Tag: fda

Farm Catch Up

It’s been a long time since  I did one of these, so let’s see what’s been going on in the farming world.

Bayer Acquisition of Monsanto Wraps Up — As of Aug. 17, Bayer had finished divesting itself of various businesses to satisfy regulators so it could complete the buy of Monsanto and it will fully acquire the company and Monsanto as an independent company will disappear. Bayer actually bought all of Monsanto back in June, but could not fully integrate the company until it satisfied the conditions set by various governments.

One has to wonder if Bayer is thinking this might not have been such a good idea. Monsanto just lost a $200+ million dollar lawsuit in California which claimed glyphosate caused someone to develop cancer and I’ve heard that there are many, many more lawsuits in the pipeline over the herbicide. And if that isn’t bad enough, Monsanto’s dicamba blend herbicides could actually end up being banned because of continued wide spread damage being caused by the herbicide drifting long distances and harming other crops, gardens, trees, bushes, etc. Despite stringent application requirements the problem has not gone away and there is a lot of pressure to ban the stuff entirely except as a pre-emergent herbicide that can only be used prior to planting. That would pretty much destroy Monsanto’s sales of dicamba resistant seeds.

You have to remember that the lawsuit mentioned above was in California where apparently just about everything causes cancer, even coffee. Which it doesn’t. Coffee, I mean. The slight correlation between drinking coffee and cancer appears to be due not to the coffee but to the temperature of the beverage. There seems to be a link (a very slight one) between drinking drinking hot beverages over 140 degrees and esophageal cancer and some others.

Milk Labeling Controversy Continues — The argument over what products can use the label “milk” continues. Despite the fact that FDA has, for decades, had an official, legal definition of what “milk” is, defining the term as the secretions of the mammary glands of animals, various makers of nut, grain and plant juices have been using the term “milk” in their labeling for years. Protests about the mislabeling and demands for enforcement of the existing regulations have been ignored for decades. But it seems the FDA is finally going to do something about it because of increased pressure, and it looks like the agency might actually start to enforce it’s own regulations in the fairly near future. I’ve talked about this before so I’m not going to repeat that.

The interesting thing is that a couple of senators tried to slip an amendment into an unrelated spending bill that would have kept the FDA from actually enforcing it’s own rules by prohibiting “the use of funds to enforce standards of identity with respect to certain food.” The amendment would not have altered FDA’s definitions, but would have kept the agency from actually enforcing it’s own rules. Exactly why these two tried to slip this through I don’t know. I’m sure they didn’t get, oh, large campaign contributions from people or organizations linked to the nut “milk” lobby. (Here is where I wish we had a sarcasm font)

Anyway, the amendment was shot down in flames by the Senate. The vote was something like 14 for, 84 against.

I’ve long believed that what we really need is a better definition of the term “bribery” and a law enforcement agency willing to enforce it.

Wisconsin Loses 382 Dairy Farms In First Half of Year — That number should give you some idea of how bad the dairy industry is doing right now. Last year Wisconsin lost about 465 dairy farms. If the attrition continue at this rate, we’re on track to lose more than 650 farms this year. It’s easy to look for scapegoats, of course. The dairy industry itself is a primary contributor to the problems thanks to massive over production. This administration’s nasty little trade war isn’t helping, of course. I’ve seen estimates that this trade war has knocked about $1.50 off the price of milk as countries that used to import our dairy products are now looking elsewhere.

Tariff Relief Program — USDA announced at the end of July it would be starting up a tariff relief program to try to make the hit farmers in the US are experiencing a bit less painful. It announced $12 billion would be funneled to farmers in one way or another using existing relief programs. The exact details are a bit muddy, and USDA seems to be in utter confusion about exactly how this is going to work, so if you’re a farmer who’s been hurt by this, don’t expect any kind of relief any time soon. Considering Perdue, the Secretary of Ag, claimed well over a year ago that the administration would renegotiate NAFTA in just a “few weeks” and they’re still fighting over it today with no end in sight, I wouldn’t count on seeing any actual money coming out of this program for some time.

Another big question is exactly where this $12 billion is going to come from because Congress hasn’t authorized any spending for this program.

Almond “milk” Recalled Because It Has Real Milk In It — HP Hood, makers of Almond Breeze nut juice, is recalling more than 145,000 cartons of it’s product because it may have actual real milk in it instead of it’s nut juice stuff.

Still More Tariffs — The administration will begin to levy 25% import duties on still more Chinese imports soon. This time it’s going to be mostly industrial products like chemicals, plastics and machine parts. China has promised it will strike back dollar for dollar by putting it’s own penalties against US products in place. And it could get worse fast, with the US apparently considering tariffs on an additional $200 billion of Chinese products. The administration has uttered threats of putting tariffs on all Chinese imports.

What a lot of people, especially those who blindly back what the administration is doing, don’t seem to realize is that this while this may hurt China a bit, the ones who are really paying for it are us, and not just in lost sales to China. A lot of these products that are being imported from China simply aren’t made anywhere else, or are made in such small quantities that the domestic makers can’t even come close to meeting the demand.

Let me point out one thing that people don’t seem to understand. That 25% tariff isn’t being paid by China.

That tariff is being paid by the people who buy the product here in the United States. We pay it. If a manufacturer makes a product that includes parts and materials that can only be sourced from China, it has to pay that extra 25%, and that’s what’s happening right now. Yes it will cut back on the amount of purchases from China, but in a lot of cases there is no choice. You pay that 25% tax or you can’t make your product.

That extra cost has to be accounted for somewhere. At the moment a lot of manufacturers are absorbing that extra cost in the hopes that this situation won’t last long. But eventually they aren’t going to be able to keep that up and they are going to have to increase the prices of their finished product. So in the long run, the people who are paying that tariff are us, the consumers.

Lost Valley Farm Saga Continues — A mega dairy in Oregon called Lost Valley Farm is in the news yet again. The farm has only been in existence less than two years, and it has already racked up an impressive list of operational violations that is unprecedented in my experience. Illegal manure disposal, illegal pumping of water from aquifers, illegal generation of wastewater, failure to obtain proper permits, violations of permits… The list goes on and on according to the Oregon Dept. of Ag. (ODA). Most recently the farm was ordered to produce no more than 65,000 gallons of waste water per day to meet permit requirements, but allegedly has continuously violated that agreement by producing as much as 375,000 gallons in excess of the limits.

Meanwhile, the farm’s bank has been going after them. They took out a $60 million loan from Rabobank to start this thing up and the bank is not exactly pleased with things. The farm agreed to sell off the cattle to try to pay down debt.

And then declared bankruptcy the day before the sale was supposed to happen to prevent the sale and keep the bank from foreclosing.

The attorney for the owner of the farm claims they are doing everything the ODA is asking, that they’ve made significant progress in meeting the requirements, etc. ODA counters by pointing out the farm has been in almost continuous violation of of the deal. And the judge handling the case is considering contempt charges against the owner.

Drinking Straw Bans — Oh, brother… Just about everyone seems to be jumping on this call to ban plastic drinking straws. Using data allegedly developed by a nine year old kid, everyone seems to now think that plastic drinking straws are killing the planet and have to be banned right now. Almost every time I look at a media outlet I’m seeing yet another article about some restaurant or town or university or some organization banning plastic drinking straws.

Look, has anyone actually thought about this? Hmm? I’m not sure about the exact numbers because they bounce all over the place because no one seems to know the actual facts, but it seems that straws account for something like 0.0002% of the plastic waste being generated by people. I’m all for reducing waste, especially plastic waste, but there are a heck of a lot more serious sources of plastic waste to go after than drinking straws.

Some places are talking about going to reusable straws made of stainless steel or some other substance that can tolerate cleaning. Have you ever tried to actually clean and sanitize a straw? Basically, you can’t. If put in a dishwasher, the water isn’t going to actually get inside of the straw to clean it. Some might trickle through it depending on how it’s oriented inside of the washer, but not enough to do a thorough job. And as for hand washing, you can run water through it, but that isn’t going to actually remove anything clinging to the inside of the straw. Or you can get, oh, a tiny, tiny brush and wash each one individually, but of course no one is going to do that. Then you’re going to have to try to sanitize it, perhaps by soaking it in some kind of bleach solution. But water is a tricky thing. Because of things like the surface tension of water, you can get air gaps in small spaces…

Do you really want to be drinking out of a straw that’s been used by someone with, oh, hepatitis, for  example, or norovirus?

Well, that’s enough for now. You’re probably getting as bored as I am. And the way the garden looks outside MrsGF and I are going to be busy processing tomatoes for a while. They’re starting to come on fast right now.

Just What Is “Milk”?

South Mountain Creamery in Maryland is in something of a bizarre situation. The farm has it’s own bottling plant and sells milk directly to consumers, and it has the FDA going after it because it’s 100% real pasteurized skim milk is, well, 100% real skim milk and nothing else.

That’s right, the FDA claims the creamery cannot label it’s skim milk as “skim milk”. It is trying to order the creamery to label it “imitation milk product” or “imitation milk” when, well, when it absolutely is not imitation anything. The FDA claims it has to be labeled “imitation” because the product does not contain artificially added vitamins.

Now, a bit of background here. The milk you buy in the grocery store is not actually pure milk. Pretty much none of it is. It has vitamins A and D added to it. Basically the bottling plant throws a ground up vitamin pill in it. Why? Because once up on a time about 90 or so years ago, we had problems with vitamin deficiencies so the government began to mandate adding extra vitamins to milk. But the fact of the matter is that this hasn’t been necessary in, well, half a century, really. And there is actually a risk of getting too much A and D. Most European countries actually ban adding adding them to milk because of the risk of overdose. Too much D can cause heart arrhythmia and other problems and too much A can be seriously toxic as well.

And in any case, the amount of A and D being added may not even be what it says on the label to begin with as the New York Times discovered back in 1992 when  independent testing of milk samples found that the actual amounts of vitamins in the milk being sold varied wildly, and in at least one case back in 1992 the level of vitamin D was so high it was dangerous causing medical problems for at least eight people.

Now I’m not going to get into the debate about whether or not D and A should or should not be added to milk. I just want to talk about this whole labeling nonsense because, well, according to the FDA’s own regulations, the agency’s actions in this case seem to be just wrong. Here is how FDA defines “milk”:

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2017]
[CITE: 21CFR131.110]

 

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B–FOOD FOR HUMAN CONSUMPTION

PART 131 — MILK AND CREAM

Subpart B–Requirements for Specific Standardized Milk and Cream

Sec. 131.110 Milk.
(a) Description. Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 8 1/4 percent milk solids not fat and not less than 3 1/4 percent milkfat. Milk may have been adjusted by separating part of the milkfat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be homogenized.

(b) Vitamin addition (Optional). (1) If added, vitamin A shall be present in such quantity that each quart of the food contains not less than 2000 International Units thereof within limits of good manufacturing practice.

(2) If added, vitamin D shall be present in such quantity that each quart of the food contains 400 International Units thereof within limits of good manufacturing practice.

(c) Optional ingredients. The following safe and suitable ingredients may be used:

(1) Carriers for vitamins A and D.

(2) Characterizing flavoring ingredients (with or without coloring, nutritive sweetener, emulsifiers, and stabilizers) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavorings.

(d) Methods of analysis. Referenced methods are from “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content–“Fat, Roese-Gottlieb Method–Official Final Action,” section 16.059.

(2) Milk solids not fat content–Calculated by subtracting the milk fat content from the total solids content as determined by the method “Total Solids, Method I–Official Final Action,” section 16.032.

(3) Vitamin D content–“Vitamin D–Official Final Action,” sections 43.195-43.208.

(e) Nomenclature. The name of the food is “milk”. The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in 101.22 of this chapter.

(1) The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name:

(i) If vitamins are added, the phrase “vitamin A” or “vitamin A added”, or “vitamin D” or “vitamin D added”, or “vitamin A and D” or “vitamins A and D added”, as is appropriate. The word “vitamin” may be abbreviated “vit.”.

(ii) The word “ultra-pasteurized” if the food has been ultra-pasteurized.

(2) The following terms may appear on the label:

(i) The word “pasteurized” if the food has been pasteurized.

(ii) The word “homogenized” if the food has been homogenized.

(f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

If you can wade through the legalese up there, you will note that “milk” is specifically defined, and it says things like “if” vitamin A is added, and “if” vitamin D is added, they must be at certain levels. But it doesn’t say they must be added for the product to be called “milk”. Nor does it say anything about a requirement to label milk as “imitation” if they are not added. So if this is accurate, FDA’s claim that this creamery’s skim milk must be labeled “imitation” is not in keeping with FDA’s own regulations.

Now there may be some regulation, somewhere, that requires milk to have added A and D in order to be called “milk” but I haven’t managed to find any regulations that state explicitly that in order to label something “milk” it must have A and D added to it.

This isn’t the first time this issue has come up. About a year ago there was a case in Florida where the state claimed the Ocheesee Creamery couldn’t label it’s skim milk as “skim milk” and had to call it “imitation skim milk”, despite the fact it was 100% skim milk. The state lost and lost badly, ending up with the 11th US Circuit Court ruling against the state and Florida having to pay almost half a million dollars.

The other thing I find curious is that despite the fact that the FDA has a rather strict definition of the term “milk”, i.e. “Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”, it doesn’t seem to have a problem with various nut and legume juices and extracts labeling themselves as “milk”, such as soy milk and pea milk and almond milk.