[Federal Register Volume 73, Number 170 (Tuesday, September 2, 2008)]
[Notices]
[Pages 51306-51309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0455]


Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits 
and Vegetables; Request for Comments and for Scientific Data and 
Information

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) is requesting comments 
and scientific data and information that may assist the agency to 
improve the guidance to industry set forth in the ``Guide to Minimize 
Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' issued 
in 1998. Specifically, FDA is seeking information about current 
agricultural practices and conditions used to grow, harvest, pack, 
cool, and transport fresh produce; risk factors for contamination of 
fresh produce associated with these practices; and possible measures 
that FDA could implement that would enhance the safety of fresh 
produce.

DATES:  Submit written comments and scientific data and information or 
electronic comments by December 31, 2008.

ADDRESSES:  Submit written comments and scientific data and information 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments and scientific data and information to 
http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section 
for electronic access to this document.

FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2024.

SUPPLEMENTARY INFORMATION:

I. Background

A. Food Safety and Fresh Produce

    FDA is responsible for ensuring the safety of all domestic and 
imported fresh fruits and vegetables consumed in the United States. 
Fresh fruits and vegetables are those that are likely to be sold to 
consumers in an unprocessed or minimally processed (i.e., raw) form. 
Fresh fruits and vegetables may be intact and whole, such as whole 
apples, or cut in the act of harvest, such as heads of lettuce and 
bunches of broccoli.
    Because most fresh produce is grown in a natural environment, it is 
vulnerable to contamination with pathogens (i.e., bacteria or other 
organisms that can cause disease). Factors that may affect the 
occurrence of such contamination include agricultural and/or post-
harvest water quality, the use of manure as fertilizer, the presence of 
wild or domestic animals in or near fields or packing areas, worker 
health and hygiene, environmental conditions, production activities, 
and equipment and facility sanitation. Consequently, the manner in 
which fresh produce is grown, harvested, packed, cooled, and 
transported is crucial to minimizing the risk of microbial 
contamination. (We use the term ``microbial contamination'' to refer to 
contamination with any microorganism.)
    Data reported to the U.S. Centers for Disease Control and 
Prevention (CDC) indicate that between 1973 and 1997 reported outbreaks 
of foodborne illness in the United States associated with fresh produce 
increased in absolute numbers and as a proportion of all reported 
foodborne outbreaks (Ref. 1). (By ``outbreak,'' we mean the occurrence 
of two or more cases of a similar illness resulting from the ingestion 
of a common food.) Unpublished data compiled by FDA indicate that from 
1996 to 2007 there were approximately 72 reported outbreaks of 
foodborne illness associated with approximately 20 fresh produce 
commodities. Of this total, 13 outbreaks were associated with tomatoes, 
11 outbreaks were associated with melons, and 24 outbreaks were 
associated with leafy greens such as lettuce and spinach (Ref. 2). 
These outbreaks involved a number of pathogens, including Escherichia 
coli (E. coli) O157:H7 and Salmonella species, and involved both 
domestic and imported produce. These totals include only those 
outbreaks in which our investigation has indicated that the 
contamination of the produce was not a result of exposure to an 
infected food handler or other unsafe food handling practice at the 
place of preparation and consumption (i.e., home or restaurant). There 
have also been a number of reported outbreaks associated with fresh 
produce in 2008.

B. FDA's GAPs/GMPs Guide

    FDA places a high priority on identifying and promoting measures 
that can reduce the incidence of foodborne illness associated with 
fresh produce. In 1998, FDA and the U.S. Department of Agriculture 
issued

[[Page 51307]]

