Contains Nonbinding Recommendations 
 
 
 
Produce Safety Rule: Enforcement Policy for 
Entities Growing, Harvesting, Packing, or 
Holding Hops, Wine Grapes, Pulse Crops, and 
Almonds  
 
Guidance for Industry 
 
 
 
 
You may submit electronic or written comments regarding this guidance at any time. Submit 
electronic comments to https://www.regulations.gov.  Submit written comments to the Dockets 
Management Staff (HFA-305), Food and Drug Administration,  5630 Fishers Lane, rm. 1061, 
Rockville,  MD 20852. All comments should be identified  with the docket number FDA-2019-D-
1266 listed in the notice of availability  published  in the Federal Register.  
 
For questions regarding this document, contact the Center for Food Safety and Applied  Nutrition 
(CFSAN) at 240-402-1700.   
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
 
 
 
March 2019   
1  Contains Nonbinding Recommendations 
Table of Contents 
 
I. Introduction 
 
II. Background 
 
III. Discussion 
 
IV. Conclusion   
 
V. References 
     
2  Contains Nonbinding Recommendations 
Produce Safety Rule: Enforcement Policy for 
Entities Growing, Harvesting, Packing, or 
Holding Hops, Wine Grapes, Pulse Crops, and 
Almonds  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, the Agency, or 
we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. 
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as 
listed on the title page. 
 
 
I. Introduction 
 
The purpose of this document is to state the intent of the Food and Drug Administration  (FDA, 
we, or the Agency) not to enforce the requirements of the Standards for the Growing,  Harvesting, 
Packing, and Holding  of Produce for Human Consumption  regulation  (21 CFR Part 112) as they 
apply to entities growing, harvesting, packing and holding  certain commodities.    
 
We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 
CFR 10.115). This guidance is immediately  effective because FDA has determined that prior 
public participation  is not feasible or appropriate (21 CFR 10.115(g)(2)).  
 
FDAs guidance documents, including  this guidance, do not establish legally  enforceable 
responsibilities.  Instead, guidances describe the Agencys 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. 
 
In this guidance, pronouns such as you refer to entities that are covered by this guidance. 
 
II. Background 
 
The FDA Food Safety Modernization  Act (FSMA) (Pub. L. 111-353) directs the FDA to better 
protect public  health by, among other things, adopting a modern, preventive, and risk-based 
approach to food safety. The final rule, Standards for the Growing,  Harvesting, Packing, and 
Holding  of Produce for Human Consumption  (the Produce Safety Rule), published  on 
November 27, 2015, established science-based minimum  standards for the safe growing, 
harvesting, packing, and holding  of fruits and vegetables grown for human consumption.  These 
3  Contains Nonbinding Recommendations 
requirements are codified in 21 CFR part 112. The Produce Safety Rule is one of the seven 
foundational  regulations that we issued as part of our implementation  of FSMA.     
 
Produce is subject to the Produce Safety Rule unless it is not covered or is eligible  for an 
exemption.  Produce is not covered by the Produce Safety Rule if it is: 
 
  Rarely consumed raw ( 112.2(a)(1)); 
  Produced for personal or on-farm consumption ( 112.2(a)(2)); or  
  Not a raw agricultural  commodity ( 112.2(a)(3)).  
Rarely consumed raw (RCR) produce refers to commodities  that FDA determined are almost 
always eaten only after being cooked, which are included in an exhaustive list at 21 CFR 
112.2(a)(1) (the RCR list). FDAs classification  of produce as rarely consumed raw was based 
on consumption  patterns reported in the National Health and Nutritional  Examination  Survey 
(NHANES), which is the most comprehensive and robust, nationally  representative dataset 
currently available on dietary intake in the United States. To be included on the RCR list, 
consumption  patterns for a commodity  had to meet certain criteria. First, the commodity  had to 
be consumed uncooked by less than 0.1 percent of the United States population;  and second, the 
commodity  had to be consumed uncooked on less than 0.1 percent of eating occasions. If a 
commodity  satisfied the first two criteria we then considered a third criterion:  that consumption 
in any form  raw, processed, or other  was reported by at least 1 percent of a weighted number 
of survey respondents. Commodities  that failed to satisfy all three of the criteria were not 
included on the RCR list. However, in the preamble to the Produce Safety Rule, we stated that 
we intended to consider updating the RCR list in the future as appropriate, and we encouraged 
stakeholders who have relevant information  to submit data that are sufficiently  robust and 
representative to allow FDA to draw scientifically  valid conclusions.    
 
