8750 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section FDA Form Number No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1040.11(a)(2) 190 1 .00 190 10 1,900 

1040.20(d)(1)(ii) through 

(d)(1)(vi) and (e)(1) and (e)(2) 

110 1 .00 110 10 1,100 

1040.30(c)(1)(ii) 1 1 .00 1 1 1 

1040.30(c)(2) 7 1 .00 7 1 7 

1050.10(d)(1) through (d)(4) and 

(f)(1) through (f)(2)(iii) 

10 1 .00 10 56 560 

Total 107,209 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1002.30 and 1002.31(a) 1,150 1,655 .5 1,903,825 198 .7 228,505 

1002.40 and 1002.41 2,950 49 .2 145,140 2 .4 7,080 

1020.30(g) 22 1 22 0 .5 11 

1040.10(a)(3)(ii) 83 1 83 1 .0 83 

Totals 235,679 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The information collection 

requirements under OMB control 

number 0910–0564 and Form FDA 

3626, the data collection instrument for 

this collection, have been consolidated 

under the information collection 

activity of OMB control number 0910–

0025, thus resulting in an adjustment 

(increase) in the current burden 

estimate. 

The burden estimates were derived by 

consultation with FDA and industry 

personnel and actual data collected 

from industry. An evaluation of the type 

and scope of information requested was 

also used to derive some time estimates. 

For example, disclosure information 

primarily requires time only to update 

and maintain existing manuals. Initial 

development of manuals has been 

performed except for new firms entering 

the industry. When information is 

generally provided to users, assemblers, 

or dealers in the same manual, they 

have been grouped together in the 

‘‘Estimated Annual Reporting Burden’’

table (table 1 of this document). 

The following information collection 

requirements are not subject to review 

by OMB because they do not constitute 

a ‘‘collection of information’’ under the 

PRA: Sections 1002.31(c); 1003.10(a), 

(b), and (c); 1003.11(a)(3) and (b); 

1003.20(a) through (h); 1003.21(a) 

through (d); 1003.22(a) and (b); 

1003.30(a) and (b); 1003.31(a) and (b); 

1004.2(a) through (i); 1004.3(a) through 

(i); 1004.4(a) through (h); 1005.21(a) 

through (c); and 1005.22(b). These 

requirements ‘‘apply to the collection of 

information during the conduct of 

general investigations or audits’’ (5 CFR 

1320.4(b)). The following labeling 

requirements are also not subject to 

review under the PRA because they are 

a public disclosure of information 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public 

(1410.10 of the FDA Staff Manual Guide 

and §§ 1020.10(c)(4), 1030.10(c)(6), 

1040.10(g), 1040.30(c)(1), and 

1050.10(d)(1)). 

Dated: February 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3258 Filed 2–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0051] 

Safety of Fresh Produce; Public 

Hearings; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearings; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

two public hearings concerning the 

safety of fresh produce. The purpose of 

the hearings is for FDA to share 

information about recent outbreaks of 

foodborne illness associated with 

microbial contamination of fresh 

produce, and to solicit comments, data, 

and other scientific information about 

current agricultural and manufacturing 

practices used to produce, harvest, pack, 

cool, process, and transport fresh 

produce; risk factors for contamination 

of fresh produce associated with these 

practices; and possible measures by 

FDA to enhance the safety of fresh 

produce. 

DATES: The first public hearing will be 

held on March 20, 2007, from 9 a.m. to 


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5 p.m. The second public hearing will 

be held on April 13, 2007, from 9 a.m. 

to 5 p.m. See section V of this document 

for additional dates on how to 

participate in the hearings. Submit 

written or electronic comments (i.e., 

submissions other than notices of 

participation and the text, 

comprehensive outline, or summary of 

an oral presentation) by June 13, 2007. 

ADDRESSES: The first public hearing will 

be held at the Ronald V. Dellums 

Federal Building, Edward Roybal 

Auditorium, 1301 Clay St., 3d floor, 

Oakland, CA 94612. The second public 

hearing will be held at the Harvey W. 

Wiley Federal Building, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, 5100 Paint 

Branch Pkwy., College Park, MD, 

20740–3835 (Metro stop: College Park 

on the Green Line). 

Submit electronic notices of 

participation for either hearing to http:// 

www.cfsan.fda.gov/~comm/ 

register.html. We encourage you to use 

this method of registration, if possible. 

You may also submit oral or written 

notices of participation by phone, by 

fax, or by e-mail, or submit the written 

full text, comprehensive outline, or 

summary of any oral presentation by fax 

or by e-mail to Isabelle Howes, U.S. 

Department of Agriculture Graduate 

School, 202–314–4713, FAX: 202–479–

6801, or e-mail: 

Isabelle_Howes@grad.usda.gov. 

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. 

