Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Public Meeting on Scoping of Environmental Impact Statement and Extension of Comment Period for Environmental Impact Statement, 13593-13598 [2014-05181]
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Proposed Rules
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electronic or written comments to FDA’s
Division of Dockets Management.
Comments on the scope of issues the
Agency should include in the EIS may
be submitted until April 18, 2014.
ADDRESSES: See section II, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document. You may submit
comments on the scope of issues the
Agency should include in the EIS,
identified by Docket No. FDA–2011–N–
0921 and/or Regulatory Information
Number (RIN) 0910–AG35, by any of the
following methods:
Issued in Washington, DC on March 5,
2014.
John S. Duncan,
Deputy Director, Flight Standards Service.
[FR Doc. 2014–05287 Filed 3–10–14; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0921]
RIN 0910–AG35
Environmental Impact Statement for
the Proposed Rule, Standards for
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption; Public Meeting on
Scoping of Environmental Impact
Statement and Extension of Comment
Period for Environmental Impact
Statement
Food and Drug Administration,
HHS.
Notification of public scoping
meeting; extension of comment period
for the Environmental Impact
Statement.
ACTION:
The Food and Drug
Administration (FDA or we) is
announcing the extension of the public
scoping period for Environmental
Impact Statement (EIS), as well as a
public scoping meeting to discuss the
scope of the EIS for the proposed rule
to establish standards for growing,
harvesting, packing, and holding of
produce for human consumption. FDA
is holding a public scoping meeting as
part of our ongoing efforts to seek public
input on the issues and alternatives that
we should consider when preparing the
EIS and to provide information about
the EIS process (including how to
submit comments, data, and other
information to the rulemaking docket),
to solicit oral stakeholder and public
comments on the scope of the EIS, and
to respond to questions about the 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
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SUMMARY:
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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 Produce Safety proposed rule’’) to
establish science-based minimum
standards for the safe growing,
harvesting, packing, and holding of
produce (78 FR 3503, January 16, 2013).
We recently announced plans to
propose revised rule language for key
parts of the Produce Safety proposed
rule, including those related to water
quality and the use of raw manure and
compost (Ref. 1).
In publishing the Produce Safety
proposed rule, we relied on a categorical
exclusion from the need to prepare an
Environmental Assessment or EIS under
21 CFR 25.30(j) (78 FR 3503 at 3616).
However, on August 19, 2013, we issued
a Notice of Intent to Prepare an
Environmental Impact Statement for the
Proposed Rule, Standards for Growing,
Harvesting, Packing, and Holding of
Produce for Human Consumption (NOI),
based on additional information,
including comments received, and upon
further analysis. In the NOI, we
explained that FDA has determined that
the proposed action may significantly
affect the quality of the human
environment (21 CFR 25.22(b)), and
therefore, an EIS is necessary for the
final rule (78 FR 50358, August 19,
2013). 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
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
21 CFR Parts 16 and 112
AGENCY:
accommodations due to a disability:
Cynthia Wise, Center for Food Safety
and Applied Nutrition (HFS–009), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1357, email: cynthia.wise@
fda.hhs.gov.
For further information about
comments for the docket: Annette
McCarthy, Center for Food Safety and
Applied Nutrition (HFS–205), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1200.
SUPPLEMENTARY INFORMATION:
Electronic Submissions
delay agency action on the review. A
copy of the advisory circulars is
available for review at https://
www.faa.gov/aircraft/draft_docs/
afs_ac/.
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): 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 Agency name and
Docket No. FDA–2011–N–0921, and RIN
0910–AG35 for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: For
questions about registering for the
meeting, to register by phone, or to
submit a notice of participation by mail,
FAX or email: Rick Williams, c/o FDA
EIS, 72 Loveton Circle, Sparks, MD
21152, 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
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November 15, 2013, and FDA later
extended the deadline for the public
scoping period to March 15, 2014 (78 FR
69006, November 18, 2013). FDA is
again extending the public scoping
period to allow FDA to hold an
upcoming public scoping meeting.
In this Federal Register notice, we are
addressing the scope of issues for
discussion at the public scoping
meeting for the purpose of assisting us
in determining which issues are
significant and will be analyzed in
depth in the EIS (see 40 CFR 1501.7).
Based on a preliminary review of
comments, currently available
information, and our analysis of the
proposed provisions, we summarize in
this document those provisions of the
Produce Safety proposed rule that may
significantly affect the quality of the
human environment, which provisions
we would include for detailed study in
the EIS. In addition, as required under
the National Environmental Policy Act
(NEPA) and its implementing
regulations, we also identify a range of
potential alternatives for each issue that
we plan to consider in the EIS. These
are set out in table 1. We note that this
EIS process is required under NEPA and
is distinct from and in addition to the
process FDA has announced to revise
parts of the propose rule and seek
comment on the revisions.
1. Microbial Standard for Agricultural
Water Used During Growing Activities
for Covered Produce (Other Than
Sprouts) Using a Direct Water
Application Method
Proposed § 112.44(c) states, ‘‘When
agricultural water is used during
growing activities for covered produce
(other than sprouts) using a direct water
application method you must test the
quality of water in accordance with one
of the appropriate analytical methods in
subpart N. If you find that there is more
than 235 colony forming units (CFU) (or
most probable number (MPN), as
appropriate) generic Escherichia coli per
100 mL for any single sample or a
rolling geometric mean (n=5) of more
than 126 CFU (or MPN, as appropriate)
per 100 mL of water, you must
immediately discontinue use of that
source of agricultural water and/or its
distribution system for the uses
described in this paragraph. Before you
may use the water source and/or
distribution system again for the uses
described in this paragraph, you must
either re-inspect the entire agricultural
water system under your control,
identify any conditions that are
reasonably likely to introduce known or
reasonably foreseeable hazards into or
onto covered produce or food-contact
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surfaces, make necessary changes, and
retest the water to determine if your
changes were effective; or treat the
water in accordance with the
requirements of § 112.43.’’ (Proposed
§ 112.3(c) defines ‘‘direct water
application method’’ as using
agricultural water in a manner whereby
the water is intended to, or is likely to,
contact covered produce or food-contact
surfaces during use of the water.) In
addition, proposed § 112.43 includes
requirements for treating agricultural
water.
As noted in the NOI, public
comments state that, in some regions,
current irrigation practices use water
that is unlikely to meet the proposed
microbial standards for much, if not all,
of the growing season. Consequently, if
such standards are finalized, ground
water is likely to be explored as a viable
alternative water source for irrigation in
these regions. Given recently
highlighted concerns of ground water
depletion in certain regions, FDA has
determined that an increased use of
ground water for irrigation, in response
to the microbial standard in § 112.44(c),
may significantly affect the quality of
the human environment in those regions
(78 FR 50358 at 50359).
In addition, our proposed
requirements for treatment of water in
§ 112.43, in the context of the microbial
standard, may result in changes in
current practices that may significantly
affect the quality of the human
environment (for example, if treated tail
waters are not contained or if treated
effluent is not properly discharged).
Therefore, we plan to consider the
possible environmental impacts in the
EIS resulting from these proposed
provisions in addition to the
environmental impacts from a range of
potential alternatives to the water
quality microbial standard proposed in
§ 112.44(c).
2. Minimum Application Intervals for
Biological Soil Amendments of Animal
Origin
Proposed § 112.56 states, in part, ‘‘If
the biological soil amendment of animal
origin is untreated, then the biological
soil amendment of animal origin must
be applied in a manner that does not
contact covered produce during
application and minimizes the potential
for contact with covered produce after
application, and then the minimum
application interval is 9 months’’
(proposed § 112.56(a)(1)(i)); and ‘‘if the
biological soil amendment of animal
origin is treated by a composting
process in accordance with the
requirements of § 112.54(c) to meet the
microbial standard in § 112.55(b), then
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the biological soil amendment of animal
origin must be applied in a manner that
minimizes the potential for contact with
covered produce during and after
application, and then the minimum
application interval is 45 days’’
(proposed § 112.56(a)(4)(i)). Proposed
§ 112.54 includes provisions for
acceptable treatment processes for
biological soil amendments of animal
origin.
Several comments received thus far
have urged FDA to reevaluate the
application restrictions for biological
soil amendments of animal origin,
which are based on the likelihood of the
soil amendment harboring pathogens.
As noted in the NOI, these proposed
requirements, if finalized, are expected
to result in changes in current use of
treated and untreated biological soil
amendments of animal origin or
potentially greater use of synthetic
fertilizers (78 FR 50358 at 50359).
Changes in the type or handling of soil
amendments, in response to the
minimum application intervals, may
significantly affect the quality of the
human environment. Therefore, we plan
to consider the possible environmental
impacts in the EIS resulting from these
proposed provisions in addition to the
environmental impacts from a range of
potential alternatives to the minimum
application intervals proposed in
§ 112.56(a)(1)(i) and (a)(4)(i).
3. Measures Related to Animal Grazing
and Animal Intrusion
Proposed § 112.82 states, in part, ‘‘At
a minimum, if you allow animals to
graze or use them as working animals in
fields where covered produce is grown,
and under the circumstances there is a
reasonable probability that grazing or
working animals will contaminate
covered produce, you must take the
following measures: (a) 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 § 112.83(b) states, ‘‘If animal
intrusion, as made evident by
observation of significant quantities of
animals, animal excreta or crop
destruction via grazing, occurs, you
must evaluate whether the covered
produce can be harvested in accordance
with the requirements of § 112.112.’’
Further, proposed § 112.112 states:
‘‘You must take all measures reasonably
necessary to identify, and not harvest,
covered produce that is reasonably
likely to be contaminated with a known
or reasonably foreseeable hazard,
including steps to identify and not
harvest covered produce that is visibly
contaminated with animal excreta.’’
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We have received comments stating
that these proposed requirements could
potentially result in changes in current
practices that would not be consistent
with wildlife conservation practices
and, thus, may adversely affect wildlife,
including endangered and threatened
species. Therefore, we plan to consider
the possible environmental impacts in
the EIS resulting from these proposed
provisions in addition to the
environmental impacts from a range of
potential alternatives to the measures
proposed in § 112.82(a) and § 112.83(b).
4. Scope of Proposed Rule and
Implications to Land Use and Land
Management
Under proposed § 112.4(a), farms with
$25,000 or less of annual value of food
sold are excluded from coverage of the
rule. Comments to the Produce Safety
proposed rule that raised environmental
concerns in relation to the Produce
Safety proposed rule requested that we
consider increasing the $25,000
threshold to exclude a larger number of
farms from the proposed rule and, thus,
reduce overall environmental impacts of
the rule. Comments also suggested that
the Produce Safety rule, if finalized as
proposed, would cause small farmers to
go out of business and potentially result
in negative environmental impacts due
to changes in land use or land
management. Therefore, we plan to
consider the possible environmental
impacts in the EIS resulting from this
proposed provision in addition to the
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environmental impacts of potential
alternatives to the $25,000 threshold for
out-of-scope farms proposed in
§ 112.4(a).
Table 1 provides a list of potential
alternatives to each of the issues
discussed previously. This table is not
intended to provide a comprehensive
list of issues and potential alternatives,
but rather is intended to provide a range
of options for environmental
consideration in the EIS. We invite
comment, as part of the scoping process,
on whether there are other issues we
should consider for indepth analysis in
the EIS and any alternatives to those
issues.
