``stabilized compost'' with the NOP definition of ``compost'' in 7 CFR
part 205. The NOP definition of ``compost'' includes a great deal of
detail about the process of composting which we do not believe is
necessary for our use of the term ``stabilized compost'' in part 112
and also could be viewed as limiting the mechanisms by which

compost can be made, which is not our intent.
    Definition of ``static composting,'' We proposed to define ``static
composting'' to mean a process to produce humus in which air is
introduced into biological material (in a pile (or row) covered with at
least 6 inches of insulating material, or in an enclosed vessel) by a
mechanism that does not include turning. We further proposed to state
that examples of structural features for introducing air include
embedded perforated pipes and a constructed permanent base that
includes aeration slots, and that examples of mechanisms for
introducing air include passive diffusion and mechanical means (such as
blowers that suction air from the composting materials or blow air into
the composting material using positive pressure).
    (Comment 107) Arguing that the definition should exclude passively
aerated systems, some commenters recommend using the term ``aerated
static composting'' to ensure proper treatment to achieve time and
temperature conditions.
    (Response) We disagree that the definition of ``static composting''
should exclude passively aerated systems. In fact, we indicate in the
definition that passive diffusion is one method for introducing air to
the composting material. Therefore, we decline to change the definition
to ``aerated static composting.'' We recognize that composting that
includes passively aerated systems may have cold spots due to uneven
aeration; however, it is not our intent to narrowly limit the way
compost is produced as long as the stabilized compost meets the
standards of Sec.  112.54(a) or (b).
    As discussed previously, we are replacing the term ``humus'' with
``stabilized compost'' in the definition of ``static composting.'' We
are also making a change to indicate that static composting may or may
not involve the use of insulating material. The revised definition of
``static composting'' reads ``static composting means a process to
produce stabilized compost in which air is introduced into biological
material (in a pile (or row) that may or may not be covered with
insulating material, or in an enclosed vessel) by a mechanism that does
not include turning. Examples of structural features for introducing
air include embedded perforated pipes and a constructed permanent base
that includes aeration slots. Examples of mechanisms for introducing
air include passive diffusion and mechanical means (such as blowers
that suction air from the composting materials or blow air into the
composting material using positive pressure).''
    Definition of ``yard trimmings.'' We proposed to define ``yard
trimmings'' to mean purely vegetative matter resulting from landscaping
maintenance or land clearing operations, including materials such as
tree and shrub trimmings, grass clippings, palm fronds, trees, tree
stumps, untreated lumber, untreated wooden pallets, and associated
rocks and soils.
    (Comment 108) We received mixed comments on the use of terms ``yard
trimmings,'' ``yard trash,'' and ``yard debris''. Some commenters
suggest using the term ``yard debris'' to refer to plant material
commonly created in the course of yard and garden maintenance through
horticulture, gardening, brush, weeds, flowers, roots, windfall fruit,
and vegetable garden debris. Some comments note that yard trimmings and
pre-consumer vegetative waste could contain arthropods or dog waste,
and suggest using a term that would be more restrictive so as to avoid
such potential inclusions, such as ``vegetation trimmings,''
``vegetable debris,'' ``foliage,'' ``excess flora,'' or ``plants,
bushes and tree parts.'' Other comments recommend defining a new
category of vegetative waste, referred to as ``wood waste,'' to include
materials such as wood pieces or particles generated as byproducts from
the manufacturing of wood products, construction, demolition, handling
and storage of raw materials, trees and stumps, sawdust, chips,
shavings, bark, pulp, hogged fuel, and log sort yard waste. These
commenters note that wood waste does not include wood pieces containing
paint, laminates, bonding agents, or chemical preservatives.