Instructions: All submissions and 

comments received must include the 

agency name and docket number found 

in brackets in the heading of this 

document. All submissions and 

comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see section VI in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Transcripts of the hearings will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.fda.gov/ohrms/ 

dockets/default.htm approximately 30 

days after the hearing. 

FOR FURTHER INFORMATION CONTACT: 

To submit an oral or written notice of 

participation by phone, by fax, or 

by e-mail, or the written full text, 

comprehensive outline, or summary 

of any oral presentation by fax or by 

e-mail: Isabelle Howes, U.S. 

Department of Agriculture Graduate 

School, 202–314–4713, FAX: 202–

479–6801, or e-mail: 

Isabelle_Howes@grad.usda.gov. All 

participants must complete 

registration. Following registration, 

you will receive a confirmation 

notice which also includes hotel 

and parking information. 

For all other questions about the 

hearings or if you need special 

accommodations due to a 

disability: Juanita Yates, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 

301–436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Food Safety and Fresh Produce 

FDA is responsible for ensuring the 

safety of all domestic and imported 

fresh and fresh-cut 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. As used in this 

document, the term ‘‘fresh-cut produce’’

refers to minimally processed fruits and 

vegetables that have been altered in 

form by peeling, slicing, chopping, 

shredding, coring, or trimming, with or 

without washing or other treatment, 

prior to being packaged for use by the 

consumer or retail establishment. 

Examples of fresh-cut products are 

shredded lettuce, sliced tomatoes, salad 

mixes, peeled baby carrots, broccoli 

florets, and cut melons. Fresh-cut 

produce does not require additional 

preparation, processing, or cooking 

before consumption, with the possible 

exception of washing or the addition of 

salad dressing or seasoning. In this 

document, we use the term ‘‘fresh 

produce’’ to describe all fresh and freshcut fruits and vegetables consumed in 

the United States. 

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 processing 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, processed, 

transported, distributed, and prepared 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 2006 there were approximately 

72 reported outbreaks of foodborne 

illness associated with approximately 

20 fresh produce commodities. Of this 

total, 12 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 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). 

When there is an outbreak of 

foodborne illness, we work with 

Federal, State, and local agencies to 

identify the source of the outbreak and 

minimize the public health impact. For 

example, on September 14, 2006, we 

issued a news release alerting 

consumers about an outbreak of E. coli 

O157:H7 in multiple States and advising 

the public not to eat bagged fresh 

spinach because it had been implicated 

in the outbreak (Ref. 3). We continued 

to issue updated press releases for 

approximately four weeks. During the 

course of the outbreak, approximately 

200 illnesses were reported to the CDC, 

including more than 30 cases of 

hemolytic uremic syndrome (HUS, a 

condition occurring mainly in children 

that can result in kidney failure), more 

than 100 hospitalizations, and 3 deaths 

(Ref. 4). In addition to working to 

identify the food involved in the 

outbreak, we worked with others to 

trace the source of the implicated 


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product to packing, cooling and 

processing facilities involved and to the 

farm to identify practices or conditions 

that may have contributed to the 

contamination of the produce. 

One challenge faced by public health 

officials during an outbreak is to quickly 

identify through traceback the sources 

of contamination. FDA’s regulations 

require the establishment and 

maintenance of records by persons who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

in the United States (21 CFR 1.326–

1.368). Such records allow for the 

identification of the immediate previous 

sources and immediate subsequent 

recipients of food, and thereby help 

FDA and other authorities determine the 

source and cause of the event. Farms 

and restaurants are excluded from these 

requirements. Traceback can be 

particularly problematic when fresh 

produce is involved. 

Eating fruits and vegetables is an 

important part of a healthy diet (Ref. 5). 

We place a high priority on identifying 

and implementing measures that can 

reduce the incidence of foodborne 

illness associated with fresh produce. 

B. Guidance Documents and Letters 

Issued by FDA to Enhance the Safety of 

Fresh Produce 

In 1998, FDA issued guidance to 

industry entitled ‘‘Guide to Minimize 

Microbial Food Safety Hazards for Fresh 

Fruits and Vegetables’’ (GAPs/GMPs 

Guide) (Ref. 6). This guide recommends 

good agricultural practices (GAPs) and 

good manufacturing practices (GMPs) 

that growers, packers, and shippers can 

undertake to address common risk 

factors in their operations and thereby 

minimize food safety hazards 

potentially associated with fresh 

produce. Implementation of risk 

reduction measures is critical; as the 

GAPs/GMPs Guide notes, current 

technologies cannot eliminate all 

potential food safety hazards associated 

with fresh produce that will be eaten 

raw. 

