I wanted to give those of you a heads up about some draft legislation in Massachusetts. This bill is currently scheduled for a hearing on September 13, 2011. It is another bad bill in yet another state. It is this patchwork of laws that activists are attempting to create in multiple states that makes me long for a Federal cosmetics bill that includes preemption.
It simply is not feasible for businesses to follow a different law in every state that they sell their products in. Without a cosmetic law that has federal preemption we will be faced with a new set of proposed regulations in one state after another. The good news is that we won in Colorado and we can win again in Massachusetts.
You can find Bill H02361 here of the Commonwealth of Massachusetts or read it with my comments below.
Petitioners: Bradley H. Jones, George N. Peterson, Elizabeth Poirier, Viriato M. deMacedo, Donald F. Humason, F. J. Barrows, George Ross, Donald Wong, Sheila Harrington, Matthew Beaton, Paul K. Frost
SECTION 1. Chapter 94 of the General Laws, as amended by chapter 154 of the acts of 2010, is hereby amended by inserting after section 329 the following new section:-
Section 330. As used in this section, section 330A, section 330B, and section 330C, the following terms, shall, unless the context clearly indicates otherwise, have the following meanings:-
“Authoritative body”, any federal, state, or private agency or formally organized program or group recognized pursuant to the General Laws as being authoritative for the purpose of identifying chemicals that cause cancer, or reproductive, or developmental toxicity.
My concern with this section of the bill that an “Authoritive Body” is defined as “any federal, state, or private agency or formally organized program or group…” This leaves the door wide open with a welcome in sign for unscientific and alarmist groups such as the Environmental Working Group (EWG) and The Campaign for Safe Cosmetics (CFSC).
“Bureau”, the bureau of environmental health.
“Commissioner”, the commissioner of public health.
“Chemical identified as causing cancer or reproductive or developmental toxicity”, a chemical identified pursuant to section 330B of chapter 94 or by an authoritative body, including, but not limited to: (a) a substance listed as known or reasonable anticipated to be a human carcinogen in a National Toxicology Report; (b) a substance given an overall carcinogenicity evaluation of Group 1, Group 2A or Group 2B by the International Agency for Research on Cancer; (c) a substance identified as a Group A, Group B1, or Group B2 carcinogen, or as a known or likely carcinogen by the United States Environmental Protection Agency; (d) a substance identified as having some clear evidence of adverse developmental, male reproductive, or female reproductive toxicity effects in a report by an expert panel of the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction.
The dangerous wording here is, “or by an authoritative body, including, but not limited to” because in the eyes of EWG and CFSC everything on earth and the majority of cosmetic ingredients should be banned. They believe in governing based on the Precautionary Principle. You can read more about the dangers of dictating legislation based on fears here.
“Department”, the department of public health.
“Director”, the director of the bureau of environmental health.
“Ingredient”, a chemical in a cosmetic, including, but not limited to: (a) chemicals that provide a technical or functional effect; (b) chemicals that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient; (c) processing aids that are present by reason of having been added to a cosmetic during the processing of such cosmetic; (d) substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect; (e) contaminants present at levels above technically feasible detection limits; (f) contaminants that may leach from container materials or form via reactions over the shelf life of a cosmetic and that may be present at levels above technically feasible detection limits; (g) components of a fragrance, flavor, or preservative declared individually by their appropriate label names; (h) any chemical identified by the phrase “and other ingredients” and determined to be a trade secret pursuant to the procedure established in Part 20 of Section 720.8 of Part 720 of Title 21 of the Code of Federal Regulations; or (i) any individual component of a botanical, petroleum-derived, animal-derived, or other ingredient that the Commissioner or the Director determines to be considered an ingredient.
The definition of a cosmetic ingredient is extremely broad here. The definition of an ingredient covers everything and the kitchen sink. Just in case they missed anything in their big stroke of ingredients they added, “or (i) any individual component of a botanical, petroleum-derived, animal-derived, or other ingredient that the Commissioner or the Director determines to be considered an ingredient.” This goes all the way back to old language on The Safe Cosmetics Act 2010 that would make ingredient list insanely long by listing every single component of everything on earth.
