Saturday, August 21, 2010

The Fire-Bellied Toad

Thanks to a marketing gimmick and a hot car, Sonshine is now the owner of a fire-bellied toad.

First off, let me say that I really didn't want any more pets than we already have. Princess takes care of the LesBuns (our two Sapphic rabbits) and much as I'd like to fantasize about us having more pets, the reality is that it's just one more chore to add onto the list of chores I already can't get done every day. So when Bagel begs for a bird, or Knuckles pines for a cat, I say no.

Today I had a booth at Stansbury Days, and I gave the kids each a dollar to spend on spinning the wheel at the pet store booth. Sonshine proudly came back with a fire-bellied toad he won. Honestly I have no idea what to do with a fire-bellied toad. This is karma coming back to bite me for the day I brought a rabbit home without asking my parents first.

FH then took Sonshine and the boys home, but due to some circumstances that are unclear, the toad died somewhere between Stansbury Days and home. FH claims that the problem was Sonshine keeping the toad under his shirt to keep him out of the sun, while Sonshine claims FH made him wait in the hot car while he ran to get some propane and the heat killed the toad. Either way, Sonshine was in a complete meltdown state. His beloved toad, become so precious to him over the course of an hour, had perished.

FH immediately went to the pet store whose booth had so cruelly saddled us with a toad destined to die, and they replaced the toad for free because he also bought an entire toad-keeping kit for an amount of money that wasn't really in our budget.

I must congratulate whoever came up with this diabolically clever marketing strategy. Give the kids a real live animal, thereby forcing the parents to either allow the animal to die or buy it a habitat and some food, preferably at your store. This takes the winning-the-goldfish-at-the-carnival trick to a whole new level, because a goldfish can live for a time in just about any container of water, while an amphibian needs a water dish and coconut husk bedding and a shoebox-sized container with appropriately vented lid. So even as I curse you, you clever marketing strategist you, I raise my glass to you and toast your health.

Friday, August 13, 2010

Safe Cosmetics Act: The Problem With Ingredients

I thought I'd go into more depth as to why I think the Safe Cosmetics Act's definition of "ingredient" makes it impossible for totally innocuous ingredients to end up on the list of safe, nontoxic ones.

Unless you're a vegan, you probably ate one of these last November:

Mmmm. Turkey with stuffing. And the traditional herb to season this tasty dish? Sage. It just isn't Thanksgiving turkey stuffing unless it's got sage in it.

Now take a look at this chemical: thujone. [emphasis added]
Studies on the pharmacological and toxicological properties of the thujones are complicated by the fact that many experiments involved the use of ill-defined mixtures of the two isomers. Since the isomers differ markedly in toxicity and convulsant activity, quantitative data on mixtures of unspecified composition have to be interpreted with caution.
The convulsant properties of thujone, and of thujone-containing plant extracts, have been recognized for a long time (see review by Pinto-Scognamiglio, 1967).
The thujone-induced convulsions are epileptiform in character and are preceded by general vaso-dilation, fall in blood pressure, slowing of cardiac rhythm and augmentation of respiratory amplitude (Pinto-Scognamiglio, 1967).
A commercial mixture of alpha- and ß-thujone was administered by gavage to groups of 20 male and 20 female weanling rats at doses of 0, 12.5, 15.0 and 50.0 mg/kg/day for 13 weeks. The dose was given in five increments daily as a suspension in aqueous agar...
No dose-related deaths occurred in the rats receiving 12.5 or 25.0 mg/kg bw but 37% of the males and 60% of the females in the 50.0 mg/kg dose group died under test.
No data from metabolic, reproductive or long-term studies were available. Much of the information reported related to unspecified isomers or mixtures thereof. It appears that ß-thujone is significantly more toxic than the alpha-isomer and that female animals are more sensitive to the toxic effects than males. It is not possible to establish an ADI for man on the information available.
OMG!!!!! This stuff causes convulsions. It could be toxic depending on which of the 2 forms of it predominate in the mixture. It hurts women more than men. There's no known safe dose of it. It KILLS RATS. If there's anything that should end up on a banned ingredient list, it should be this, right?

