This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

1852 

Vol. 80, No. 9 

Wednesday, January 14, 2015 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 112 

[Docket No. FDA–2014–N–2244] 

RIN 0910–AG35 

Draft Environmental Impact Statement 

for the Proposed Rule, Standards for 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption; Notice for Public 

Meeting on Draft Environmental Impact 

Statement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA or we) has made 

available for public review and 

comment the Draft Environmental 

Impact Statement (EIS) for the proposed 

rule establishing standards for the 

growing, harvesting, packing, and 

holding of produce for human 

consumption. The document is 

available in Docket No. FDA–2014–N– 

2244. FDA is also announcing a public 

meeting to discuss the Draft EIS. The 

purpose of the public meeting is to 

inform the public of the findings in the 

Draft EIS, to provide information about 

the EIS process (including how to 

submit comments, data, and other 

information to the docket), to solicit oral 

stakeholder and public comments on 

the Draft EIS, and to provide 

clarification, as needed, about the 

contents of the Draft EIS. 

DATES: See section II, ‘‘How to 

Participate in the Public Meeting’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document for date and time of the 

public meeting, closing dates for 

advance registration, and information 

on deadlines for submitting either 

electronic or written comments on the 

Draft EIS. 

ADDRESSES: You may submit comments 

by any of the following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper): Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–2244. All comments received 

may be posted without change to 

http://www.regulations.gov, including 

any personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Public Meeting: See section II, ‘‘How 

to Participate in the Public Meeting’’ in 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: 

For questions about the Draft 

Environmental Impact Statement, or 

submitting comments contact: Annette 

McCarthy, Center for Food Safety and 

Applied Nutrition (HFS–205), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–1057. 

For questions about registering for the 

meeting, to register by phone, or to 

submit a notice of participation by mail, 

FAX, or email, contact: Rick Williams, 

c/o FDA EIS, 72 Loveton Circle, Sparks, 

MD 21152; telephone: 410–316–2377; 

FAX: 410–472–3289; email: RWilliams@

jmt.com. 

For general questions about the 

meeting, to request an opportunity to 

make an oral presentation at the public 

meeting, to submit the full text, 

comprehensive outline, or summary of 

an oral presentation, or for special 

accommodations due to a disability, 

contact: Cynthia Wise, Center for Food 

Safety and Applied Nutrition (HFS– 

300), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, telephone: 240–402–1357, 

email: cynthia.wise@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353), signed 

into law by President Obama on January 

4, 2011, enables FDA to better protect 

public health by helping to ensure the 

safety and security of the food supply. 

FSMA amends the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) to 

establish the foundation of a 

modernized, prevention-based food 

safety system. As part of our 

implementation of FSMA, we published 

the Proposed Rule: Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption (hereafter referred to as 

‘‘the 2013 proposed rule’’) to establish 

science-based minimum standards for 

the safe growing, harvesting, packing, 

and holding of produce (78 FR 3504, 

January 16, 2013). On September 29, 

2014, FDA issued a supplemental notice 

of proposed rulemaking (‘‘the 

supplemental proposed rule’’), 

amending certain specific provisions of 

the 2013 proposed rule (79 FR 58434). 

Taken together, these publications 

constitute FDA’s proposed standards for 

the growing, harvesting, packing, and 

holding of produce for human 

consumption (‘‘the Produce Safety 

Proposed Rule’’). 

FDA announced a ‘‘Notice of Intent’’ 

(NOI) to prepare an EIS to evaluate the 

potential environmental effects of the 

Produce Safety Proposed Rule in the 

Federal Register on August 19, 2013 (78 

FR 50358). In the NOI, FDA also 

announced the beginning of the scoping 

process and solicited public comments 

to identify issues to be analyzed in an 

EIS. The NOI asked for public comment 

by November 15, 2013, and FDA later 

extended the deadline for the comment 

period to April 18, 2014 (79 FR 13593; 

March 11, 2014). A public scoping 

meeting was held on April 4, 2014, in 

College Park, MD. 

