This is a guest Blog Post by Jerell Klaver.
In the last few days there has been a lot of talk about Colorado House Bill 10-1248 known as the “COLORADO SAFE PERSONAL CARE PRODUCTS ACT”. Elissa was initally approached to speak in favor of this bill, and with a title of Safe Personal care Products Act who couldnt speak against it? Then we read the Bill.
WOW! After reading it became very apparent that this bill had nothing to do with Personal Care Safety, but rather had everything to do with the destruction of Manufacturing jobs here in Colorado, putting Colorado Manufacturing under the control of the United Nations in France, and providing a great gravy train for lawyers. If this Bill passes it will result in ethical small business engaged in organic and natural product manufacturing in Colorado to be plagued by numerious of lawsuits, civil penalties, and probably result in companies like ours having to close our doors or move out of Colorado.
It is very important that I provide you with a quick recap about our company Salus, Elissa and myself.
- Salus Natural Body Care was founded by Elissa and Jerell Klaver
- Salus a Woman and Veteran Colorado Small Business.
- Elissa is a Cancer (Leukemia) Survivor.
- Our second son Gabriel passed away due to a chromosome translocation birth defect.
As you can tell the prevention and cure of Cancer and Birth Defects are so very, very important to us. We even created a company that is committed to making safe personal care and products that are made with certified organic and natural ingredients.
SALUS is in STRONG OPPOSITION TO THIS BILL AS IT IS CURRENTLY WRITTEN.
What does the fine print of this Bill achieve?
- It ends Colorado Manufacturing of Personal Care products,
- Puts the UN and other agencies in control of Colorado Manufacturing regulations,
- Implements a highly litigious environment, and discourages related businesses,
- It further may result in the importation of NON-Colorado products to be sold in Colorado.
Simply put, this bill as introduced is ANTI-Colorado and ANTI-USA, ANTI-Manufacturing. When States are begging for jobs and tax revenues, Colorado may be taking actions to increase unemployment, close companies, and take jobs away from hard working people. This Bill does not prevent the consumers use of any ingredient identified in the Bill. It simply prohibits the Manufacturing of items.
I will not be addressing the specific ingredients as there has been some great analysis done into the specific ingredientsthat may be included in this legislation, and how many of them may not even be cancerous, nor cause birth defects. My next post tonight will include a link to all of these great articles. My focus here is to address the current Bill as it has been introduced.
So lets look at the actual language of the Bill as it has been introduced focusing on the Definitions section of the Bill. . My comments are in Blue Bold, and underlined, with links to the respective websites appropriate.
27 25-5-1203. Definitions. AS USED IN THIS PART 12, UNLESS THE
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1 CONTEXT OTHERWISE REQUIRES:
2 (1) “AUTHORITATIVE BODY” MEANS THE FOLLOWING AGENCIES OR
3 FORMALLY ORGANIZED PROGRAMS OR GROUPS RECOGNIZED AS
4 AUTHORITATIVE FOR PURPOSES OF IDENTIFYING CHEMICALS THAT CAUSE
5 CANCER OR REPRODUCTIVE TOXICITY:
6 (a) THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
7 OR ITS SUCCESSOR AGENCY;
The EPA
8 (b) THE UNITED STATES FOOD AND DRUG ADMINISTRATION, OR ITS
9 SUCCESSOR ENTITY;
The FDA
10 (c) THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND
11 HEALTH, OR ITS SUCCESSOR ENTITY;
NIOSH is part of The Department of Health and Human Services Centers for Disease Control and Prevention (CDC)
12 (d) THE NATIONAL TOXICOLOGY PROGRAM, OR ITS SUCCESSOR
13 PROGRAM; AND
NTP is part of The Department of Health and Human Services
14 (e) THE INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, OR
15 ITS SUCCESSOR AGENCY.
The IARC is part of the World Health Organization (WHO) which is part of the United Nations (UN).
The IARC is located in FRANCE.
