The deadline for chemical manufacturers to perform and submit confirmatory testing results for existing or new products to the FDA/EMA has past. September 26, 2022
A discussion on potential root causes
If you are a manufacturer who regularly uses ethyl alcohol in your production process, you’ve undoubtedly received statements regarding the new testing requirements mandated by the USP.
Methanol has found its way into the ethanol supply chain and the new regulations will change the way your company works. Annual or spot-testing has been replaced with a scenario where testing every batch is the new normal in the face of this new threat.
QUANTUM Analytics Group provides accurate, efficient and consistent testing for a wide variety of manufacturers including cosmetics, flavor & fragrance, OTC pharmaceutical, medical device and private label contractors.
Whether you use a few gallons a week or thousands of gallons a day, QUANTUM can manage your methanol tests and safeguard your production process timelines. Let us know how your processes are affected by the new regulations. Call 800-448-2968 to speak with one of our experts.
It may seem obvious, but you’d be surprised how many companies miss this simple strategy when faced with the new “test-every-batch” scenario. You might be used to buying alcohol one gallon at a time. But you’ll pay to test each gallon. Consider moving up to a 55-gallon drum and pay once to test the entire drum. Quite simply – with these new regulations…buy in bulk!
A recently released congressional report found heavy metals in some popular brands of baby food. Read the Report
Arsenic, cadmium, lead and mercury have dominated the news for the past few months when elevated levels were found in some batches of baby food. But while the FDA struggles to place new standards and limits in lieu of this seemingly rare occurrence of the big 4, a much broader issue faces food and beverage manufacturers on a daily basis.
60 years ago the industrialization of farming began. Since then, global pesticide use has grown steadily to 4.1 million tons per year in 2017, an increase of nearly 81% from 1990. Countless tests have proven that humans and animals have been exposed to increasing levels of chemical contaminants and although they are beneficial for crop production extensive use of pesticides can possess serious consequences due to their bio-magnification and persistent nature. Today there are nearly 1,000 pesticide ingredients registered in the U.S. and many are produced at increasingly higher toxicity to stay ahead of poison resistant weeds and insects.
Pesticide contamination is a constant concern for food and beverage manufacturers. Maximum residue levels for a specific pesticide chemical that is permitted in or on a specific human or animal food can change overnight. And the media storm associated with warning letters, fines or a re-call from the EPA for non-compliance is detrimental.
Food product contamination (including the big four and some 800 registered pesticides) comes from some combination of 3 main sources; biological, physical or chemical. Currently, many food manufacturers have internal staff with instrumentation that can identify a certain pathogen (biological) or target a defective closure (physical). Detection of chemical contaminants, however, can be much more complex. It takes improved systems and techniques to achieve reliable ppm or ppb detection along with a high level of experience with sample prep and adoption of a rigorous method.
Organochlorine pesticides like DDT, methoxychlor, dieldrin, chlordane, toxaphene, mirex, kepone, lindane, and benzene hexachloride are chlorinated hydrocarbons that were used extensively from the 1940s through the 1960s in agriculture and mosquito control. Most have been taken off market, yet some are still registered for use in the US.
Organophosphorus pesticides include malathion, parathion, diazinon, fenthion, dichlorvos, chlorpyrifos and ethion. These chemicals account for a large share of all insecticides used in the United States. The residues of OPs are found on fruit trees, grains, cotton, sugarcane, lettuce, and cabbage and other vegetable crops.
Herbicides like Glyphosate and Atrazine. The active ingredient in the herbicide Roundup, which was made by Monsanto (now owned by Bayer). It is by far the most widely used pesticide in the world. It can now be found in the majority of rivers, streams, ditches and wastewater treatment plants, as well as in 70 percent of rainfall samples.
Hexachlorobenzene was introduced in 1945 as a fungicide for crop seeds, and is now found in all food types. It was banned for agricultural purposes in the EU as of 1981. Unfortunately it is still used as an industrial chemical and is released to the environment through waste incineration and a host of other high temperature, poor combustion processes. Worse still are highly toxic chlorinated dibenzo-p-dioxins, chlorinated dibenzofurans, and polychlorinated biphenyls with the major route of human exposure through our food supply.
Surprisingly, many pesticides that were outright banned or in the process of phasing out in the EU, China and Brazil are still widely used in the USA, at the level of tens to hundreds of millions of pounds annually.
Over 40 years ago, Quantum Analytics Group was hired by a major baby food manufacturer to test apples used in baby food for trace levels of Ethylene Dibromide – used as a pesticide and fumigant for grains and fruit, water-proofing preparations and an ingredient for anti-knock gasoline mixtures.
We tested raw, whole apples as well as finished product (apple sauce) utilizing GC analysis with electron capture/Hall detector and then double-confirmed with GCMS.
Our analysis concluded that the apple skin had EDB residue resulting in a noticeable level of EDB in the finished product – but not at levels that were deemed dangerous by the EPA at the time.