In the Produce Safety Proposed Rule, 

FDA proposed science-based minimum 

standards for the safe production and 

harvesting of produce. As discussed in 

the Draft EIS (Ref. 1), out of these 

standards, we identified four provisions 

that could potentially significantly 

affect the quality of the human 


wreier-aviles on DSK4TPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Proposed Rules 1853 

environment, if finalized (hereinafter 

referred to as ‘‘potentially significant 

provisions’’). For each of the potentially 

significant provisions, FDA then 

identified alternative provisions to 

consider. The potentially significant 

provisions are: (1) Standards directed to 

agricultural water, (2) standards 

directed to biological soil amendments 

(BSA) of animal origin, (3) standards 

directed to domesticated and wild 

animals, and (4) general provisions (i.e., 

cumulative impacts). Additionally, an 

overarching ‘‘No Action’’ Alternative 

was considered for the purpose of 

evaluating conditions in the absence of 

any final rule. 

For standards directed to agricultural 

water, we considered the following 

alternatives: (1) As proposed by FDA, 

i.e., a statistical threshold value (STV) 

not exceeding 410 colony forming units 

(CFU) of generic Escherichia coli per 

100 ml of water and a geometric mean 

(GM) not exceeding 126 CFU of generic 

E. coli per 100 ml of water, along with 

options to achieve the standard by 

applying either a time interval between 

last irrigation and harvest using a 

microbial die-off rate of 0.5 log per day 

and/or a time interval between harvest 

and end of storage using an appropriate 

microbial die-off or removal rates, 

including during activities such as 

commercial washing (proposed 21 CFR 

112.44(c)); (2) a microbial quality 

standard of no more than 235 CFU (or 

most probable number (MPN), as 

appropriate) generic E. coli per 100 ml 

for any single sample or a rolling GM 

(n=5) of more than 126 CFU (or MPN, 

as appropriate) per 100 ml of water, as 

was proposed in the 2013 proposed 

rule; (3) as proposed (i.e., Alternative 1), 

but with an additional criterion 

establishing a maximum generic E. coli 

threshold ; and (4) for each of the 

alternatives above, consider the 

environmental impacts of two different 

interpretations of the definition of 

‘‘direct water application method’’ in 

proposed § 112.3(c): (a) To include root 

crops that are drip irrigated and (b) to 

exclude root crops that are drip 

irrigated. 

For standards directed to BSAs of 

animal origin, FDA considered 

standards for both untreated and treated 

BSAs. For untreated BSAs of animal 

origin, the alternatives considered 

included a range of minimal application 

intervals (the time between application 

and harvest) when the BSA is applied 

in a manner that does not contact 

covered produce during application and 

minimizes the potential for contact with 

covered produce after application. The 

alternative application intervals 

evaluated were: (1) 9 months, (2) 0 

months, (3) 90 and 120 days, consistent 

with the National Organic Programs’ 

regulations in 7 CFR 205.203(c)(1), (4) 6 

months, and (5) 12 months. For 

standards directed to treated BSAs, the 

alternatives considered included a range 

of application intervals when the BSA is 

composted in accordance with the 

requirements proposed in § 112.54(c) 

and applied in a manner that minimizes 

the potential for contact with covered 

produce during and after application. 

The application intervals evaluated 

were: (1) As proposed by FDA, 0 days 

(proposed § 112.56(a)(4)(i)), (2) 45 days, 

and (3) 90 days. 

