Vinaora Nivo Slider

The Cardno ChemRisk View

  • Home
    Home This is where you can find all the blog posts throughout the site.
  • Categories
    Categories Displays a list of categories from this blog.
  • Tags
    Tags Displays a list of tags that have been used in the blog.
  • Bloggers
    Bloggers Search for your favorite blogger from this site.
  • Archives
    Archives Contains a list of blog posts that were created previously.
  • Login
    Login Login form
Subscribe to this list via RSS Blog posts tagged in FDA
Posted by on in Centers of Excellence

Posted on behalf of Rachel Novick and Alison Bowman. 

...
Continue reading
Hits: 152
Rate this blog entry:

Posted by on in Centers of Excellence

Posted on behalf of author, Angela Perez.

...
Continue reading
Hits: 2451
Rate this blog entry:
0

Posted by on in Centers of Excellence

Posted on behalf of author Fian Louie

...
Continue reading
Hits: 3009
Rate this blog entry:
0

Posted by on in Centers of Excellence
Substances that are intentionally added to foods are defined as food additives by the U.S. Food and Drug Administration (FDA), under the Federal Food, Drug, and Cosmetic Act (sections 201(s) and 409). Food additives require premarket review and FDA approval of safety before they can be used. However, substances that are considered "generally recognized as safe" (GRAS) are excluded from the definition of food additives. Unlike food additives, substances that are determined to be GRAS for their intended use do not require premarket review or FDA approval.

The FDA has established two means for determining that the use of a food substance is GRAS: (1) scientific procedures, or (2) experience. For the use of a substance to be GRAS as determined by scientific means, scientific data about the substance's use must be widely known. Furthermore, there must be consensus among qualified experts that the use of the substance is safe. GRAS determinations that are based on experience rely on a substantial history of safe consumption by many consumers, and are limited to substances that were used in food before 1958. It is important to note that a GRAS determination is not made for a substance per se, but rather is limited to the intended use of a particular substance. This means that a substance that is GRAS for one use may not be determined to be GRAS for all uses.

In 1997, the FDA implemented a GRAS notification program. Individuals or companies can voluntarily notify the FDA if they have determined that the use of a particular substance is GRAS. This notification typically includes information about the substance, the conditions of its use (including the foods in which it is used and the levels present in those foods), and the population likely to consume the substance. Additionally, the notice contains a discussion of the data supporting the GRAS determination. The FDA evaluates whether the notice provides a sufficient basis for the GRAS determination. The FDA writes a response letter to the notifier, indicating either that: (1) the FDA does not question the basis of the GRAS determination, (2) the notice does not provide a sufficient basis of the GRAS determination, or (3) the notifier requests that the FDA cease to evaluate the GRAS notification. Over 600 notifications have been submitted to the FDA since 1997, and the FDA maintains a publically available inventory of these notifications and their FDA evaluation letters on their website.

Posted on behalf of the author, Bethany Winans 
Hits: 3907
Rate this blog entry:
0

Posted by on in Centers of Excellence

Following a thorough scientific review, the Food and Drug Administration (FDA) recently approved genetically engineered (GE) salmon as safe for human consumption. Genetic engineering is already approved by the FDA and widely used in plants such as corn and soybeans for purposes of enhancing flavor, increasing crop output, and resistance to pests and disease. However, the approval of AquAdvantage salmon, manufactured by AquaBounty Technologies, Inc., represents the first GE animal to be available to consumers.

The GE salmon contains a growth hormone gene from the Chinook Pacific salmon which is kept continuously active by another gene from an eel-like creature, the ocean pout. Whereas non-GE Atlantic salmon intermittently produces growth hormone during the year, the GE salmon produces growth hormone throughout the year and experiences accelerated growth, thus reducing the time required for the salmon to reach market size. The supplier of the newly approved GE salmon suggest that their product is "environmentally responsible", because localized land-based production facilities offer both a small carbon footprint, as well as less impact on ocean resources.

As part of the approval process, the FDA reviewed data provided by AquaBounty Technologies and other peer-reviewed literature to assess the claims and safety of the GE salmon. The FDA determined that the GE salmon is as safe and nutritious to eat as non-GE salmon, safe for the health of the fish, meets claims of faster growth, and would not "have a significant environmental impact".

Concurrently, the FDA also indicated that current law does not require labeling of GE salmon or foods containing ingredients from GE salmon. However, the FDA also issued draft recommendations for voluntary labeling of salmon that has or has not been genetically engineered.

...
Continue reading
Hits: 2221
Rate this blog entry:
0

The Cardno ChemRisk View

We're glad you decided to check us out.

Cardno ChemRisk is a respected scientific consulting firm headquartered in San Francisco with locations and consultants across the U.S. While our website provides a formal look at our capabilities, the Cardno ChemRisk View provides an informal voice too. Various Cardno ChemRisk consultants will be sharing news and views about current trends, happenings and methodologies in the industry. We’ll also highlight activities of interest at Cardno ChemRisk, within confidentiality restrictions of course.

The intent is to keep you informed and enable productive conversations, so please join in and get to know our staff and what makes our people unique. We are enthusiastic about the blogging experience and hope you will return often to learn and share. Stay tuned by subscribing to our blog or clicking on the RSS feed.