TABLE 1—LIST OF ISSUES AND CORRESPONDING POTENTIAL ALTERNATIVES TO BE CONSIDERED IN THE ENVIRONMENTAL
IMPACT STATEMENT FOR THE PRODUCE SAFETY RULE
Proposed action
Potential alternatives
1. Microbial standard for agricultural water.
A. Proposed § 112.44(c), which states:
‘‘When agricultural water is used during growing activities for covered produce (other than sprouts) using a
direct water application method you must test the
quality of water in accordance with one of the appropriate analytical methods in subpart N. If you find that
there is more than 235 colony forming units (CFU)
(or most probable number (MPN), as appropriate) generic E. coli per 100 mL for any single sample or a
rolling geometric mean (n=5) of more than 126 CFU
(or MPN, as appropriate) per 100 mL of water, you
must immediately discontinue use of that source of
agricultural water and/or its distribution system for the
uses described in this paragraph’’.
See discussion in 78 FR 3503 at 3568–3569.
(Proposed § 112.3(c) defines ‘‘direct water application
method’’ as using agricultural water in a manner
whereby the water is intended to, or is likely to, contact covered produce or food-contact surfaces during
use of the water.)
2. Minimum application intervals for biological soil
amendments of animal origin.
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Issue
A. Proposed § 112.56(a)(1)(i), which states:
‘‘If the biological soil amendment of animal origin is untreated, then the biological soil amendment of animal
origin must be applied in a manner that does not
contact covered produce during application and minimizes the potential for contact with covered produce
after application, and then the minimum application
interval is 9 months’’.
See discussion in 78 FR 3503 at 3581, 3582.
i. No action.
ii. As proposed, i.e., no more than 235 colony forming
units (CFU) (or most probable number (MPN), as appropriate) generic E. coli per 100 mL for any single
sample or a rolling geometric mean (n=5) of more
than 126 CFU (or MPN, as appropriate) per 100 mL
of water.
iii. A detectable generic limit E. coli per 100 mL less
stringent than proposed.
iv. A flexible water quality standard that allows for adjustment to a specified microbial quality standard
based on mitigation steps that occur after application
of agricultural water and prior to consumption. For
example, the World Health Organization recommends
a minimum microbial quality for water of 1,000 CFU
generic E. coli per 100 mL for water used on root
crops that are eaten raw, and 10,000 CFU generic E.
coli per 100 mL for water used on leaf crops, which
is dependent upon a 2-log reduction due to die-off
between last irrigation and consumption (includes
die-off in the field and during distribution) and a 1-log
reduction attributed to washing prior to consumption.
v. For each of the options mentioned, consider the environmental impacts of two different interpretations of
the definition of ‘‘direct water application method’’ in
§ 112.3(c): (1) To include root crops that are drip irrigated; and (2) to exclude root crops that are drip irrigated.
i. No action.
ii. As proposed, i.e., applied in a manner that does not
contact covered produce during application and minimizes the potential for contact with covered produce
after application, and then the minimum application
interval is 9 months.
iii. Applied in a manner that does not contact covered
produce during application and minimizes the potential for contact with covered produce after application,
and then the minimum application interval is 0 days.
iv. U.S. Department of Agriculture’s National Organic
Program (USDA/NOP) application intervals for the
use of raw manure as a soil amendment, i.e., 90
days or 120 days before harvest, depending on
whether or not the edible portion of the crop has direct contact with the soil (as specified in 7 CFR
205.203(c)(1)).
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Proposed Rules
TABLE 1—LIST OF ISSUES AND CORRESPONDING POTENTIAL ALTERNATIVES TO BE CONSIDERED IN THE ENVIRONMENTAL
IMPACT STATEMENT FOR THE PRODUCE SAFETY RULE—Continued
Issue
Proposed action
Potential alternatives
B. Proposed § 112.56(a)(4)(i), which states:
‘‘If the biological soil amendment of animal origin is
treated by a composting process in accordance with
the requirements of § 112.54(c) to meet the microbial
standard in § 112.55(b), then the biological soil
amendment of animal origin must be applied in a
manner that minimizes the potential for contact with
covered produce during and after application, and
then the minimum application interval is 45 days’’.
See discussion in 78 FR 3503 at 3583.
3. Measures related to animal grazing and animal intrusion.
A. Proposed § 112.82(a), which states:
‘‘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’’.
See discussion in 78 FR 3503 at 3587.
B. Proposed § 112.83(b), which states:
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4. Scope of proposed rule
and implications to land
use.
‘‘If animal intrusion, as made evident by observation of
significant quantities of animals, animal excreta or
crop destruction via grazing, occurs, you must evaluate whether the covered produce can be harvested in
accordance with the requirements of § 112.112’’.
See discussion in 78 FR 3503 at 3587.
A. Proposed § 112.4(a), which excludes farms with
$25,000 or less of annual value of food sold from
coverage of the rule.
See discussion in 78 FR 3503 at 3549.
II. How To Participate in the Public
Meeting
FDA is holding the public meeting on
the scope of the EIS for the proposed
rule to establish standards for growing,
harvesting, packing, and holding of
produce for human consumption to
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v. Applied in a manner that does not contact covered
produce during application and minimizes the potential for contact with covered produce after application,
and then the minimum application interval is 6
months.
vi. Applied in a manner that does not contact covered
produce during application and minimizes the potential for contact with covered produce after application,
and then the minimum application interval is 12
months.
i. No action.
ii. As proposed, i.e., applied in a manner that minimizes
the potential for contact with covered produce during
and after application, and then the minimum application interval is 45 days.
iii. Applied in a manner that minimizes the potential for
contact with covered produce during and after application, and then the minimum application interval is 0
days.
iv. Applied in a manner that minimizes the potential for
contact with covered produce during and after application, and then the minimum application interval is
90 days.
i. No action.
ii. As proposed, i.e., an adequate waiting period between grazing and harvesting.
iii. A minimum waiting period of 9 months, consistent
with proposed § 112.56(a)(1)(i) for the use of raw manure as a soil amendment.