Under the approach this bill is asking for a simple product that contains cocoa butter, olive oil and lavender essential oil would have an ingredient deck that looks like this: Olive Oil (Tri-Glycerides of Palmitic, Di-Glycerides of Palmitic, Palmitoleic, Stearic, Oleic, Linoleic, Arachidic Acid, Linolenic Acid, Squalene, Beta Carotene, Campesterol, Methylenecholesterol, Stigmasterol, Sitosterol, Fucosterol, 28-Isofucosterol, Stigmadienol, Brassicasterol, 7-Cholestenol,Ergostadienol, Avenasterol, Triterpene Alcohols, Tirucallol, Taraxerol, Dammaradienol Beta-Amyrin Germanicol, Butyrospermol, Parkeol, Cycloartenol, Tirucalladienol, 24-Methlene 24-Dihydroparkeol, 24-Methlenecycloartanol, Cyclobranol, 4-Methyl Sterols, Esters of Tyrosol, Esters of Hydroxytyrosol, Vitamin E (Tocopherols), Carotenoids, Oleuropein), Cocoa Butter (Tri and Diglycerides of Stearic Acid, Palmitic Acid, Lead, Oleic Acid, Linoleic Acid, Isoleic Acid, Beta Carotene, p-Hydroxybenzoic Acid, Vanillic Acid, Ferulic Acid, Syringic Acid, Phenylehtylamine, Theophylline, Aliphatic Esters, Aromatic Carbonyls, Caffeine, Theobromine, Diketopiperazines and Alkylpryazines), Lavender Essential Oil ( Cineole Octanol, Octanone, Alpha Bisabolol, Alpha Cadinol, Alpha Humelene, Alpha Phellandrene, Apha Pinene, Alpha Terpinene, Alpha Terpineol, Alpha Terpinyl Acetate, Alpha Thujene, Alpha Thujone, Beta Bisabolol, Beta Pinene, Beta Thujone, Borneol, Bornyl Acetate, Camphene Camphor, Cineolealpha Terpineol, Carvone, Caryophyllene, Carophyllene Oxide, CIS Alpha Terpineol, CIS Alpha Bisabolene, CIS Carveol, CIA Linalol Epoxide, CIS Ocimene, Citronellal, Citronellol, Coumarine, Cuminaldehyde, Eugenol, Furfural, Geraniol, Geranyl Acetate, Geranyl Butyrate, Hexanol, Hexyl Tiglate, Isoborneol, Lavandulol, Lavandulyl Acetate, Limonene, Linanlol, Linalyl Acetate, Methyl Heptenone, Myrcene, Nerol, Neryl Acetate, Oleanolic Acid, P Cymene, Rosemarinic Acid, Sabinen, Terpinenol, Terpinolene, Trans Carveol, Trans Epoxy Linalyl Acetate, Trans Linanol Epoxide, Trans Ocimene, Ursolic Acid)
“Technically feasible detection limits” can be as low as 1 ppb (part per billion is 0.000000001 of your finished product. This means that your sweet orange essential oil is going to now need to list phthalates because they can be detected at higher than 1 ppb and all your fragrance oils will have a very long list of components. “Common contaminants include biocides and phthalates, and traces of heavy metals have been found in cold-pressed citrus oils.” Robert Tisserand
This section has the finger prints of CFSC all over it. Check out the links to the Safe Cosmetics Act 2011 here.
“Ingredient of concern”, any ingredient reported to the bureau by a manufacturer for being a chemical identified as causing cancer, or reproductive, or developmental toxicity.
“Manufacturer”, any entity, including a distributor, whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations.
Section 330A. (a) Any manufacturer of any cosmetic product subject to regulation by the federal Food and Drug Administration that is sold in the commonwealth shall, on a schedule and in electronic or other format as determined by the bureau, provide the bureau with a complete and accurate list of its cosmetic products that, as of the date of submission, are sold in the state and that contain any ingredient that is a chemical identified as causing cancer, or reproductive, or developmental toxicity, as defined in section 330. Any ingredient determined to be a trade secret shall be treated by the bureau in a manner consistent with the requirements of Part 20 and Part 720 of the Title of the Code of Federal Regulations. Any information submitted by a manufacturer pursuant to this section shall identify each chemical both by name and Chemical Abstract Service number and shall specify the product or products in which the chemical is contained.
