Wednesday, January 16, 2019

How To Tincture Herbs With the Folk Method

The Folk Method Makes Herbal Tinctures Easy 

People are often confused about how to make herbal tinctures using the "formula" or "calculation"  or  "weight to volume" method that I teach in my book. I give very detailed directions and these directions will result in a very precise product. However, if you are not making tinctures to sell, you can fudge a bit and do not have to be so precise.  For those of you who do not like the math or are confused, I suggest trying the folk method in the beginning. This involves no math and makes the process very easy. Once you have used the folk method and feel confident, you can go on to using the formula method of extraction if you want to be more consistent and precise in your herbal tincture making.  I suggest you read this in its entirety before beginning as the tips on type of alcohol and water content in plants might change how you approach your project.

 

The Type of Alcohol You Use Is Important

In the pure folk method of tincturing herbs, people often use whatever hard liquor they have around. When I make a tincture using the folk method, I usually use organic grain alcohol which is 95% alcohol strength and has no flavor. (I don't like to support GMO derived alcohol.) However, people can use whatever they have as long as it is something that is 80 proof or 40% alcohol such as vodka. This will generally ensure enough alcohol to preserve the product and extract most of the constituents desired.

Herbal Tid Bit

The "Folk Method" does not calculate for the percent of alcohol used. Some plants are better extracted with a higher amount of alcohol such as resinous herbs, and there may be a concern about having a high enough alcohol strength to extract the resin or other materials. If you know your herb should have more alcohol used to extract it you can use 95% alcohol  found in the liquor store. I purchase organic alcohol from Organic Alcohol Co.

There is nothing precise about this method, so forget using it if this is going to bother you. There are also some times where it is best not to use the folk method. We will cover this at the end. 

 

Adding the Alcohol and Herb

Peppermint Herb
Start by filling a jar about 1/3 -1/2 full with fresh or dried
plant material. Pour alcohol over the top of the herbs. Please realize that dry herbs will really soak up the alcohol so you may need to add extra liquid later. You can check the next day to see if you need to add more alcohol. The alcohol must stay over the top of the plant by at least 1/4 inch at all times to keep it from oxidizing. If you are making a tincture with a fresh plant rather than a dry plant, you won't need to add more alcohol later. This is due to the water content in the fresh plant. In the case of the dry plant extract, the plant material will suck alcohol into its dry cells. So you will have to add more alcohol later.  If you are adding alcohol to dry plant, you will definitely need to check it the next day to see how much more alcohol needs to be added to it.


Blenderize Your Herb and Alcohol

A vitamix makes this easy. A regular blender works too.
Now in its simplest form, you don't even use a blender to mix the herb and alcohol. You just pour the alcohol over the herb, shake it off and on and wait. However, most people using this method will use a blender to mix the alcohol and the herb together. This breaks up the plant into smaller particles and lets the alcohol get absorbed into the plant quicker and allows it to come into contact with more plant material, thereby extracting more of the goodness from the plant. This can also be accomplished with a mortar and pestle. It is just much slower than a blender, but does give you a good work-out.  


Herbal Tid Bit

You have a choice of purchasing whole dry herb or cut and sift herb. For many herbs, whole form is best to purchase as the more it was cut up and pulverized, the more oxidized the herb becomes while sitting on the store shelf. Being oxidized means it will loose its healing powers quicker. Some plant roots or barks can be so hard that you can not cut them up yourself, so in these cases using whole plant might just exasperate you. If you do find yourself with some tough roots or bark, I suggest you pre-soak them in alcohol to allow them to soften up before trying to blend them. (I once had to soak a root for months to soften it up before blending it.) Otherwise you might break your blender. 

 

Let It Extract And Then Press It Out

Echinacea Tincture being pressed.
Once your herb and liquid are mixed together, and there is adequate liquid (at least 1/4-1/2" above the plant material) to keep the herb from oxidizing in the air, put a lid on the container and steep for 4 to 6 weeks in a cool, dark place such as a pantry or closet. Shake it often. Then strain or press out the liquid or menstruum. You can press it with  a potato ricer or by using a strainer, cloth and some muscle power.