iv. A minimum waiting period of 90 days and 120 days,
consistent with the USDA/NOP-specified application
intervals for the use of raw manure as a soil amendment.
i. No action.
ii. As proposed, i.e., if animal intrusion occurs, you
must evaluate whether the covered produce can be
harvested, and you must take all measures reasonably necessary to identify, and not harvest, covered
produce that is reasonably likely to be contaminated.
iii. If animal intrusion is reasonably likely to occur, take
measures to exclude animals from fields where covered produce is grown.
i. No action.
ii. As proposed, i.e., farms with $25,000 or less of annual value of food sold are excluded from coverage
of the rule.
iii. Farms with $50,000 or less of annual value of food
sold are excluded from coverage of the rule.
iv. Farms with $100,000 or less of annual value of food
sold are excluded from coverage of the rule.
v. Farms with $25,000 or less of annual value of covered produce sold are excluded from coverage of the
rule.
inform the public of the provisions of
the proposed rule that may significantly
affect the quality of the human
environment and anticipated
alternatives we plan to consider in the
EIS, to provide information about the
EIS process (including how to submit
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comments, data, and other information
to the rulemaking docket), to solicit oral
stakeholder and public comments on
the scope of the EIS, and to respond to
questions about the EIS. The meeting
will be held on April 4, 2014, from 1
p.m. until 5 p.m., at Wiley Auditorium,
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Harvey W. Wiley Federal Bldg., 5100
Paint Branch Pkwy., College Park, MD
20740. Due to limited space and time,
FDA encourages all persons who wish
to attend the meeting 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
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. A court recorder will be
available on the meeting premises to
accept additional oral remarks.
FDA encourages persons and groups
who have similar interests to
consolidate their information for
presentation by a single representative.
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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) for the rulemaking. All
relevant data and documentation should
be submitted with the comments to
Docket No. FDA–2011–N–0921.
Table 2 of this document provides
information on participation in the
public meetings:
TABLE 2—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS
Date
Electronic address
Address
Wiley Auditorium, Harvey W. Wiley Federal
Bldg., 5100 Paint
Branch Pkwy., College
Park, MD 20740.
We encourage you to
use electronic registration if possible.1
College Park, MD Public
meeting.
April 4, 2014, from 1
p.m. to 5 p.m.
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetingsConferences/default.htm.
Deadline for registration
March 28, 2014 ..............
Request to make a Public Comment.
March 28, 2014 ..............
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetingsConferences/default.htm
Docket No. FDA–
2011–N–0921.
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetingsConferences/default.htm.2
Request special accommodations due to a
disability.
Closing date for comments.
March 28, 2014 ..............
Cynthia Wise, email:
cynthia.wise@fda.hhs.
gov.
Other information
........................................
There is no registration fee for the
public meetings. Early registration is recommended because
seating is limited.
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 https://www.regulations.gov, including any personal information
provided.
See FOR FURTHER INFORMATION CONTACT.
April 18, 2014.
1 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; 410–316–2377; FAX: 410–472–3289; email: RWilliams@jmt.com.
2 You 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, 240–402–1357, email:
cynthia.wise@fda.hhs.gov.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
III. Comments, Transcripts, and
Recorded Video
Information and data submitted
voluntarily to FDA during the public
meeting will become part of the
administrative record for the relevant
rulemaking and will be accessible to the
public at https://www.regulations.gov.
The transcript of the proceedings from
the public meeting will become part of
VerDate Mar<15>2010
17:01 Mar 10, 2014
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the administrative record for each
relevant rulemaking. Please be advised
that as soon as a transcript is available,
it will be accessible at https://
www.regulations.gov and at FDA’s
FSMA Web site at: https://www.fda.gov/
Food/GuidanceRegulation/FSMA/
default.htm. It may also be viewed at the
Division of Dockets Management (see
ADDRESSES). A transcript will also be
available in either hardcopy or on CD–
PO 00000
Frm 00006
Fmt 4702
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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 https://
www.fda.gov/Food/
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Proposed Rules
GuidanceRegulation/FSMA/
default.htm.
IV. Request for Comments
Interested persons may submit either
electronic comments regarding the
issues to be included in the EIS for the
proposed rule to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments 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, and
will be posted to the docket at https://
www.regulations.gov.
V. Reference
The following reference has 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 and is available
electronically at https://
www.regulations.gov.
1. Statement from FDA Deputy
Commissioner for Foods and Veterinary
Medicine, Michael Taylor, on Key Provisions
of the Proposed FSMA Rules Affecting
Farmers. December 19, 2013, available from
https://www.fda.gov/Food/
GuidanceRegulation/FSMA/
ucm379397.htm?source=govdelivery&utm_
medium=email&utm_source=govdelivery.
Dated: March 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–05181 Filed 3–10–14; 8:45 am]
BILLING CODE 4160–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2005–AL–0002; FRL–9907–
75-Region 4]
Approval and Promulgation of
Implementation Plans: Alabama: Error
Correction and Disapproval of
Revisions to the Visible Emissions
Rule; Extension of Comment Period
Environmental Protection
Agency (EPA).
ACTION: Proposed rule; extension of
comment period.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
AGENCY:
EPA is announcing an
extension of the public comment period
for the proposed rule entitled ‘‘Approval
and Promulgation of Implementation
Plans: Alabama: Error Correction and
SUMMARY:
VerDate Mar<15>2010
16:13 Mar 10, 2014
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Disapproval of Revisions to the Visible
Emissions Rule.’’ The proposed rule was
published in the Federal Register on
February 13, 2014. Written comments
on the proposed rule were to be
submitted to EPA on or before March
17, 2014 (30-day comment period). As
requested, EPA is extending the original
public comment period by 60 days. The
public comment period will now close
on May 16, 2014.