16 (2) “CHEMICAL IDENTIFIED AS CAUSING CANCER OR REPRODUCTIVE
17 TOXICITY” MEANS A CHEMICAL IDENTIFIED BY AN AUTHORITATIVE BODY
18 AS ANY OF THE FOLLOWING:
19 (a) A SUBSTANCE LISTED IN A NATIONAL TOXICOLOGY REPORT ON
20 CARCINOGENS AS KNOWN OR REASONABLY ANTICIPATED TO BE A HUMAN
21 CARCINOGEN;
What does A SUBSTANCE LISTED IN A NATIONAL TOXICOLOGY REPORT mean? Can this be defined as any item listed in a report on carcinogens, even if it is not found to be identified to be carcinogenic or or causing reproductive toxicity? This is VERY vague.
22 (b) A SUBSTANCE GIVEN AN OVERALL CARCINOGENICITY
23 EVALUATION OF “GROUP 1″, “GROUP 2A”, OR “GROUP 2B” BY THE
24 INTERNATIONAL AGENCY FOR RESEARCH ON CANCER OR ITS SUCCESSOR
25 AGENCY;
This is unclear, however my assumption is that it is refering to the Complete List of Agents evaluated and their classification by the IARC.
Group 1
Group 2A
Group 2B
26 (c) A SUBSTANCE IDENTIFIED BY THE UNITED STATES
27 ENVIRONMENTAL PROTECTION AGENCY, OR ITS SUCCESSOR AGENCY, AS A
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1 “GROUP A”, “GROUP B1″, OR “GROUP B2″ CARCINOGEN OR AS A KNOWN OR
2 PROBABLE CARCINOGEN;
Althought this is unclear, I am of the understanding that this is meant to refer to the:
FDA Integrated Risk Information System (IRIS), based off of 1986. http://www.epa.gov/iris/
Where you can search the items here. http://www.epa.gov/ncea/iris/search_human.htm
3 (d) A SUBSTANCE IDENTIFIED IN A REPORT BY AN EXPERT PANEL OF
4 THE NATIONAL TOXICOLOGY PROGRAM’S CENTER FOR THE EVALUATION OF
5 RISKS IN HUMAN REPRODUCTION, OR A SUCCESSOR ENTITY, AS HAVING
6 SOME OR CLEAR EVIDENCE OF ADVERSE DEVELOPMENTAL, MALE
7 REPRODUCTIVE, OR FEMALE REPRODUCTIVE TOXICITY EFFECTS; OR
This again is very unclear. My best educated guess is that this is refering to the The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) of which it is referring to the Report on Carcinogens (RoC)
where the detailed lists can be found at
http://ntp.niehs.nih.gov/index.cfm?objectid=32BA9724-F1F6-975E-7FCE50709CB4C932
and
http://ntp.niehs.nih.gov/ntp/roc/eleventh/append/indexa.pdf
however THIS IS NOT FOR CERTIN.
8 (e) A SUBSTANCE IDENTIFIED BY THE NATIONAL INSTITUTE FOR
9 OCCUPATIONAL SAFETY AND HEALTH, OR ITS SUCCESSOR ENTITY, AS A
10 POTENTIAL OCCUPATIONAL CARCINOGEN.
This may be referring to the section on Occupational Cancer where the list can be found here:
11 (3) (a) “MANUFACTURER” MEANS ANY PERSON WHOSE NAME
12 APPEARS ON THE LABEL OF A PERSONAL CARE PRODUCT PURSUANT TO THE
13 REQUIREMENTS OF 21 CFR 701.12.
21 CFR 701.12 is the FDA’s regulations for Cosmetic Labeling.
Specifically… § 701.12 Name and place of business of manufacturer, packer, or distributor.
(a) The label of a cosmetic in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
14 (b) “MANUFACTURER” DOES NOT INCLUDE A RETAILER THAT SELLS
15 PERSONAL CARE PRODUCTS AT RETAIL TO CONSUMERS UNLESS THE
16 RETAILER IS ALSO THE MANUFACTURER OF THE PERSONAL CARE PRODUCT.
Companies (like SALUS) that make their own product and sell it at retail would fall under this category.
This also means that a Retailer can sell any product that they do not manufacturer.
This is where questions are initially raised on who may sell in Colorado, Is the Door now open to prohibit Colorado Companies from manufacturing and selling in Colorado, while NON-Colorado companies can sell in Colorado?