Well, you survived Thanksgiving, didn't you? Other than having to listen to your grandpa and your great-uncle talk about politics, I mean. You see, thujol is a compound found naturally in sage. You actually ATE some of this awful stuff! In your turkey! You fed it to your kids! Your sisters and brothers and parents ate it too!

Why didn't it kill you? Were you just lucky?

Not every compound is toxic in every dose. You ate a serving of stuffing, and in that entire batch of stuffing was a tiny bit of sage, and in that tiny bit of sage was a tinier bit of thujol. That tiny bit of thujol was enough to make your stuffing taste good, but not enough to give you seizures. So clearly there's some level or dose of thujol that's perfectly safe to eat for dinner, even if you're a woman. Just because the precise safe level isn't known, or isn't consistent from person to person, doesn't mean it's unsafe at any level for anyone.

This is why I say that the "white list" of totally safe ingredients mandated by the Safe Cosmetics Act is only going to have fairy dust and powdered unicorn horn on it. Because if even food-grade sage isn't safe in any dose, what is?

Question: next Thanskgiving, are you going to insist your stuffing be sent to a lab to be tested to make sure the thujol level isn't too high? No? Why not? Is it because you know it's very likely to be safe, given how small the dose is? Well, if you're not going to send your turkey to the lab, why on Earth would you think cosmetics that contain similarly tiny amounts of sage essential oil need to go to the lab?

Tuesday, August 10, 2010

The Safe Cosmetics Act

I've recently become aware of the Safe Cosmetics Act (HR 5786), a piece of legislation currently under consideration. Right now it's in committee. It's sponsored by Rep. Jan Schakowsky, D-BizarroWorld. My regular readers know I prefer to read through legislation before I endorse or oppose it on the blog, and I was able to read through this bill. In my opinion, it is well up to its reputation as "CPSIA for cosmetics." Well, you all know how I feel about CPSIA. I don't want to see happen to my soapmaking friends what happened to us children's product makers. Since I took the time to read the bill through and take notes, I thought I'd share those notes with the class.

First of all, the bill's sponsor is a real piece of work. I won't go into it here, but suffice it to say she's not all that articulate and logical. It's pretty clear that she had some staffers, or at least someone other than her, write this bill. And whoever wrote it is good at what they do. It's more clearly thought out in many places than CPSIA, which was mostly a 60-page version of "just make the nasty nasty lead go away." In fact, if you start reading the legislation at Section 612, and you are of a moderately statist frame of mind, it doesn't sound like all that bad of a law. The problem comes when you combine the law with the definitions in the first part of the bill. Put the two pieces together, and you can tell that whatever her skills, the person who wrote the law hadn't learned CPSIA's most important lesson: that an industry can be killed by micromanagement at the molecular level.

Let's start by going over some of the more problematic sections of the bill.

Section 612:
You have to register annually to produce cosmetics. Registration entails listing some basic contact information, the number of employees, and the suppliers of your ingredients. Ingredient supplier lists are NOT subject to FOIA and thus (I think) the agency can't be forced to disclose them through a FOIA request. Of course, they could always voluntarily disclose them; they don't seem to be protected in any way. Registration seems minimal enough (though why it's the government's business is beyond me), but if you change anything (e.g. hire an employee or have to buy materials from a different supplier) you have 60 days to make the change. Cottage industry shouldn't have a problem with that, since it basically means you'd have to update your registration every 2 months. Larger small businesses would find this difficult to comply with. It also would be problematic if a backlog in processing all these registrations occurs, or if it effectively prohibits custom formulations. It sounds to me, though, like if you end up doing a custom formulation with materials from a new supplier, all you'd have to do is notify the government with a letter (or possibly even an email). It's a hassle, though, and one more straw on the camel's back. Still, this sort of registration is better than the sort that's in CPSIA.

I suppose the purpose of this provision is nominally to make it possible for a supplier who discovers their ingredients are tainted to tell the FDA and then the FDA will tell their customers. I'm not sure how that's better than the supplier just telling their own customers. After all, they do usually know who their own customers are. [shakes fist] Bunch of federal busybodies!

