Kayla has done a fabulous job breaking down the Safe Cosmetics Act of 2011. We are starting at the end of the bill and working our way to the beginning. Here is the post that breaks down SEC 614 Safety Standard and Good Manufacturing Practices.
KEY: All Plain Text is directly from H.R. 2359 as it is written, Green is my commentary and Blue to show previous text from The Safe Cosmetic Act 2011.
‘‘SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING PRACTICES.
‘‘(a) SAFETY STANDARD.—
‘‘(1) IN GENERAL.—Taking into account the expected use of a cosmetic, the Secretary shall establish a safety standard that, with respect to a cosmetic or an ingredient in a cosmetic provides a reasonable certainty of no harm (as such term is defined in section 611(7)) from exposure to the cosmetic or ingredient and protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient.
This made me wonder how “reasonable certainty of no harm” could possibly be defined…read on.
‘‘(2) STANDARDS FOR ESTABLISHING SAFETY STANDARD.—In establishing the safety standard under paragraph (1), the Secretary shall ensure that—
‘‘(A) the likely level of exposure to all sources of the ingredient or cosmetic (including environmental sources) that will result under the safety standard presents not more than in a million risk for any adverse health effect in any vulnerable population at the lower 95th percentile confidence interval; or ‘‘(B) the safety standard results in exposure to the amount or concentration of an ingredient or cosmetic that is shown to produce no adverse health effects, incorporating an margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources (including environmental sources).
I admit. I had to read this section a few dozen times to follow along. In order to set the safety standard in which a “reasonable certainty of no harm” can be caused by a cosmetic or ingredient for any adverse health effects you must consider:
- Exposure of all sources of the cosmetic, an ingredient or a component of an ingredient including other cosmetics, lifestyle, environment and so forth of every potential user of your finished cosmetic. (Exactly how can anyone do that?)
- After considering all, you must be absolutely certain that there is no more than a one in a million chance of ANY adverse health effect to said potential users. (Again, how?)
- You must make your product that is for the average consumer as if you are making it for the vulnerable populations. Which was earlier defined as ‘‘(9) VULNERABLE POPULATIONS.—The term ‘vulnerable populations’ includes pregnant women, infants, children, the elderly, people with compromised immune systems, and highly exposed populations, including workers employed by hair salons, nail salons, beauty salons, spas, other establishments that provide cosmetic treatment services for humans, and cosmetic manufacturing plants.” SCA 2011 I have major problems with this concept. This would mean that since I have asthma and allergies and there is way more than a 1 in a million chance that a soap containing fragrance oil would cause an adverse health effect (i.e. shortness of breath, rash, hives, asthma attack) that cosmetic companies would not have the right to sell a strawberry scented soap or any scented product for that matter. And you won’t have the right to purchase it all because the government doesn’t trust me in the “vulnerable population” to avoid purchasing and using the strawberry scented soap.
- I’m going to need a refresher course on Statistics in order to explain the “at the lower 95th percentile confidence interval” portion of this section. According to the Yale Stats website “a confidence interval gives an estimated range of values which is likely to include an unknown population parameter, the estimated range being calculated from a given set of sample data.” You can read more here on confidence intervals.
- Whether you are a small business, crafter, soapmaker, aromatherapist or big business everyone must comply with this section of the legislation. And you thought registration and a fee was the problem with this bill. Try regulation that no one can comply with and holes so big the government can find ample reasons to shut you down.
‘‘(3) USE OF OTHER FEDERAL STANDARDS.—If any Federal agency has promulgated a standard for an ingredient that satisfies the requirements under paragraph (1), the Secretary may treat such standard as the safety standard under paragraph (1) for purposes of such ingredient.
Definition of promulgation is “the act of formally proclaiming or declaring a new statutory or administrative law after its enactment.” This means that you will have to keep watch on every Federal agency if you haven’t registered your business. If you register your business then it will fall upon the FDA to notify all registered businesses upon a change in the regulation of an ingredient.
‘‘(4) APPLICATION OF SAFETY STANDARD.—
The Secretary may only determine that an ingredient or a cosmetic meets the safety standard under paragraph (1) if there is a reasonable certainty of no harm from exposure to the ingredient or cosmetic.
This appears to be repeating the fact that there must be less than a one in a million chance of an adverse health effect.
‘‘(b) GOOD MANUFACTURING PRACTICES.—
‘‘(1) IN GENERAL.—The Secretary shall issue guidance prescribing good manufacturing practices for cosmetics and ingredients, including quality control procedures that the Secretary determines are necessary, and shall update such regulations as necessary.
You can read about current Good Manufacturing Practices here.
‘‘(2) CONSIDERATION OF SMALL BUSINESS.—In developing the guidance under paragraph (1), the Secretary shall consider how such practices will impact small businesses.
It is nice to see this added. There are some practices in cGMP that are antiquated and difficult for small businesses to comply with. For instance: “Production (d.)Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.” Of course, since this is not defined it does leave it open to them making the requirements more difficult to follow even thought they “considered” the impact on small businesses.