Produce otherwise covered by the Produce Safety Rule is eligible  for exemption from most of its 
requirements if the produce is commercially  processed to adequately reduce the presence of 
microorganisms  of public health significance,  and certain recordkeeping and documentation 
requirements are satisfied (the commercial processing exemption,  21 CFR 112.2(b)). 
 
In the final rule, we announced staggered compliance dates, based on business size. Sprout 
growers are subject to earlier dates, but for all other growers covered by the Produce Safety Rule, 
the compliance date for very small businesses is January 27, 2020; for small businesses it is 
January 28, 2019; and for all other businesses it is January 26, 2018.1 However, based in part on 
feedback from stakeholders that more time was necessary to ensure growers have the training 
and information  needed to comply with the regulations,  FDA announced that routine produce 
safety inspections would not begin until the spring of 2019 (see 
https://www.fda.gov/NewsEvents/Speeches/ucm575499.htm). 
 
                                              
1 On March 18, 2019, FDA issued a final rule that extends the compliance dates for all of the agricultural water 
provisions in the Produce Safety Rule (for produce other than sprouts) to 2022-2024, depending on the size of the 
farm. See 84 FR 9706.   
4  Contains Nonbinding Recommendations 
III. Discussion 
 
Following  the publication  of the final rule, FDA received feedback from some stakeholders that 
certain covered commodities  should be exempt from the requirements of the Produce Safety 
Rule.  
 
A. Hops 
In the final rule, hops were not included  on the RCR list because FDA could not conclude that 
hops are not consumed uncooked in any measurable quantity by most consumers across the 
United States (see 80 FR 74354 at 74394). However, FDA did note that hops used in the making 
of beer are eligible  for the commercial processing exemption;  we said that brewing beer 
adequately reduces the presence of microorganisms  of public  health significance through means 
other than a cook step (e.g., pH, alcohol content, fermentation) (see 80 FR 74354 at 74394).  
 
Following  publication  of the final rule, FDA received a request from hops growers that hops be 
exempt from the Produce Safety Rule on the grounds that the beer brewing process is recognized 
as adequately reducing the presence of microorganisms  of public  health significance and hops 
are not used outside of the brewing process (Ref. 1). Our own analysis has led FDA to believe 
that, given hops unique circumstances, we should further explore options for potentially 
exempting the commodity  from the Produce Safety Rule. Informed in part by our conclusion in 
the final rule that hops used in the making of beer receive adequate pathogen reduction, we 
intend to exercise enforcement discretion for entities growing,  harvesting, packing, or holding 
hops while we explore this topic further and possibly  pursue rulemaking.    
 
B. Wine Grapes 
In the final rule, wine grapes were not included on the RCR list. Based on the NHANES datasets 
used to establish the RCR list, the uncooked consumption  data available for grapes, wine and 
sherry exceeded the relevant quantitative criteria. In the preamble to the final rule, we noted that 
we did not have information  on specific grape cultivars or varieties that are exclusively  grown 
for use in winemaking to establish a separate category covering only wine grapes. 
Additionally,  we stated that we were aware that some grape varietals are multi-purpose  in use, 
i.e., used as both wine grapes and table grapes (see 80 FR 74354 at 74395). However, FDA noted 
that grapes used in the making of wine are eligible  for the commercial processing exemption ( 
112.2(b)(1)) and stated that winemaking  adequately reduces the presence of microorganism  of 
public health significance through means other than a cook step (e.g., pH, alcohol content, 
fermentation) (see 80 FR 74354 at 74395).  
 
Following  publication  of the final rule, FDA received feedback from wine grape growers that 
only certain grape varietals are used for winemaking  and these varietals differ from those 
marketed as table grapes or for other uses. These wine grape growers also indicated that the 
growing and harvesting practices differ between wine grape and other grapes (Refs. 2, 3). We 
also note that in the Consolidated  Appropriations  Act, 2019, Congress stated: None of the funds 
5  Contains Nonbinding Recommendations 
made available by this or any other Act may be used to enforce the [Produce Safety Rule] with 
respect to the regulation of the production,  distribution,  sale, or receipt of grape varietals that are 
grown, harvested and used solely for wine and receive commercial processing that adequately 
reduces the presence of microorganisms  of public health significance (Pub. L. 116-6, section 
758). 
 
