2003.
screening compounds with widespread endocrine
activity, including estrogens, progestins, and andro-
gens, which is desirable for EDSP tests. Because the
tests are relatively inexpensive compared to many
of the other proposed screening tests and many
compounds can be tested simultaneously, these
                                                                                      SBIR Impact
models are ideal.                                                             ■ The widespread finding of endocrine-disrupting chemicals (EDCs) in
                                                                                the environment has dramatically increased the need for standardized
The in vitro oocyte GVBD and amphibian lifecycle
models will provide the scientific community with a
cost-effective, rapid, and reliable method of testing
EDCs. The ability to rapidly and cost-effectively                          ■ Fort Environmental Laboratories (FEL) developed model systems using
screen for and evaluate the mechanisms of EDCs is                            Xenopus for rapid evaluation of EDCs.
an attractive alternative to the current laborious
and expensive testing systems used today. Increas-                           ■ The models developed can broadly screen compounds with widespread
ing concerns over the finding of EDCs in the envi-                             endocrine activity and are ideal for high-throughput testing.
ronment have dramatically increased the need for
standardized assays. FEL is well-positioned to capi-                                ■ FEL occupies a unique market niche because of the significant
talize on this emerging market as a pioneer and                                       increase in interest in the use of these amphibians as indicators of
leader in this field.
                                                                                      environmental health.
Company History and Awards

Fort Environmental Laboratories, an environmental
           toxicology consulting firm and laboratory,
           is the only commercial laboratory in the
           United States to specialize in the toxico-
           logical study of amphibians and reptilian
           species. Co-founded in December 2000
           by Drs. Douglas and Deanne Fort and

                                                                                                                  SBIR Success Stories                       29

To top