Draft Qualitative Risk Assessment of Activity /Food Combinations fo Activities (Outside farm Definition) Conducted in a facility Co-Located on a Farm; Availability

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA-2012-N-1258]

Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability

Agency

Food and Drug Administration, HHS.

Action

Notification; request for comments.

Summary

The Food and Drug Administration (FDA) is announcing the availability of, and requesting comment on, a document entitled “Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” (the draft RA). The purpose of the draft RA is to provide a science-based risk analysis of those activity/food combinations that would be considered low risk. FDA conducted this draft RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA. Elsewhere in this issue of theFederal Register, FDA is using the results of the draft RA to propose to exempt food facilities that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities identified in the draft RA as low-risk activity/food combinations from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for hazard analysis and risk-based preventive controls.

Dates

Submit either electronic or written comments on the draft RA by February 15, 2013.

Addresses

Submit electronic comments to http://. Submit written comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

For Further Information Contact

Jenny Scott,Center for Food Safety and Applied Nutrition (HFS-300),Food and Drug Administration,5100 Paint Branch Pkwy.,College Park, MD 20740,240-402-2166.

Supplementary Information

I. Background

On January 4, 2011, FSMA (Pub. L. 111-353) was signed into law. Section 103 of FSMA, Hazard analysis and risk-based preventive controls, amends the FD&C Act to create a new section 418 with the same name. Section 418 of the FD&C Act (21 U.S.C. 350g) contains requirements applicable to food facilities that are required to register under section 415 of the FD&C Act (21 U.S.C. 350d) and mandates Agency rulemaking. Section 418(a) of the FD&C Act is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) of the FD&C Act specifies that the purpose of the preventive controls is to prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 (21 U.S.C. 342) or misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)). Section 418(b) of the FD&C Act requires that the hazard analysis identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility. Sections 418(c)-(i) of the FD&C Act contain additional requirements applicable to facilities, including requirements for preventive controls (section 418(c)), monitoring (section 418(d)), corrective actions (section 418(e)), verification (section 418(f)), recordkeeping (section 418(g)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)). Elsewhere in this issue of theFederal Register, FDA is issuing a proposed rule (the proposed preventive controls rule) to implement section 418 of the FD&C Act.

Section 103(c) of FSMA requires rulemaking in two areas: (1) Clarification of the activities that are included as part of the definition of the term “facility” under section 415 of the FD&C Act (Registration of food facilities) and (2) possible exemption from or modification of requirements of section 418 and section 421 (U.S.C. 350j) (Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report) of the FD&C Act for certain facilities as FDA deems appropriate. Section 415 of the FD&C Act directs FDA to require by regulation that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with FDA. The registration requirement in section 415 of the FD&C Act does not apply to farms. Our regulations that implement section 415 and require food facilities to register with FDA are established in part 1 (21 CFR part 1), subpart H (Registration of food facilities) (hereinafter the section 415 registration regulations).

Section 103(c)(1)(C) of FSMA directs the Secretary of Health and Human Services (the Secretary) to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover: (1) Specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (2) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.

Section 103(c)(1)(D)(i) of FSMA requires that the Secretary consider the results of the science-based risk analysis, and exempt certain facilities from the requirements in section 418 (including requirements for hazard analysis and preventive controls), and the mandatory inspection frequency in section 421, or modify the requirements in sections 418 or 421 of the FD&C Act, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk. Section 103(c)(1)(D)(ii) of FSMA provides, in relevant part, that the exemptions or modifications described in section 103(c)(1)(D)(i) shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the FD&C Act.

II. Qualitative Risk Assessment

As explained in the draft RA, we conducted the qualitative risk assessment to identify activity/food combinations that would be considered low risk (Ref. 1). We focused on activity/food combinations that we identified as being conducted on farms, but we did not consider activity/food combinations that would be solely within the farm definition (such as growing fruits and vegetables) and, thus, are not relevant to the requirements of section 103 of FSMA. We considered the risk of activity/food combinations rather than separately considering the risk of specific food categories because doing so better enabled us to focus on whether a specific manufacturing, processing, packing, or holding activity conducted on food on a farm warranted an exemption from, or modified requirements for, the provisions of section 418 of the FD&C Act. In the remainder of this document, we use the term “farm mixed-type facility” to refer to an establishment that grows and harvests crops or raises animals and may conduct other activities applicable to farms and to food facilities co-located on farms.