Since the language used says, ““Manufacturer”, any entity, including a distributor, whose name appears on the label of a cosmetic product…” that means that every manufacturer who sells product into Massachusetts will be governed by this law. Since there is currently no Federal law that includes preemption we could end up with a patchwork of regulations from state to state. It would not matter if you lived and worked in Massachusetts – f you wanted to sell product into the state you would be required to follow this law.
(b) Each such manufacturer shall submit said list one year after this act takes effect and shall update said list according to a schedule determined by the bureau.
(c) The commissioner shall compile and maintain a master list of all manufacturers selling cosmetics, in the commonwealth, that sell or distribute products that contain ingredients that are chemicals identified as causing cancer, or reproductive, or developmental toxicity, as well as, a master list of all ingredients of concern.
(d) Up-to-date master lists shall be reported to the attorney general, the executive office of energy and environmental affairs, the department, as well as, the General Court and made available to the public on an annual basis as determined by the commissioner.
(e) This section shall not apply to any manufacturer of cosmetic products having fewer than 100 employees or with annual aggregate sales of cosmetic products, both within and outside of Massachusetts, of less than $5,000,000 during the previous year.
This would exempt most small businesses from following the Massachusetts law.
Section 330B. (a) In order to determine the potential health effects of exposure to ingredients of concern in cosmetics sold in the commonwealth, the bureau may conduct an investigation of one or more cosmetic products that contain said ingredients of concern or of other ingredients that are of concern to the bureau for potentially causing cancer or biologically adverse effects on the reproductive systems of female or male humans or animals, including alterations to the female or male reproductive system development, the related endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions that are dependent on the integrity of the reproductive system.
It is interesting that it states “one or more cosmetic products that contain said ingredients” can be tested. This would make the section above that exempts small businesses a mute point because they would still be fair game to be chosen for this random test. And will the state of Massachusetts create a testing facility for these tests? Or hire scientists to do the research in order to understand the data that they collect?
(b) An investigation conducted pursuant to subsection (a) may include, but not be limited to, a review of available health effects data and studies, work-site health hazard evaluations, epidemiological studies to determine the health effects of exposure to chemicals in various sub-populations, and exposure assessments to determine total exposures to individuals in various settings.
(c) If an investigation is conducted the director may require the manufacturer of any product subject to the investigation to submit relevant health data and studies to the bureau.
Another place in which the small businesses previously exempt could get caught up in this regulation.
(d) The bureau may require a manufacturer of products subject to investigation to submit to the bureau relevant health data and studies reasonably available to the manufacturer and other available information as requested by the bureau, including, but not limited to:
(1) all reasonably available information regarding the physical, chemical, and toxicological properties of chemicals in products under investigation;
(2) the concentration of ingredients of concern in the product under investigation;
Wow! That means that you won’t have to just give your ingredient list to them but also surrender your formula!
(3) the amount by volume or weight of the product that comprises the average daily application or use;
(4) sales and use data necessary to determine where the product is used in the occupational setting;
And you need to give them a list of your customers.
(5) exposure and fate information;
(6) tests of the finished cosmetics; and
And they are requiring undefined pre-market tests on your products.
(7) any other information used to substantiate the safety of such cosmetics or ingredients.
More undefined pre-market testing.
(e) The bureau shall establish reasonable deadlines for the submittal of information required pursuant to section 330B.
(f) This section shall not apply to any manufacturer of cosmetic products having fewer than 100 employees or with annual aggregate sales of cosmetic products, both within and outside of Massachusetts, of less than $5,000,000 during the previous fiscal year.
This is interesting. My guess is that it is in here because small businesses were so loud in Colorado and with attempts made in 2007, 2008, 2009 and 2010 against excessive regulation. I don’t believe this will stand up through mark-up unless they specifically state that the random tests of finished cosmetics will only be done on registered companies and not from a random field sampling of cosmetics sold in the state.
Another caution is to not think too small. Your business might be a one man show right now, but any business can take off and become a 5 million dollar company. Allowing a patch work of regulation to take place in every state just because in some states you are currently exempt is dangerous to your growth.
Section 330C. (a) The commissioner and the director shall require manufacturers to label cosmetic products sold and distributed in the commonwealth with a consumer warning if the product contains a known carcinogen or chemical identified as causing reproductive or developmental toxicity. The label shall include the signal word “WARNING or CAUTION” and the commissioner and the director shall promulgate such rules and regulations as it shall deem necessary to implement the provisions of this section.