We have continued to study the growing,  harvesting, packing, holding,  and use of wine grapes 
and believe that they are a sufficiently  distinct commodity  and one that receives adequate 
pathogen reduction, as discussed in the preamble of the final rule  that we can exercise 
enforcement discretion for those grape varietals that are grown, harvested, and used solely for 
wine while we further explore options for potentially  exempting this commodity  from the 
Produce Safety Rule.2   
C. Pulse Crops 
Pulses are the dry, edible seeds of plants in the legume family (Ref. 4). The term pulses 
includes only crops harvested solely in dried form and does not include crops harvested green for 
food, such as green peas or green beans, or crops used mainly for oil extraction (Ref. 4). The 
Food and Agricultural  Organization  of the United Nations (FAO) has identified  11 types of pulse 
crops: dry beans, broad beans, dry peas, chick-peas, cow peas, pigeon peas, lentils,  bambara 
beans, vetches, lupins  and pulses NES (not elsewhere specified) (Ref. 5).  
In  112.2(a)(1) of the Produce Safety Regulation,  some pulse crops are on the RCR list and are 
therefore exempt from the regulation (specifically,  black beans, great Northern beans, kidney 
beans, lima beans, navy beans, pinto beans, chickpeas, and lentils),  while other pulse crops are 
not on the RCR list. The general category of peas is identified  as covered produce in 
 112.1(b)(1). We did not differentiate between succulent peas and succulent podded peas 
(neither of which are pulse crops) and dry peas (which are pulse crops) in  112.1(b)(1); none of 
these types of pea met the criteria for rarely consumed raw. The NHANES consumption  data 
for both succulent peas and succulent podded peas exceeded the relevant quantitative  criteria, 
and therefore succulent peas and succulent podded peas are covered produce under the final rule. 
We did not include dry peas on the RCR list because they did not meet the third criteria for 
rarely consumed raw due to limited  consumption  data in NHANES. In addition,  cowpea beans 
(black-eyed peas), a pulse crop, are also specifically  listed as covered produce, because they also 
did not meet the third criteria for rarely consumed raw due to limited  consumption  data (see 80 
FR 74354 at 74394). The RCR list is exhaustive, whereas the examples of covered produce are a 
non-exhaustive list; therefore, any pulse crops that are not listed as rarely consumed raw are 
covered by the Produce Safety rule if they meet the other criteria for coverage (e.g., being a raw 
agricultural  commodity).     
FDA has received feedback from pulse growers that all pulse crops should be included in the 
RCR list, as they are all dried, processed, and cooked prior to consumption (Ref. 6). As we have 
                                              
2 We are aware that individual farms might not have sufficient information to determine, on an industry-wide basis, 
which grape varietals are grown, harvested, and used solely for making wine. At this time, in situations where the 
individual farm grows, harvests, and uses the varietal solely for making wine, we intend to exercise enforcement 
discretion with respect to the growing and harvesting of the varietal on that farm. 
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continued to explore this topic, we have taken note of the fact that succulent peas and dry peas 
are recognized as distinct commodities  in terms of grading  dry peas are graded by the United 
States Department of Agriculture (USDA) Grain Inspection, Packers and Stockyards 
Administration  (GIPSA) and succulent peas are graded by USDA Agricultural  Marketing 
Service (AMS) (Refs. 7, 8) (note that AMS refers to succulent peas as fresh peas). After 
conducting a review of how pulse crops are grown, harvested, packed, held, and used, we have 
decided to exercise enforcement discretion for entities growing, harvesting, packing, or holding 
pulse crops that are not currently classified as rarely consumed raw while we explore this topic 
further and consider pursuing rulemaking  to address the unique circumstances of these 
commodities3.    
D. Almonds 
In the final rule, FDA concluded that almonds did not meet the criteria to be considered rarely 
consumed raw because the NHANES analysis did not conclude that less than 0.1% of the 
population  consumed the product uncooked and that the commodity  is consumed uncooked on 
less than 0.1 percent of eating occasions (see 80 FR 74354 at 74392). Following  the publication 
of the final rule, FDA has received input from almond growers and we have conducted our own 
analysis of the commodity.   
As we have continued to explore this topic, we have taken note of the fact that virtually  all 
almonds commercially  produced in the United States are grown in California (Refs. 9,10). Under 
the California  Almond Federal Marketing Order (7 CFR Part 981) issued by USDA AMS, all 
almonds shipped from handlers to locations within the United States, Canada, or Mexico must 
undergo a treatment for the control of Salmonella. Examples of validated treatment processes for 
almonds under this marketing order are blanching,  roasting, steam treatment, and treatment with 
propylene oxide (Ref. 11).   
After conducting  a review of how almonds are grown, harvested, packed, held, processed, and 
used, FDA has decided to exercise enforcement discretion for entities growing,  harvesting, 
packing, or holding  almonds while we explore this topic further and consider pursuing 
rulemaking  to address the unique circumstances of this commodity.    
 
