My condolences for the difficulties you have -- and will continue -- to face on this subject. The unfortunate part of your ordeal is that there is no clear guidance -- whether regulatory or industry -- that is clearly observed and standardized throughout the entire industry. With FSMA rolled out, I expect things are better than before, but it still is fairly difficult to get a bearing on things until you fully develop your own personal "supply chain" of sorts. Even for myself, it took 12+ years of working experience in Food Safety to accumulate my knowledge on the subject, but I will try my best to share what I know that can help you.
Know Your Agencies
USDA: FSIS (US Domestic)
Inspection Arena: Most processed meat (bovine, swine, and poultry) products; seafood of the Siluriformes family.
FDA (US Domestic)
Inspection Arena: Egg/Dairies (excluding those that are introduced into a product containing meat as a sub-component); non-meat / seafood products; drugs, additives, etc.
Note: trying to figure out who handles what is a challenge worthy of writing a book on its own. The above is a generalization, but it never hurts to reach out to both and subscribe to their resources. When it comes to general labeling policies, GRAS ingredient studies, etc., FDA typically is the go-to agency, whereas USDA FSIS is more focused on processing plant inspection policies, HACCP / GMP's (now + HARPC/cGMP's), etc. It's important to note that a large majority of market withdrawals and recalls occur due to mislabeling of allergens! That's why you'll want to stay subscribed to recall alerts.
Start Making Friends
Every food manufacturer, processor, or co-packer that follows industry & retailer standards have what's called a QA/QC team (Quality Assurance / Quality Control). These guys are the ones responsible -- like yours truly -- for making sure a vast multitude of varying programs are properly maintained, updated, audited, and enforced. Unfortunately, they are very rarely company stakeholders and the culture of the administrative / management environment can cause a lot of friction, stress, and constant cognitive dissonance. These guys have a thankless job; if they've done things right, you'll likely never know they existed, whereas if someone's calling for them, it's hardly ever good news. So make sure to always speak courteously to them, since you'll be asking them for favors!
What exactly will you be asking? Here's a list of questions I'd recommend the following (but not limited to):
- Start off by informing them you are an end consumer, and you have a dietary sensitivity (soy protein allergy)
- Ask them if they are GFSI-certified? If not, are they 3rd party audited at all? If not, do they have HACCP/HARPC/FSMA implemented?
- Ask them if they have an allergen management SOP in place? Supply chain control program (otherwise known as Supplier Approval Program). Do they conduct validation activities for it, e.g., SSOP allergen verification swabbing.
- For the product you're looking into specifically, when was the last time the label was verified for accuracy? Are there any potential sources of soy derivatives that could have been missed (e.g., processing release agents, food-grade lubricants containing soy lecithin, soybean oil inappropriately exempted under reasoning of being highly refined, etc).
- Are they willing to provide a Product Specification Sheet and Allergen Chart (3-column format)?
- Do they export to Canada / EU?
Now, here's an explanation of why each question is significant:
- This alerts them right away that you're not calling them to waste their time or submit a standard complaint. They'll be more likely to provide their assistance, whether it be out of good will or fear of litigation.
- Despite their limited resources and best efforts, regulatory agencies don't set the bar when it comes to the measure of efficacy in processing plant practices and standards. They do establish the legislative criteria, perform random inspections (and/or daily for USDA-inspected plants), and make examples of cases that get picked up by the media. For day-to-day (or year-to-year) standards, it's actually retailer driven by means of 3rd party auditing; the GFSI standard is a global food safety benchmark, which defines and accredits auditing schemes and bodies; these schemes (SQF, BRC, ISO/FSSC 22000, GlobalGAP, etc) hold a much more stringent standard and perform an annual audit for registered facilities to recertify them. Holding certification in relation to that would address most of your concerns, as they would need to have most of what is asked for in this list in order to pass. If they don't, but still have HACCP & GMP audits done annually, this is basically meeting the bare minimum for a facility to survive in today's industry, and likely they aren't selling to major domestic retailers. If they don't even have those in place, you don't need to bother continuing with the list of questions.
- See above.