Usually in the folk method you don't even bother filtering the tincture after it is strained. You simply use as is.  This is really all there is to the folk method. In many cases this will work just fine. If you want it filtered, let it sit for 24 hours or more to settle out some of the debris, then decant it off, leaving the debris behind and pour the liquid through a filter in your kitchen such as a non-bleached coffee filter.


Improving the Folk Method In Special Situations

Echinacea Tincture Macerating
The folk method is best used to extract dried plant materials. As I mentioned previously, people usually use an alcohol such as Vodka when using the folk method. Fresh plants have moisture in them and as soon as you mix the fresh plant with the alcohol, you are diluting the alcohol. If the plant has 75% moisture in it, you are diluting the alcohol a lot. For this situation, a 190 proof or 95% alcohol is really a better choice.  Fresh plants that have little moisture content or fresh plants that have constituents in them that you can extract with low amounts of alcohol will do well with the folk method and using an alcohol like vodka that has 40-45% alcohol.  

When you want to use this method with dry plant material that needs high amounts of alcohol, I would again suggest using 190 proof (95%) alcohol. Doing this will allow you to get a good extraction from plant material  such as resins. Another situation necessitating 95% alcohol is when the plant being tinctured is fresh and it has a high moisture content and/or has constituents that necessitate a moderate to high amount of alcohol to extract them. Yet another situation would be when you want to make a fresh plant tincture stronger by extracting additional plant material in the menstruum. This makes the final product stronger and necessitates more explanation than I am going to go into here.

Reasons I often don't use the Weight to Volume Method

• This method does not allow me to know the strength of my product.

• Lack of consistancy in my products & not being sure about how much to give since I don't know the strength.

• This method can lead to an alcohol strength that is too little or too much which can lead to inadequate extraction as well as excessive, unnecessary alcohol in a product. 



Weight to Volume Method

Method

This method is also called the formula or calculation method. It is much more tedious, has extensive directions, and yes it does involve math. You will find these directions in my book "Herbal Medicine from the Heart of the Earth". You can also look for an herbalist living in your area that teaches classes on how to make herbal tinctures. Getting hands on experience is really the best thing when learning how to make herbal products.



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Monday, January 14, 2019

Celebrating the Circle of Life

Celebrating the Circle of Life
Through the Teachings of The Medicine Wheel


with Deborah Frances R.N., N.D. / Beautiful Little Dancing Crow
Naturopath, Herbalist, Lakota Elder

When: Saturday and Sunday
February 9th & 10, 2019 • 10AM - 5PM

Where: PrayerPHarm
Ashland, OR


Class participants will have an opportunity to experience the Healing Power of Spirit and Nature as we circle through each of the Four Directions of The Medicine Wheel with ancient Earth-centered teachings and shamanic journeying. 


Plant and Animal Spirit Medicines will be welcomed through each of the Four Directions and teachings will be shared.
Students will participate in building a Medicine Wheel on the land.

Tuition:
Sliding Scale: $150 - $250

Older children are welcome to attend and price includes on-site childcare for younger ones. Let us know ahead if you will need this service.

To Register:
Using Paypal - Send $50 deposit to deborah.frances@yahoo.com
Please be sure to include your NAME & PHONE number

For more information please contact Dr. Frances at 971-322-9626

To read Dr. Frances’ blog go to:
www.drdeborahfrances.wordpress.com/blogwww.drdeborahfrances.wordpress.com/blogCelebrating the Circle of LIfe Throught the Teachings of The Medicine Wheel.pdf

Saturday, January 5, 2019

Toxic Mold Summit & Some Basics On Mold & Related Illness

I thought many of you would be interested to see there is a mold summit being put on by Jeffrey Smith. (The same person who educated so many people on GMO dangers in the past.) 

Don't forget I have a ton of data about mold and how to prevent water damage in your home, how to clean it up if you already have it and the steps to take if reacting to a water damaged building and the treatment process at my website (I will be moving my website soon and changing the name).