For standards directed at 

domesticated animals, we considered 

alternatives under which, if working 

animals are used in a growing area 

where a crop has been planted, 

measures would be required to prevent 

the introduction of known or reasonably 

foreseeable hazards into or onto covered 

produce with the waiting period 

between grazing and harvesting varying 

by alternative. The following 

alternatives were evaluated: (1) As 

proposed by FDA, an adequate waiting 

period between grazing and harvesting 

for covered produce in any growing area 

that was grazed to ensure the safety of 

the harvested crop (proposed 

§ 112.82(a)); (2) a minimum waiting 

period of 9 months; and (3) a minimum 

waiting period of 90 days and 120 days 

before harvest, depending upon whether 

the edible portion of the crop contacts 

the soil (applying the timeframes for 

raw manure set forth in the National 

Organic Programs’ regulations in 7 CFR 

205.203(c)(1)). For standards directed to 

wild animals, we considered 

alternatives to the proposed requirement 

that under circumstances when there is 

a reasonable probability that animal 

intrusion will contaminate covered 

produce, the grower would be required 

to monitor those areas that are used for 

a covered activity for evidence of animal 

intrusion: (1) As needed during the 

growing season based on (i) the grower’s 

covered produce and (ii) the grower’s 

observations and experience; and (2) 

immediately prior to harvest. The 

alternatives evaluated were: (1) As 

proposed by FDA, if animal intrusion 

occurs—as made evident by observation 

of significant quantities of animals, 

animal excreta or crop destruction via 

grazing—the grower must evaluate 

whether the covered produce can be 

harvested in accordance with the 

requirements of proposed § 112.112 

(proposed § 112.83(a) and (b)) and (2) if 

animal intrusion is reasonably likely to 

occur, the grower must take measures to 

exclude animals from fields where 

covered produce is grown. 

The cumulative impacts of the 

proposed rule were considered using a 

range of alternatives to the general 

provision in proposed § 112.4, which 

would specify the farms that would be 

covered under the rule based on the 

farm’s annual sales of produce. The 

alternatives evaluated were to cover 

those farms that have: (1) As proposed 

by FDA, an average annual monetary 

value of produce sold during the 

previous 3-year period of more than 

$25,000 (on a rolling basis) (proposed 

§ 112.4); (2) an average annual monetary 

value of food sold during the previous 

3-year period of more than $50,000 (on 

a rolling basis); (3) an average annual 

monetary value of food sold during the 

previous 3-year period of more than 

$100,000 (on a rolling basis); and (4) an 

average annual monetary value of 

covered produce sold during the 

previous 3-year period of more than 

$25,000 (on a rolling basis). 

FDA has made this Draft EIS available 

for public review and comment in 

Docket No. FDA–2014–N–2244 (See Ref. 

1). 

II. How To Participate in the Public 

Meeting 

FDA is holding the public meeting on 

February 10, 2015, from 1 p.m. until 4 

p.m., at Wiley Auditorium, Harvey W. 

Wiley Federal Bldg., 5100 Paint Branch 

Pkwy., College Park, MD 20740, to 

discuss the Draft EIS for the proposed 

rule to establish standards for growing, 

harvesting, packing and holding of 

produce for human consumption. Due 

to limited space and time, FDA 

encourages all persons who wish to 

attend the meetings to register early and 

in advance of the meeting. There is no 

fee to register for the public meeting, 

and registration will be on a first-come, 

first-served basis. Onsite registration 

will be accepted, as space permits, after 

all preregistered attendees are seated. 

Those requesting an opportunity to 

make an oral presentation during the 

time allotted for public comment at the 

meeting are asked to submit a request in 

advance and to provide information 

about the specific topic or issue to be 

addressed. Due to the anticipated high 

level of interest in presenting public 

comments and the limited time 

available, FDA is allocating 4 minutes to 

each speaker to make an oral 

presentation. FDA will provide 

opportunities to submit written 

comments at the meeting; there will not 

be an opportunity to display materials 

such as slide shows, videos, or other 

media during the meeting. If time 

permits, individuals or organizations 


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1854 Federal Register / Vol. 80, No. 9 / Wednesday, January 14, 2015 / Proposed Rules 

that did not register in advance may be 

granted the opportunity to make an oral 

presentation. FDA would like to 

maximize the number of individuals 

who make a presentation at the meeting 

and will do our best to accommodate all 

persons who wish to make a 

presentation or express their opinions at 

the meeting. 