The fee schedule that's allowed for in the law is a blank check, and you all know why we shouldn't sign blank checks. FDA is to determine the fees later, so if they decide they need to spend a whole lot of your money, that's how much they'll ask for. Only businesses with gross receipts of $1 million or more are affected by the registration fees. One doubts the bill's writer has ever had any business experience; otherwise she would know that $1 million gross sales doesn't take a particularly large business to achieve. (Sure, you won't get near there if you're just selling a few soaps at the farmer's market, but a tiny home-based body product business could meet that mark.) And of course this means that we'll start to see businesses deliberately flying under the $1 million mark, because that extra lip balm just won't bring in enough revenue to cover the fee they now have to pay.

Section 613:
Somebody must have liked the retroactivity provisions of CPSIA, because they're in the Safe Cosmetics Act too. A year from enactment, all cosmetics have to meet the new labeling requirements. Unlike CPSIA, which allowed just six months for the changes, SCA is allowing 1 year. I don't know what the retail cycle is like for cosmetics or how fast they spoil, but a year sounds to me like a lower bound on how much time would be appropriate. I'm guessing this will mean a lot of cosmetics will get thrown away a year after enactment, unless manufacturers start complying with the labeling requirements early.

Section 614:
If you've got any testing data on your ingredients, the government wants you to share it with the class. You have a year in which to get it into the required electronic format (to be determined later). Reading this section I'm reminded of how CPSIA required us to comply with regulations by a deadline well before the date the regulations were even written. How much you wanna bet the FDA will come out with the details of the electronic format less than a week before the deadline, leaving manufacturers large and small (but mostly large, since they're the ones likely to have data) to scramble to get it in?

Also, you should only submit safety info that the government doesn't already have, using your incredible psychic powers to decide which info they have and don't have. OK, maybe they won't require you to be psychic. Maybe they'll task an entire bank of phone answerers to take your "Do you have this info already? How about that info?" calls. Or maybe it'll be one big Charlie Foxtrot like CPSIA was for the CPSC.

Oh, and you also have to make this info available to your retailers on request. (You don't have to make it available to consumers, but while you're getting it into an undefined electronic format, maybe you'd be able to post it on your website too.) At least the law doesn't require you to have this data; it just requires you to submit it if you have it. It would have been nice if they'd adopted that "if you've got it, share it" standard for lead testing certification in CPSIA.

On the same day as this submission deadline (evidently nobody realized that "1 year after enactment" and "12 months after enactment" are the same day), the FDA is required to publish it in a publicly available database, scrubbed of all confidential information. The mind boggles. I'm pretty sure government hasn't ever done ANYTHING in less than 24 hours, let alone something of this magnitude. This is going to be one exciting goat rodeo.

Based on this database of info, then, the FDA has an extra year after the submission deadline to use it to compile a list of which ingredients are safe and which aren't. The ones that aren't have to be put on either a prohibited list or a restricted list. If you submit additional information later, they have 90 days to update the list. FDA already has a list of banned ingredients, but evidently it's just not good enough and it has to be informed by the goat rodeo database. Anything that's "carcinogenic" (as determined by studies by anyone the FDA trusts) is required to go on either the prohibited or restricted list. There's no provision for the dosage, though an ingredient that's only a carcinogen if eaten daily by the pallet load for 80 years might end up on the restricted list and not the prohibited list, because the prohibited list is only for ingredients which are determined "unsafe in any amount." This interpretation, whether an ingredient is "unsafe in any amount," is made by the FDA and based on the "science" of anybody they feel they trust, so you can bet that if somebody there gets a bee in their bonnet about formaldehyde or lead or any other compound that naturally occurs in trace amounts, it'll end up on the prohibited list. There is one good thing though: the FDA is required to take public comments before they prohibit something potentially "carcinogenic." Nevertheless, it's written into the law that any "carcinogenic" substance is unsafe until proven safe by the Secretary's opinion.

In addition to this "black list" and "gray list," there's also to be a "white list" of totally safe ingredients that aren't carcinogenic in any way, in any amount. Based on my knowledge of chemistry, this list will have about 2 ingredients on it: fairy dust and ground unicorn horn.