In the draft RA, we describe the approach applied to define a low-risk activity and low-risk activity/food combinations to determine food types out of scope of the draft RA, and to evaluate hazards associated with foods within the scope of the draft RA (Ref. 1). We followed the risk assessment framework of the Codex Alimentarius Commission (Ref. 2), which involves hazard identification, hazard characterization, exposure assessment, and risk characterization. The draft RA addresses nine specific questions:

Question 1: What are the foods that would be manufactured, processed, packed, or held by a farm mixed-type facility?

Question 2: What are the activities that might be conducted by farm mixed-type facilities on those foods?

Question 3: What are the hazards reasonably likely to occur in those foods?

Question 4: For the purpose of determining whether an activity/food combination is low risk, which hazards should be considered to have a reasonable probability of causing serious adverse health consequences or death?

Question 5: For the purpose of determining whether an activity/food combination is low risk, what foods have inherent controls that significantly minimize or prevent a biological hazard that is reasonably likely to occur in these foods and that is reasonably likely to cause serious adverse health consequences or death?

Question 6: What interventions significantly minimize or prevent ahazard that is reasonably likely to occur in these foods and that is reasonably likely to cause serious adverse health consequences or death?

Question 7: Which of these activities are reasonably likely to introduce, or increase the potential for occurrence of, hazards that are reasonably likely to cause serious adverse health consequences or death and what are these hazards?

Question 8: Which of these activities are interventions to significantly minimize or prevent hazards that are reasonably likely to cause serious adverse health consequences or death from consumption of these foods?

Question 9: Which activity/food combinations are low risk, i.e., what on-farm activity/food combinations are not reasonably likely to introduce hazards that are reasonably likely to cause serious adverse health consequences or death or serve as preventive controls (interventions) to significantly minimize or prevent a hazard that is reasonably likely to cause serious adverse health consequences or death?

As discussed in the draft RA, a specific activity may have a different classification within the classes of manufacturing, processing, packing, and holding (with consequences for what regulations apply to the activity) based on whether the food being operated upon is a raw agricultural commodity (RAC) or a processed food and whether a RAC was grown or raised on the farm performing the activity or a farm under the same ownership (Ref. 1). In the draft RA, we first characterize the risk of activity/food combinations without the overlay of the applicable statutory and regulatory framework. Doing so focuses the risk characterization on the risk of the activity/food combinations themselves. We then add that regulatory overlay and characterize the risk of activity/food combinations in three regulatory groups shaped by the applicable regulatory factors and the resulting activity classifications:

  • Regulatory Group Type 1: Low-risk packing and holding activities that might be conducted on a farm on food not grown, raised, or consumed on that farm or another farm under the same ownership;
  • Regulatory Group Type 2: Low-risk manufacturing and processing activities that might be conducted on a farm on the farm's own RACs for distribution into commerce; and
  • Regulatory Group Type 3: Low-risk manufacturing and processing activities that might be conducted on a farm on food other than the farm's own RACs for distribution into commerce.

We are seeking comments that can be used to improve:

  • The approach used;
  • The assumptions made;
  • The data used; and
  • The transparency of the draft RA.

Specifically we request comment on:

  • The definitions of “low-risk activity” and “low-risk activity/food combination”;
  • The food types and activity/food combinations that we are considering outside the scope of the draft RA and those we are considering within the scope of the draft RA;
  • The approach to characterizing the risk of an activity/food combination;
  • The questions addressed by the draft RA; and
  • The answers to those questions.

We submitted a draft RA to a group of scientific experts external to FDA for peer review and revised the draft RA, as appropriate, considering the experts' comments. A report concerning the external peer review is available for public review and can be accessed from our Web site (Ref. 3). We will consider public comments regarding the draft RA in preparing a final version of the RA.

III. Comments

Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding the draft RA to the Division of Dockets Management (seeADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

The draft RA is available electronically at http://www.regulations.gov and at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.

