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#1 OPizza

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Posted 04 November 2019 - 02:41 PM

Was reading this article on Food Safety News regarding a recent recall due to allergen mislabeling. 

 

https://www.foodsafe...-pork-sausages/

 

Was confused regarding reason for recall...

 

"The sausage contains sesame seed, which is an allergen and must be declared on product labels according to federal law. Failing to properly list allergens on product labels is considered misbranding by the USDA."

 

When did this become an Allergen?



#2 Murae

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Posted 04 November 2019 - 03:14 PM

Hi OPizza,

 

Do you know if the product was inteded to be shipped to Europe?

 

I understand there are differences in what is classed as an allergen between the US and Europe (as well as other nations)

 

In the EU there are 14 designated allergens https://erudus.com/1...-for-consumers/

 

Sesame is one of them.

 

Regards

Murae



#3 SQFconsultant

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Posted 04 November 2019 - 03:23 PM

Depends on the country - a number of countries recognize sesame seed as an allergen.


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#4 OPizza

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Posted 04 November 2019 - 03:25 PM

The article states it was made in California and distributed in California.



#5 The Food Scientist

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Posted 04 November 2019 - 03:55 PM

That's the thing with US federal law. Never clear. Even with Sulfites not being one of the big 8, they still shall be declared if over a specific amount. 


Everything in food is science. The only subjective part is when you eat it. - Alton Brown.


#6 The Food Scientist

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Posted 04 November 2019 - 03:58 PM

I'm thinking its a USDA meat/poultry special thing:

 

https://www.fsis.usd...pdf?MOD=AJPERES


Everything in food is science. The only subjective part is when you eat it. - Alton Brown.


#7 GMO

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Posted 04 November 2019 - 05:23 PM

I didn't realise it wasn't on the list for the US but interestingly it is considered to now be the 9th highest risk allergen.

 

https://www.aaaai.or...releases/sesame

 

The article is interesting because while it's *only* 0.2% of the US population impacted, half had received treatment in an emergency room due to this meaning they get full blown anaphylaxis.  I suppose the manufacturer could have been displaying an abundance of caution.  If you had a risk of hospitalising one in a thousand of your consumers because of a metal contaminant or a chemical contaminant, you'd probably recall it right?   Well the risks are similar here.  Not saying all manufacturers would take that approach but it's a possibility and probably the right thing to do.



#8 kfromNE

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Posted 04 November 2019 - 05:58 PM

I didn't realise it wasn't on the list for the US but interestingly it is considered to now be the 9th highest risk allergen.

 

https://www.aaaai.or...releases/sesame

 

The article is interesting because while it's *only* 0.2% of the US population impacted, half had received treatment in an emergency room due to this meaning they get full blown anaphylaxis.  I suppose the manufacturer could have been displaying an abundance of caution.  If you had a risk of hospitalising one in a thousand of your consumers because of a metal contaminant or a chemical contaminant, you'd probably recall it right?   Well the risks are similar here.  Not saying all manufacturers would take that approach but it's a possibility and probably the right thing to do.

 

 

GMO - sesame has been on the radar and would be the next allergen to be added if another one was added. It's been the topic of debate recently. 



#9 kfromNE

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Posted 04 November 2019 - 06:01 PM

Out of my curiosity and to make sure I'm not missing anything - I have emailed FARRP to see if they know why the USDA did a recall. When I get a response, I'll let everyone know.



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#10 arahman

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Posted 04 November 2019 - 07:38 PM

Sesame and  Sulphites are both in Canada top 10 food allergens

 

https://www.canada.c...-allergies.html 

 

were you exporting to canada OPizza?



#11 Hank Major

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Posted 04 November 2019 - 08:23 PM

People are trying to overcome Congressional and FDA inertia and force sesame to be added to the "major" food allergens list.



#12 Charles.C

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Posted 04 November 2019 - 08:40 PM

The answer appears basically quite simple.

 

I assume sausages are classified as meat.

 

 

4. Are there any other areas not covered by FALCPA?

Yes, there are quite a few areas where the law does not apply:

  • Prescription drugs
  • Over-the-counter drugs
  • Personal care items such as cosmetics, shampoo, mouthwash, toothpaste or shaving cream.
  • Any food product regulated by the USDA, which includes meat, poultry, or certain egg products.
  • Any product regulated by the Alcohol, Tobacco Tax and Trade Bureau (ATTB). This includes alcoholic drinks, spirits, beer and tobacco products.
  • Any restaurant foods or foods that are placed in a wrapper or container in response to a person's order for that food. This includes street vendors, festival foods, fast food restaurants.
  • Kosher labeling
  • Pet foods, supplements, and supplies

https://www.kidswith...ection-act.aspx

 

Attached File  sasame.PNG   67.56KB   2 downloads

 

Attached File  Allergens-Slides-RobertsonHale-Seys-031617.pdf   846.57KB   12 downloads


Edited by Charles.C, 04 November 2019 - 08:43 PM.
added

Kind Regards,

 

Charles.C


#13 The Food Scientist

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Posted 04 November 2019 - 09:00 PM

The answer appears basically quite simple.