17 (4) (a) “PERSONAL CARE PRODUCT”, “COSMETICS”, OR “COSMETIC
18 PRODUCT” MEANS, CONSISTENT WITH “COSMETICS”, AS DEFINED IN 21
19 U.S.C. SEC. 321 (i) OF THE FEDERAL “FOOD,DRUG, AND COSMETIC ACT”:
21 U.S.C. SEC. 321
20 (I) ANY ARTICLE INTENDED TO BE RUBBED, POURED, SPRINKLED,
21 OR SPRAYED ON, INTRODUCED INTO, OR OTHERWISE APPLIED TO THE
22 HUMAN BODY OR ANY PART THEREOF FOR CLEANSING, BEAUTIFYING,
23 PROMOTING ATTRACTIVENESS, OR ALTERING A PERSON’S APPEARANCE;
The language of the bill is confusing as the actual FDA regulation goes on to say:
and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
QUESTION: Does this mean that SOAP manufacturing is or is not included as part of this legislation?
24 AND
25 (II) ANY ARTICLE INTENDED FOR USE AS A COMPONENT OF ANY
26 ARTICLES DESCRIBED IN SUBPARAGRAPH (I) OF THIS PARAGRAPH (a).
27 (b) “PERSONAL CARE PRODUCT”, “COSMETICS”, OR “COSMETIC
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PRODUCT” INCLUDES, IN 1 ADDITION TO THOSE ARTICLES DESCRIBED IN
2 PARAGRAPH (a) OF THIS SUBSECTION (4), ANY COSMETIC PRODUCT
3 SUBJECT TO REGULATION BY THE FEDERAL FOOD AND DRUG
4 ADMINISTRATION.
5 25-5-1204. Prohibition – sale of personal care products
6 containing unsafe chemicals. ON OR AFTER SEPTEMBER 1, 2011, A
7 MANUFACTURER SHALL NOT SELL, OFFER FOR SALE, DISTRIBUTE FOR SALE,
8 OR DISTRIBUTE FOR USE IN THIS STATE ANY PERSONAL CARE PRODUCT
9 THAT CONTAINS A CHEMICAL IDENTIFIED AS CAUSING CANCER OR
10 REPRODUCTIVE TOXICITY.
This is the kicker inserting FDA definitions from the FDA’s 21 CFR 701.12
The manufacturer, packer, or distributor SHALL NOT SELL,
The manufacturer, packer, or distributor SHALL NOT OFFER FOR SALE,
The manufacturer, packer, or distributor SHALL NOT DISTRIBUTE FOR SALE
The manufacturer, packer, or distributor SHALL NOT DISTRIBUTE FOR USE IN THIS STATE ANY PERSONAL CARE PRODUCT THAT CONTAINS A CHEMICAL IDENTIFIED AS CAUSING CANCER
A manufacture as defined above is a Colorado Company or a Company that manufactures in the State of Colorado.
- This means a Colorado manufacturer CANNOT SELL.
- A Colorado manufacturer CANNOT OFFER FOR SALE
- A Colorado manufacture CANNOT DISTRIBUTE
This means JOBS WILL BE LOST IN COLORADO
IT IS UNCLEAR at this time if NON-Colorado Companies will retain the ability to sell into Colorado.
However it is reasonable to expect that NON-Colorado companies will still be able to sell directly in Colorado if this Bill becomes law as written.
11 25-5-1205. Enforcement by private citizens – civil penalty.
12 (1) ANY PERSON ALLEGING A VIOLATION OF SECTION 25-5-1204 MAY
WOW! All a person has to do is ALLEGE a violation and the Colorado Manufacturer will be hauled into court.
Lets see, if a company has 99.9999% organic ingredients in a product, yet they use an item as defined in this Bill, they are in violation of this law.