FDA encourages persons and groups 

who have similar interests to 

consolidate their information for 

presentation by a single representative. 

After reviewing the presentation 

requests, FDA will notify each 

participant before the meeting of the 

approximate time their presentation is 

scheduled to begin, and remind them of 

the presentation format (i.e., 4-minute 

oral presentation without visual media). 

While oral presentations from specific 

individuals and organizations will be 

necessarily limited due to time 

constraints during the public meeting, 

stakeholders may submit electronic or 

written comments discussing any issues 

of concern to the administrative record 

(the docket). All relevant data and 

documentation should be submitted 

with the comments to Docket No. FDA– 

2014–N–2244. 

Table 1 provides information on 

participation in the public meeting: 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET

Date Electronic address Address Other information 

College Park, MD Public 

Meeting.

February 10, 2015, 1 p.m. 

to 4 p.m.

http://www.fda.gov/Food/

NewsEvents/Workshops

MeetingsConferences/

default.htm.

Wiley Auditorium, Harvey 

W. Wiley Federal Bldg., 

5100 Paint Branch 

Pkwy., College Park, 

MD 20740.

Deadline for Registration ... February 3, 2015 .............. http://www.fda.gov/Food/

NewsEvents/Workshops

MeetingsConferences/

default.htm, Docket No. 

FDA–2014–N–2244 

We encourage you to use 

electronic registration if 

possible.1.

There is no registration fee 

for the public meetings. 

Early registration is recommended because 

seating is limited. 

Request to Make a Public 

Comment.

February 3, 2015 .............. http://www.fda.gov/Food/

NewsEvents/Workshops

MeetingsConferences/

default.htm.2

....................................... Requests made on the day 

of the meeting to make 

an oral presentation will 

be granted as time permits. Information on requests to make an oral 

presentation may be 

posted without change 

to http://www.regulations

.gov, including any personal information provided. 

Request Special Accommodations Due to a Disability.February 3. 2015 .............. Cynthia Wise email: cynthia.wise@fda.hhs.gov.See FOR FURTHER INFORMATION CONTACT.

Closing Date for Written 

Comments.

March 13, 2015.

1For questions about registering for the meeting, to register by phone, or to submit a notice of participation by mail, Fax, or email, contact: 

Rick Williams, c/o FDA EIS, 72 Loveton Circle, Sparks, MD 21152; telephone: 410–316–2377; FAX: 410–472–3289; email: RWilliams@jmt.com. 2You may also request to make an oral presentation at the public meeting via email. Please include your name, title, firm name, address, and 

phone and FAX numbers as well as the full text, comprehensive outline, or summary of your oral presentation and send to: Cynthia Wise, Center 

for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740, telephone: 240–402– 

1357, email: cynthia.wise@fda.hhs.gov. 

III. Comments, Transcripts, and 

Recorded Video 

Information and data submitted 

voluntarily to FDA during the public 

meeting will become part of the 

administrative record and will be 

accessible to the public at http://

www.regulations.gov. The transcript of 

the proceedings from the public meeting 

will become part of the administrative 

record. Please be advised that as soon as 

a transcript is available, it will be 

accessible at http://www.regulations.gov 

and at FDA’s FSMA Web site at 

http://www.fda.gov/Food/Guidance

Regulation/FSMA/default.htm. It may 

also be viewed at the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. A 

transcript will also be available in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to the Division of Freedom of 

Information (ELEM–1029), 12420 

Parklawn Dr., Element Bldg., Rockville, 

MD 20857. Additionally, FDA will be 

live webcasting and recording the 

public meeting. Once the recorded 

video is available, it will be accessible 

at FDA’s FSMA Web site at http://www.

fda.gov/Food/GuidanceRegulation/

FSMA/default.htm. 

IV. Reference 

1. Draft Environmental Impact Statement for 

the Proposed Rule: Standards for 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption. 

Dated: January 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00564 Filed 1–12–15; 4:15 pm] 

BILLING CODE 4164–01–P 


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