Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an IngredientSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient
					
		
		March 2009


	Read the Federal Register Notice 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2009-D-0060
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


*This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.*

**Table of Contents**

Introduction
	Discussion
	Considerations for Evaluating the Effectiveness of Certain *Salmonella* Control Measures
		Recommendations
	FDA Web Site References
	References Without Web Site Addresses
	Non-FDA Web Site References

I. Introduction

This guidance is intended for manufacturers who use a peanut-derived product as an ingredient in a food product. Peanut-derived products include peanuts, peanut butter, peanut paste, peanut meal, and peanut granules. We are issuing this guidance because recent outbreaks indicate the potential for foodborne illness resulting from the consumption of foods containing peanut-derived products if a peanut-derived product used as an ingredient is contaminated with *Salmonella* species (*Salmonella* spp.) (Ref. 1). FDA may take enforcement action, including pursuing product seizure, where food has tested positive for *Salmonella* spp(2)

This guidance does not provide recommendations for producers of peanut-derived products. Importantly, this guidance does not diminish the responsibility of producers of peanut-derived products to ensure that foods that they produce are not "adulterated" under the Federal Food, Drug, and Cosmetic Act (the act) or otherwise in violation of the law.(3) Remedies for violations of the act include seizure, injunction, and criminal prosecution.(4)

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Discussion

A. Considerations for Evaluating the Effectiveness of Certain*Salmonella* Control Measures

*Salmonella*spp. are bacteria that ordinarily are sensitive to heat and high acidity. This sensitivity is often the basis for food processing used to control the presence of the organism. For example, it takes only 3 seconds to achieve a 5-log reduction in *Salmonella* at 71 °C (equivalent to 160 °F) in fruit juices (Ref. 4).

While considered heat sensitive, *Salmonella* spp. can become heat resistant in dry food products such as powdered milk or in low water activity products like chocolate syrup and peanut butter (Refs. 5 and 6). The relationship of *Salmonella* heat resistance to water activity has been well-studied at water activities between 0.99 and 0.85. Generally, *Salmonella*becomes more heat resistant as the water activity of a food becomes lower (Refs. 7 and 8). For example, it takes less than 5 minutes to achieve a 5-log reduction of *Salmonella* at 140 °F in a food with a water activity of 0.99 (Ref. 9). However, it takes 50 minutes to achieve the same reduction of *Salmonella* at 140 °F in a food with a water activity of 0.85 (Ref. 10).

The influence of the food on the heat resistance of *Salmonella* is not limited to the effects of water activity. The composition of the food (such as fat content, protein content, and acidity) may also affect heat resistance. For example, it can take more than 6 hours to obtain a 5-log reduction of *Salmonella*in milk chocolate at a temperature of 194 °F and more than 30 hours to achieve the same log reduction at 160 °F (Ref. 5).

The water activity of peanut-derived products is generally low; for example, the water activity of peanut butter and peanut paste is typically 0.35 or less (Ref.11). There are few data available on the heat resistance of *Salmonella* at such extremely low water activities. Moreover, many peanut-derived products, such as peanut butter and peanut paste, have a high fat content. In general, based on the available information about the heat resistance of *Salmonella* spp., *Salmonella* is expected to be even more resistant to heat in foods like peanut butter and peanut paste than it would be in a food with a water activity such as 0.85.

The effectiveness of processing conditions used to reduce *Salmonella* spp. in a particular food product may depend on whether, and to what extent, an ingredient with a very low water activity is rehydrated. There are some processes that are likely to adequately reduce(5) *Salmonella* spp. introduced into a food through an ingredient containing a peanut-derived product such as peanut butter or peanut paste. If *Salmonella*-containing peanut butter or peanut paste is completely mixed into a high water activity food, given sufficient time to fully rehydrate, and then either heat processed for an adequate length of time at temperatures greater than 160 °F or acidified to a pH of 3.5 or less, then we would expect the *Salmonella*to be adequately reduced.