You Are Actually Dealing With Much More Than Mold

There is so much more than mold in water-damaged buildings that cause this biotoxin response that we call a "mold" illness/susceptibility. It is technically more appropriate to call it CIRS (chronic inflammatory response syndrome) due to a water-damaged building, rather than "mold illness" or toxic mold illness or mold susceptibility. However, "mold illness" is largely what it is called by people. It is important that people realize they are dealing with much more than mold. Water-damaged buildings have a variety of nasties growing in them and releasing biotoxins. They contain a variety of pathogens inflammagens and toxigens. Secondary metabolites of mold and bacteria have been found in carpeting, heating, ventilation and air-conditioning systems, wallpaper and dust. 

Culprits in a Water Damage Building That Causes the Illness

Some of the specific nasties you can find in a water-damaged building are mold, bacteria, amoebas, actinomycetes and mycobacteria. Additionally, the chemicals in the building materials can create an environement that alters these oranisms as well as adds to the release of toxins. You can have a release of mycotoxins, bacterial endotoxins, beta glucans, mannans, proteinases, hemolysins, c-type lectins, spirocyclic drimanes, and volatile organic compounds. It is thought that the combination of these various toxins from a variety of organisms is what causes the illness. Indeed, mycotoxins which are the toxins molds make, have been identified in body fluids as well as tissue samples of people exposed to water-damaged buildings. Indeed in one clinical study Ochratoxin A (a mycotoxin) was found in 83% of over 100 individuals tested with chronic illness and a history of water-damaged building exposure. Since it is so hard to test for all of the offending organisms and their biotoxins they release into the environment and there are not tests to test for many of them in body fluids, it is easier to test for the inflammatory reaction to these toxic elements. I will talk about this in a later blog.

Today We Will Examine What Mold Really Is

Molds are a type of fungi. They are multicellular and grow in filamentous hyphae (long thread-like branches). Networks of these hyphae form a mycelium which is considered a single organism. They produce airborne spores. They break down organic waste and are therefore an important part of natures recycling system. They cannot photosynthesize and just like humans they rely on organic matter for nutrition. 

Mold can grow on virtually any organic material as long as moisture and oxygen are present. There are molds that grow on wood, paper, carpet, food, and insulation. Because mold eats or digests what it is growing on, it can damage a building and its furnishings. If left unchecked, mold eventually can cause structural damage to building materials. 


They reproduce using both sexual and asexual methods. Molds may produce mycotoxins which can be harmful to our health as well as our animal's health.


Yeast is not mold: Yeast is also a type of fungi but it is not a mold. They are single celled microscopic fungi with an oval shape. They reproduce by mitosis (budding). There are different types of yeast such as Saccharomyces in wine and beer or Candida albicans (can bud and also grow via hyphae as well as make chlamydospores) which creates opportunistic infections in humans and animals. Candida and other yeasts, like molds may produce toxins which can be harmful to humans and animals.


It has been known for some time that fungi and the mycotoxins they create can cause health problems. However, we have focused mainly on mold allergies and mold infections (colonization). We were aware of the internal exposure to fungi such as Candida overgrowth in our intestines, or athlete's foot, as well as the infectious growth of various unusual and more serious molds seen mainly in immunocompromised individuals. There are also chronic rhinosinusitis problems caused by fungi such as Aspergillus, Chaetomium, Fusarium, Penicillium, and Trichoderma. It was Dr. Ritchie Shoemaker that brought our attention to the mold toxicity in our environment which has been causing illness in genetically susceptible individuals. This illness has been overlooked for many years by practitioners simply due to our ignorance of it. It is my opinion that much of what we call "Chronic Fatigue", Chronic Lymes", "Fibrolyalgia", and "Morgellans" is really "Mold" Illness or more specifically illness due to water-damaged buildings. I also have no doubt that this susceptibility is associated with many other inflammatory diseases. 

The Bottom Line


"Mold Illness" is a biotoxin illness caused by exposure to a water-damaged building. 