guidance to industry entitled ``Guide to Minimize Microbial Food Safety 
Hazards for Fresh Fruits and Vegetables'' (Ref. 3), to enhance the 
safety of fresh produce, to assist the fresh produce industry in 
addressing common risk factors in their operations, and to minimize 
potential food safety hazards. (The document is referred to hereinafter 
as the ``GAPs/GMPs Guide''--GAPs is an abbreviation of ``good 
agricultural practices'' and GMPs is an abbreviation of ``good 
manufacturing practices.'') While FDA recognizes current technologies 
cannot eliminate all potential food safety hazards associated with 
fresh produce that will be eaten raw, the GAPs/GMPs Guide emphasizes 
that implementation of risk reduction measures is critical to 
minimizing these potential food safety hazards. The agency has worked 
with the fresh produce industry and other food safety partners since 
the issuance of the GAPs/ GMPs Guide to promote its recommendations and 
to advance the scientific knowledge applicable to enhancing the safety 
of fresh produce, and the GAPs/GMPs Guide has been used as a basis for 
a number of food safety programs, both in the United States and 
internationally. Choices by buyers to purchase from producers and other 
suppliers that provide self- or third-party audit verification that 
they are following the GAPs/GMPs Guide have further promoted adoption 
of the guidance.
    Subsequent to the issuance of the GAPs/GMPs Guide, FDA has 
undertaken a number of produce safety initiatives that have enhanced 
its understanding of the effectiveness of the GAPs/GMPs Guide in 
reducing the risk of produce-associated foodborne illness. Examples 
include the 2004 ``Produce Safety From Production to Consumption: 2004 
Action Plan to Minimize Foodborne Illness Associated with Fresh Produce 
Consumption,'' commonly called the ``Produce Safety Action Plan'' (Ref. 
4), which focuses on prevention of contamination, minimization of 
public health impacts when contamination does occur, communication with 
the public and stakeholders, and facilitation and support of research; 
the multi-year ``Leafy Greens Safety Initiative'' (Ref. 5), launched in 
2006 in collaboration with the State of California, which involves 
assessment of practices and conditions at select farms and facilities 
in California, including adoption and implementation of good 
agricultural practice and good manufacturing practice recommendations 
(for packing houses) and requirements (for fresh-cut processing 
facilities); and the 2007 ``Tomato Safety Initiative'' (Ref. 6), a 
multi-year collaboration similar to the ``Leafy Greens Safety 
Initiative'' with the States of Virginia and Florida, as well as 
several universities and members of the produce industry.
    Available data and FDA's experience suggest that the GAPs/GMPs 
Guide (and other public and private sector efforts) have accurately 
identified certain potential sources of microbial contamination of 
fresh produce, such as agricultural water and worker health and 
hygiene. Data and experience also indicate that the recommendations in 
the GAPs/GMPs Guide can be effective when implemented. However, the 
fact that outbreaks of foodborne illness associated with fresh produce 
continue to occur supports a close examination of the extent to which 
the recommendations in the GAPs/GMPs Guide have been implemented; the 
extent to which they have been effective, if implemented properly; and 
what additional or different interventions might be appropriate to 
reduce the risk of future outbreaks. The agency recognized when it 
issued the GAPs/GMPs Guide in 1998 that it would need to be updated 
``[a]s new information and technological advances expand the 
understanding of those factors associated with identifying and reducing 
microbial food safety hazards'' (Ref. 3). In the 10 years since the 
GAPs/GMPs Guide was released many changes have occurred in the produce 
industry, and a great deal of new knowledge and information have become 
available. In addition, the agency now has 10 years experience in 
implementing this guidance and observing how and the extent to which it 
has been implemented by the industry.
    In addition to the initiatives described previously, in 2007 FDA 
held two public hearings to inform stakeholders about produce-
associated outbreaks and to solicit comments to inform the agency in 
determining the next steps (Ref. 7). In both instances, the agency 
asked a series of questions. Among these questions, we asked whether 
FDA's current GAPs/GMPs Guide needs to be expanded or otherwise 
revised, and if the response was yes, we solicited comments about what 
areas need to be expanded or otherwise revised. Comments were generally 
in agreement that the basic principles set out in the 1998 guidance 
remain sound. However, they were split on whether FDA should update the 
GAPs/GMPs Guide and, if so, how it might be revised. Several comments 
suggested the GAPs/GMPs Guide should provide more specific and 
directive recommendations. A number of comments suggested that the 
GAPs/GMPs Guide needs more explicit information to facilitate risk 
assessment. Other comments urged FDA to keep the GAPs/GMPs Guide broad 
in scope, and to focus instead on education/outreach to promote 
adoption of existing recommendations.
    FDA has taken the comments received in response to the 2007 public 
hearings into consideration and incorporated relevant suggestions as it 
conducts the produce safety activities mentioned in this Federal 
Register document and other activities implementing the ``Produce 
Safety Action Plan.'' However, because most comments did not provide 
substantive information or data in response to this question, FDA has 
determined that it would benefit from another, more focused opportunity 
for public comment.
    Thus, FDA is now soliciting comments and scientific data and 
information on any possible measures and technological advances that 
would assist the agency in improving the agency's current GAPs/GMPs 
Guide. Specifically, FDA is seeking information and comment on the 
issues and questions in section II of this document. When possible, 
please provide scientific information and data in support of your 
comments. In addition, please provide information as specific as is 
feasible about the estimated costs and benefits associated with your 
responses (e.g., the costs and benefits of current practices and/or the 
cost and benefits of any recommendations you may make). FDA is not 
seeking information and comment on issues of traceability in this 
document, because FDA plans to do so in the context of a public 
meeting.

II. Issues and Questions

    Issue 1: The GAPs/GMPs Guide addresses potential sources of 
microbial contamination associated with a range of issues, or 
variables, such as: Water (both agricultural water and post harvest 
water uses); manure and municipal bio-solids; worker health and 
hygiene; packing facility sanitation; transportation; and traceback 
(Ref. 3). Data from our experience over the past decade support the 
inclusion of many of these issues as risk factors for produce-
associated foodborne illness outbreaks. Some of these potential sources 
of contamination in particular, such as worker health and hygiene, 
water quality (pre- and post-harvest), domestic and wild animal issues, 
and facility and equipment sanitation have been cited frequently by 
investigators during inspections at farms and facilities that were 
implicated in outbreak investigations. On the other hand,

[[Page 51308]]

although there remains a significant potential for contamination, some 
issue areas, such as the intentional use of manure or bio-solids as an 
agricultural input, have not been cited as a potential source of 
contamination to the same extent. The current guidance does not attempt 
to rank the potential hazard variables in terms of relative risk or 
importance.
    Question 1. Should any future GAPs/GMPs Guide rank or prioritize 
among potential issues according to relative risk or importance? If 
yes, please offer suggestions of how that information could most 
effectively be presented in a way that does not detract from the broad 
scope of the current guidance.
    Issue 2: The GAPs/GMPs Guide tends to be arranged by issue area, 
while more recent industry commodity specific supply chain guidelines 
are divided according to where the commodity is within the supply chain 
(e.g., production, packing, distribution) and/or the chronological 
order of activities at each step.
    Question 2. How should the GAPs/GMPs Guide be organized to enhance 
its usefulness?
    Question 3. While the GAPs/GMPs Guide has been generally accepted 
and widely adopted, we know that there are entities in the fresh 
produce industry that are not aware of it. What measures can be taken, 
and by whom, to expand awareness by the fresh produce industry of the 
GAPs/GMPs Guide?
    Question 4. How should the GAPs/GMPs Guide be modified to motivate 
all operations to implement? Please include information on economic 
impact.
    Question 5. Can the GAPs/GMPs Guide be applied equally to, and 
implemented by, domestic and foreign growers and packers? If not, 
should the GAPs/GMPs Guide be revised to incorporate additional options 
or special considerations (e.g., utilizing draft animals for 
agricultural tasks) for application and implementation? Please explain.
    Question 6. Is there a need for additional guidance to assist an 
operator in determining which provisions of the Current Good 
Manufacturing Practice regulations in part 110 (21 CFR part 110) (e.g., 
post-harvest water quality, disease control, cleanliness, and 
supervision) could be implemented voluntarily for operations that 
currently are excluded under Sec.  110.19? If so, which ones?
    Issue 3: Written food safety plans, sanitation standard operating 
procedures (SSOPs), standard operating procedures (SOPs), and 
monitoring records serve as useful tools for both industry and 
regulators. Such records assist operators to conduct operations in a 
manner that enhances the safety of fresh produce. For growers, an 
assessment of factors such as the field environment and agricultural 
inputs contributes to the development of written food safety plans and 
SOPs, and also helps to determine which factors should be monitored and 
the frequency of such monitoring. (The use of the term ``assessment'' 
refers to an evaluation conducted by, or on behalf of, a grower or 
operator to identify measures to enhance food safety.)
    Written food safety plans, SOPs, SSOPs, and monitoring records also 
assist regulators to verify consistent and long-term implementation of 
certain practices. On-site inspections, either alone or in conjunction 
with records review, are another approach to such verification. (The 
use of the term ``inspection'' refers to an evaluation conducted by, or 
on behalf of, a regulator to evaluate whether operations comply with 
applicable guidance or regulations. The term ``audit'' refers to a self 
or third-party evaluation of whether operations are consistent with 
voluntary guidelines and written food safety plans or SSOPs developed 
by the grower, operator, or buyer.)
    Question 7. Should the GAPs/GMPs Guide recommend that growers and/
or other relevant operations develop a written food safety plan, 
written SOPs, and/or written SSOPs? If so, please describe the types of 
information or recommendations that you believe would be helpful.
    Question 8. Records can be divided into the following two broad 
groups: (1) Records to facilitate traceback, and (2) non-traceback or 
operational records. Does the GAPs/GMPs Guide provide sufficient 
recommendations regarding record keeping? If not, please describe what 
would be most helpful and why, e.g., information about the record 
keeping regulation (21 CFR 1 subpart J), guidance on what makes a 
``good'' record, guidance on periodic record review and verification, 
and required or recommended record retention times. What types of 
monitoring records or other documentation would be most useful to 
industry and regulators?
    Question 9. The recent produce safety initiatives concerning leafy 
greens and tomatoes (Refs. 5 and 6) have highlighted the importance of 
performing environmental assessments (e.g., assessing water source 
quality, water distribution systems, animal presence, and other risk 
factors that may be associated with the production environment) before 
planting, throughout production, and prior to harvest. Would it be 
useful to enhance coverage of these concepts in the GAPs/GMPs Guide? If 
yes, please describe.
    Question 10. Several newer produce safety programs, such as the 
California Leafy Green Products Handler Marketing Agreement (Ref. 8), 
incorporate recommendations (or requirements) for microbial testing. 
Does the information on microbial testing in the GAPs/GMPs Guide 
provide sufficient information to assist operators in designing a 
meaningful and cost effective testing program? If not, please describe 
what types of additional information would be most useful, such as how 
and where microbial testing might best be used to achieve food safety 
objectives, e.g., building a history of agricultural water quality, 
making best management decisions, verifying food safety operations.
    Question 11. Some comments submitted in connection with the 2007 
public hearings expressed concerns that field management activities 
intended to minimize microbial hazards, such as removing vegetation to 
reduce animal harborage near the production field, could have a 
negative, albeit unintended, impact on the environment and water sheds, 
among other areas. What data support these concerns? Could/should the 
GAPs/GMPs Guide do more to identify, address, and possibly mitigate 
unintended environmental consequences of food safety measures?
    Question 12. Are there existing regulatory requirements at the 
Federal, State, or local level that act as a disincentive (or as an 
incentive) for growers or other operators to implement agricultural or 
manufacturing practices that should be taken into consideration when 
updating this guidance to reduce the risk of microbial contamination of 
fresh produce? If yes, please identify and explain.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket

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management system. Electronic comments or submissions will be accepted 
by FDA only through FDMS at http://www.regulations.gov.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    1. Sivapalasingam, S., et al. ``Fresh Produce: A Growing Cause 
of Outbreaks of Foodborne Illness in the United States, 1973 through 
1997,'' Journal of Food Protection 67(10): 2342-53, 2004.
    2. U.S. Food and Drug Administration, 1996 to 2007 Produce 
Outbreaks (unpublished compilation).
    3. U.S. Food and Drug Administration, ``Guide to Minimize 
Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' 
October 26, 1998, available at http://www.cfsan.fda.gov/~dms/
prodguid.html.
    4. U.S. Food and Drug Administration, ``Produce Safety From 
Production to Consumption: 2004 Action Plan to Minimize Foodborne 
Illness Associated with Fresh Produce Consumption,'' October 2004, 
available at http://www.cfsan.fda.gov/~dms/prodpla2.html.
    5. U.S. Food and Drug Administration, ``Leafy Greens Safety 
Initiative--2nd year,'' October 4, 2007, available at http://
www.cfsan.fda.gov/~dms/lettsaf2.html.
    6. U.S. Food and Drug Administration, ``Tomato Safety 
Initiative,'' June 12, 2007, available at http://www.cfsan.fda.gov/
~dms/tomsafe.html.
    7. ``Safety of Fresh Produce; Public Hearings; Request for 
Comments'' (72 FR 8750, February 27, 2007), Public hearings held on 
March 20, 2007, and April 13, 2007, http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2007-N-0380.
    8. California Leafy Green Products Handler Marketing Agreement, 
available at http://www.caleafygreens.ca.gov.

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/~dms/prodguid.html.

    Dated: August 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20187 Filed 8-29-08; 8:45 am]
BILLING CODE 4160-01-S