- Be careful! There is a tendency for older labels to go unupdated for a long time without notice. There are also cases where the manufacturer does not use a "contains: " statement. If they aren't doing their due diligence or some other factor weighs into the process, these can easily get missed or outdated. Processing aids like release agents (chemicals used to help product not stick to conveyor belts), or other potential sources for cross contamination (food grade lubricants are used by maintenance on equipment), or insufficient management of supply chain (soybean oil is only allergen-free when highly refined; if today their regular soybean oil manufacturer was short, they need to verify their backup supplier's source is also exempt, etc).
- Product specs should provide a more technical and detailed overview of the product, whereas allergen chart provides a list of allergens they handle, how they are stored in relation to other allergens, and if they are run on the same line. Some are more and some are less detailed; this depends on the plant, but here's an example of one I've created for use at work.
- Our northern neighbors (Canada's CFIA & Health Canada) have more stringent allergen management and labeling requirements than us, as do the EU (hence, my sheet above shows so many different allergens and sensitizing agents). If the company exports any products to either of them, then by default they should have address additional allergens and have more strict practices in place / better awareness in labeling practices.
Leave Nothing To Chance
There are swab test-kits available for purchase online that can indicate whether a food contact surface (maybe food directly, ask vendor for how to do so) has protein residue or not. These are either 24-hour swabs or instant adenosine triphosphate tests (the latter may not be for allergen proteins, but you can ask if they have instant swabs for allergen proteins). Take everything anyone tells you with a grain of salt -- especially if they aren't the QA Manager or QC technicians themselves.
There are also other positions / titles, e.g., SQF Practitioner or SQFP, PCQI, etc. If they have one of these guys on their team, chances are they're doing things right!
If It's Not Documented, It Never Happened
Keep a written record of everything, ask a copy for everything, and hold them to the same expectation! They should have a 3-5 year record retention policy in place, so not being able to find something is never an excuse (unless they're a real amateur or mom-and-pop's operation).
That's all I can think of at the moment off the top of my head! I hope it helps you at least a little, and don't hesitate to reach out to me with any additional questions.
EDIT: Oops! Forgot to address your other questions related to this.
What should I be aware of on the labels outside of direct warnings? I'm worried that a product may contain soy without warning of it, like: Manufactured on equipment that processes peanut, other tree nuts.
When you see "May Contain" statements or statements like the one you referenced above, it's basically the manufacturer's way of saying "we can't guarantee it's not there, but you can't sue us either way since we're admitting it in print". While it is a bit frustrating, what you need to realize is that considering the practices of some plants out there, these guys are actually doing a decent thing by observing proper labeling procedures. However, you'll want to note the processor's names and stay away from them since they don't manage the allergen of concern (but, they aren't required to indicate the exact facility that produces the product, and a company or brand holder may contract multiple facilities to pack any one product; this is where getting friendly with the QA's will help you out).
Is a product that possibly contains soy required to make this clear?
Nope! But it's not necessarily a bad thing. For example, highly refined soybean oil results in the product being rendered safe in terms of allergenic or sensitivity reactions (reference). There are other examples, like this specific soy lecithin when used as a release agent with less than 2% residual in finished product (reference A, B, C). However, the expectation is that if it can cause an allergic reaction, you should be able to clearly see "soy" somewhere on the ingredient declaration (whether in-line, or more likely nowadays in a "contains" statement). If they can't preclude its presence, then a "may contain" statement should be used, etc.
EDIT 2:
As @KateGregory has pointed out and brought to my attention, I shouldn't have arbitrarily written this from a US domestic perspective (shame on me!). Luckily, most of what I wrote above still applies, as I was speaking from the perspective of a facility that is audited to the GFSI benchmarking standard (international). For regulatory guidance and standards though, please refer to:
- CFIA / Health Canada for Canadian standards
- Here and here for EU guidance, though I'm fairly certain there is another more official guidance code somewhere I can't seem to locate at the moment.
- For another 3rd party auditing guidance, BRC is an excellent GFSI standard that originates from the EU as well.
If I've missed any other English-speaking localities, please feel free to point that out to me!