After the ingredients on which we have data are all classified (and Lord knows how long that will take, since there are literally thousands of ingredients used in cosmetics), the FDA has to make a priority list of the top 300 ingredients they need more info about to make their determination. I didn't choose the number 300 randomly; somebody else pulled that number out of her butt. It's actually in the bill, because evidently they know that after they get done with their goat rodeo database, there will be a minimum of 300 ingredients left to put on the list. Also, they're required to add 100 ingredients to the list every year. I didn't make that number up either. They have to do that until they run out of ingredients to add to the list, a process estimated to take about 1000 years to terminate as people get more innovative with their cosmetics. OK, I admit I pulled the 1000 year figure out of my butt. In practice, this process will probably slow to a trickle after a few years, because that's about how long it'll take them to kill all the innovation in the industry.

This section says they'll have 2 years to gather data where they may on these listed ingredients, after which they have to put them on either the black, gray, or white lists. But Section 615 says that an ingredient will be automatically banned if it remains on the priority list for 5 years. It's pretty clear that they expect some ingredients to remain in limbo after their 2 year expiration, because Section 615 also contains a provision that any ingredient that stays on the list longer than 2 years will generate a complete paperwork nightmare... for its manufacturers. They will be obliged to send letters to every single one of their customers and the public informing them of the ingredient's pending status. Sounds like a great way to punish somebody they don't like, eh? Especially considering the FDA doesn't have to actually do anything with the ingredients that are on this list except collect all the information anyone is willing to give them.

In making their determination, they have to get public comments (but can shorten the period as much as they like, as long as they can rationalize it) and they get to consider such nontrivial things as whether the ingredient "persists in the environment" or is "found in drinking water" (doesn't that include just about everything?) You can tell they're thinking about phthalates, because they also put "endocrine disruptor" on the list of considerations. These "consumer" groups have a hard-on for phthalates. I can't imagine why; everyone knows BPA is the new trendy chemical fear.

There is one bright side to all this: there doesn't appear to be any prohibition in the bill on using these undetermined ingredients while they're under consideration, so at least they're not taking the "ban first, collect data later" approach that had CPSIA suddenly banning ballpoint pens and bicycle tire valve stems.

Section 615:
If you don't share your information on safety with the FDA, you will be banned from distributing or selling cosmetics. You will also be responsible for keeping up with FDA's progress on the priority list, because once an ingredient gets on the "black list" you have six months to take all your products that contain it off the market. If it gets on the "gray list" (as it seems most ingredients will, including many natural ones) and you've got too much of it in your product, you also have six months to take it off the market or change your formulation. Section 616 says you don't have to do an immediate recall unless you really screw the pooch and put out a product that kills or maims someone. The six month time limit may indicate that Schakowsky wasn't paying too close attention to the bill text. I'm surprised she didn't write it into the bill that you have to build a time machine and travel back in time to prevent you ever making the product in the first place, so devoted is she to public safety.

Section 616:
The major loophole in this section, which is about recalling truly horrid stuff, is the definition of "serious adverse event." One would hope that this would be limited to death and maiming, but given that we're talking about government, one would probably be wrong. Anaphylactic shock could be considered a "serious adverse event." I know something about anaphylactic shock since a third of my family has serious food allergies. One thing people don't generally realize is that it strikes unpredictably sometimes; you may not know you're allergic to something until you have a severe reaction to it after having used it safely many times. For every thing under the sun, there's somebody allergic to it. I really don't feel a product needs to be pulled off the market if someone, somewhere turns up allergic to it. The FDA, however, may have a different opinion.

Oh, and you can also trigger these massive sudden recalls if you merely forgot to register your establishment this year.

Oh, and also they can just issue an order for you to recall your stuff, regardless of all these rules. You don't mind that, do you?