13 BRING AN ACTION AGAINST THE MANUFACTURER IN A COURT OF
14 COMPETENT JURISDICTION IN THE COUNTY WHERE THE VIOLATION
15 OCCURRED. UPON FINDING A VIOLATION, IN ADDITION TO ANY OTHER
16 RELIEF AUTHORIZED BY LAW, THE COURT SHALL ORDER THE
17 MANUFACTURER TO CEASE AND DESIST CONDUCT VIOLATING SECTION
18 25-5-1204 AND SHALL ORDER THE MANUFACTURER TO PAY THE
19 PREVAILING PARTY REASONABLE ATTORNEY FEES AND COSTS.
WOW! Pay Attorney fees and costs for a potential oversight from a item that may be cancerous in France? Johnny come lawyer has got to love this. It is highly probably that Colorado company will not be able to get product liability insurance. Colorado Manufacturing is under the control of decisions made in PARIS FRANCE.
20 (2) A MANUFACTURER THAT VIOLATES SECTION 25-5-1204 IS
21 SUBJECT TO A CIVIL PENALTY OF UP TO FIVE THOUSAND DOLLARS PER
22 VIOLATION PER PRODUCT FOR A FIRST OFFENSE, AND UP TO TEN THOUSAND
23 DOLLARS PER VIOLATION PER PRODUCT FOR A SECOND OR SUBSEQUENT
24 OFFENSE. PENALTIES COLLECTED PURSUANT TO THIS SECTION SHALL BE
25 DEPOSITED IN THE GENERAL FUND.
Lets get this straight. A Colorado company that focuses on Natural and Organic Ingrediants, that used an item that may be just a word on a report in France, that may have Gross revenues per month of $10,000 is now fined Millions of Dollars?
26 SECTION 2. Act subject to petition – effective date -
27 applicability. (1) This act shall take effect at 12:01 a.m. on the day
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1 following the expiration of the ninety-day period after final adjournment
2 of the general assembly (August 11, 2010, if adjournment sine die is on
3 May 12, 2010); except that, if a referendum petition is filed pursuant to
4 section 1 (3) of article V of the state constitution against this act or an
5 item, section, or part of this act within such period, then the act, item,
6 section, or part shall not take effect unless approved by the people at the
7 general election to be held in November 2010 and shall take effect on the
8 date of the official declaration of the vote thereon by the governor.
9 (2) This provisions of this act shall apply to manufacturer conduct
10 on or after the applicable effective date of this act.
Thank you,
Jerell Klaver
EDITED TO INCLUDE
A BIG THANK YOU to the following Blogs /Authors
Kayla Fioravanti, RA Chief Formulator, Registered Aromatherapist at Essential Wholesale Labs
DONNA MARIA COLES JOHNSON, CEO + Founder: IBN Social Network
Robert Tisserand’s blog “Tunnel Vision” http://roberttisserand.com/2010/02/tunnel-vision/
Donna Marie’s blog “Oppose the Colorado Safe Personal Care Product Act” http://www.indiebusinessblog.com/2010/02/23/oppose-the-colorado-safe-personal-care-products-act/
Ann-Marie’s blog “You Can Die from Salt Too” http://soap-queen.blogspot.com/2010/02/you-can-die-from-salt-too.html
Cindy Jones’ blog, “Colorado Safe Cosmetics Act” http://sagescript.blogspot.com/2010/02/colorado-safe-cosmetics-bill.html
Kelly Bloom’s blog, “Colorado Safe Personal Care Products Act” http://southernsoapers.com/news/causes-concerns/colorado-safe-personal-care-products-act/
Lisa Rodgers’ blog, “Colorado Safe Personal Care Products Act : How Will it Effect You?” http://cactusandivy.blogspot.com/2010/02/colorado-safe-personal-products-act-how.html
Katherine Corkill blog, “Oppose Colorado Safe Personal Care Products Act.” http://sterlingminerals.blogspot.com/2010/02/oppose-colorado-safe-personal-care.html
Happi Magazine mentions the topic in “Preservative Market Update” http://www.happi.com/articles/2007/05/preservative-market-update
Handcrafted Soapmakers Guild “From the President, Colorado Safe Personal Care Product Act” http://www.soapguild.org/blog/2010/02/from-the-president-colorado-safe-personal-care-products-act/
Cosmetic & Toiletries site, “Bill Proposes the Colorado Safe Personal Care Product Act.” http://www.cosmeticsandtoiletries.com/regulatory/region/northamerica/84985577.html
Michelle Gilbert’s blog “Colorado versus the cosmetic industry” http://sarvasoap.com/blog/?p=706