On February 5, 2004, FDA issued a 

letter to firms that grow, pack, or ship 

fresh lettuce and fresh tomatoes, 

expressing concern regarding outbreaks 

of foodborne illness associated with the 

consumption of fresh lettuce and fresh 

tomatoes, and recommending actions to 

enhance the safety of these products 

(Ref. 7). On November 4, 2005, FDA 

issued a second letter to firms that grow, 

pack, process or ship fresh and fresh-cut 

lettuce, reiterating concerns about 

continuing outbreaks (Ref. 8). In the 

November 2005 letter, FDA strongly 

encouraged applicable firms to review 

their current operations in light of the 

GAPs\GMPs Guide, as well as other 

available information regarding the 

reduction or elimination of pathogens 

on fresh produce. FDA encouraged firms 

to consider modifying their operations 

to ensure that they were taking the 

appropriate measures to provide a safe 

product to the consumer. FDA 

recommended that firms from the farm 

level through the distribution level 

undertake these steps. 

On March 1, 2006, FDA issued a draft 

entitled ‘‘Guide to Minimize Microbial 

Food Safety Hazards of Fresh-cut Fruits 

and Vegetables’’ (the Fresh-cut Guide) 

(Ref. 9). The draft Fresh-cut Guide is 

intended to be used in conjunction with 

the GAPs/GMPs Guide, which covers 

stages prior to fresh-cut processing, with 

the current GMPs in part 110 (21 CFR 

part 110), which contain food safety 

practices applicable to processors who 

manufacture, process, pack, or hold 

processed food, and with the FDA Food 

Code (Ref. 10), which focuses on 

activities at subsequent stages, such as 

retail. The FDA Food Code gives State 

and local governments a scientifically 

sound technical and legal basis for 

regulating the retail and food service 

segment of the industry (restaurants and 

grocery stores and institutions such as 

nursing homes). State, local, tribal, and 

Federal regulators use the FDA Food 

Code as a model to develop or update 

their own food safety rules and to be 

consistent with national food regulatory 

policy. (For more information on the 

FDA Food Code, see http:// 

www.cfsan.fda.gov/~dms/ 

foodcode.html.) FDA is currently 

working to finalize the Fresh-cut Guide. 

C. Produce Safety Action Plan 

In October 2004, FDA issued the 

‘‘Produce Safety from Production to 

Consumption: 2004 Action Plan to 

Minimize Foodborne Illness Associated 

with Fresh Produce Consumption’’ or 

Produce Safety Action Plan (PSAP) (Ref. 

11). The PSAP expands on the areas 

covered by the GAPs/GMPs Guide for 

farms and packing, to extend to all parts 

of the food supply chain from farm 

through retail or consumer preparation 

and consumption. The PSAP does not 

cover frozen fruits and vegetables, fruit 

and vegetable juices, or other 

commodities, such as tree nuts, that are 

neither fruits nor vegetables and not 

typically regarded as produce. The 

PSAP has four main objectives which 

are to: (1) Prevent contamination of 

fresh produce with pathogens; (2) 

minimize the public health impact 

when contamination of fresh produce 

occurs; (3) improve communication 

with producers, packers, processors, 

transporters, distributors, preparers, 

consumers, and other government 

entities about the safety of fresh 

produce; and (4) facilitate and support 

research relevant to the contamination 

of fresh produce. For each objective, the 

PSAP identifies steps or actions that 

could contribute to the achievement of 

that objective. The PSAP has 

measurable goals and outcomes, and 

several steps outlined in the PSAP are 

already in progress or have been 

completed. For example, we issued the 

draft Fresh-cut Guide as part of the 

PSAP objective regarding prevention of 

contamination. 

D. Partnerships and Collaborations 

Because following the GAPs/GMPs 

Guide is voluntary, FDA and food safety 

partners in the public and private 

sectors have stressed education and 

outreach to industry to promote 

adoption of the guidance. Buyer 

requirements that producers and other 

suppliers provide self- or third-party 

audit verification that they are following 

the GAPs/GMPs Guide have further 

promoted adoption of the guidance. We 

have worked with the fresh produce 

industry since the release of the GAPs/ 

GMPs Guide to promote its 

recommendations and to advance the 

scientific knowledge applicable to 

enhancing the safety of fresh produce. 

For example, in conjunction with the 

PSAP, we have provided technical 

assistance to industry in developing 

several commodity specific guidelines 

that cover the entire supply chain. 

Commodity-specific industry guidelines 

exist for three foods: Melons, lettuce 

and leafy greens, and tomatoes (see Refs. 

12, 13, and 14). An additional industry 

guideline on green onions and herbs is 

in progress. Between 1996 and 2006, 

these commodities together accounted 

for approximately 80 percent of the 

foodborne outbreaks associated with 

produce (Ref. 2). 

In August 2006 we launched the 

‘‘Lettuce and Leafy Greens Initiative,’’

which involved assessments of practices 

and conditions at select farms and 

facilities in California. The initiative, 

conducted in collaboration with the 

California Department of Health 

Services and the California Department 

of Food and Agriculture, is intended to 

be a multi-year effort and may be a 

model for other initiatives in the future. 

E. Other Food Safety Measures 

The provisions in part 110 (Current 

Good Manufacturing Practice In 

Manufacturing, Packing, Or Holding 

Human Food) establish requirements 

and recommendations as follows that 

apply in determining whether a food is 

adulterated: (1) Within the meaning of 


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section 402(a)(3) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 341(a)(3)), in that the food has 

been manufactured under such 

conditions that it is unfit for food; or (2) 

within the meaning of section 402(a)(4) 

of the act, in that the food has been 

prepared, packed, or held under 

insanitary conditions whereby it may 

have become contaminated with filth, or 

whereby it may have been rendered 

injurious to health. Under § 110.19(a), 

establishments engaged solely in the 

harvesting, storage, or distribution of 

one or more raw agricultural 

commodities (as defined in section 

201(r) of the act (21 U.S.C. 321)), are not 

subject to the requirements of part 110. 

However, under § 110.19(b), we may 

issue special regulations if it is 

necessary to cover these excluded 

operations. In addition, the GAPs/GMPs 

Guide recommends that operations 

excluded from the provisions of part 

110 consider implementing the current 

GMPs required or recommended in part 

110 as appropriate. 

For foods other than fresh produce, 

we have issued regulations designed to 

enhance food safety, including safety 

related to microbial pathogens (see, e.g., 

21 CFR part 113, concerning thermally 

processed low-acid foods packaged in 

hermetically sealed containers; 21 CFR 

part 114, concerning acidified foods; 21 

CFR 15.51, concerning refrigeration of 

shell eggs held for retail distribution; 21 

CFR part 120, concerning hazard 

analysis and critical control point 

(HACCP) systems for juice; and 21 CFR 

part 123, concerning HACCP 

requirements for fish and fishery 

products). Some FDA regulations to 

enhance the safety of particular food 

products (e.g., the HACCP requirements 

in 21 CFR part 120 for juice and in 21 

CFR part 123 for fish and fishery 

products) contain training and other 

requirements for performing particular 

functions. For some food products, we 

have augmented our regulations with 

nonbinding guidance to assist industry 

in complying with the regulations (e.g., 

FDA’s Juice HACCP Hazards and 

Controls Guidance (available at http:// 

www.cfsan.fda.gov/~dms/ 

guidance.html) and Fish And Fisheries 

Products Hazards And Controls 

Guidance (available at http:// 

www.cfsan.fda.gov/~dms/ 

guidance.html)). 

F. Next Steps 

We believe that the measures outlined 

in the PSAP, the GAPs/GMPs Guide, 

and other public and private sector 

actions, when implemented, have or can 

be effective in reducing the risk of 

microbial contamination of fresh 

produce. In particular, the GAPs/GMPs 

Guide has been used as a basis for a 

number of food safety programs, both in 

the United States and internationally. 

However, the fact that outbreaks of 

foodborne illness associated with fresh 

produce continue to occur supports a 

close examination of the extent to which 

these measures have been implemented; 

whether they have been effective, if 

implemented properly; and what 

additional or different interventions 

might be appropriate to reduce the risk 

of future outbreaks. As a next step, we 

intend to hold two public hearings 

regarding the safety of fresh produce. 

The purpose and scope of the hearings, 

each of which will be governed by part 

15 (21 CFR part 15) of FDA’s 

regulations, are described in section II of 

this document. 

II. Purpose and Scope of the Hearings 

We want to share information about 

recent outbreaks of foodborne illness 

associated with microbial 

contamination of fresh produce, and to 

invite comments, data, and other 

scientific information about: Current 

agricultural and manufacturing 

practices used to produce, harvest, pack, 

cool, process, and transport fresh 

produce; risk factors for contamination 

of fresh produce associated with these 

practices; and possible measures by 

FDA to enhance the safety of fresh 

produce. 

This notice describes the scope of the 

hearings. We invite information and 

comment on the issues and questions in 

section III of this document. If you are 

interested in these hearings or this 

subject, you may address as many of the 

following questions as you wish. We do 

not expect you to address all questions. 

When possible, please provide scientific 

information and data in support of your 

comments. In addition, to the extent 

possible, please provide as specific 

information 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). 

III. Issues and Questions for Discussion 

Issue 1: In the supply chain for fresh 

produce (e.g., farms, packing houses, 

cooling facilities, and fresh-cut 

processing facilities), various factors can 

contribute to the risk of microbial 

contamination of fresh produce. We 

request information to enable us to 

identify and understand such factors 

more fully. 

Question 1. For each stage in the 

supply chain, and for each industry 

sector, what are the risks or practices 

that could lead to microbial 

contamination of fresh produce? 

Question 2. How can or should 

current practices be changed to reduce 

the risk of contamination? 

Question 3. For each stage in the 

supply chain, and for each industry 

sector, what current practices 

(including, for example, following the 

GAPs/GMPs Guide) reduce the risk of 

microbial contamination of fresh 

produce? What data are available to 

support a conclusion that the risk of 

such contamination is lower than it 

would be without the practice in place? 

Question 4. Is fresh produce, or inputs 

such as agricultural water, sampled and 

tested for pathogens or indicator 

organisms at any stage of the supply 

chain? If yes, please describe the 

sampling and testing done. 

Issue 2: As described more fully in 

sections I.B through I.E of this 

document, we already have 

implemented several measures to 

enhance the safety of fresh produce and 

other foods within FDA’s jurisdiction. 

Question 5. Beyond the Federal 

actions described in sections I.B. 

through I.E, what new Federal actions, 

if any, are needed to enhance the safety 

of fresh produce? On what aspects of the 

produce supply chain should the 

measures focus? 

Question 6. In identifying possible 

Federal interventions or actions, to what 

extent can or should we take into 

account the wide variation within the 

fresh produce industry with respect to, 

e.g., the size and type of establishments, 

the nature of the commodity produced, 

the practices used in production, and 

the vulnerability of particular 

commodities to contamination? To what 

extent should such measures apply to 

specific products, sectors of the 

industry, regions, or businesses? For 

example, is there a need for special 

treatment for different commodity 

groups? 

Issue 3: Traceback can be problematic 

when unpackaged fresh produce is 

involved in an outbreak, especially for 

products which may undergo several 

packing and repacking steps in the 

supply chain with multiple 

opportunities for commingling. Even 

with respect to packaged and labeled 

products, traceback is difficult if there 

are insufficient records to identify the 

specific farm, field, or block of origin; if 

the records lack sufficient specificity 

about where the fresh produce went 

after leaving the packing or processing 

facility; or if there are discrepancies 

between records of incoming and 

outgoing product. 

Question 7. What types of records and 

other information, from what types of 


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facilities, are or would be most useful in 

facilitating traceback efforts? 

Issue 4: Written food safety plans, 

sanitation standard operating 

procedures (SSOPs), and monitoring 

records can serve as useful tools for both 

industry and regulators. Such records 

can assist operators in conducting 

operations in a manner that could 

enhance the safety of fresh produce. For 

growers, an assessment of factors such 

as the field environment and 

agricultural inputs could contribute to 

the development of written food safety 

plans and SSOPs, and also could help 

to determine which factors should be 

monitored and the frequency of 

monitoring. (In the following questions 

we use the term ‘‘assessment’’ when 

referring to an evaluation conducted by, 

or on behalf of, a grower or operator to 

identify measures to enhance food 

safety.) 

Written food safety plans, SSOPs, and 

monitoring records also can assist 

regulators in verifying that certain 

practices are being followed 

consistently and properly over time. 

Onsite inspections, either alone, or in 

conjunction with records review, are 

another approach to such verification. 

(We use the term ‘‘inspection’’ when 

referring to an evaluation conducted by, 

or on behalf of, a regulator to evaluate 

compliance and the term ‘‘audit’’ to 

refer to a self- or third-party evaluation 

of whether operations adhere to, for 

example, voluntary guidelines or 

written food safety plans or SSOPs 

developed by the grower, operator, or 

buyer.) 

Question 8. Are written food safety 

plans, written SSOPs, periodic 

assessments, training, and/or the 

establishment and maintenance of 

records useful for risk identification and 

risk mitigation or management 

purposes? If yes, to what extent are 

these practices in place, and in what 

sectors of the industry? 

Issue 5: As noted in section II.D of 

this document, some buyers require that 

producers and other suppliers provide 

self- or third-party audit verification 

that they are following the GAPs/GMPs 

Guide. However, the extent to which 

these verifications reflect adherence to 

the guidance is not well-established. 

Question 9. How should adherence to 

the GAPs/GMPs Guide or new produce 

safety guidance(s) be measured and 

verified by the grower or operator, 

government regulators, or third-party 

auditors, in the event of any new 

recommended Federal action or in the 

event you are not recommending any 

new Federal action? 

Question 10. If you are recommending 

any new Federal measures, please 

describe how they might affect certain 

small businesses, such as roadside 

stands, farm gate operations, farmers’

markets, or other small businesses 

involved in direct sales. 

IV. Notice of Hearings Under 21 CFR 

Part 15 

By delegation from the Commissioner 

of Food and Drugs (the Commissioner) 

(Staff Manual Guide 1420.21, section 

1(b)), the Associate Commissioner for 

Policy and Planning finds that it is in 

the public interest to permit persons to 

present information and views at a 

public hearing regarding the safety of 

fresh produce and is announcing that 

the public hearings will be held in 

accordance with part 15. The presiding 

officer will be the Commissioner or his 

designee. The presiding officer will be 

accompanied by a panel of FDA 

employees with relevant expertise. 

Persons who wish to participate in 

either hearing (either by making a 

presentation or as a member of the 

audience) must file a notice of 

participation (see ADDRESSES, DATES, 

FOR FURTHER INFORMATION CONTACT, and 

‘‘How to Participate in the Hearings’’ in 

section V of this document). By 

delegation from the Commissioner (Staff 

Manual Guide 1420.21, section 1(b)), the 

Associate Commissioner for Policy and 

Planning has determined under 

§ 15.20(c) that advance submissions of 

oral presentations are necessary for the 

panel to formulate useful questions to 

be posed at the hearings under 

§ 15.30(e), and that the submission of a 

comprehensive outline or summary is 

an acceptable alternative to the 

submission of the full text of the oral 

presentation. Because we anticipate 

attendance at the hearings to be high, 

we request that individuals and 

organizations with common interests 

consolidate their requests for oral 

presentation and request time for a joint 

presentation through a single 

representative. After reviewing the 

notices of participation and 

accompanying information, we will 

schedule each oral presentation and 

notify each participant of the time 

allotted to the presenter and the 

approximate time that the presentation 

is scheduled to begin. If time permits, 

we may allow interested persons who 

attend one or both hearings but did not 

submit a notice of participation in 

advance to make an oral presentation at 

the conclusion of one or both hearings. 

The hearing schedules will be available 

at the hearings. 

After the hearings, the schedules will 

be placed on file in the Division of 

Dockets Management (see ADDRESSES) 

under the docket number listed in 

brackets in the heading of this notice. 

To ensure timely handling of any 

mailed notices of participation, 

presentations, or comments, any outer 

envelope should be clearly marked with 

the docket number listed in brackets in 

the heading of this notice along with the 

statement ‘‘Safety of Fresh Produce; 

Public Hearing.’’

Under § 15.30(f), the hearings are 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (part 

10 (21 CFR part 10, subpart C)). Under 

§ 10.205, representatives of the 

electronic media may be permitted, 

subject to the procedures and 

limitations in § 10.206, to videotape, 

film, or otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearings will be transcribed as 

stipulated in § 15.30(b). The transcript 

will be available on the Internet at 

http://www.fda.gov/ohrms/dockets/ 

default.htm, and orders for copies of the 

transcript can be placed at the hearing 

or through the Division of Dockets 

Management (see ADDRESSES). 

Any handicapped persons requiring 

special accommodations to attend the 

hearings should direct those needs to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). 

To the extent that the conditions for 

the hearings, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

these provisions as specified in §§ 10.19 

and 15.30(h). In particular, § 15.21(a) 

states that the notice of hearing will 

provide persons an opportunity to file a 

written notice of participation with the 

Division of Dockets Management within 

a specified period of time. If the public 

interest requires, e.g., if a hearing is to 

be conducted within a short period of 

time, the notice may name a specific 

FDA employee and telephone number to 

whom an oral notice of participation 

may be given. If the public interest 

requires, the notice may also provide for 

submitting notices of participation at 

the time of the hearing. In this 

document, the conditions for the 

hearings specify that notices of 

participation be submitted 

electronically to an agency Internet site, 

to a contact person (outside of FDA) 

who will accept notices of participation 


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Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 8755 

by mail, telephone, fax, or e-mail, or in 

person on the day of the hearing (as 

space permits). We are using these 

procedures for submitting notices of 

participation, rather than provide for the 

submission of notices of participation to 

the Division of Dockets Management, 

because the hearing is to be conducted 

within a short period of time and these 

procedures are more efficient. In 

addition, these procedures provide more 

flexibility to persons who wish to 

participate in the hearings than would 

be provided if participants were 

required to submit the notice of 

participation in writing to the Division 

of Dockets Management. By delegation 

from the Commissioner (Staff Manual 

Guide 1420.21, section 1(f)(2)(i)), the 

Associate Commissioner for Policy and 

Planning finds under § 10.19 that no 

participant will be prejudiced, the ends 

of justice will thereby be served, and the 

action is in accordance with law if 

notices of participation are submitted by 

the procedures listed in this notice 

rather than to the Division of Dockets 

Management. 

V. How to Participate in the Hearings 

Registration by submission of a notice 

of participation is necessary to ensure 

participation and will be accepted on a 

first-come, first-served basis. The notice 

of participation may be submitted 

electronically (see ADDRESSES). The 

notice of participation also may be 

submitted orally, by fax, or by e-mail 

(see ADDRESSES and FOR FURTHER

INFORMATION CONTACT). We encourage 

you to submit your notice of 

participation electronically. A single 

copy of any notice of participation is 

sufficient, except that any person who 

wishes to participate in both hearings 

must submit a separate notice of 

participation for each hearing. 

