
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11572-11574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0321]


Risk Assessment of Foodborne Illness Associated With Pathogens 
From Produce Grown in Fields Amended With Untreated Biological Soil 
Amendments of Animal Origin; Request for Scientific Data, Information, 
and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and 
information.

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SUMMARY: The Food and Drug Administration (FDA or we) is requesting 
scientific data, information, and comments that would assist the Agency 
in its plan to develop a risk assessment for produce grown in fields or 
other growing areas amended with untreated biological soil amendments 
of animal origin (including raw manure). The risk assessment will 
evaluate and, if feasible, quantify the risk of human illness 
associated with consumption of produce grown in fields or other growing 
areas amended with untreated biological soil amendments of animal 
origin that are potentially contaminated with enteric pathogens, such 
as Escherichia coli O157:H7 or Salmonella. The risk assessment also 
will evaluate the impact of certain interventions, such as use of a 
time interval between application of the soil amendment and crop 
harvest, on the predicted risk. The risk assessment is intended to 
inform policy decisions with regard to produce safety.

DATES: Submit either electronic or written comments and scientific data 
and information by May 3, 2016.

ADDRESSES: You may submit comments and scientific data and information 
as follows:

Electronic Submissions

    Submit electronic comments and scientific data and information in 
the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments and 
scientific data and information submitted electronically, including 
attachments, to http://www.regulations.gov will be posted to the docket 
unchanged. Because your comment will be made public, you are solely 
responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments and scientific data and information, that 
information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments and scientific data and 
information submitted to the Division of Dockets Management, FDA will 
post your comment, as well as any attachments, except for information 
submitted, marked and identified, as confidential, if submitted as 
detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0321 for ``Risk Assessment of Foodborne Illness Associated 
with Pathogens from Produce Grown in Fields Amended with Untreated 
Biological Soil Amendments of Animal Origin; Request for Comments, 
Scientific Data, and Information''. Received comments and scientific 
data and information will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments and scientific data and information only 
as a written/paper submission. You should submit two copies total. One 
copy will include the information you claim to be confidential with a 
heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL 
INFORMATION''. The Agency will review this copy, including the claimed 
confidential information, in its consideration of comments and 
scientific data and information. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and scientific data and information and you must 
identify this information as ``confidential.'' Any information marked 
as ``confidential'' will not be disclosed except in accordance with 21 
CFR 10.20 and other applicable disclosure law. For more information 
about FDA's posting of comments and scientific data and information to 
public dockets, see 80 FR 56469, September 18, 2015, or access the 
information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments and scientific data and 
information received, go to http://

[[Page 11573]]

www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION: 

I. Background

A. What are the food safety concerns related to untreated biological 
soil amendments of animal origin?

    Biological soil amendments of animal origin (BSAAO) can be a source 
of contamination of produce with pathogens that can cause human 
illness. Human pathogens in BSAAO, once introduced to the growing 
environment, may be inactivated at a rate that is dependent upon a 
number of environmental, regional, and other agricultural and 
ecological factors. The rate of pathogen population decline over time 
is also influenced by the types of BSAAO and application methods. 
Furthermore, the types of produce and whether or not BSAAO may come 
into contact with a harvestable portion of the crop influences the 
likelihood of pathogen transfer from the amended soil to produce (Ref. 
1).
    Some produce farms use untreated BSAAO for various reasons, 
including that they are inexpensive, readily available, and rich 
nutrient sources for growing crops. Whether it is feasible for a farm 
to use untreated BSAAO as a principal nutrient source depends on 
numerous factors, including whether there is a required time interval 
between application and harvest and the length of such an interval 
(which may affect the nutrients retained or available from BSAAO), and 
crop nutrient demand (i.e., the nutrients needed to support crop 
growth). Typical examples of untreated BSAAO are raw cattle manure, 
poultry litter, swine slurry, and horse manure. FDA acknowledges that 
required application intervals for certain uses of untreated BSAAO 
could influence the number of crop cycles a farm is able to undertake 
each year and/or the choices farms make regarding which type of 
amendment to apply (e.g., raw manure, composted manure, or other 
nutrient sources).

B. How did FDA's rule on produce safety address BSAAO?

    In January 2013, based in part upon authority provided by the FDA 
Food Safety Modernization Act, we published a proposed Produce Safety 
Rule entitled ``Standards for the Growing, Harvesting, Packing, and 
Holding of Produce for Human Consumption'' (78 FR 3504, January 16, 
2013). Among other provisions related to BSAAO, the proposed rule 
included at Sec.  112.56(a)(1)(i) (21 CFR 112.56(a)(1)(i)) a 9-month 
minimum application interval for untreated BSAAO applied in a manner 
that does not contact covered produce during application and minimizes 
the potential for contact with covered produce after application (78 FR 
3504 at 3637). In response to public comments, we withdrew this 
proposed 9-month minimum application interval in a supplemental 
proposed rulemaking that we published on September 29, 2014 (79 FR 
58434 at 58457 through 58461). In the supplemental proposed rule, we 
acknowledged the limited body of currently available scientific 
evidence relating to the proposed 9-month interval and the need for 
additional research in this area, and described our planned risk 
assessment and research agenda (79 FR 58434 at 58460 through 58461). 
Accordingly, we deferred our decision on an appropriate minimum 
application interval.
    On November 27, 2015, we published a final Produce Safety Rule 
entitled ``Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption,'' (80 FR 74354). The final rule is 
now codified at 21 CFR part 112. In the preamble to the final rule, we 
restated our decision with respect to the appropriate minimum BSAAO 
application interval (80 FR 74354 at 74463). We reserved one of the 
provisions in the final rule's Subpart F (Biological Soil Amendments of 
Animal Origin and Human Waste) because we continue to believe that a 
quantitative application interval standard is necessary and anticipate 
locating such a future standard in that provision. As finalized, the 
Produce Safety Rule establishes that there is no minimum application 
interval required when untreated BSAAO are applied in a manner that 
does not contact covered produce during or after application (Sec.  
112.56(a)(1)(ii)), and the minimum application interval is [reserved] 
when applied in a manner that does not contact produce during 
application and minimizes the potential for contact with produce after 
application (Sec.  112.56(a)(1)(i)).

II. FDA's Risk Assessment

    FDA, in consultation with the U.S. Department of Agriculture, is 
conducting a risk assessment to evaluate the risk of human illness 
associated with the consumption of produce grown in growing areas 
amended with untreated BSAAO that are potentially contaminated with 
enteric pathogens such as E. coli O157:H7 or Salmonella. The risk 
assessment will evaluate the impact of different agricultural and 
ecological conditions and certain interventions, such as use of a time 
interval or intervals between application of untreated BSAAO and crop 
harvest, on the predicted risk. The risk assessment will take into 
account available data and information on relevant steps in the produce 
food safety continuum including: The initial prevalence and levels of 
pathogens in untreated BSAAO; the methods used to apply untreated BSAAO 
to soils; pathogen survival (and growth) in untreated BSAAO and soils 
amended with untreated BSAAO; pathogen transfer to produce grown in 
amended soils; pathogen survival and growth on produce; and pathogen 
survival, growth, and cross-contamination during storage and other 
steps in the supply chain (e.g., washing). The risk assessment will 
include characterization of the variability and uncertainty of pathogen 
survival and growth under different agricultural and ecological 
conditions (e.g., soil types, application methods, or geographic 
locations/climatic factors) and time intervals between application of 
untreated BSAAO and crop harvest. The risk assessment is intended to 
inform policy decisions with regard to produce safety.

III. Issues for Consideration

    FDA is requesting comments and scientific data and other 
information relevant to this risk assessment. We are particularly 
interested in scientific data and information concerning, but not 
limited to, the following factors that may affect the risk of human 
illness associated with the consumption of produce grown in fields or 
other growing areas amended with untreated BSAAO (including raw 
manure):
    1. Data on the prevalence and levels of pathogens.
    a. The frequency of detecting the presence of pathogens in 
untreated BSAAO and soil amended with BSAAO, such as Salmonella in 
poultry litter, and E. coli O157:H7 and other pathogenic Shiga-toxin 
producing E. coli in cattle manure. Samples may be obtained at 
different stages of untreated BSAAO storage prior to application, or 
after

[[Page 11574]]

application. If available, for each data point, we also invite 
information regarding the following:
    [ssquf] The type of untreated BSAAO (e.g., animal origin and 
content);
    [ssquf] how the untreated BSAAO, including raw manure, was sampled 
and handled prior to analysis;
    [ssquf] the size of the analytical unit (i.e., detection limit) and 
test method;
    [ssquf] the number of positives, the total number of samples, and 
the time period in which the testing was conducted; and
    [ssquf] sampling protocol (e.g., simple random, stratified random, 
targeted).
    b. The pathogen concentration, i.e., the number of pathogen cells 
per amount (unit volume or weight), in contaminated untreated BSAAO or 
soil amended with untreated BSAAO, especially cattle manure and poultry 
litter. If available, for each data point, we ask that the data be 
provided in unaggregated form and that Most Probable Number (MPN) 
patterns as well as raw data (e.g., number of positive and negative 
tubes per serial dilution) be provided.
    2. Data and information on survival of pathogens (e.g., Salmonella, 
E. coli O157:H7), and pathogen transfer to produce.
    a. Kinetic data that describe the survival (or inactivation) or 
growth of pathogens in untreated BSAAO, especially cattle manure and 
poultry litter;
    b. Kinetic data that describe the survival (or inactivation) or 
growth of pathogens in soil amended with untreated BSAAO, especially 
cattle manure and poultry litter, as influenced by soil type, untreated 
BSAAO type, application method, geographic locations/climatic factors 
(e.g., temperature, days of sunlight, intensity of solar irradiation, 
moisture, rainfall) and other factors;
    c. The mechanisms for pathogen transfer from soils to specific 
types or categories of produce, such as leafy greens, or to produce 
generally, and associated transfer coefficients, including irrigation 
and rain water splash, direct contact between produce and soil, 
machinery or people or animals contaminated by soil and directly 
contacting produce during growth and harvest of produce;
    d. Pathogen transfer rates (i.e., transfer coefficients) from 
amended soils to specific types or categories of produce, such as leafy 
greens, or to produce generally, as influenced by soil type, untreated 
BSAAO type, application method, climate factors, commodity type or any 
other pertinent factors not listed here;
    e. The survival of pathogens on produce in the field or other 
growing area before harvest; and
    f. The variability in the survival of different Salmonella 
serotypes, different subtypes of E. coli O157:H7, or other pathogens of 
public health significance in amended soils under field, greenhouse, or 
laboratory conditions.
    3. On-farm practices with regard to the use of untreated BSAAO, 
including, but not limited to, the following aspects.
    a. The extent to which untreated BSAAO are used in different 
regions in the United States, as well outside the United States in 
regions that export produce to the United States;
    b. The types of untreated BSAAO and the soil type, and associated 
physical and chemical parameters (including but not exclusive to 
nutrient content, moisture and pH); and the crops typically grown in 
each BSAAO-amended soil type;
    c. Characterization of the proportion of produce farms that have 
one or more soil types per geographical location;
    d. The amount of untreated BSAAO applied per unit surface (e.g., 
per acre) or the ratio of untreated BSAAO/soil, including typical ratio 
and variability by commodity type, including, for example, row crops 
such as leafy greens;
    e. The time of year, number of applications, and amount of 
untreated BSAAO that are applied;
    f. The method of application (e.g., surface, incorporated), and 
whether or not the amended soil is covered (e.g., with plastic mulch);
    g. Produce commodity type and cropping cycles;
    h. Climate conditions and irrigation practices after soil is 
amended, before and after planting; and
    i. The crop density (e.g., the number of rows per bed, and the 
distance between adjacent rows in a bed), distance between two crop 
beds (furrow width), and the influence of such factors on pathogen 
transfer.
    4. Harvesting, handling, and storage conditions that may affect 
pathogen detection and levels, survival, growth, or inactivation 
between harvest and retail sale along the farm-to-fork continuum.
    a. The harvesting practices and the average conditions as well as 
the range of climactic conditions prior to harvesting (e.g., time and 
temperature, rain events) under which produce is handled in the field 
and in packing operations;
    b. The survival, growth, or inactivation of pathogens on produce 
(including, for example, specific commodities or categories such as 
leafy greens, or produce generally) during transportation and storage;
    c. Typical storage conditions (e.g., time, temperature) for produce 
(including, for example, specific commodities or categories, such as 
leafy greens, or produce generally), from harvest until consumer 
purchase and whether and how those storage conditions affect pathogen 
levels; and
    d. The types and concentration of antimicrobial chemicals or other 
treatments, if any, applied to the water used for wash or transport of 
produce during farm or other distribution operations prior to retail, 
and the efficacy of these treatments in reducing pathogen levels, as 
well as the likelihood of cross-contamination during wash or transport.
    5. Storage conditions such as times and temperatures that may 
affect pathogen growth and/or survival during transportation and 
storage of produce in the consumer's home, and consumer handling 
practices with respect to produce after purchase, including data and 
information on consumer washing practices.
    We are also interested in other comments concerning, but not 
limited to, the types of untreated BSAAO, produce commodities, relevant 
agricultural and ecological conditions, and appropriate mitigation 
strategies that the Agency should consider in the risk assessment.

IV. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. Food and Drug Administration, 2015. ``Final Qualitative 
Assessment of Risk to Public Health from On-Farm Contamination of 
Produce.'' Available at: http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM470780.pdf. Accessed 
January 20, 2016.

    Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04712 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P