DATES: Comments must be received on
or before May 16, 2014.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R04–
OAR–2005–AL–0002, by one of the
following methods:
1. www.regulations.gov: Follow the
on-line instructions for submitting
comments.
2. Email: R4-RDS@epa.gov.
3. Fax: 404–562–9019.
4. Mail: ‘‘EPA–R04–OAR–2005–AL–
0002,’’ Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960.
5. Hand Delivery or Courier: Lynorae
Benjamin, Chief, Regulatory
Development Section, Air Planning
Branch, Air, Pesticides and Toxics
Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960. Such
deliveries are only accepted during the
Regional Office’s normal hours of
operation. The Regional Office’s official
hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal
holidays.
Instructions: Direct your comments to
Docket ID No. ‘‘EPA–R04–OAR–2005–
AL–0002.’’ EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit through
www.regulations.gov or email,
information that you consider to be CBI
or otherwise protected. The
www.regulations.gov Web site is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
www.regulations.gov, your email
address will be automatically captured
PO 00000
Frm 00007
Fmt 4702
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and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: EPA has established a docket
for this action under Docket
Identification No. EPA–R04–OAR–
2005–AL–0002. All documents in the
docket are listed on the
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through
www.regulations.gov or in hard copy at
the Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960. EPA
requests that, if at all possible, you
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional
Office’s official hours of business are
Monday through Friday, 8:30 to 4:30,
excluding federal holidays.
FOR FURTHER INFORMATION CONTACT: Mr.
Joel Huey, Regulatory Development
Section, Air Planning Branch, Air,
Pesticides and Toxics Management
Division, Region 4, U.S. Environmental
Protection Agency, 61 Forsyth Street
SW., Atlanta, Georgia 30303–8960. The
telephone number is (404) 562–9104.
Mr. Huey can also be reached via
electronic mail at huey.joel@epa.gov.
SUPPLEMENTARY INFORMATION: The
proposed rule was signed by the Acting
Region 4 Regional Administrator on
January 24, 2014, and published in the
Federal Register on February 13, 2014
(79 FR 8645). The proposed action
provided a 30-day public comment
period. EPA has received four requests
for an additional 30 to 60 days to
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[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Proposed Rules]
[Pages 13593-13598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05181]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 112
[Docket No. FDA-2011-N-0921]
RIN 0910-AG35
Environmental Impact Statement for the Proposed Rule, Standards
for Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption; Public Meeting on Scoping of Environmental Impact
Statement and Extension of Comment Period for Environmental Impact
Statement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public scoping meeting; extension of comment
period for the Environmental Impact Statement.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
extension of the public scoping period for Environmental Impact
Statement (EIS), as well as a public scoping meeting to discuss the
scope of the EIS for the proposed rule to establish standards for
growing, harvesting, packing, and holding of produce for human
consumption. FDA is holding a public scoping meeting as part of our
ongoing efforts to seek public input on the issues and alternatives
that we should consider when preparing the EIS and to provide
information about the EIS process (including how to submit comments,
data, and other information to the rulemaking docket), to solicit oral
stakeholder and public comments on the scope of the EIS, and to respond
to questions about the 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 to FDA's Division of Dockets Management.
Comments on the scope of issues the Agency should include in the
EIS may be submitted until April 18, 2014.
ADDRESSES: See section II, ``How to Participate in the Public Meeting''
in the SUPPLEMENTARY INFORMATION section of this document. You may
submit comments on the scope of issues the Agency should include in the
EIS, identified by Docket No. FDA-2011-N-0921 and/or Regulatory
Information Number (RIN) 0910-AG35, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
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 Agency name
and Docket No. FDA-2011-N-0921, and RIN 0910-AG35 for this rulemaking.
All comments received may be posted without change to https://www.regulations.gov, including any personal information provided. For
additional information on submitting comments, see the ``Request for
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meeting, to register by phone, or to submit a notice of
participation by mail, FAX or email: Rick Williams, c/o FDA EIS, 72
Loveton Circle, Sparks, MD 21152, 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: Cynthia Wise, Center for
Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1357, email: cynthia.wise@fda.hhs.gov.
For further information about comments for the docket: Annette
McCarthy, Center for Food Safety and Applied Nutrition (HFS-205), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, 240-402-1200.
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 Produce Safety proposed
rule'') to establish science-based minimum standards for the safe
growing, harvesting, packing, and holding of produce (78 FR 3503,
January 16, 2013). We recently announced plans to propose revised rule
language for key parts of the Produce Safety proposed rule, including
those related to water quality and the use of raw manure and compost
(Ref. 1).
In publishing the Produce Safety proposed rule, we relied on a
categorical exclusion from the need to prepare an Environmental
Assessment or EIS under 21 CFR 25.30(j) (78 FR 3503 at 3616). However,
on August 19, 2013, we issued a Notice of Intent to Prepare an
Environmental Impact Statement for the Proposed Rule, Standards for
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption (NOI), based on additional information, including comments
received, and upon further analysis. In the NOI, we explained that FDA
has determined that the proposed action may significantly affect the
quality of the human environment (21 CFR 25.22(b)), and therefore, an
EIS is necessary for the final rule (78 FR 50358, August 19, 2013). 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
[[Page 13594]]
November 15, 2013, and FDA later extended the deadline for the public
scoping period to March 15, 2014 (78 FR 69006, November 18, 2013). FDA
is again extending the public scoping period to allow FDA to hold an
upcoming public scoping meeting.
In this Federal Register notice, we are addressing the scope of
issues for discussion at the public scoping meeting for the purpose of
assisting us in determining which issues are significant and will be
analyzed in depth in the EIS (see 40 CFR 1501.7). Based on a
preliminary review of comments, currently available information, and
our analysis of the proposed provisions, we summarize in this document
those provisions of the Produce Safety proposed rule that may
significantly affect the quality of the human environment, which
provisions we would include for detailed study in the EIS. In addition,
as required under the National Environmental Policy Act (NEPA) and its
implementing regulations, we also identify a range of potential
alternatives for each issue that we plan to consider in the EIS. These
are set out in table 1. We note that this EIS process is required under
NEPA and is distinct from and in addition to the process FDA has
announced to revise parts of the propose rule and seek comment on the
revisions.