The notice of participation must 

include your name, title, business 

affiliation (if applicable), address, 

telephone number, fax number (if 

available), and e-mail address (if 

available). If you wish to request an 

opportunity to make an oral 

presentation during the open public 

comment period of the hearing, your 

notice of participation also must include 

the title of your presentation, the 

sponsor of the oral presentation (e.g., 

the organization paying travel expenses 

or fees), if any; and the approximate 

amount of time requested for the 

presentation. Presentations will be 

limited to the questions and subject 

matter identified in section III of this 

document, and, depending on the 

number of requests received, we may be 

obliged to limit the time allotted for 

each presentation. 

Persons who wish to request an 

opportunity to make an oral 

presentation at the March 20, 2007, 

public hearing must submit a notice of 

participation (register) by March 2, 

2007. All other persons wishing to 

register to attend the March 20, 2007, 

public hearing must submit a notice of 

participation by March 12, 2007. 

Persons who request an opportunity to 

make an oral presentation at the March 

20, 2007, public hearing also must 

submit either the full text of the oral 

presentation, or a comprehensive 

outline or summary of the oral 

presentation, by March 12, 2007. 

Persons requiring special 

accommodations due to a disability 

must register by March 6, 2007. 

Persons who wish to request an 

opportunity to make an oral 

presentation at the April 13, 2007, 

public hearing must submit a notice of 

participation by March 23, 2007. All 

other persons wishing to register to 

attend the April 13, 2007, public 

hearing must submit a notice of 

participation by April 6, 2007. Persons 

who request an opportunity to make an 

oral presentation at the second public 

hearing also must submit either the full 

text of the oral presentation, or a 

comprehensive outline or summary of 

the oral presentation, by April 6, 2007. 

Under § 15.20(c), if you request an 

opportunity to make an oral 

presentation you must submit your 

presentation (either as the full text of 

the presentation, or as a comprehensive 

outline or summary) by e-mail or by fax. 

See ADDRESSES and FOR FURTHER

INFORMATION CONTACT for information on 

where to send your presentation. 

Individuals who request an 

opportunity to make an oral 

presentation will be notified of the 

scheduled time for their presentation 

prior to the hearing. Depending on the 

number of oral presentations, we may 

need to limit the time allotted for each 

oral presentation (e.g., 5 minutes each). 

As stated earlier, we request that 

interested persons and groups having 

similar interests consolidate their 

requests for oral presentation and 

present them through a single 

representative. If you need special 

accommodations due to a disability, 

please inform us (see FOR FURTHER

INFORMATION CONTACT). 

We will also accept registration 

onsite; however, space is limited and 

will be closed when the maximum 

seating capacity is reached. If space is 

available, on-site registration will be 

accepted on a first-come, first-served 

basis. Requests for an opportunity to 

make a presentation from individuals or 

organizations that did not register to 

make an oral presentation may be 

granted if time permits. 

Persons who registered for the hearing 

should check in at the on-site 

registration desk between 8:30 and 9 

a.m. Persons who wish to register onsite 

on the day of the hearing should do so 

at the registration desk between 8:30 

and 9 a.m. We encourage all 

participants to attend the entire day. 

Because the hearings will be held in 

Federal buildings, hearing participants 

must present photo identification and 

plan adequate time to pass through the 

security system. 

VI. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments in response to this document 

and notice of hearings for consideration 

at or after the hearings in addition to, or 

in place of, a request for an opportunity 

to make an oral presentation (see section 

V of this document). Submit two paper 

copies of any written comments, except 

that individuals may submit one 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. 

FDA is inviting public comment in 

writing and at the public hearings. 

These comments are sought to inform 

FDA decisionmaking about possible 

regulatory action with respect to the 

safety of fresh produce. Written or 

electronic comments (i.e., submissions 

other than notices of participation and 

the text, comprehensive outline, or 

summary of an oral presentation) may 

be submitted until June 13, 2007. The 

administrative record of the hearing will 

remain open until June 13, 2007. 

VII. 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, 

1996–2006 Produce Outbreaks (unpublished 

compilation). 

3. U.S. Food and Drug Administration, 

FDA News Release, ‘‘FDA Warning on 

Serious Foodborne E. coli O157:H7 


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8756 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 

Outbreak,’’ P06–131, September 14, 2006, 

available at http://www.fda.gov/po/indexes/ 

2006news.html. 

4. U.S. Centers for Disease Control and 

Prevention, ‘‘Update on Multi-State Outbreak 

of E. coli O157:H7 Infections From Fresh 

Spinach, October 6, 2006, available at http:// 

www.cdc.gov/ecoli/2006/september/updates/ 

100606.htm. 

5. U.S. Department of Health and Human 

Services and U.S. Department of Agriculture, 

‘‘Dietary Guidelines for Americans 2005,’’

January 2005, available at http:// 

www.healthierus.gov/dietaryguidelines/. 

6. 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. 

7. U.S. Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, Office of Plant and Dairy Foods, 

‘‘Letter to Firms that Grow, Pack, or Ship 

Fresh Lettuce and Fresh Tomatoes,’’ February 

5, 2004, available at http:// 

www.cfsan.fda.gov/~dms/prodltr.html. 