IV.  Conclusion 
 
We are considering pursuing  rulemaking to address the unique circumstances of these 
commodities.  In the meantime, FDA intends to exercise enforcement discretion with respect to 
the Produce Safety Rule for entities growing,  harvesting, packing or holding  hops, wine grapes, 
pulse crops, and almonds. This means that we will not expect entities growing,  harvesting, 
                                              
3 Pulse crops that are included on the RCR list in the final rule continue to be exempt from the Produce Safety 
Regulation.  
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packing, or holding  these commodities  to meet any of the Produce Safety Regulation 
requirements with respect to these commodities.   
 
We will consider revising our intent to exercise enforcement discretion if, for example, new 
information  becomes available regarding safety concerns associated with the production  and 
consumption  of these commodities.  In addition,  the statutory prohibition  against the introduction 
or delivery for introduction  into interstate commerce of adulterated food (section 301(a) of the 
FD&C Act (21 U.S.C. 331(a)) continues to apply, regardless of our intent to exercise 
enforcement discretion with respect to the Produce Safety Rule. For example, under section 
402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)), a food shall be deemed to be adulterated if it 
has been prepared, packed, or held under insanitary conditions  whereby it may have become 
contaminated with filth, or whereby it may have been rendered injurious  to health, regardless of 
whether the food is a commodity  for which we intend to exercise enforcement discretion under 
the Produce Safety Rule. 
 
V.  References 
 
Ref. 1:  Hop Growers of America Letter to FDA, May 9, 2018 and Hop Growers of America 
Letter to FDA Hops Administrative  Record, August 29, 2018. 
 
Ref. 2:  California  Wine Growers Letter to Susan Mayne, June 15, 2017.  
 
Ref. 3:  Napa Valley Vintners letter to Scott Gottlieb,  July 7, 2017. 
 
Ref. 4:  http://www.fao.org/pulses-2016/news/news-detail/en/c/337107/,  accessed on Feb. 13, 
2019. 
 
Ref. 5:  http://www.fao.org/es/faodef/fdef04e.htm,  accessed on Feb. 13, 2019. 
 
Ref. 6:  Treatment of Pulses Under FSMA, A summary from the USA Dry Pea & Lentil Council, 
April 17, 2018. 
 
Ref. 7:  https://www.gipsa.usda.gov/fgis/standards/wholedrypeas.pdf,  accessed on Feb. 13, 2019. 
 
Ref. 8:  https://www.ams.usda.gov/grades-standards/pea-pods-grades-and-standards,  accessed on 
Feb. 13, 2019. 
 
Ref. 9:  Almond Board of California:  Almond Industry/Food Safety Overview, Presentation to 
FDA, May 17, 2017. 
 
Ref. 10:  https://downloads.usda.library.cornell.edu/usda-
esmis/files/zs25x846c/bc386n064/rr172065h/NoncFruiNu-06-26-2018.pdf,  accessed on Feb. 13, 
2019. 
 
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Ref. 11:  http://www.almonds.com/processors/processing-safe-product/pasteurization,  accessed 
on Feb. 13, 2019.  
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