V. References

The following references have been placed on display in the Division of Dockets Management (seeADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in theFederal Register.)

1. FDA, “Draft Qualitative Risk Assessment. Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm,” 2012. Available at: http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.

2. Codex Alimentarius Commission, “Codex Alimentarius Commission Procedural Manual, Twentieth Edition,” 2011.

3. FDA, “Peer Review Report. External Peer Review of the FDA/CFSAN Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm,” 2012. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.

Dated: January 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-124 Filed 1-4-13; 11:15 am]
BILLING CODE 4160-01-P

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Section V List of References 1 Thru 3

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Reference 1 Draft Qualitative Risk Assessment Risk of Activity/Food Combinations for Activities Outside the Farm Definition...

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Reference 2 Codex Alimentarius Commission Procedural Manual Twentieth Edition

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Reference 3 Peer Review Report. External Peer Review of the FDA CFSAN Draft Qualitative Risk Assessment Risk of Activity Food...

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Section VIII List of References 1 Thru 103 re Draft Qualitative Risk Assessment Risk of Activity/Food Combinations for Activities...

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Abstract: VIII
 

Reference 1 Bacteriological Survey of Sixty Health Foods

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Reference 2 Occurrence of Uranium and 222Radon in Glacial and Bedrock Aquifers in the Northern United States, 1993 2003 US...

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Reference 3 Ochratoxins a Global Perspective

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Reference 4 Understanding Food Safety Regulations for Farm Direct Sales A Study of Connecticut Massachusetts New York and Vermont

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Reference 5 Mycotoxins and Food Supply

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Reference 6 Food Allergy Among Children in the United States

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Reference 7 Salmonella Typhimurium Infections Associated With Peanut Products

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Reference 8 Outbreak of Salmonella Serotype Enteritidis Infections Associated With Raw Almonds United States and Canada 2003 2004

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Reference 9 Multistate Outbreaks of Salmonella Infections Associated With Raw Tomatoes Eaten in Restaurants United States 2005...

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Reference 10 Multistate Outbreak of Salmonella Infections Associated With Peanut Butter and Peanut Butter Containing Products...

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Reference 11 Botulism

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Reference 12 Foodborne Outbreak Online Database FOOD

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Reference 13 Investigation Update Multistate Outbreak of E Coli O157 H7 Infections Associated With In Shell Hazelnuts

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Reference 14 Surveillance for Foodborne Disease Outbreaks United States 2008

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Reference 15 Norovirus Clinical Overview

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Reference 16 Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria Monocytogenes in Ready...

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Reference 17 Direct Healthcare Costs of Selected Diseases Primarily or Partially Transmitted by Water

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Reference 18 Farmers Market Reference Guide Chapter 14 Unprocessed Fruits and Vegetables

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Reference 19 Farmers Market Reference Guide Chapter 13 Requirements of Processed Packaged Foods and Baked Goods

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Reference 20 Farmers Market Reference Guide Chapter 23 Requirements For Items Exempt From Inspection

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Reference 21 Growth and Survival of Escherichia Coli O157 H7 Under Acidic Conditions

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Reference 22 Salmonella Species

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Reference 23 Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a Request From the Commission...

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Reference 24 Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables

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Referrence 25 Food Code 2009

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Reference 26 Food Code 2009 Annex 3 Public Health Reasons Administrative Guidelines Chapter 1 Purpose and Definitions

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Reference 27 Food Code 2009 Annex 3 Public Health Reasons Administrative Guidelines Chapter 3 Food

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Reference 28 Food Code 2009 Chapter 1 Purpose and Denititions

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Reference 29 Food Code 2009 Chapter 3 Food

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Reference 30 Pesticide Monitoring Program FY 2008

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Reference 31 FDA Foods Program The Reportable Food Registry A New Approach to Targeting Inspection Resources and Identifying...

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Reference 32 Health Hazard Assessment for Gluten Exposure in Individuals With Celiac Disease Determination of Tolerable Daily...

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Reference 33 Bad Bug Book: Foodborne Pathogenic Microorganisms and Natural Toxins Handbook. Second Edition

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Reference 34 FDA Foods Program The Reportable Food Registry A New Approach to Targeting Inspection Resources and Identifying...

