Hazard Analysis – Environmental Testing

Environmental testing for microbiological bioburden hazards is an integral part of the testing program designed by Priority One. Introduction of microbial adulterants during holding or processing is monitored utilizing USP Method 1116 for continued evaluation of microbial limits in controlled areas. This method was adopted by Priority One voluntarily, from the pharmaceutical codes. Dietary supplement regulations do not require this, but we believe it is imperative for quality.

Large plantation of medicinal plants Echinacea purpurea

Organic and Whole herbs are subjected to irradiating, and ETO(a pesticide) for sterilization in many cases.  Even though irradiation is not approved by the United States and the European Union, it still is prevalent, especially in “organic “ materials due to their naturally high microbial contents.

Fresh Herbs

Priority One guarantees that all our botanical’s are radiation-free. Unlike many of our competitors, we have a standard monitoring program to insure that no radiation is used in the sterilization of our botanical’s. When sterilization is needed, we use a dry-steam technology or other non-destructive technologies. (Note: only whole unprocessed herbs require treatment, and only when their total aerobic counts are found to be out of compliance.)

Priority One was one of the first companies to recognize the danger of wild crafted herbs. We use our international sources to achieve the ultimate benefit of natively grown plant sustainably cultivated  in its natural habitat. This has lessened the use of pesticides or fertilizers. While protecting endangered herbs.

Every day worldwide 2500 acres of raw land are disturbed by man. According to GSA Today  as of 1995, ~43% of Earth’s surface area had experienced human-induced degradation (Daily, 1995). Ellis and Ramankutty (2008) concluded that more than 75% of Earth’s ice-free land area could no longer be considered wild. Of earth’s ice-free land area, 83% is likely directly influenced by human beings (Sanderson et al., 2002). Our pollutants affect plant and animal physiology worldwide (McKibben, 1989, e.g., p. 38, 58)

Needless to say the world’s gene pool of wild herbs is dwindling.  By searching out strong stable international connections Priority One maintains eco friendly sources for our formulations.  Lending our support to companies that are good stewards of the earth, such as Naturex who has a proven record of sustainability-program-principles.

We have developed an industrial networking relationship with international companies who have developed unique complex systems for animal health, environmentally responsible botanical harvesting, and 100% radiation free sterilization techniques.

Diagram of risk

70% of ALL antibiotics sold in the United States are consumed by HEALTHY animals.  56% of Australian antibiotics are consumed by their healthy animals, and while not publishing the percentage of antibiotic use for their healthy animals New Zealand’s Foodsafety.govt.nz supports the needed continued use of antibiotics for “preventative or prophylactic use”

90 % of our our glands are sourced from Denmark, and unlike Australian, or New Zealand glands, Denmark is the only country that has been antibiotic, and growth hormone free for all bovine and and porcine glands since 1998.  This means that our glands are pure, untreated, and retain the best balance of naturally occurring hormones available on the market.  The last 10% are sourced from New Zealand. See our blog on Glandular Sources for more information on Denmark’s record.

Floods, droughts, fires, and earthquakes are major causes of adulteration in the food chain.

Through our Hazard Analysis Program we are able to block natural event adulteration’s. All raw ingredients have potential risk  of contamination, bioburden, and other dangers. By identification of such risks ahead of time, the mitigation process enables us to significantly reduce such hazards.  Priority One has developed a robust Hazard Analysis Program that does just that.

Our Quality Assurance team use this program to  identify hazards in the ingredient supply chain and then develop testing protocols unique to each ingredient.  These mitigation’s create targets for testing.  Designing a minimum of 1 upstream and one downstream precaution for each hazard that is identified. Our Hazard Analysis Review post called  “A peek into our rigorous vendor approval program” provides more information on how we block adulteration’s.

We do not rely on COA (Certificate of Analysis) from raw ingredient manufacturers. We test all raw ingredients for purity, potency, and well as environmental or bioburdens that may be present before we allow any raw materials be used in our manufacturing process. All ingredients are quarantined until they have been approved and released for production.


We realize our integrity in this regard is relied upon by yourself and your patients. With this in mind we are meticulous in our procuring, testing, verifying and producing the highest quality and clinical strength supplements, that you can stand behind with confidence.

Danielle Baumgart, President


DHEA or dehydroepiandrosterone is a prohormone produced in the adrenal glands and testes. As a prohormone, it can be converted into testosterone and/or estrogens in various peripheral target tissues throughout the body.

Blood sample for DHEA (dehydroepiandrosterone) hormone test
Blood sample for DHEA (dehydroepiandrosterone) hormone test

However, plasma DHEA decreases about 80% between the ages of 25 and 75 years. This is determined by measuring the blood marker for measuring DHEA, called DHEA-S. DHEA-S levels were found to be significantly lower in men with aging male symptoms such as decreased sexual desire and dysfunction cites a study involving 348 male patients.

DHEA supplementation in older men and women demonstrated in a double-blind, placebo-controlled study were 280 healthy men and women ages 69 to 79 were given 50 mg of DHEA or placebo daily for a year. The results were that supplementation reestablished “young” concentrations of DHEA-S and modestly increase testosterone and estradiol levels. The authors of this study concluded “that 50 mg of DHEA administration over one year normalized some effects of aging but does not create “Supermen or Superwomen”

As a prohormone, supplementation with DHEA appears to be relatively safe and effective. Nevertheless, there is value in assessing blood serum DHEA-S levels for individuals planning to use DHEA regulate prick. There is a particularly important population younger than 40 years of age who are more likely to have naturally higher levels of DHEA.

References: Journal of Endocrinology. 2005; 187:169-196.; Aging 2011; 3:533-542.; Urology 2005; 66:597-601; J Clin Endocrinol Metab, September 2013, 98(9):3615–3626.

Mitigations – More From Our Hazard Analysis Program

Raw herbs
Raw herbs

Our ingredient mitigations are  determined by risk level.

Mitigations describe how a risk level is reduced by the design of our quality systems. Immediate precautions are designed to block hazards in normal conditions. Also included in these mitigations are at least one upstream and one downstream protection to block the hazard from entering the processing chain.

Blocking the Risks
Blocking the Risks

These mitigations are ingredient-specific and are added to each ingredient specification sheet, assuring that each time that ingredient is received it is reviewed and tested for its unique hazard(s). All ingredients have risks and require systems to block sources of contaminants. 

We do not rely on the supplier for your patient’s safety. Risks such as radiation contamination, heavy metals, E. coli, salmonella, staph, dangerous spores, and economic adulteration are monitored by our rigorous testing methodology. By identifying such risks ahead of time, the mitigation process enables us to block these hazards.

Antimicrobial Susceptibility
Antimicrobial Susceptibility

All finished products are tested for the heavy metals arsenic, cadmium, lead, and mercury. This is done by our primary third party laboratory that we have hand selected. This laboratory holds the coveted international ISO 17025 certificate.

Danielle Baumgart, President


Danielle S. Baumgart, President
Priority One Nutritional Supplements Inc