81 FR 11572 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 43 (March 4, 2016)

Page Range		11572-11574
FR Document		2016-04712

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.

Federal Register, Volume 81 Issue 43 (Friday, March 4, 2016)

[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11572-11574]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

11574 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices

application. If available, for each data e. The survival of pathogens on greens, or produce generally) during
point, we also invite information produce in the field or other growing transportation and storage;
regarding the following: area before harvest; and c. Typical storage conditions (e.g.,
D The type of untreated BSAAO (e.g., f. The variability in the survival of time, temperature) for produce
animal origin and content); different Salmonella serotypes, different (including, for example, specific
D how the untreated BSAAO, subtypes of E. coli O157:H7, or other
commodities or categories, such as leafy
including raw manure, was sampled pathogens of public health significance
greens, or produce generally), from
and handled prior to analysis; in amended soils under field,
harvest until consumer purchase and
D the size of the analytical unit (i.e., greenhouse, or laboratory conditions.
whether and how those storage
detection limit) and test method; 3. On-farm practices with regard to
conditions affect pathogen levels; and
D the number of positives, the total the use of untreated BSAAO, including,
number of samples, and the time period but not limited to, the following aspects. d. The types and concentration of
in which the testing was conducted; and a. The extent to which untreated antimicrobial chemicals or other
D sampling protocol (e.g., simple BSAAO are used in different regions in treatments, if any, applied to the water
random, stratified random, targeted). the United States, as well outside the used for wash or transport of produce
b. The pathogen concentration, i.e., United States in regions that export during farm or other distribution
the number of pathogen cells per produce to the United States; operations prior to retail, and the
amount (unit volume or weight), in b. The types of untreated BSAAO and efficacy of these treatments in reducing
contaminated untreated BSAAO or soil the soil type, and associated physical pathogen levels, as well as the
amended with untreated BSAAO, and chemical parameters (including but likelihood of cross-contamination
especially cattle manure and poultry not exclusive to nutrient content, during wash or transport.
litter. If available, for each data point, moisture and pH); and the crops 5. Storage conditions such as times
we ask that the data be provided in typically grown in each BSAAO-
and temperatures that may affect
unaggregated form and that Most amended soil type;
pathogen growth and/or survival during
Probable Number (MPN) patterns as c. Characterization of the proportion
transportation and storage of produce in
well as raw data (e.g., number of of produce farms that have one or more
the consumer’s home, and consumer
positive and negative tubes per serial soil types per geographical location;
d. The amount of untreated BSAAO handling practices with respect to
dilution) be provided.
2. Data and information on survival of applied per unit surface (e.g., per acre) produce after purchase, including data
pathogens (e.g., Salmonella, E. coli or the ratio of untreated BSAAO/soil, and information on consumer washing
O157:H7), and pathogen transfer to including typical ratio and variability by practices.
produce. commodity type, including, for We are also interested in other
a. Kinetic data that describe the example, row crops such as leafy greens; comments concerning, but not limited
survival (or inactivation) or growth of e. The time of year, number of to, the types of untreated BSAAO,
pathogens in untreated BSAAO, applications, and amount of untreated produce commodities, relevant
especially cattle manure and poultry BSAAO that are applied; agricultural and ecological conditions,
litter; f. The method of application (e.g., and appropriate mitigation strategies
b. Kinetic data that describe the surface, incorporated), and whether or that the Agency should consider in the
survival (or inactivation) or growth of not the amended soil is covered (e.g., risk assessment.
pathogens in soil amended with with plastic mulch);
untreated BSAAO, especially cattle g. Produce commodity type and IV. Reference
manure and poultry litter, as influenced cropping cycles; The following reference is on display
by soil type, untreated BSAAO type, h. Climate conditions and irrigation
in the Division of Dockets Management
application method, geographic practices after soil is amended, before
(see ADDRESSES) and is available for
locations/climatic factors (e.g., and after planting; and
viewing by interested persons between
temperature, days of sunlight, intensity i. The crop density (e.g., the number
of solar irradiation, moisture, rainfall) of rows per bed, and the distance 9 a.m. and 4 p.m., Monday through
and other factors; between adjacent rows in a bed), Friday; they are also available
c. The mechanisms for pathogen distance between two crop beds (furrow electronically at http://
transfer from soils to specific types or width), and the influence of such factors www.regulations.gov. FDA has verified
categories of produce, such as leafy on pathogen transfer. the Web site address, as of the date this
greens, or to produce generally, and 4. Harvesting, handling, and storage document publishes in the Federal
associated transfer coefficients, conditions that may affect pathogen Register, but Web sites are subject to
including irrigation and rain water detection and levels, survival, growth, change over time.
splash, direct contact between produce or inactivation between harvest and 1. Food and Drug Administration, 2015.
and soil, machinery or people or retail sale along the farm-to-fork ‘‘Final Qualitative Assessment of Risk to
animals contaminated by soil and continuum. Public Health from On-Farm
directly contacting produce during a. The harvesting practices and the Contamination of Produce.’’ Available at:
growth and harvest of produce; average conditions as well as the range http://www.fda.gov/downloads/Food/
d. Pathogen transfer rates (i.e., transfer of climactic conditions prior to FoodScienceResearch/
coefficients) from amended soils to harvesting (e.g., time and temperature,
jstallworth on DSK7TPTVN1PROD with NOTICES

RiskSafetyAssessment/UCM470780.pdf.
specific types or categories of produce, rain events) under which produce is Accessed January 20, 2016.
such as leafy greens, or to produce handled in the field and in packing Dated: February 29, 2016.
generally, as influenced by soil type, operations;
Leslie Kux,
untreated BSAAO type, application b. The survival, growth, or
method, climate factors, commodity inactivation of pathogens on produce Associate Commissioner for Policy.
type or any other pertinent factors not (including, for example, specific [FR Doc. 2016–04712 Filed 3–3–16; 8:45 am]
listed here; commodities or categories such as leafy BILLING CODE 4164–01–P

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Document Created: 2018-02-02 15:05:35
Document Modified: 2018-02-02 15:05:35

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; request for comments and for scientific data and information.
Dates		Submit either electronic or written comments and scientific data and information by May 3, 2016.
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.
FR Citation		81 FR 11572

81 FR 11572 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 43 (March 4, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration