Farm-to-Consumer Legal Defense Fund
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Send a personal message to your legislators through our petition system by clicking on “Oppose HR 2749“.  

Talking Point:  HR 2749 would impose an annual registration fee of $500 on any “facility” that holds, processes, or manufactures food.  Although “farms” are exempt, the agency has defined “farm” narrowly.  And people making foods such as lacto-fermented vegetables, cheeses, or breads would be required to register and pay the fee, which could drive beginning and small producers out of business during difficult economic times.

* * * * * * *

Excerpt from June 15 Post by Pete Kennedy(page references to Pallone’s version–See corresponding Waxman’s version at end):


Under current law, all “food facilities” are required to register with the Secretary of the Department of Health and Human Services (HHS) [21 USC § 350d].   The registration requirement is for one time only and no fee is charged.  The FSEA would amend the current law to add significant requirements.


The FSEA would require facilities to register annually [section 101(b)(1)–p. 3], rather than a one-time registration.  Registrants would also be required to pay an annual fee of $500, to be adjusted for inflation [section 101, Part6, sec 743(b)(1)(A)–p. 10]. 


The term “facility” does not include “farms” for purposes of registration in either the current law or under the bill [21 USC § 350d(b)(1)].  But what exactly is a “farm”?  The FDA’s current regulations take a very narrow view of what qualifies as a farm:

“…a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.  Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting.  The term “farm” includes:

“(i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and

“(ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.” [21 CFR § 1.227(3)] (emphasis added)

“Manufacturing/processing” is defined as “making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients.  Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.” [21 CFR § 1.227(6)]  In other words, any farm that makes jam, cans vegetables, or packages cut fruit would not be considered a “farm” under the regulation unless the food is consumed only on the farm! 

In a subsequent guidance document, FDA expanded the definition of “farm”:  “The term ‘farm’ also includes facilities that manufacture/process, pack, or hold food, provided that all food used in those activities is grown, raised, or consumed on that farm or another farm under the same ownership.” (emphasis added).  Under the guidance document, a “farm” can process food if the raw ingredients are grown or raised on that farm.  In other words, a farmer could make lacto-fermented foods from his own produce; but a farmer who obtains produce from a neighbor to make such foods (unless consumed there) would no longer be considered a “farm” and would be subject to FDA registration. 

Even under the guidance document, many small farms and artisanal producers could be required to register.  FDA has not enforced this requirement strictly so far, but that is no guarantee about future actions by the agency.  And if the agency were to revoke the guidance document and enforce the registration requirement in accordance with the definition of “farm” contained in the regulations, many farms would be required to register and, under the FSEA, pay an annual fee.


The FSEA would also mandate that registrations be submitted in electronic format only [section 101(b)(1)(C)–p. 4].  Amish and Mennonite food producers having to register would thus be faced with a choice of violating either their religious faith or the law, while other food producers could face added expense and problems if they do not have the necessary technology.  Failure to properly register would constitute misbranding and would be a violation of the law [section 101a–p. 3].

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Waxman’s version (June 17)

* * Pallone section 101(b)(1)-p. 3 = Waxman pp. 6-7  * *


     (1) IN GENERAL.—Section 415(a) (21 U.S.C. 350d(a)) is amended—

          (A) in the first sentence of paragraph (1)—

                 (i) by striking ‘‘require that’’ and inserting ‘‘require that, on or before December 31 of each year,’’; and

                (ii) by striking ‘‘food for consumption in the United States’’ and inserting ‘‘food for consumption in the United States or for export from the United States’’; 

          (B) in subparagraphs (A) and (B) of paragraph (1), by inserting ‘‘and pay the registration fee required under section 743’’ after ‘‘submit a registration to the Secretary’’ each place it appears;

          (C) in the first sentence of paragraph (2), by inserting ‘‘in electronic format’’ after ‘‘submit’’; and 

          (D) in paragraph (4), by inserting after the first sentence the following: ‘‘The Secretary shall remove from such list the name of any facility that fails to reregister in accordance with this section, that fails to pay the registration fee required under section 743, or whose registration is canceled by the registrant, canceled by the Secretary in accordance with this section, or suspended by the Secretary in accordance with this section.’’.

* * Pallone section 101, Part6, sec 743(b)(1)(A)-p. 10 = Waxman p. 13 * *

 ‘‘(b) FEE AMOUNTS.—

          ‘‘(1) IN GENERAL.—The registration fee under subsection (a) shall be—

                ‘‘(A) for fiscal year 2010, $500; and

                ‘‘(B) for fiscal year 2011 and each subsequent fiscal year, the fee for fiscal year 2010 as adjusted under subsection (c).

* * Pallone section 101(b)(1)(C)-p. 4 = Waxman pp. 98-99 [see above, first cite] * *

* * Pallone section 101a-p. 3= Waxman p. 6 * *


(a) MISBRANDING.—Section 403 (21 U.S.C. 343) is amended by adding at the end the following:

       ‘‘(z) If it was manufactured, processed, packed, or held in a facility that is not duly registered under section 415, including a facility whose registration is canceled or suspended under such section.’’.

The “Oppose HR 2749” petition is posted at

Information provided courtesy Farm-to-Consumer Legal Defense Fund (

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