Section 617:
So suppose BPA gets deposed as the reigning toxin scare du jour, and some other ingredient accedes to the throne; let's call it Ingredient X. Here's how that will work: Mrs. Biz E. Body sends a letter to the FDA complaining about Ingredient X and wanting it banned. The FDA decides this request is "reasonable" because Mrs. Body represents the Organization of Concerned Consumers, an offshoot of the Concerned Consumers Organization (reference link) and they like those people. Then the FDA has six months to publish a review of Ingredient X and decide whether, as Mrs. Body wants, it should be banned. And as we have seen, it's not that hard to get an ingredient banned; all you need is a bogus study that comes from a source the FDA has decided it can trust (like the Organization of Concerned Consumers) and a sympathetic FDA.

Boy, there's sure no opportunities for cross-pollination or mutual back-scratching there!

Section 618:
Now here's the provision that's got the cottage industry up in arms: the requirement to register every product. As if it's not bad enough you have to tell the government all your suppliers and keep that updated every year, for each product you also have to disclose where it's made, who distributes it, what the product is and what it's used for, the entire ingredient deck (more on that in a minute), any warnings and directions it comes with, and the name and address of the poor sap responsible for maintaining all this information. If any of this changes, you have to re-notify the government "in a timely manner" (whatever that means). If you roll out a new product you have six months to file it. This starts one year after enactment. Boy, is that going to be a busy day, what with the rollout of the goat rodeo database simultaneous with the deadline to submit to the goat rodeo database and everybody's annual registrations all coming due!

The FDA then has to make a list (thank goodness, not a database, just a big long scroll like the one Santa Claus has) of each and every lip balm and lotion that's made in everyone's basement all over the country. But then they have to add all this stuff to the database of safe ingredients. And guess when they have to do it by? Yeah, 1 year after enactment-- the same day that's the deadline for you to submit your product registrations. And for you to submit your product safety information. Which is supposed to go in the same database which has to be rolled out by that same day.

I get the feeling somebody failed to realize the magnitude of the task they were imposing on the FDA. It sure doesn't sound like only 12 months' work to me. But that's typical. These kinds of bills are written by people who think the entire toy industry consists of Hasbro, Mattel, and maybe a couple of people at the farmer's market. I bet they think the cosmetics industry is Maybelline and Revlon and maybe Avon or Mary Kay.

I've heard complaints that this provision would cause problems for small manufacturers who carry, say, 40 or 50 different flavors of lip balm. They'd have to produce that many individual submissions. However, most of the ingredients of things like that would be the same from flavor to flavor, and if they're printing labels they probably already have their ingredient lists in some copy-and-pastable form. That would make the submissions roughly analogous to the General Conformity Certificates that CPSIA requires. Those actually aren't that hard to do. I have dozens of different products and I was able to generate my GCCs pretty quickly once I'd made a template for them. I just swapped out the pictures, and hit the item numbers with a search-and-replace. It's a pain in the rear to have to do it, but it really wasn't that much work, and if you've got a useful slave teenager handy she can do it for you in a few hours.

There's a bright side to all this registration, and that is that they're not requiring you to get permission to make cosmetics, just to tell them when you do.

I'll deal with the ingredient deck issue when I address the definitions at the end of the post.

Section 619:
If something serious happens as a result of someone using your cosmetics, you have 15 days from when you hear about it to notify the FDA. You have to tell them who got hurt and how, and the FDA will then release this information publicly (scrubbed of the patient's identifying data).

Section 620:
Your ingredients aren't confidential, but the proportions of them are. FDA can't reveal those when asked. If there's anything you've submitted that they might think should be non-confidential but you think should be confidential, you can petition for it to be made confidential. So for example, suppose you did a study on the safety of an ingredient, and that study contained information on the formulations of your product. Normally the study would be considered non-confidential, but you can petition for it to be made confidential because it contains your proprietary information. Of course, they can always deny it. But you can't then decide it isn't safe to submit your private study, because the law requires you to submit it.

Section 621:
States and localities are allowed to pass more stringent regulations than these for their own reasons. I've heard this used as an anti-SCA argument, that this law would then subject them to 51 different sets of regulations. I've got a couple of news bits for people who believe that. First, it's more than 51; localities can do it too. Second, that this isn't new, nor is it limited to cosmetics. Before CPSIA there were independent standards for product safety in several states, and they all overlapped and interacted with federal standards. For example, before CPSIA banned crystal rhinestones, California limited their use to one ounce (if I remember the amount correctly). Illinois has a 40 ppm lead standard for paint while CPSIA only requires 90 ppm. States, under the 10th Amendment, have always been free to pass whatever damn-fool laws they feel like in addition to what damn-fool laws the federal government has. If their law is less strict than the federal law AND they claim it pre-empts the federal standard, then they can be taken to court. But nothing's ever stopped them before from making a stricter standard.

Section 622:
The lawmakers are concerned that all this is going to result in a bunch more animal testing, so they want FDA to make lists of alternative testing methods. And publish them by... one year after enactment.

Section 623:
All the agencies besides FDA that might have useful information pertaining to cosmetics get to form a commission so they can fight amongst themselves over who has jurisdiction over what. Also so they can hire more staff to help out this commission.

Section 624:
FDA gets money to do all this. Unfortunately for them, if their experience is anything like CPSC's they won't see a dime of that money until after the goat rodeo. Best of luck to them.

Section 3, which inexplicably comes after Section 624:
If you sell cosmetics "for professional use" (meaning it's sold or used in salons), you have to obtain a Material Safety Data Sheet for your cosmetics if you have anything at all hazardous in your product. To get you all started, here's the MSDS for water. (It's pretty hazardous. I love how it says "Chronic inhalation overexposure not encountered" though.) This is going to be really tough for cottage industry. I know a lot of tiny cosmetics makers have their products sold in local salons in their small towns. This will end that practice outright, because none of them can afford to get a MSDS made up.

If you distribute cosmetics for professional use, you have to pass on to your customer these MSDS sheets that you get from your manufacturer. If you run a salon, you have to then pass these on to your employees. And if they ask, you have to get them translated into Spanish and Vietnamese. No kidding, those two languages are specifically mentioned in the bill.

Section 4:
FDA has to ask the other government agencies if they have information on the ingredients they put on their priority list. They can also adopt other agencies' standards. So if CPSC says you can only have a certain percentage of a phthalate in a squeaky toy, FDA can say you can only have that same percentage of a phthalate in a cosmetic.

And now, Section 611:
I've saved the best for last. Up until now this bill sounds like it merely creates a goat rodeo that will be amusing to watch. But here's where the bad stuff kicks in. All these lists-- the black list, gray list, white list, and priority list-- are lists of ingredients. What constitutes an ingredient? Here's the official definition:

      (1) INGREDIENT- The term `ingredient' means a chemical in a cosmetic, including--

        `(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) the components of a fragrance, flavor, or preservative declared individually by their appropriate label names; and

        `(H) any individual component of a botanical, petroleum-derived, animal-derived, or other ingredient that the Secretary determines be considered an ingredient.
In English, an ingredient is:
(A) Something you put in your cosmetics.
(B) Something that's in something you put in your cosmetics.
(C) Stuff you added to your cosmetics to make it easier to process.
(D) Stuff you added to your cosmetics because it does something.
(E) Tiny molecular amounts of contaminants you may or may not have known were in your other ingredients, but could have known if you sent it to a lab.
(F) Molecules you have no way of knowing would get into your cosmetics from the container because you hadn't previously put any cosmetics into that container then watched it for years to see what would happen.
(G) Every little molecular component of every essential oil, flavoring, or preservative.
(H) Every little molecular component of a botanical, relying on the official List Of Ingredients to tell you what these are. (Note that you're supposed to include this information on the stuff you have to submit before this official List Of Ingredients gets rolled out.)

And there's your Catch-22. The sheer size of such an ingredient label aside, you're supposed to list the molecular components of your ingredients, and know how they all interact with your packaging. Are they freaking serious? Do they think chemistry degrees come in Cracker Jack boxes? They say you're not required to send your cosmetics off to the lab, but how the hell are you supposed to know what's going on at a molecular level unless you do? If you're making batches of 10, do you have to test each batch? This is every bit as insane as CPSIA.

Sorry for the extreme length of this post, but I wanted to get it all out tonight, because I knew that if I split it up into multiple posts I'd never finish the series.