However, if a peanut-derived product such as peanut butter or peanut paste added to a food product such as ice cream remains identifiable as a lump, particle, or "swirl," any *Salmonella* spp. in the peanut-derived product likely would remain in the low water activity environment of the peanut-derived product and, thus, remain highly resistant to heat. As another example, if a peanut-derived product such as peanut butter or peanut paste added to a food product is thoroughly mixed into a food such as a bakery product mix, *Salmonella* spp. originally present in the peanut-derived product has the potential to diffuse uniformly in the mix, rehydrate, and become less resistant to heat. However, even if *Salmonella* present in the peanut-derived product has the potential to diffuse and rehydrate in a bakery product mix, factors such as the amount of time between preparing the bakery product mix and cooking it could affect the susceptibility to heat of the *Salmonella* spp. when exposed to the heat of the baking process. In addition, knowing that a baked good is heated at an oven temperature such as 375 °F for a fixed time (such as 10 minutes) does not provide information about the temperature actually achieved at the coldest point in the bakery product, the uniformity of the temperature achieved in the bakery product, and the actual duration of time that the bakery product experienced its final temperature.

B. Recommendations

Because procedures used to manufacture finished products containing a peanut-derived product as an ingredient may or may not adequately reduce the presence of *Salmonella*spp., FDA recommends that:

Manufacturers of foods containing a peanut-derived product as an ingredient obtain peanut-derived product only from suppliers with validated processes in place to adequately reduce the presence of *Salmonella* spp. (e.g., by 5 logs).
	Manufacturers purchasing a peanut-derived product as an ingredient in a form for which no such validated process is available (e.g., raw shelled or blanched peanuts), and manufacturers that have purchased a peanut-derived product about which questions have been raised concerning the potential presence of *Salmonella* spp. in a particular lot or lots, ensure that their own manufacturing process would adequately reduce the presence of *Salmonella* spp. (e.g., by 5 logs) (based upon a combination of time and temperature, or other means). In evaluating the ability of their manufacturing processes to reduce the presence of Salmonella spp. in the finished product, such manufacturers should take the following considerations into account:
	Based on the available data and information, the processing conditions appropriate to adequately reduce *Salmonella* spp. in a particular food product vary depending on the specific characteristics of the food product.
		Determining the processing conditions appropriate to adequately reduce *Salmonella* spp. in a particular food product involves considerable expertise in both food microbiology and the physics of heat transfer.
		The most reliable way to determine whether a manufacturing process would reduce the presence of *Salmonella* spp. in a food product containing a peanut-derived product as an ingredient is to conduct a scientific study to determine the death rate of *Salmonella* spp. in the product using microbiological challenge studies, taking into account properties of the food (such as water activity, fat content and pH).
		A history of negative microbiological tests for *Salmonella* spp. in the finished product, while useful in a verification program for a process, is not sufficient, by itself, to determine the adequacy of a process in reducing the presence of *Salmonella*.FDA is aware that the Grocery Manufacturers Association (GMA), collaborating with other food industry organizations in a *Salmonella* Control Task Force, has very recently published an industry guidance document reviewing and synthesizing information about industry programs in place to control *Salmonella* spp. and help ensure the safety of low-moisture food products (Refs. 12 and 13). Manufacturers that use a peanut-derived product as an ingredient in a food product may find GMA's document useful. Please be aware that FDA is not responsible for the content of GMA's document, which FDA did not create and has not verified.

III. FDA Web Site References

The following references were available on FDA's Web site as of February 4, 2009. We also have placed these references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday.

FDA. 2009. Recall of Products Containing Peanut Butter; *Salmonella* Typhimurium, Accessed and printed February 4, 2009. As of the date of this guidance, this Web site is an active site that adds information over time to provide the most current information about the outbreak. Persons who access this Web site after February 4, 2009, may find more information than the information we placed in the Division of Dockets Management.
	FDA. 2005. Compliance Policy Guide Sec. 527.300 Pathogens in Dairy Products (7106.08). Accessed and printed February 8, 2009.
	FDA. 1995. Compliance Policy Guide Sec. 555.300 Foods, Except Dairy Products - Adulteration with *Salmonella* (7120.20). Accessed and printed February 8, 2009.IV. References Without Web Site Addresses

We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday.

