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  1. Food Safety Modernization Act (FSMA)

Report on the 2015 Food Processing Sector Study

The Food Safety Modernization Act (FSMA) requires many deliverables from FDA, among them special reports and studies to be submitted to Congress.

Submitted June 9, 2016

Report to Congress on the Food Processing Sector Study
Submitted Pursuant to Section 103(a) of the FDA Food Safety Modernization Act,
Public Law 111-353
U.S. Department of Health and Human Services
Food and Drug Administration


The FDA Food Safety Modernization Act (FSMA) (Public Law 111-353), signed into law on January 4, 2011, entrusted FDA with new authority and legislative mandates designed to improve the safety of the food supply. Section 103(a) of FSMA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a new section 418, which requires the Secretary of Health and Human Services (HHS) to conduct a study of the food processing sector under the Secretary’s jurisdiction to provide data needed for defining key terms in promulgating a regulation requiring hazard analysis and risk-based preventive controls in food facilities. Specifically, FSMA section 103(a) creates section 418(l) of the FD&C Act which states:

"(5) Study.--
"(A) In general.--The Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine--
"(i) the distribution of food production by type and size of operation, including monetary value of food sold;
"(ii) the proportion of food produced by each type and size of operation;
"(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity;
"(iv) the incidence of foodborne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; and
"(v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities.
"(B) Size.--The results of the study conducted under subparagraph (A) shall include the information necessary to enable the Secretary to define the terms `small business' and `very small business', for purposes of promulgating the regulation under subsection (n). In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested.
"(C) Submission of report.--Not later than 18 months after the date of enactment the FDA Food Safety Modernization Act, the Secretary shall submit to Congress a report that describes the results of the study conducted under subparagraph (A).”
As required by section 418(l)(5)(C) of the FD&C Act, this report summarizes the results of the study. 


Under contract with FDA, the Research Triangle Institute conducted a study in collaboration with U.S. Department of Agriculture’s (USDA) Economic Research Service (ERS), American Farm Bureau (AFB), and Agricultural Marketing Service (AMS) to address the requirements of section 418(l)(5) of the FD&C Act. The full study report is included here as an appendix. Section 1 of the study report provides an introduction that describes general study definitions and organization. Section 2 addresses FD&C Act sections 418(l)(5)(A)(i), (ii), and (iii) using commercially available data and other sources, and Section 3 addresses FD&C Act sections 418(l)(5)(A)(iv) and (v) using an expert elicitation approach with references to the available literature.  

Food Processing Sector Study

Key results of the portion of the study on the size and scope of the food industry are as follows:

  • Based on current data, the food processing industry generates total annual revenue of approximately $211 billion across about 20,519 establishments, including pet food and animal feed processing facilities but excluding facilities not affected by the FSMA (e.g., meat, poultry, egg products, juice, and seafood processing).
  • About 85% of establishments in the food processing industry have fewer than 100 employees.
  • About 61% of total food industry sales are made by food processing establishments with fewer than 100 employees.
  • Less than 2% of food processing establishments are co-located on farms according to Dun & Bradstreet data, and 8% of growers with produce sales said they were packing on the farm, according to USDA Census of Agriculture data, although they may not have been packing produce. According to industry experts, estimates of co-located farms range from less than 1% to 55% across different commodities.

Key results of the portion of the study on foodborne illness risk are as follows:

  • Fresh produce, dry (low-moisture) foods, and refrigerated foods ranked the highest in terms of contributing to human foodborne illness risk, while sugars and sweets, milled and pressed foods, and beverages ranked the lowest.
  • Exposure to animal feed and pet food ranked low in contributing to human illness.
  • There was no consistent pattern across food categories in terms of which sizes of establishments contributed most to foodborne illness risk.
  • No foods can be said to have no reported or known hazards.
  • Although more foodborne illness risk is attributed to food processing than to commingling, transporting, or storing, all of these other activities contribute to foodborne illness risk to some degree.
  • The relative importance of processing in contributing to foodborne illness risk compared with farm production activities, retail operations, and consumer food handling is unknown.
  • The scale of processing activity is important as a contributor to foodborne illness risk, while the duration of activity contributes to increased foodborne illness risk for only some activities and some foods.


This report required by FSMA section 103(a) describes the results of the study of the food processing sector conducted in accordance with section 418(l)(5)(A) of the FD&C Act. The study utilized a wide range of data sources, industry and commodity experts from several federal agencies, including USDA’s ERS, AFB, and AMS, along with experts from several states and the private sector. The results of the study are the most comprehensive efforts to date for characterizing the number and types of food facilities that are co-located on farms and helps characterize the risks from commingling, transporting, or storing food. The comprehensive nature of the study has helped FDA identify risk-based processing activities on farms by size and activity in promulgating regulations on hazard analysis and risk-based preventive controls (see 80 FR 55908 and 80 FR 56170).  

Appendix: Food Processing Sector Study Report

2015 Food Processing Sector Study (PDF: 1MB)

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