 

I assume sausages are classified as meat.

 

 

 

attachicon.gif sasame.PNG

 

attachicon.gif Allergens-Slides-RobertsonHale-Seys-031617.pdf

 

So it's saying "Meats" are not covered under FALCPA, yet it was recalled due to misbranding for undeclared allergenss.... ODD. But I would assume fresh meats are not, this is processed/packaged in a manufacturer so which is why it is regulated? 


Edited by The Food Scientist, 04 November 2019 - 09:01 PM.

Everything in food is science. The only subjective part is when you eat it. - Alton Brown.


#14 Charles.C

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Posted 04 November 2019 - 09:13 PM

So it's saying "Meats" are not covered under FALCPA, yet it was recalled due to misbranding for undeclared allergenss.... ODD. But I would assume fresh meats are not, this is processed/packaged in a manufacturer so which is why it is regulated? 

 

It simply means that USDA make their own rules.

 

An explicit list of allergens for which USDA require labelling seems elusive.  Open-ended ?


Edited by Charles.C, 04 November 2019 - 09:17 PM.
added

Kind Regards,

 

Charles.C


#15 kfromNE

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Posted 04 November 2019 - 09:23 PM

So it's saying "Meats" are not covered under FALCPA, yet it was recalled due to misbranding for undeclared allergenss.... ODD. But I would assume fresh meats are not, this is processed/packaged in a manufacturer so which is why it is regulated?

 

This product was rightly recalled due to not all ingredients being labeled as sesame was found in the product but not found in the ingredient statement.

 

"Under the Federal Meat Inspection Act ( FMIA), the Poultry Products Inspection Act ( PPIA), and the Egg Products Inspection Act ( EPIA), under which the Food Safety and Inspection Service (FSIS) operates, all ingredients used to formulate a meat, poultry, or egg product must be declared in the ingredients statement on product labeling. A product is misbranded under the FMIA, PPIA, or EPIA when it contains ingredients that are permitted but are not declared on product labeling"

 

The allergen part though - that still does confuse me since as other's have stated - FALCPA does not apply to USDA items.



#16 Charles.C

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Posted 04 November 2019 - 09:35 PM

This product was rightly recalled due to not all ingredients being labeled as sesame was found in the product but not found in the ingredient statement.

 

"Under the Federal Meat Inspection Act ( FMIA), the Poultry Products Inspection Act ( PPIA), and the Egg Products Inspection Act ( EPIA), under which the Food Safety and Inspection Service (FSIS) operates, all ingredients used to formulate a meat, poultry, or egg product must be declared in the ingredients statement on product labeling. A product is misbranded under the FMIA, PPIA, or EPIA when it contains ingredients that are permitted but are not declared on product labeling"

 

The allergen part though - that still does confuse me since as other's have stated - FALCPA does not apply to USDA items.

 

Do you mean you don't understand why USDA  do not follow FALCPA ? it's the Law ?


Kind Regards,

 

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#17 kfromNE

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Posted 04 November 2019 - 09:46 PM

Do you mean you don't understand why USDA  do not follow FALCPA ? it's the Law ?

 

Does the Food Allergens Labeling and Consumer Protection Act (FALCPA) apply to meat, poultry, and egg products under FSIS jurisdiction?
No. The FALCPA passed by Congress did not amend or implement regulations and policies for meat, poultry, and egg products in the acts related to them: the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA). FSIS encourages the use of allergen statements, consistent with FALCPA, and other statements that highlight the presence or absence of ingredients of public health concern; particularly the "big eight" allergens. FSIS will consider rulemaking to require allergen statements if it does not continue to observe, through its prior label approval system, widespread voluntary compliance with the use of allergen statements on meat, poultry, and egg product labels. The Agency's compliance policy guide on the use of allergens statements can be found at http://www.fsis.usda...rgens/index.asp.