Other Illness That May Cause Similar Symptoms

Mycotoxins (mold toxins) are a subset of biotoxins. There are other biotoxins besides mycotoxins that can cause a similar disease symptomology as mycotoxins do. They can come from toxic algae, a bite from a toxic insect or snake. I will discuss this in the future.

Learning About Mold Susceptibility

Some years back I realized I had a mold susceptibility and was reacting to water-damaged buildings. No one seemed to know much about it in the medical community and initially it was hard to find data. However, I read all the research I could find on the subject (There was more than I would have thought, but hard to find.) and all of Dr. Shoemakers data as it was being made available. He was not teaching Docs at the time or I would have taken his classes. I took his wonderful clinical data, the research I read mixed with what was known about biotransformation (detox) processes in the body and put together enough knowledge to help myself and others by using a  mix of binders, herbs, diet, supplements and lifestyle changes. If you think this may be an issue for you or someone you love, I suggest you learn more about "mold illness/susceptibility" as something can be done about it. You can read some prior blogs I wrote on my own experience as well as more details on mold susceptibility here:


I have also made it my new years resolution to educate folks more on mold, so you will be seeing more blogs on this very soon. Additionally, I have a book in the works.

Friday, January 4, 2019

FluMist ® Quadrivalent - The Cautions & Side Effects

If you or your family members get immunized for the flu, you might want to take a quick look at the possible complications  and  the contraindications for FluMist ®  Quadrivalent as listed by the company that makes it. Usually your practitioner does not have time to tell you about these cautions and may not even have time to read the cautions and side effects themseleves, so I am taking some pertinent points from the manufacturers data and sharing it with you. I have organized them below. None of this is my own personal opinion. This is all from the manufacturer and I have provided links to their "Prescribing Information" so  you can fact check yourself if you like or get more details.

Just The Facts


Contains MSG -monosodium glutamate - Here is the inactive ingredient list: monosodium glutamate, gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, and gentamicin. (gentamicin is an antibiotic)

Contains egg residue. If you have an egg allergy, you should not be using it.

Do not give to children and adolsescents up to 17 years of age who are receiving aspirin therapy due to the association of Reye's syndrome with aspirin and wild-type influenza infection.

• There is a risk of hopsitalization and wheezing in children under 2 years of age who receive FluMist ®  Trivalent and they list this as possible with the Quadrivalent also .

• Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist Quadrivalent administration. 

• FluMist Quadrivalent has not been studied in persons with severe asthma or active wheezing.

• If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and risks.

• The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FluMist were runny nose or nasal congestion in all persons 2-49 years, fever >100°F in children 2-6 years, and sore throat in adults 18-49 years. Among children 2-17 years who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever >100°F. Among adults 18-49 years who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat

How Does FluMist ®  Quadrivalent  work? Immune mechanisms conferring protection against influenza following receipt of FluMist Quadrivalent vaccine are not fully understood; serum antibodies, mucosal antibodies, and influenza-specific T cell may play a role. 

• FluMist and FluMist Quadrivalent contain live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients (shedding). FluMist Quad FluMist  and trivalent has not been studied in immunocompromised persons. The effectiveness of FluMist has not been studied in immunocompromised persons.

The safety of FluMist Quadrivalent in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established.

Management of Acute Allergic Reactions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine

 FluMist ® Quadrivalent may not protect all individuals receiving the vaccine. I did not see a test of effectiveness for FluMist Quadrivalent but did see this one for FluMist 
The primary endpoint of the trial was the reduction in the proportion of participants with one or more episodes of any febrile illness, and prospective secondary endpoints were severe febrile illness and febrile upper respiratory illness. Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50 through 64 years of age. Primary and secondary effectiveness endpoints from the age group 18 through 49 years are presented in Table 8. Effectiveness was not demonstrated for the primary endpoint in adults 18 through 49 years of age.