This means that cosmetics sold in Massachusetts will carry the same working label as ones in California.
(b) All cosmetics that are available for retail sale shall be labeled in a manner that complies with the requirements under subsection (a) and manufacturers shall comply with subsection (a) no later than 2 years after the passage of this act.
(c) If a manufacturer, who sells cosmetic products containing chemical identified as causing cancer or reproductive or developmental toxicity, fails to comply with this section, the manufacturer’s relevant products shall be deemed adulterated and misbranded pursuant to section 186 and section 187 of chapter 94.
(d) The bureau shall report to the attorney general, the executive office of energy and environmental affairs, the department, as well as, the General Court investigations made pursuant to subsection (a) of section 330B, enforcement action, and recommendations, if any, together with drafts of legislation necessary to carry out its recommendations, by filing the same with the clerk of the House of Representatives on an annual basis as determined by the commissioner.
(e) This section shall not apply to any manufacturer of cosmetic products having fewer than 100 employees or with annual aggregate sales of cosmetic products, both within and outside of Massachusetts, of less than $5,000,000 during the previous fiscal year.
Interesting that this is third time that they stated it. I can see growing companies and bigger companies splitting of their brands and divisions in order to work around this law.
SECTION 2. Section 186 of said chapter 94, is hereby amended by inserting after the word, “use.” in line 107, the following new paragraph:- Sixth, if a product containing a chemical identified as causing cancer or reproductive or developmental toxicity is not labeled pursuant to section 330C of chapter 94.
SECTION 3. Section 187 of said chapter 94, is hereby amended by inserting after the word, “misleading.” in line 175, the following new paragraph:- Fourth, if a product containing a chemical identified as causing cancer or reproductive or developmental toxicity is not labeled pursuant to section 330C of chapter 94.
SECTION 4. Notwithstanding any general or special law to the contrary, there shall be a special commission, called the Commission on Safe Cosmetics, to study and report on the implementation of the Massachusetts Safe Cosmetics Act, as well as the need for additional legislation to regulate cosmetics sold and distributed in the commonwealth. The commission shall consist of the attorney general; the commissioner of the department of environmental protection; the secretary of energy and environmental affairs; the commissioner of public health; the director of environmental health; 3 members of the house of representatives, 2 of whom shall be appointed by the speaker of the house, and 1 of whom shall be appointed by the minority leader of the house; 3 members of the senate, 2 of whom shall be appointed by the senate president, and 1 of whom shall be appointed by the senate minority leader; 5 members appointed by the attorney general, 1 of whom shall be a distributor of cosmetics, 2 of whom shall be experts in the area of toxicity: one from the UMass Lowell Center for Sustainable Production and one from The Warner Institute of Green Chemistry, and 2 of whom shall be the owners of businesses in the commonwealth that sells cosmetics, at least 1 of which has signed the Compact for Safe Cosmetics; and 1 member shall be appointed by the governor. The scope of the commission shall include, but not be limited to: researching, evaluating, and developing recommendations regarding the economic, environmental, and public health benefits and costs of regulating cosmetics sold and distributed in the commonwealth, specifically of phasing out ingredients containing chemicals identified as causing cancer or reproductive or developmental toxicity, pursuant to section 330 of chapter 94, and when possible substituting them with safer alternatives. The commission shall research, assess, and develop recommendations regarding the commonwealth’s current green chemistry capacity and the commonwealth’s economic development potential for safe cosmetics ingredients. The commission shall consult with environmental advocacy organizations, such as the Massachusetts Breast Cancer Coalition, Clean Water Action, and the Massachusetts Coalition for Occupational Safety and Health, as well as, manufacturers, retailers, local units of government, and other interested parties, including providing at least one opportunity for public comment as well as the public review of the commission’s draft report. The commission shall prepare a final report of the findings and recommendations together with recommendations for legislation to implement those recommendations by filing the same with the clerks of the senate and house not later than July 31, 2012. The commission shall not receive compensation.
The most telling section of this bill is right here in this section. The Commission on Safe Cosmetics created by this bill must contain “…2 of whom shall be the owners of businesses in the commonwealth that sells cosmetics, at least 1 of which has signed the Compact for Safe Cosmetics.” The compact is now a closed group and whoever is a signer in Massachusetts right now would automatically be eligible for a seat on this commission. The Campaign for Safe Cosmetics wrote themselves right into this bill.