1. Microbial Standard for Agricultural Water Used During Growing
Activities for Covered Produce (Other Than Sprouts) Using a Direct
Water Application Method
Proposed Sec. 112.44(c) states, ``When agricultural water is used
during growing activities for covered produce (other than sprouts)
using a direct water application method you must test the quality of
water in accordance with one of the appropriate analytical methods in
subpart N. If you find that there is more than 235 colony forming units
(CFU) (or most probable number (MPN), as appropriate) generic
Escherichia coli per 100 mL for any single sample or a rolling
geometric mean (n=5) of more than 126 CFU (or MPN, as appropriate) per
100 mL of water, you must immediately discontinue use of that source of
agricultural water and/or its distribution system for the uses
described in this paragraph. Before you may use the water source and/or
distribution system again for the uses described in this paragraph, you
must either re-inspect the entire agricultural water system under your
control, identify any conditions that are reasonably likely to
introduce known or reasonably foreseeable hazards into or onto covered
produce or food-contact surfaces, make necessary changes, and retest
the water to determine if your changes were effective; or treat the
water in accordance with the requirements of Sec. 112.43.'' (Proposed
Sec. 112.3(c) defines ``direct water application method'' as using
agricultural water in a manner whereby the water is intended to, or is
likely to, contact covered produce or food-contact surfaces during use
of the water.) In addition, proposed Sec. 112.43 includes requirements
for treating agricultural water.
As noted in the NOI, public comments state that, in some regions,
current irrigation practices use water that is unlikely to meet the
proposed microbial standards for much, if not all, of the growing
season. Consequently, if such standards are finalized, ground water is
likely to be explored as a viable alternative water source for
irrigation in these regions. Given recently highlighted concerns of
ground water depletion in certain regions, FDA has determined that an
increased use of ground water for irrigation, in response to the
microbial standard in Sec. 112.44(c), may significantly affect the
quality of the human environment in those regions (78 FR 50358 at
50359).
In addition, our proposed requirements for treatment of water in
Sec. 112.43, in the context of the microbial standard, may result in
changes in current practices that may significantly affect the quality
of the human environment (for example, if treated tail waters are not
contained or if treated effluent is not properly discharged).
Therefore, we plan to consider the possible environmental impacts in
the EIS resulting from these proposed provisions in addition to the
environmental impacts from a range of potential alternatives to the
water quality microbial standard proposed in Sec. 112.44(c).
2. Minimum Application Intervals for Biological Soil Amendments of
Animal Origin
Proposed Sec. 112.56 states, in part, ``If the biological soil
amendment of animal origin is untreated, then the biological soil
amendment of animal origin must be applied in a manner that does not
contact covered produce during application and minimizes the potential
for contact with covered produce after application, and then the
minimum application interval is 9 months'' (proposed Sec.
112.56(a)(1)(i)); and ``if the biological soil amendment of animal
origin is treated by a composting process in accordance with the
requirements of Sec. 112.54(c) to meet the microbial standard in Sec.
112.55(b), then the biological soil amendment of animal origin must be
applied in a manner that minimizes the potential for contact with
covered produce during and after application, and then the minimum
application interval is 45 days'' (proposed Sec. 112.56(a)(4)(i)).
Proposed Sec. 112.54 includes provisions for acceptable treatment
processes for biological soil amendments of animal origin.
Several comments received thus far have urged FDA to reevaluate the
application restrictions for biological soil amendments of animal
origin, which are based on the likelihood of the soil amendment
harboring pathogens. As noted in the NOI, these proposed requirements,
if finalized, are expected to result in changes in current use of
treated and untreated biological soil amendments of animal origin or
potentially greater use of synthetic fertilizers (78 FR 50358 at
50359). Changes in the type or handling of soil amendments, in response
to the minimum application intervals, may significantly affect the
quality of the human environment. Therefore, we plan to consider the
possible environmental impacts in the EIS resulting from these proposed
provisions in addition to the environmental impacts from a range of
potential alternatives to the minimum application intervals proposed in
Sec. 112.56(a)(1)(i) and (a)(4)(i).
3. Measures Related to Animal Grazing and Animal Intrusion
Proposed Sec. 112.82 states, in part, ``At a minimum, if you allow
animals to graze or use them as working animals in fields where covered
produce is grown, and under the circumstances there is a reasonable
probability that grazing or working animals will contaminate covered
produce, you must take the following measures: (a) 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 Sec. 112.83(b) states, ``If animal intrusion, as made
evident by observation of significant quantities of animals, animal
excreta or crop destruction via grazing, occurs, you must evaluate
whether the covered produce can be harvested in accordance with the
requirements of Sec. 112.112.'' Further, proposed Sec. 112.112
states: ``You must take all measures reasonably necessary to identify,
and not harvest, covered produce that is reasonably likely to be
contaminated with a known or reasonably foreseeable hazard, including
steps to identify and not harvest covered produce that is visibly
contaminated with animal excreta.''
[[Page 13595]]
We have received comments stating that these proposed requirements
could potentially result in changes in current practices that would not
be consistent with wildlife conservation practices and, thus, may
adversely affect wildlife, including endangered and threatened species.
Therefore, we plan to consider the possible environmental impacts in
the EIS resulting from these proposed provisions in addition to the
environmental impacts from a range of potential alternatives to the
measures proposed in Sec. 112.82(a) and Sec. 112.83(b).
4. Scope of Proposed Rule and Implications to Land Use and Land
Management
Under proposed Sec. 112.4(a), farms with $25,000 or less of annual
value of food sold are excluded from coverage of the rule. Comments to
the Produce Safety proposed rule that raised environmental concerns in
relation to the Produce Safety proposed rule requested that we consider
increasing the $25,000 threshold to exclude a larger number of farms
from the proposed rule and, thus, reduce overall environmental impacts
of the rule. Comments also suggested that the Produce Safety rule, if
finalized as proposed, would cause small farmers to go out of business
and potentially result in negative environmental impacts due to changes
in land use or land management. Therefore, we plan to consider the
possible environmental impacts in the EIS resulting from this proposed
provision in addition to the environmental impacts of potential
alternatives to the $25,000 threshold for out-of-scope farms proposed
in Sec. 112.4(a).
Table 1 provides a list of potential alternatives to each of the
issues discussed previously. This table is not intended to provide a
comprehensive list of issues and potential alternatives, but rather is
intended to provide a range of options for environmental consideration
in the EIS. We invite comment, as part of the scoping process, on
whether there are other issues we should consider for indepth analysis
in the EIS and any alternatives to those issues.
Table 1--List of Issues and Corresponding Potential Alternatives To Be
Considered in the Environmental Impact Statement for the Produce Safety
Rule
------------------------------------------------------------------------
Potential
Issue Proposed action alternatives
------------------------------------------------------------------------
1. Microbial standard for A. Proposed Sec. i. No action.
agricultural water. 112.44(c), which ii. As proposed,
states: i.e., no more than
``When agricultural 235 colony forming
water is used units (CFU) (or
during growing most probable
activities for number (MPN), as
covered produce appropriate)
(other than generic E. coli per
sprouts) using a 100 mL for any
direct water single sample or a
application method rolling geometric
you must test the mean (n=5) of more
quality of water in than 126 CFU (or
accordance with one MPN, as
of the appropriate appropriate) per
analytical methods 100 mL of water.
in subpart N. If iii. A detectable
you find that there generic limit E.
is more than 235 coli per 100 mL
colony forming less stringent than
units (CFU) (or proposed.
most probable iv. A flexible water
number (MPN), as quality standard
appropriate) that allows for
generic E. coli per adjustment to a
100 mL for any specified microbial
single sample or a quality standard
rolling geometric based on mitigation
mean (n=5) of more steps that occur
than 126 CFU (or after application
MPN, as of agricultural
appropriate) per water and prior to
100 mL of water, consumption. For
you must example, the World
immediately Health Organization
discontinue use of recommends a
that source of minimum microbial
agricultural water quality for water
and/or its of 1,000 CFU
distribution system generic E. coli per
for the uses 100 mL for water
described in this used on root crops
paragraph''. that are eaten raw,
See discussion in 78 and 10,000 CFU
FR 3503 at 3568- generic E. coli per
3569.. 100 mL for water
(Proposed Sec. used on leaf crops,
112.3(c) defines which is dependent
``direct water upon a 2-log
application reduction due to
method'' as using die-off between
agricultural water last irrigation and
in a manner whereby consumption
the water is (includes die-off
intended to, or is in the field and
likely to, contact during
covered produce or distribution) and a
food-contact 1-log reduction
surfaces during use attributed to
of the water.). washing prior to
consumption.
v. For each of the
options mentioned,
consider the
environmental
impacts of two
different
interpretations of
the definition of
``direct water
application
method'' in Sec.
112.3(c): (1) To
include root crops
that are drip
irrigated; and (2)
to exclude root
crops that are drip
irrigated.
2. Minimum application A. Proposed Sec. i. No action.
intervals for biological 112.56(a)(1)(i), ii. As proposed,
soil amendments of animal which states: i.e., applied in a
origin. ``If the biological manner that does
soil amendment of not contact covered
animal origin is produce during
untreated, then the application and
biological soil minimizes the
amendment of animal potential for
origin must be contact with
applied in a manner covered produce
that does not after application,
contact covered and then the
produce during minimum application
application and interval is 9
minimizes the months.
potential for iii. Applied in a
contact with manner that does
covered produce not contact covered
after application, produce during
and then the application and
minimum application minimizes the
interval is 9 potential for
months''. contact with
See discussion in 78 covered produce
FR 3503 at 3581, after application,
3582.. and then the
minimum application
interval is 0 days.
iv. U.S. Department
of Agriculture's
National Organic
Program (USDA/NOP)
application
intervals for the
use of raw manure
as a soil
amendment, i.e., 90
days or 120 days
before harvest,
depending on
whether or not the
edible portion of
the crop has direct
contact with the
soil (as specified
in 7 CFR
205.203(c)(1)).
[[Page 13596]]
v. Applied in a
manner that does
not contact covered
produce during
application and
minimizes the
potential for
contact with
covered produce
after application,
and then the
minimum application
interval is 6
months.
vi. Applied in a
manner that does
not contact covered
produce during
application and
minimizes the
potential for
contact with
covered produce
after application,
and then the
minimum application
interval is 12
months.
B. Proposed Sec. i. No action.
112.56(a)(4)(i),
which states:
``If the biological ii. As proposed,
soil amendment of i.e., applied in a
animal origin is manner that
treated by a minimizes the
composting process potential for
in accordance with contact with
the requirements of covered produce
Sec. 112.54(c) to during and after
meet the microbial application, and
standard in Sec. then the minimum
112.55(b), then the application
biological soil interval is 45
amendment of animal days.
origin must be iii. Applied in a
applied in a manner manner that
that minimizes the minimizes the
potential for potential for
contact with contact with
covered produce covered produce
during and after during and after
application, and application, and
then the minimum then the minimum
application application
interval is 45 interval is 0 days.
days''. iv. Applied in a
See discussion in 78 manner that
FR 3503 at 3583.. minimizes the
potential for
contact with
covered produce
during and after
application, and
then the minimum
application
interval is 90
days.