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Reference 35 Listeria Monocytogenes Risk Assessment VII Interpretation and Conclusions

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Reference 36 Quantitative Assessment of Relative Risk to Public Health From Foodborne Listeria Monocytogenes Among Selected...

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Reference 37 Multiple Telephone Conversations Between August 26th and September 9th 2002 and Between November 19th and 20th 2002...

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Reference 38 Food GMP Modernization Working Group Summary of Food Recalls 1999 2003

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Reference 39 Emails Related to Soybean Processing

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Reference 40 Produce Related Outbreaks and Illnesses

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Reference 41 Analysis of Food Recalls Initiated in 2008 2009 by an FDA CGMP Working Group

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Reference 42 FDA Memorandum EMail Related to on Farm Processing 2012b

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Reference 43 Foreign Object Submissions to the RFR

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Reference 44 On Farm Food Types and Activities

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Reference 45 Hepatitis A Transmitted by Food

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Reference 46 Occurrence of Selected Radionuclides in Ground Water Used for Drinking Water in the United States A Targeted...

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Reference 47 Risk Assessment of Listeria Monocytogenes in Ready to Eat Foods Interpretative Summary Executive Summary of the Main...

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Reference 48 Risk Assessment of Listeria Monocytogenes in Ready to Eat Foods Technical Report

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Reference 49 Incidence of Listeriosis and Related Mortality Among Groups at Risk of Acquiring Listeriosis

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Reference 50 Granum Bacillus Cereus

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Publication Reference: Food Microbiology: Fundamentals and Frontier 3rd edition20, pp. 445-455, ASM Press, 2007
 

Reference 51 Hyman et al Food and Drug Administration Surveillance of the Role of Foreign Objects in Foodborne Injuries

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Publication Reference: Public Health Reports, 108:54-59, 1993
 

Reference 52 Institute of Food Technologists Analysis and Evaluation of Preventive Control Measures for the Control and Reduction...

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Reference 53 Institute of Food Technologists Evaluation and Definition of Potentially Hazardous Foods

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Reference 54 International Commission on Microbiological Specifications for Foods Clostridium Botulinum Microorganisms in Foods 5...

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Reference 55 International Commission on Microbiological Specifications for Foods Salmonellae Microorganisms in Foods 5...

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Reference 56 International Commission on Microbiological Specifications for Foods Staphylococcus Aureus Microorganisms in Foods 5...

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Reference 57 International Commission on Microbiological Specifications for Foods Cereals and Cereal Products Microorganisms in...

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Reference 58 International Commission on Microbiological Specifications for Foods Cocoa Chocolate, and Confectionery...

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Reference 59 International Commission on Microbiological Specifications for Foods Nuts Oilseeds and Dried Legumes Microorganisms...

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Reference 60 International Commission on Microbiological Specifications for Foods Soft Drinks Fruit Juices Concentrates and Fruit...

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Reference 61 International Commission on Microbiological Specifications for Foods Sugar Syrups and Honey Microorganisms in Foods 6...

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Reference 62 International Commission on Microbiological Specifications for Foods Fruit and Fruit Products Microorganisms in Foods...

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Reference 63 Isaacs et al An International Outbreak of Salmonellosis Associated With Raw Almonds Contaminated With a Rare Phage...

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Reference 64 Ito et al Effect of pH on Growth of Clostridium Botulinum in Foods

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Reference 65 Jantschke et el Physical Hazards and Controls HACCP A Systematic Approach to Food Safety

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Reference 66 Jay Intrinsic and Extrinsic Parameters of Foods That Affect Microbial Growth Modern Food Microbiology

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Reference 67 Johnson Clostridium Botulinum Food Microbiology Fundamentals and Frontiers

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Reference 68 Koutsoumanis et al Modeling the Boundaries of Growth of Salmonella Typhimurium in Broth As a Function of Temperature...