One last list of cautions from their paperwork:
Who may not be able to get FluMist Quadrivalent?
Tell your healthcare provider if you or your child: are currently wheezing, have a history of wheezing if under 5 years old, have had Guillain-Barré syndrome, have a weakenedimmune system or live with someone who has a severely weakened immune system, have problems with your heart, kidneys, or lungs, have diabetes, are pregnant or nursing, are taking Tamiflu®, Relenza®, amantadine® or rimantadine®. (Remember that your practitioner may not even know these are issues regarding FluMist®  Quadrivalent and you may need to educate them.)

For more details or to check up on my data, here is the manufacturers disclosure and prescribing information.

Wednesday, January 2, 2019

GMO Labeling Law is Out & I Reviewed it For You


The Federal Register document on National Bioengineered Food Disclosure Standards has arrived.  I read through it and will share the important points here with you.


The national bioengineered food disclosure standard  or NBFDS

The Ten Important Points Covered Below Are:   

• The Name 
• How The Govt. Identifies a Bioengineered Food
• The Types of Food That Have to Be Labeled
• Which Foods are Exempt
• Demonstrating Existance or Non-existance of a Bioengineered Substance
• List of Bioengineered Foods 
• Threshold for Contaminated Product
• Label and Labeling Placement
• Enforcement or Should We Say Lack of Enforcement
• When The Labeling Begins

The Name 

You know genetically modified food as GMOs or genetically modified organisms. Most people in the United States use the term genentically modified organism. However, in research the title used for GMOs is genetically engineered or bioengineered food.  Bioengineered food is what the govt. is using and what you will see on labeling. So don't look for GMO, look for bioengineered food.


How the Govt. Identifies a Bioengineered Food/Substance?

A food that contains genetic material that has been modified through in vitro
recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.

The Types of Food That Have to Be Labeled

Bioengineered substances that humans consume. Animal food was specifically mentioned to be left out. It was not omitted by accident. Additionally, those animals who are fed bioengineered food and then fed to you are also not included  even though RoundUp used on many bioengineered crops and fed to animals is known to accumulate in animal tissue. Therefore most consumers would want to know if RoundUp Ready soy or RoundUp Ready corn was fed to the steer, pig or chicken they are consuming. However, that is not going to happen. 

Besides meat being excluded, so are eggs. Chewing gum was included as well as items used for drink, dietary supplements, processing aids and enzymes. Distilled spirits, wines and malt beverages are not subject to this labeling law, with the exception of wines with less than 7% alcohol by volume and beers brewed without malted barley and hops. Yes, it seems weird but this has to do with the agencies and rules already responsible for labeling these items. I doubt you want the details. (Trying to keep this short so you will read it and pass it on.)

If the food has multiple ingredients listed on the label it comes under this law only if the most predominant ingredient (by weight and first on list) would be subject to the labeling requirements or if the most predominant ingredient of the food is broth, stock, water or a similar solution and the second-most predominant Ingredient in the product would be subject to the labeling requirement. This means if a multi-ingredient food product that contains meat, poultry, or egg product (none of which need to be labeled) is the first ingredient of the ingredient list on the food label, it would not be subject to the national bioengineered food disclosure standard (NBFDS) rules even if it contained other ingredients that were bioengineered. An example given for the ruling is if a multi-ingreidnet product had pork as the first ingredient and bioengineered corn as the second ingredient on the label, it would not be subject to this ruling and would not have to be labeled as bioengineered. Seafood except for catfish and meat such as venison and rabbit are subject to the NBFDS and therefore if a multi-ingredient product contained one of these as the predominant ingredient that product would be subject to declaring any and all  items that were bioengineered.

Refined bioengineered foods don't count: For refined foods that are derived from bioengineered crops, no disclosure is required if the food does not contain detectable modified genetic material. Basically, this means if you started with bioengineered corn but now you  have modified it chemically to the point that it is so refined that you can't tell the product started as bioengineered corn, it does not have to be labeled. In fact, just the processing records can be used to prove lack of bioengineered material for some processed foods as it is known the end product is no longer anything similar to the food it started with and therefore does not test positive as a bioengineered food any more. This means it would not require additional laboratory testing to prove the lack of modified genetic material.

