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Food

Does the FSMA Proposed Rule for Produce Safety Apply to You? What You Need to Know About Proposed Rule

September 2014

Proposed Rule for Produce Safety Main Page

View the Original Version released with the Original Proposed Rule in January 2013


Proposed Standards for Produce Safety - Coverage and Exemptions/Exclusions for Proposed 21 PART 112

Does your farm grow, harvest, pack or hold produce? Sections 112.1 and 112.3(c)

We define “produce” in section 112.3(c).

YES

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NO Arrow right

You are NOT covered by this rule.

Does your farm on average (in the previous 3yrs) have $25k or less in annual produce sales? Section 112.4(a)

NO

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YES Arrow rightYou are NOT covered by this rule. 
 

Is your produce one of the commodities that FDA has identified as rarely consumed raw? Section 112.2(a)(1)

(If you grow, harvest, pack or hold more than one produce commodity, you must ask this question separately for each one to determine whether that particular produce commodity is covered by this rule.)

NO

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YES Arrow rightThis produce is NOT covered by this rule.

Is your produce for personal/on-farm consumption? Section 112.2(a)(2)

NO

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YES Arrow rightThis produce is NOT covered by this rule.

Is your produce a Raw Agricultural Commodity (RAC)? Section 112.2(a)(3)

(The Federal Food, Drug, and Cosmetic act defines a “Raw Agricultural Commodity” as 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.)
 

YES

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NO Arrow rightProduce that is not a RAC is NOT covered by this rule.

Is your produce intended for commercial processing with a “kill step”? Section 112.2(b)(1)

NO

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YES Arrow rightThis produce is NOT covered by this rule, EXCEPT you must establish and keep certain documentation. Sections 112.(b)(2) and (3).
 

Does your farm on average (in the previous 3yrs) as per Section 112.5:

  • have < $500k annual food sales, AND
  • a majority of the food (by value) sold directly to "qualified end-users"?

"Qualified End-User" Section 112.3(c) means:

  • the consumer of the food (“consumer” is not a business) OR
  • a restaurant or retail food establishment that is located—
    (i) in the same State as the farm that produced the food; OR
    (ii) not more than 275 miles from such farm.
NO

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YES Arrow rightYou are EXEMPT from this rule except you must meet certain modified requirements as per Section 112.6.
 
You are COVERED by this rule.  

 

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