8. U.S. Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, Office of Plant and Dairy Foods, 

‘‘Letter to California Firms that Grow, Pack, 

Process, or Ship Fresh and Fresh-cut 

Lettuce,’’ November 4, 2005, available at 

http://www.cfsan.fda.gov/~dms/ 

prodltr2.html. 

9. U.S. Food and Drug Administration, 

‘‘Guide to Minimize Microbial Food Safety 

Hazards of Fresh-Cut Fruits and Vegetables,’’

March 2006, available at http:// 

www.cfsan.fda.gov/~dms/prodgui2.html. 

10. U.S. Department of Health and Human 

Services, Public Health Service, Food and 

Drug Administration, FDA Food Code, 2005, 

available at http://www.cfsan.fda.gov/~dms/ 

foodcode.html. 

11. 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. 

12. Produce Marketing Association and 

United Fresh Fruit and Vegetable 

Association, ‘‘Commodity Specific Food 

Safety Guidelines for the Melon Supply 

Chain,’’ November 7, 2005, available at 

http://www.cfsan.fda.gov/~dms/ 

melonsup.html or http://www.cfsan.fda.gov/ 

~acrobat/melonsup.pdf. 

13. International Fresh-Cut Produce 

Association, Produce Marketing Association, 

United Fresh Fruit and Vegetable 

Association, Western Growers Association; 

Commodity Specific Food Safety Guidelines 

for the Lettuce and Leafy Greens Supply 

Chain; April 25, 2006, available at http:// 

www.cfsan.fda.gov/~dms/lettsup.html or 

http://www.cfsan.fda.gov/~acrobat/ 

lettsup.pdf. 

14. North American Tomato Trade Work 

Group, ‘‘Commodity Specific Food Safety 

Guidelines for the Fresh Tomato Supply 

Chain, May 2006, available at http:// 

www.cfsan.fda.gov/~dms/tomatsup.html or 

http://www.cfsan.fda.gov/~acrobat/ 

tomatsup.pdf. 

Dated: February 21, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 07–891 Filed 2–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0480] 

Draft Guidance for Industry on 

Complementary and Alternative 

Medicine Products and Their 

Regulation by the Food and Drug 

Administration; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Complementary and 

Alternative Medicine Products and 

Their Regulation by the Food and Drug 

Administration.’’ In recent years, the 

practice of complementary and 

alternative medicine (CAM) has 

increased in the United States, and we 

have seen increased confusion as to 

whether certain products used in CAM 

are subject to regulation under the 

Federal Food, Drug, and Cosmetic Act 

(the act) or Public Health Service Act 

(PHS Act). We have also seen an 

increase in the number of CAM 

products imported into the United 

States. Therefore, the draft guidance 

discusses when a CAM product is 

subject to the act or the PHS Act. 

DATES: Submit written or electronic 

comments on the draft guidance by 

April 30, 2007. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Philip L. Chao, Office of Policy and 

Planning (HF–23), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–0587. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Complementary and Alternative 

Medicine Products and Their Regulation 

by the Food and Drug Administration.’’

The term ‘‘complementary and 

alternative medicine’’ (CAM) 

encompasses a wide array of health care 

practices, products, and therapies that 

are distinct from practices, products, 

and therapies used in ‘‘conventional’’ or 

‘‘allopathic’’ medicine. 

In the United States, the practice of 

CAM has risen dramatically in recent 

years. In 1992, Congress established the 

Office of Unconventional Therapies, 

which later became the Office of 

Alternative Medicine (OAM), to explore 

‘‘unconventional medical practices.’’ In 

1998, OAM became the National Center 

for Complementary and Alternative 

Medicine (NCCAM). NCCAM is a center 

within the National Institutes of Health. 

The Institute of Medicine, in its book 

entitled, Complementary and 

Alternative Medicine in the United 

States, stated that more than one-third 

of American adults reported using some 

form of CAM and that visits to CAM 

providers each year exceed those to 

primary care physicians (see Institute of 

Medicine, Complementary and 

Alternative Medicine in the United 

States, pages 34 through 35 (2005)). 

As the practice of CAM has increased 

in the United States, we have seen 

increased confusion as to whether 

certain products used in CAM (which, 

for convenience, we will refer to as 

‘‘CAM products’’) are subject to 

regulation under the act or the PHS Act. 

We have also seen an increase in the 

number of CAM products imported into 

the United States. Therefore, the draft 

guidance discusses when a CAM 

product is subject to the act or the PHS 

Act. (When the draft guidance mentions 

a particular CAM therapy, practice, or 

product, it does so in order to provide 

background information or to serve as 

an example or illustration; any mention 

of a particular CAM therapy, practice, or 

product should not be construed as 

expressing FDA’s support for or 

endorsement of that particular CAM 

therapy, practice, or product or, unless 

specified otherwise, as an agency 

determination that a particular product 


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