#18 Charles.C

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Posted 04 November 2019 - 10:27 PM

Does the Food Allergens Labeling and Consumer Protection Act (FALCPA) apply to meat, poultry, and egg products under FSIS jurisdiction?
No. The FALCPA passed by Congress did not amend or implement regulations and policies for meat, poultry, and egg products in the acts related to them: the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA). FSIS encourages the use of allergen statements, consistent with FALCPA, and other statements that highlight the presence or absence of ingredients of public health concern; particularly the "big eight" allergens. FSIS will consider rulemaking to require allergen statements if it does not continue to observe, through its prior label approval system, widespread voluntary compliance with the use of allergen statements on meat, poultry, and egg product labels. The Agency's compliance policy guide on the use of allergens statements can be found at http://www.fsis.usda...rgens/index.asp.

 

Hi kfromNE,

 

TBH, the above seems fairly succint to me plus the amplification in the sublink -

 

Under the Federal Meat Inspection Act ( FMIA), the Poultry Products Inspection Act ( PPIA), and the Egg Products Inspection Act ( EPIA), under which the Food Safety and Inspection Service (FSIS) operates, all ingredients used to formulate a meat, poultry, or egg product must be declared in the ingredients statement on product labeling. A product is misbranded under the FMIA, PPIA, or EPIA when it contains ingredients that are permitted but are not declared on product labeling.

FSIS recognizes that there are many foods and food ingredients to which some individuals may have some degree of intolerance or possible allergic reaction. That is why complete labeling is so critically important. FSIS supports practices that promote accurate informative product labeling including voluntary statements on labels that alert people who have sensitivities or intolerances to the presence of specific ingredients. .........

 

 

I agree that "including" and "voluntary" are somewhat antagonistic. The former seems to have won out.

It also seems reasonable that USDA should issue a list of allergens (and "sensitivities/intolerances"?)  which require labelling. Perhaps they do ?

 

Ultimately It appears that USDA (substantially) disagrees with FDA over the scope of allergen  labelling. Similar to the labelling of RTE/NRTE ?


Kind Regards,

 

Charles.C


#19 kfromNE

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Posted 05 November 2019 - 01:20 PM

Hi kfromNE,

 

 

Ultimately It appears that USDA (substantially) disagrees with FDA over the scope of allergen  labelling. Similar to the labelling of RTE/NRTE ?

 

Charles - you would be correct. They do disagree.

 

When I asked an allergen expert - this was their response.

"USDA-FSIS often identifies allergies as a reason for recalls involving foods that are not commonly allergenic.  Past incidents have involved corn and rice.  When questioned FSIS indicates that some consumers are allergic to these foods (almost always true, just not very many).  So, a sesame recall is not out of scope for USDA-FSIS."

 

I'll take this one as a learning experience since I've always worked/dealt with FDA regulations but now work in a FDA/USDA dual jurisdiction plant.

Oh the joys of having two federal organizations and rules in the USA in regards to food manufacturing  :headhurts:


Edited by kfromNE, 05 November 2019 - 01:22 PM.


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#20 GMO

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Posted 05 November 2019 - 02:20 PM

Charles - you would be correct. They do disagree.

 

When I asked an allergen expert - this was their response.

"USDA-FSIS often identifies allergies as a reason for recalls involving foods that are not commonly allergenic.  Past incidents have involved corn and rice.  When questioned FSIS indicates that some consumers are allergic to these foods (almost always true, just not very many).  So, a sesame recall is not out of scope for USDA-FSIS."

 

 

 

 

I'd say 1 in 500 isn't that uncommon.  You'd worry if you were giving 1 in 500 people food poisoning for example.



#21 kfromNE

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Posted 05 November 2019 - 03:29 PM

I'd say 1 in 500 isn't that uncommon.  You'd worry if you were giving 1 in 500 people food poisoning for example.

 

I don't think they were necessarily referring to sesame but in general. That's how I took it.

 

In the end the item was mislabeled and recalled due to the fact it was missing an ingredient.



#22 majoy

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Posted 05 November 2019 - 05:22 PM

Just a reminder, Illinois recently require sesame to be declared on the label..

 

http://www.fdalawblo...national-trend/

 

However, this product is sold in California, so not related, but i understood this is mislabeling by not declaring all ingredients of the products.


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#23 Mulan1010

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Posted 06 November 2019 - 10:39 PM

Please look at the wording.  The USDA did not issue a recall for this product.  It was a public health alert and the wording in the article is not quite the same as the wording issued in the alert. Wording from the FSIS Alert: "WASHINGTON, Nov. 2, 2019 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert because New York Style Sausage Co., a Sunnyvale, Calif. establishment, sold 77 pounds of raw pork sausage products that were misbranded. The products contain sesame seed, an allergen, which is not declared on the product label. A recall was not requested because it is believed that products are no longer available for consumers to purchase."

 

Regardless whether it is is one of the 8 major allergens listed in the US or not, 1) Sesame is an allergen to some people and 2) the product was misbranded because it had an ingredient that was not on the label; it is a common practice for USDA to encourage companies to issue a recall for misbranding.  

 

We all need to remember that the "Allergens" listed for each country are just the food items that a majority of people have reactions to but it does not mean that the other ingredients listed are not an allergen to someone.  I have a cousin that is severely allergic to strawberries and a friend that is allergic to onions; both of them have major swelling of their face, throat and tongue and affects their breathing within 10 minutes. Misbranding or improper labeling is very serious whether it involves a major allergen listed for a country or not as someone could be affected any one of the ingredients; you never know.

 

Also, there was an article yesterday (NOV 05 2019) by News Desk on the FSN site that FDA is considering adding Sesame to the major allergens list for the USA so it is on the forefront for a change in the US.



#24 Tony-C

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Posted 07 November 2019 - 02:57 AM

Reactions to sesame can be severe, incorrect ingredient labelling or even no labelling can have devastating consequences:

Pret allergy death: parents describe final moments with their daughter



#25 Charles.C

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Posted 07 November 2019 - 08:48 AM

A few possibly interesting bits I noticed during this thread  -

 

FDA regulated items

 

What foods cause the majority of allergies?
While more than 160 foods can cause allergic reactions in people with food allergies, the Food Allergen Labeling and Consumer Protection Act (FALCA) has identified the eight most common allergenic foods. These eight foods account for 90 percent of food allergic reactions. They are: milk, eggs, fish (such as bass, flounder, cod), crustacean shellfish (such as crab, lobster, shrimp), tree nuts (such as almonds, walnuts, pecans), peanuts, wheat, and soybeans. These eight, and any ingredient that contains protein derived from one or more of them, are designated as "major food allergens" by the FALCPA, which was passed by Congress in 2004 and became effective in 2006.

https://www.fsis.usd...and-food-safety

 

 

 I was unable to locate the quantitative data which validated the above stated 90%.

 

[Added December, 2005] Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA's labeling requirements?

No. FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, "cross-contact " occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment.
https://www.fda.gov/...rgens-edition-4

 

 

The Legalities of (FDA) allergen labelling ,

Attached File  Allergen Labeling Regulations,2014.pdf   223.22KB   5 downloads

 

 

USDA-Regulated Items

 
Published 10/29/2009 08:31 AM   |    Updated 08/15/2018 04:06 AM
 

Is there a "sensitivity level" below which potential allergens or known allergens may be permitted for use without declaration on the label regulated by the USDA?

 

All ingredients used to formulate a meat or poultry product must be declared by common or usual name except for substances whose use has been determined to be consistent with FDA's labeling definition of an incidental additive or processing aid (21 CFR 101.100(a)(3)). For meat, poultry, and egg products under the jurisdiction of FSIS, the Agency makes determinations of whether ingredients are processing aids or incidental additives on a case-by-case basis. FSIS is not aware of any threshold level below which an ingredient that contains protein does not need declaration.

https://askfsis.cust...kVSM2clMjElMjE=

 

 

The above appears to imply that any list of (food) allergens requiring labelling would be "open-ended".

 

 

The USDA regulations demand that ingredients are listed on the products that fall under its aegis, but allergen labelling is voluntary.

This means that many allergen-derived ingredients could ‘mask’ allergen content under vague or more unusual terms — such as vegetable starch, dextrose, casein and others. That said, the USDA’s Food Safety and Inspection Service (FSIS) estimate that there is up to 90% voluntary compliance with the FALCPA allergen labelling regulations.

 

https://www.foodsmat...zola-05018.html

(detailed study into US versus EU Food Allergen Labelling )

 

 

 “Sesame allergies have probably increased more than any other type of food allergy over the past 10 to 20 years. They’re now clearly one of the six or seven most common allergens in the U.S
 

Attached File  Open-Sesame, the case for labelling as allergen,ca 2014.pdf   1.24MB   6 downloads

( a [highly] revelatory investigation to support sesame labelling)

 

 

FSIS supports the voluntary addition of allergen statements (e.g. “contains” statements) on meat and poultry product labels immediately following the ingredients statement

 

Attached File  FSIS Allergens Compliance Guidelines,2015.pdf   903.19KB   5 downloads


Kind Regards,

 

Charles.C





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