How Existance or Non-existance of a bioengineered Substance is Demonstrated

A companies records can be used to  demonstrate that modified genetic material is not detectable.
 1) The company can demonstrate that modified genetic material is not detectable with records verifying that the food is sourced from a non-bioengineered crop or non-bioengineered salmon.
2) Companies can demonstrate that modified genetic material is not detectable in the food with records verifying that the food has been subjected to a refinement process
“validated”to render modified genetic material undetectable.(What we talked about above.)
3) Testing can also be used to show GM material is not detectable.


List of currently known bioengineered foods 

This list includes bioengineered foods that may be produced in other countries.

The list: alfalfa, apple (ArcticTM varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple (pink flesh), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugarbeet.

Anyone may submit recommendations about foods that could be added to or deleted from the list at any time. The list will be reviewed and updated on an annual basis. Companies have 18 months to change their labels when revisions to the list are made.

If a company has knowledge that they are selling a bioengineered food that is not on the list, they must still label their food as bioengineered.

Exempt Foods

Incidental additives that are present in food at an insignificant level and do not have any technical or functional effect in the food are exempt from certain labeling requirements under the FDCA and are also being exempted here for what appears to be a matter of consistency in labeling. 
incidental additives are: Substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect. An example of incidental additives would be: Substances migrating to food from equipment or packaging or otherwise affecting food that are not food additives. 

With respect to treatment of yeasts, enzymes, or any other microorganisms, AMS agrees that if they qualify as incidental additives that are not required to be labeled as ingredients on a food label, then they do not require disclosure as bioengineered foods. However, bioengineered yeasts, enzymes, and other organisms that do not qualify as incidental additives that are not required to be labeled as ingredients may require disclosure as bioengineered foods unless they meet the requirements of another provision (for instance, by establishing that their modified genetic material is not detectable).

There are exemptions for some establishments. Food served in a restaurant or similar retail food establishment and very small food manufacturers with annual receipts of less than $2.5 million are exempt.

As mentioned previously, food derived from an animal will not be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance.


Threshold for Contaminated Product


What if someone accidently buys and sells a bioengineered food as non-bioengineered and does not  label it as bioengineered?

A threshold for the inadvertent or technically unavoidable presence of bioengineered substances of up to five percent (5%) for each ingredient is given as an allowance. However, no such allowance for any bioengineered presence that is intentional is given.

Label And Labeling Placement

The placement of bioengineered disclosure is to be on the information panel, although it can also be on the main panel or for small packaging an alternate panel.

Regulated companies have several disclosure options (text, symbol, electronic or digital link,
and/or text message, with additional options available to small food manufacturers or for small or very small packages.

The product can list text that says it contains a bioengineered product or it can use a symbol.
The black and white adopted symbol can be seen here.  The colored symbol can be seen here. 
You want to make sure you and everyone else knows exactly what this symbol looks like as it was made to look as if it was depicting something beautiful in nature and will likely be ignored by anyone who does not know what the symbol is.In fact they might assume it is some "green" feature.

The third disclosure option available for regulated entities to use is an electronic or digital
link disclosure. Such a link must be accompanied by the statement “Scan here for more food information” or equivalent language that reflects technological changes. If a regulated entity decides to utilize electronic or scannable technology to convey bioengineered food information, they must also provide options for the consumer to access the disclosure by calling a phone number.

Enforcement (or lack of enforcement) Of This Labeling Rule

This act authorizes AMS to enforce compliance with the standard only through record audits and examinations, hearings, and public disclosure as a summary of the results of audits, examinations, and similar activities. There is no authority to recall any food subject to the labeling rule “on the basis of whether the food lacks a disclosure that the food is bioengineered.”  There are no fines, no ramifications except that any company who is not complying will be known to the public through the public disclosure of the results. The public will simply have to vote with their wallets if they see a company is not complying.

When This Begins

Mandatory compliance begins on January 1, 2022, and all regulated entities must comply with the requirements of the NBFDS beginning on that date. 
 
There are a couple of places you can read all these sordid details:The Federal Register or This public inspection document also at the federal register.