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Reference 69 Leff New Farm Stand Regulations Now in Effect Expand Options University of California Small Farm News Volume 10 2009

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Reference 70 Leyer et al Acid Adaptation Promotes Survival of Salmonella spp in Cheese

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Publication Reference: Applied and Environmental Microbiology, 58:2075-2080, 1992
 

Reference 71 Massachusetts Department of Public Health Residential Kitchens Questions and Answers

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Reference 72 Meng et al Enterohemorrhagic Echerichia Coli Food Microbiology Fundamentals and Frontiers

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Reference 73 Montville et al Growth Survival and Death of Microbes in Foods Food Microbiology Fundamentals and Frontiers

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Reference 74 Muth et al Food Processing Sector Study Contract

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Reference 75 New York Department of Agriculture and Markets Agricultural Districts Guidelines for Review of Local Laws Affecting...

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Reference 76 Notermans Control in Fruits and Vegetables Clostridium Botulinum Ecology and Control in Foods

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Publication Reference: Chapter 9, pp. 223-260, Marcel Dekker Inc., 1993
 

Reference 77 Olsen Regulatory Action Criteria for Filth and Other Extraneous Materials Review of Hard or Sharp Foreign Objects As...

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Reference 78 Oregon Department of Agriculture Farm Direct Specific Commodities

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Reference 79 Ortega Protozoan Parasite Food Microbiology Fundamentals and Frontiers

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Reference 80 Painter et al Listeriosis in Human Listeria, Listeriosis and Food Safety

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Reference 81 Pestka et al Deoxynivalenol Toxicology and Potential Effects on Humans

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Reference 82 Ross et al Analysis of Food Allergic and Anaphylactic Events in the National Electronic Injury Surveillance System

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Reference 83 Sampson Update on Food Allergy

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Reference 84 Sampson Food Allergy Accurately Identifying Clinical Reactivity

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Reference 85 Scallan et al Foodborne Illness Acquired in the United States Major Pathogens

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Reference 86 Scott et al Measurement of Water Activity Aw Acidity and Brix Compendium of Methods for the Microbiological...

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Reference 87 Scott et al Control of Salmonella in Low Moisture Foods I Minimizing Entry of Salmonella into a Processing Facility

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Publication Reference: Food Protection Trends, 29:342-353, 2009.
 

Reference 88 Shephard Risk Assessment of Aflatoxins in Food in Africa Food Additives and Contaminants Part A Chemistry Analysis...

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Reference 89 Sicherer et al Clinical Features of Acute Allergic Reactions to Peanut and Tree Nuts in Children

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Reference 90 Sicherer et al Food Allergy

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Reference 91 Simon A Population Based Epidemiologic Analysis of Deaths From Anaphylaxis in Florida

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Reference 92 Swaminathan et al Listeria Monocytogenes Food Microbiology Fundamentals and Frontiers

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Reference 93 Taylor et al Food Allergies and Other Food Sensitivities Food Technology 2001

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Reference 94 The Institute of Food Technologists Evaluation and Definition of Potentially Hazardous Foods

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Reference 95 Timbo et al Sulfites A Food and Drug Administration Review of Recalls and Reported Adverse Events

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Reference 96 Townsend et al Inhibition of the Growth of Clostridium Botulinum by Acidification

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Publication Reference: Journal of Food Science, 19:536-542, 1954.
 

Reference 97 United Nations Scientific Committee on the Effects of Atomic Radiation UNSCEAR 2008 Report to the General Asssembly...

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Reference 98 University of California Small Farm Program Food Safety at Farmers Markets and Agritourism Venues

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Reference 99 Washington State Department of Agriculture Small Farm and Direct Marketing Handbook Sixth Edition

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Reference 100 Williams et al Human Aflatoxicosis in Developing Countries A Review of Toxicology Exposure Potential Health...

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Publication Reference: American Journal of Clinical Nutrition, 80:1106-1122, 2004
 

Reference 101 World Health Organization FAQs Japan Nuclear Concerns

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Reference 102 Yang et al Adverse Reactions to Sulfites

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Reference 103 Yocum et al Epidemiology of Anaphylaxis in Olmsted County A Population-Based Study

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Comment Period Closed
Feb 15 2013, at 11:59 PM ET
ID: FDA-2012-N-1258-0001
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Date Posted: Jan 16, 2013
CFR: CFR Part 117
Federal Register Number: 2013-00124
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