3. Measures related to A. Proposed Sec. i. No action.
animal grazing and animal 112.82(a), which ii. As proposed,
intrusion. states: i.e., an adequate
``An adequate waiting period
waiting period between grazing and
between grazing and harvesting.
harvesting for iii. A minimum
covered produce in waiting period of 9
any growing area months, consistent
that was grazed to with proposed Sec.
ensure the safety 112.56(a)(1)(i)
of the harvested for the use of raw
crop''. manure as a soil
See discussion in 78 amendment.
FR 3503 at 3587.. iv. A minimum
waiting period of
90 days and 120
days, consistent
with the USDA/NOP-
specified
application
intervals for the
use of raw manure
as a soil
amendment.
B. Proposed Sec. i. No action.
112.83(b), which ii. As proposed,
states: i.e., if animal
intrusion occurs,
you must evaluate
whether the covered
produce can be
harvested, and you
must take all
measures reasonably
necessary to
identify, and not
harvest, covered
produce that is
reasonably likely
to be contaminated.
iii. If animal
intrusion is
reasonably likely
to occur, take
measures to exclude
animals from fields
where covered
produce is grown.
``If animal
intrusion, as made
evident by
observation of
significant
quantities of
animals, animal
excreta or crop
destruction via
grazing, occurs,
you must evaluate
whether the covered
produce can be
harvested in
accordance with the
requirements of
Sec. 112.112''.
See discussion in 78
FR 3503 at 3587..
4. Scope of proposed rule A. Proposed Sec. i. No action.
and implications to land 112.4(a), which ii. As proposed,
use. excludes farms with i.e., farms with
$25,000 or less of $25,000 or less of
annual value of annual value of
food sold from food sold are
coverage of the excluded from
rule. coverage of the
See discussion in 78 rule.
FR 3503 at 3549.. iii. Farms with
$50,000 or less of
annual value of
food sold are
excluded from
coverage of the
rule.
iv. Farms with
$100,000 or less of
annual value of
food sold are
excluded from
coverage of the
rule.
v. Farms with
$25,000 or less of
annual value of
covered produce
sold are excluded
from coverage of
the rule.
------------------------------------------------------------------------
II. How To Participate in the Public Meeting
FDA is holding the public meeting on the scope of the EIS for the
proposed rule to establish standards for growing, harvesting, packing,
and holding of produce for human consumption to inform the public of
the provisions of the proposed rule that may significantly affect the
quality of the human environment and anticipated alternatives we plan
to consider in the EIS, to provide information about the EIS process
(including how to submit comments, data, and other information to the
rulemaking docket), to solicit oral stakeholder and public comments on
the scope of the EIS, and to respond to questions about the EIS. The
meeting will be held on April 4, 2014, from 1 p.m. until 5 p.m., at
Wiley Auditorium,
[[Page 13597]]
Harvey W. Wiley Federal Bldg., 5100 Paint Branch Pkwy., College Park,
MD 20740. Due to limited space and time, FDA encourages all persons who
wish to attend the meeting 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 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. A court
recorder will be available on the meeting premises to accept additional
oral remarks.
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) for the rulemaking. All relevant data and
documentation should be submitted with the comments to Docket No. FDA-
2011-N-0921.
Table 2 of this document provides information on participation in
the public meetings:
Table 2--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
Date Electronic address Address Other information
----------------------------------------------------------------------------------------------------------------
College Park, MD Public meeting. April 4, 2014, https://www.fda.gov/ Wiley Auditorium,
from 1 p.m. to 5 Food/NewsEvents/ Harvey W. Wiley
p.m. WorkshopsMeetings Federal Bldg.,
Conferences/ 5100 Paint Branch
default.htm. Pkwy., College
Park, MD 20740.
Deadline for registration....... March 28, 2014.... https://www.fda.gov/ We encourage you There is no
Food/NewsEvents/ to use electronic registration fee
WorkshopsMeetings registration if for the public
Conferences/ possible.\1\ meetings. Early
default.htm registration is
Docket No. FDA- recommended
2011-N-0921. because seating
is limited.
Request to make a Public Comment March 28, 2014.... https://www.fda.gov/ .................. Requests made on
Food/NewsEvents/ the day of the
WorkshopsMeetings meeting to make
Conferences/ an oral
default.htm.\2\ presentation will
be granted as
time permits.
Information on
requests to make
an oral
presentation may
be posted without
change to https://www.regulations.gov ov, including any
personal
information
provided.
Request special accommodations March 28, 2014.... Cynthia Wise, See FOR FURTHER
due to a disability. email: INFORMATION
cynthia.wise@fda. CONTACT.
hhs.gov.
Closing date for comments....... April 18, 2014.
----------------------------------------------------------------------------------------------------------------
\1\ 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;
410-316-2377; FAX: 410-472-3289; email: RWilliams@jmt.com.
\2\ You 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, 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 for the relevant
rulemaking and will be accessible to the public at https://www.regulations.gov. The transcript of the proceedings from the public
meeting will become part of the administrative record for each relevant
rulemaking. Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov and at
FDA's FSMA Web site at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm. It may also be viewed at the Division of Dockets
Management (see ADDRESSES). 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 https://www.fda.gov/Food/
[[Page 13598]]
GuidanceRegulation/FSMA/default.htm.
IV. Request for Comments
Interested persons may submit either electronic comments regarding
the issues to be included in the EIS for the proposed rule to https://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments 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, and will be posted to the docket at https://www.regulations.gov.
V. Reference
The following reference has 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 and is
available electronically at https://www.regulations.gov.
1. Statement from FDA Deputy Commissioner for Foods and
Veterinary Medicine, Michael Taylor, on Key Provisions of the
Proposed FSMA Rules Affecting Farmers. December 19, 2013, available
from https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.
Dated: March 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05181 Filed 3-10-14; 8:45 am]
BILLING CODE 4160-01-P