Contains Nonbinding Recommendations
Additional copies are available from:
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Food and Drug Administration
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You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Contains Nonbinding Recommendations
Table of Contents
Contains Nonbinding Recommendations
Guidance for Industry(1)
Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient
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.
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.
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.
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.
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 Salmonellae. 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.
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.