[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
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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