Ultimately, EDB was removed from use as a soil fumigant in the United States in 1983 but still used in other applications.
Last year, the USDA found 58 percent of foods sampled had detectable pesticide residue. There were 337 food recalls in 2019… and 363 in 2020.
Growing numbers could suggest that more companies are voluntarily recalling their products as soon as a potential public health threat surfaces, a trend that is likely related to the Food Safety Modernization Act (FSMA), a 2011 law that gave the FDA more powerful enforcement mechanisms.
“Some of the most glaring food safety headlines of the second quarter (of 2020) were fueled by food safety and public health advocates who continue to pressure companies and regulators alike for more safeguards,” the Recall Index reports. “We’re used to seeing their perspective in the media, but in some cases, they’ve turned it up a notch.”
FDA employs a three-fold strategy to enforce EPA’s tolerances for pesticide chemical residues in human and animal foods. In its regulatory pesticide residue monitoring program, FDA selectively tests a broad range of imported and domestic commodities for approximately 800 pesticide residues.
Read the 2020 Food and Beverage FDA Pesticide Residue Monitoring Program Q&A Report.
With nearly 800 different pesticides being reported, we highly recommend all food and beverage companies set up regular screening programs and a proper risk assessment. Call (866) 840-6948 to discuss recommendations on developing a custom screening program that will keep your specific ingredients and finished products ahead of varying standards and limits.
In addition, your questions about specific contaminant issues like allegations of plastic contamination; chemical migration in packaging; unknown substances found in products; complaints of off-odors or off-flavors and products exposed to environmental contamination…can all be answered.
Remember, the real cost of a recall…is your reputation.
Arsenic, cadmium, lead and mercury dominated the news last year when elevated levels were found in some batches of baby food and infant formula. But now a new study by Consumer Reports finds high levels of cadmium and lead in certain brands of chocolate bars
Consumer reports tested 28 different dark chocolate bars from a mix of brands. The study used California's maximum allowable dose level (MADL) for lead (0.5 ug/day) and cadmium (4.1 ug/day). Cadmium and lead were found present in all 28 bars. For 23 of the bars, eating just an ounce a day would put an adult over a level that public health authorities and CR's experts say may be harmful for at least one of those heavy metals. Five of these 23 bars were above those levels for both cadmium and lead, with one having a cadmium level at 229% of the MADL, and another having a lead level of 265% of the MADL
Even if you aren't a frequent consumer of chocolate, lead and cadmium can still be a concern. It can be found in many other common food -such as sweet potatoes, spinach, and carrots-and small amounts from multiple sources can add up to dangerous levels. So how and where do these metals end up in dark chocolate and other foods? For chocolate, the source of cadmium is the bioaccumulation by the cocoa tree of naturally occurring cadmium in the soil. The cadmium tends to concentrate in the cocoa bean, generally in the cocoa bean solids. Lead on the other hand appears to get into cacao after beans are harvested, principally from environmental sources such as lead laden dust and soil.
So, what does this study and those of baby foods and infant formula point to? The sources of the metals resulted from the natural bioaccumulation of those metal elements found in the soil, and from surrounding environmental sources. These cautionary tales highlight the importance of routinely assessing naturally occurring ingredients used in food, pharmaceuticals, nutritional supplements, cosmetics and other products for trace and heavy metals as well as other potential impurities and contaminants.
Quantum has expansive capabilities for the analysis of trace metals and elemental impurities. And, our scientists have a wide breath of experience and knowledge in the application of atomic absorption and atomic emission spectroscopy. We have over 30 years of experience in the use and application of these analytical techniques, and with the many sample preparation techniques, which include various wet digestion, ashing and microwave digestion methods. Our laboratories maintain a full complement of instrument capabilities which include flame and graphite furnace atomic absorption (AAS), inductively coupled plasma-atomic emission (ICP-AES or ICP-OES) and inductively couple plasma-mass spectrometry (ICP-MS) instruments. These capabilities allow us to perform testing not only using ICP-AES or ICP-MS , but also the many numerous compendial methods (i.e. USP, NF, FCC, EP, AOAC) that require flame or graphite furnace AAS..
Quantum provides comprehensive analytical testing in support of pharmaceuticals, medical devices, personal care products, cosmetics, consumer products, foods, electronics, dietary supplements and dietary ingredients . These include the testing of ingredients, intermediates, raw materials, in-process samples and finished products for trace and heavy metals originating from process equipment, catalysts or found present naturally.
QUANTUM Analytics Group Solves Problems. Our approach is to work closely with each client collaboratively, handling every project with personal care, and giving every client one-on-one attention. Then, through this collaborative approach, and our unique blend of experience and expertise, we focus on providing accurate, efficient and consistent data and results to address and resolve question with trace and heavy metals that impact your products.
For a Free Consultation Call 866-840-6948 to speak with one of our experts.