Mazzotta, AS. 2001. Thermal Inactivation of Stationary-Phase and Acid-Adapted *Escherichia coli* O157:H7, *Salmonella*, and *Listeria monocytogenes* in Fruit Juices. *Journal of Food Protection* 64 (3): 315-320.
	Goepfert JM, Biggie, and RA. 1968. Heat Resistance of *Salmonella Typhimurium* and *Salmonella seftenberg* 775W in Milk Chocolate. *Applied Microbiology* 16: 1939-1940.
	Shachar D, and Yaron S. 2006. Heat Tolerance of *Salmonella enterica* Serovars Agona, Enteritidis, and Typhimurium in Peanut Butter. *Journal of Food Protection* 11: 2687-2691.
	Corry J. 1976. The Safety of Intermediate Moisture Foods with Respect to *Salmonella*. In *Intermediate Moisture Foods*, eds R Davies, G Birch and K Parker, 215-238. London: Applied Science Publishers Ltd.
	D'Aoust J-Y. 1989. *Salmonella*. In *Foodborne Bacterial Pathogens*, ed M Doyle, 327-445. New York: Marcel Dekker.
	Baird-Parker AC, Boothroyd M, and Jones E. 1970. The Effect of Water Activity on the Heat Resistance of Heat Sensitive and Heat Resistant Strains of S*almonellae*. *Journal of Applied Bacteriology* 33: 515-522.
	Gibson B. 1973. The Effect of High Sugar Concentrations on the Heat Resistance of Vegetative Microorganisms. *Journal of Applied Bacteriology* 36: 365-376.
	Burnett S, Gehm E, Weissinger, WR, and Beuchat LR. 2000. Survival of *Salmonella* in peanut butter and peanut butter spread. Journal of Applied Microbiology 89 (3): 472-477.V. Non-FDA Web Site References

The following references were available on the Internet on the date identified in the reference list. As of February 5, 2009, FDA had verified the Web site addresses it makes available as a hyperlink from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to the Web sites after posting this guidance on its Web site. We have placed these references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday.

Grocery Manufacturers Association. 2009. Control Of *Salmonella* In Low-Moisture Foods. (available in PDF - 540KB) Accessed and printed on February 5, 2009.
	Grocery Manufacturers Association. 2009. Annex to Control Of *Salmonella* In Low-Moisture Foods. (available in PDF - 201KB) Accessed and printed on February 5, 2009.(1) This guidance has been prepared by the Division of Plant and Dairy Food Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

(2) See e.g., Compliance Policy Guide (CPG) Sec. 527.300 Pathogens in Dairy Products (7106.08) and CPG Sec. 555.300 Foods, Except Dairy Products - Adulteration with *Salmonella* (7120.20) (Refs. 2 and 3).

(3) The circumstances under which food is deemed adulterated are set forth in section 402 of the Act, and related prohibitions applicable to adulterated food are contained in section 301 (21 U.S.C. 342 & 331).

(4) See, e.g., sections 301(a) through (c) and section 303(a).

(5) In this document, we use the phrase "adequately reduce" to mean capable of reducing the presence of *Salmonella* to an extent sufficient to prevent illness. The extent of reduction sufficient to prevent illness usually is determined by the estimated extent to which *Salmonella* spp. may be present in the food combined with a safety factor to account for uncertainty in that estimate. For example, if it is estimated that there would be no more than 1000 (i.e., 3 logs) *Salmonella* organisms in the food, and a safety factor of 100 (i.e., 2 logs) is employed, a process adequate to reduce *Salmonella* spp. would be a process capable of reducing *Salmonella* spp. by 5 logs.

Related Information

Produce & Plant Products Guidance Documents & Regulatory InformationSubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2009-D-0060.

                                                                                  Content current as of:
      09/20/2018
         
                  
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Nuts & Nut ProductsSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop