10 replies to this topic

[dboreen]

We are largely a fish processing plant. In seafood, we do not do any other processing aside from filleting and portioning fish. We do not mix any ingredients in the building at all. 

 

We were cited during an FDA audit for not having a labeling step as a CCP in our HACCP plan. We were also cited because our labels did not state that an allergen was present. 

 

I did some digging in the Code of Federal Regulations and looks like only if it is not a raw agricultural commodity, it does not need to specify the allergen.

I also found the difinitions of "agricultural commodity" in Title 7 (Agriculture) and "raw agricultural commodity" in Title 21 (Food and Drugs).

 

My question is, Would a whole fish or fish fish fillet constitue as a raw agricultural commodity? The definition in Title 21 (Food and Drugs) does not go beyond the example of fruit, where the definition in Title 7 specifically mentions examples of fish and seafood products.

Also, would that mean we could argue the citation?

 

((see below for references)) 

 

 

 

21 U.S.C.

United States Code, 2011 Edition
Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
Sec. 343 - Misbranded food

 

(w) Major food allergen labeling requirements

(1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either—

(A) the word “Contains”, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i) of this section; or

(B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) of this section is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when—

(i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or

(ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title.

 

 

 

Title 7 Subtitle B Chapter XLII Part 4284 Subpart J General § 4284.902

§ 4284.902 Definitions

 

Agricultural commodity. An unprocessed product of farms, ranches, nurseries, and forests and natural and man-made bodies of water, that the Independent Producer has cultivated, raised, or harvested with legal access rights. Agricultural commodities include plant and animal products and their by-products, such as crops, forestry products, hydroponics, nursery stock, aquaculture, meat, on-farm generated manure, and fish and seafood products. Agricultural commodities do not include horses or other animals raised or sold as pets, such as cats, dogs, and ferrets.

 

 

 

21 U.S.C.
United States Code, 2019 Edition
Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
Sec. 321 - Definitions; generally
From the U.S. Government Publishing Office, www.gpo.gov

 

CHAPTER II—DEFINITIONS 1 SEC. 201. [21 U.S.C. 321] ®

The term ‘‘raw agricultural commodity’’ means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

 

[kfromNE]

If they cited you - they would need to specify which part of the code they are citing you under. 

 

I'd ask that question then go from there. 

[dboreen]

If they cited you - they would need to specify which part of the code they are citing you under. 

 

I'd ask that question then go from there. 

The CFR number provided for the citation was 21 CFR 123.6©(2)

((see below))

 

 

21 CFR 123.6©(2)

List the critical control points for each of the identified food safety hazards, including as appropriate:

 

(i) Critical control points designed to control food safety hazards that could be introduced in the processing plant environment; and

(ii) Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest;

 

 

 

And in their summary, they stated "The firm did not identify the fish labeling step as a critical control point and the firm is not monitoring that labels are accurate and adequately declare that the products contain the fish allergen." I didn't know that labeling was considered a mandatory CCP...

 

Our labels for fish state the name of the product and do not contain any other ingredients; Since the are a seafood product that is not processed according to the definition in the US code, they would be a raw agricultural commodity, right? Which leads me to believe that the allergen statement would not be necessary?

((see below))

 

 

CHAPTER II—DEFINITIONS1 SEC. 201. [21 U.S.C. 321]

 

(gg) The term "processed food" means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.

 

21 CFR 123.6©(2)

List the critical control points for each of the identified food safety hazards, including as appropriate:

 

(i) Critical control points designed to control food safety hazards that could be introduced in the processing plant environment; and

(ii) Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest;

[Scampi]

I'm a wondering if the inspector is talking (in a round about way) of sulphites...........which would be a CCP and would have to be declared on the label.................but I'm just fishing here (sorry couldn't' help myself)

[jfrey123]

This is an odd take for me...  Does everyone who processes allergens within their plant have label control as an automatic CCP?  I don't think our plants do, and we sometimes package items that contain dairy (cheese) and peanut butter.  We describe the process for label approval and control in a separate program, and we do mention the label checks in our labeling step of our HACCP flow diagram.  Seems to satisfy everyone.

 

For the OP:  Is labeling described as a step in your HACCP plan and HA?  If so, you could risk matrix the allergen at that step, and I'd wager you'd be able to justify no CCP needed so long as the label program talks about all product must be labeled as a fish allergen (considering it's the only ingredient you handle).  I can only imagine the finding here originated because labeling of allergens wasn't addressed in the HACCP plan, but that's only an assumption on my part.

[kingstudruler1]

Im not a fish person.    see section 19 of FDA guidance link.   In particular table 19-2 & 3   

https://www.fda.gov/.../80637/download

 

Im guessing that had the allergen been listed they might not have gone HACCP on you.  

 

They are not going to let you use the raw ag commodity exemption.  

 

When you say your labels contain the name of the product what do you mean?   they appear to be saying that its not declared.  

[dboreen]

Im not a fish person.    see section 19 of FDA guidance link.   In particular table 19-2 & 3   

https://www.fda.gov/.../80637/download

 

Im guessing that had the allergen been listed they might not have gone HACCP on you.  

 

They are not going to let you use the raw ag commodity exemption.  

 

When you say your labels contain the name of the product what do you mean?   they appear to be saying that its not declared.  

 

Im not a fish person.    see section 19 of FDA guidance link.   In particular table 19-2 & 3   

https://www.fda.gov/.../80637/download

 

Im guessing that had the allergen been listed they might not have gone HACCP on you.  

 

They are not going to let you use the raw ag commodity exemption.  

 

When you say your labels contain the name of the product what do you mean?   they appear to be saying that its not declared.  

When I say our labels contain the name of the product, I am saying the labels state specifically the name of the fish; "Walleye," for instance. However, "Contains Fish" is not present on every label for product that is fish.

 

Thank you for your input! :) 

[dboreen]

This is an odd take for me...  Does everyone who processes allergens within their plant have label control as an automatic CCP?  I don't think our plants do, and we sometimes package items that contain dairy (cheese) and peanut butter.  We describe the process for label approval and control in a separate program, and we do mention the label checks in our labeling step of our HACCP flow diagram.  Seems to satisfy everyone.

 

For the OP:  Is labeling described as a step in your HACCP plan and HA?  If so, you could risk matrix the allergen at that step, and I'd wager you'd be able to justify no CCP needed so long as the label program talks about all product must be labeled as a fish allergen (considering it's the only ingredient you handle).  I can only imagine the finding here originated because labeling of allergens wasn't addressed in the HACCP plan, but that's only an assumption on my part.

Labeling is addressed in our separate allergen program documnet, HACCP flow chart, and HA, but not the HACCP plan - since we do not declare it a CCP.

 

Thank you for your input! :)

[kingstudruler1]

When I say our labels contain the name of the product, I am saying the labels state specifically the name of the fish; "Walleye," for instance. However, "Contains Fish" is not present on every label for product that is fish.

 

Thank you for your input! :) 

 

that is your problem.   kinda disappointing they were clear on what they were expecting.    from the fda labeling guidance:

 

https://www.fda.gov/.../81606/download

 

F8. Does FALCPA provide any specific direction for declaring the presence ofingredients from the three food groups that are designated as “major food allergens (i.e.,tree nuts,fish, and Crustacean shellfish)”? Answer: Yes. FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp). F9. Under section 403(w)(1) ofthe FD&C Act, a major food allergen must be declared using the name ofthe food source from which the major food allergen is derived. Section 403(w)(2) ofthe FD&C Act provides that, in the case offish or Crustacean shellfish,the term “name ofthe food source from which the major food allergen is derived” means the “species” offish or Crustacean shellfish. Whatis the “species” offish or Crustacean shellfish for purposes of section 403(w)(2)? Answer: A declaration of the “species” of fish or Crustacean shellfish for purposes of complying with Section 403(w)(2) should be made using the acceptable market name provided in FDA's The Seafood List. The Seafood List is a compilation of existing acceptable market names for imported and domestically available seafood. We note, however, that if a “Contains” statement is used to declare the source of the fish or Crustacean shellfish, we would not object to just the type of fish or Crustacean shellfish being used, e.g., “Contains salmon” or “Contains trout.”

[dboreen]

that is your problem.   kinda disappointing they were clear on what they were expecting.    from the fda labeling guidance:

 

https://www.fda.gov/.../81606/download

 

F8. Does FALCPA provide any specific direction for declaring the presence ofingredients from the three food groups that are designated as “major food allergens (i.e.,tree nuts,fish, and Crustacean shellfish)”? Answer: Yes. FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp). F9. Under section 403(w)(1) ofthe FD&C Act, a major food allergen must be declared using the name ofthe food source from which the major food allergen is derived. Section 403(w)(2) ofthe FD&C Act provides that, in the case offish or Crustacean shellfish,the term “name ofthe food source from which the major food allergen is derived” means the “species” offish or Crustacean shellfish. Whatis the “species” offish or Crustacean shellfish for purposes of section 403(w)(2)? Answer: A declaration of the “species” of fish or Crustacean shellfish for purposes of complying with Section 403(w)(2) should be made using the acceptable market name provided in FDA's The Seafood List. The Seafood List is a compilation of existing acceptable market names for imported and domestically available seafood. We note, however, that if a “Contains” statement is used to declare the source of the fish or Crustacean shellfish, we would not object to just the type of fish or Crustacean shellfish being used, e.g., “Contains salmon” or “Contains trout.”

Thank you! This is an extremely helpful link! :)

[G M]

It seems very strange to me that they're trying to dictate what your CCPs are.

 

The only plan we have that uses labeling as a CCP, has that as its only CCP because its a for-further-processing item.