    (Response) We are retaining the term ``yard trimmings'' to refer to
purely vegetative matter resulting from landscaping maintenance or land
clearing operations. Commenters were split on whether we should use
this term or an alternate term such as ``yard debris,'' ``vegetation
trimmings,'' or ``wood waste'' to express the same meaning, and no
comment provided a reason to think ``yard trimmings'' would be
confusing or problematic. The materials commenters listed as yard
debris, vegetation trimmings, or wood waste are encompassed within our
definition of ``yard trimmings.'' We use the term ``yard trimmings'' to
avoid potentially negative connotations associated with the word
``trash,'' even though some components of our definition (e.g.,
untreated wooden pallets) arguably are not ``trimmings.'' Dog droppings
and other animal wastes are not yard trimmings. However, we recognize
that even in purely vegetative material such as that described in the
definition of ``yard trimmings,'' there is the potential for unknown
and unavoidable contamination with animal waste. We have concluded that
the likelihood of contaminating produce with pathogens by use of
biological soil amendments that are not known to contain, and not
likely to contain significant animal waste or human waste (e.g., yard
trimmings, pre-consumer vegetative waste) is low, and therefore they
are not subject to the requirements of this rule. We decline to define
the term ``yard trimmings'' in a way that makes such materials subject
to the requirements in this rule.
    Definition of ``you.'' We proposed to define ``you'' to mean a
person who is subject to some or all of the requirements in this part.
    (Comment 109) Some comments ask that we revise this proposed
definition to directly link it to the owner or operator in charge of
the covered farm. One comment also states the person responsible for
compliance with the produce rule is not necessarily the owner of the
farmland, but could sometimes be the owner of the business or the
person with effective operational control over the farm business, such
as owners, tenants, partners, or employees.
    (Response) We are revising this definition to state that ``you,''
for the purposes of part 112, means the owner, operator, or agent in
charge of a covered farm that is subject to some or all of the
requirements of part 112. We are also making corresponding edits to the
questions and provisions in Sec. Sec.  112.4, 112.5, 112.6, and 112.7
to reflect this revision. Specifically these edits include replacing
the term ``you'' or ``I'' with ``farm(s).''
3. Other Comments
    (Comment 110) Some comments state that terms such as ``minimize,''
``periodic,'' ``regular,'' and ``when necessary and appropriate'' as
used within the proposed provisions have no clear definitions, and
suggest that these terms should be defined.
    (Response) As explained in the 2013 proposed rule (see section IV.D
of that document; 78 FR 3504 at 3529-3521), we developed the regulatory
framework for this rule taking into account the need to tailor the
requirements to specific on-farm routes of contamination. We have
incorporated flexibility into our requirements, wherever appropriate,
relying on an integrated approach that employs various mechanisms. In
some cases, the produce safety standards in part 112 are very similar
to those contained in the

Food CGMP regulation, especially where the routes of contamination are
well-understood and appropriate measures are well-established and
generally applicable across covered produce commodities (e.g.,
personnel qualifications, training, health, and hygiene; harvesting,
packing, and holding activities; equipment, tools, buildings, and
sanitation). We rely on this approach where possible, in part, because
of the diversity of the industry with respect to size, agricultural
practices, and knowledge of food safety. Such standards are intended to
be flexible and inherently necessitate the use of terms such as
``periodic,'' ``when necessary,'' and ``when appropriate.'' While we
believe these terms are generally understood, we have provided examples
throughout the rule to help covered farms better understand the
requirements.
    (Comment 111) Some comments request that we define the term
``crop'' to mean both edible and inedible cultivated plants. These
commenters state that such a definition is necessary to avoid confusion
in instances where edible portions of a plant come into contact with
harvested but inedible portions of the plant that may be used, for
example, in the production of biofuels, clothing, and bio-degradable
household products.
    (Response) The science-based minimum standards that we are
establishing in part 112 apply to the growing, harvesting, packing, and
holding of produce for human consumption. Produce that is not
reasonably expected to be directed to a food use (for example, produce
that is reasonably expected to be used in the production of biofuels,
clothing, or household products) is not subject to the requirements of
part 112. Therefore, we do not agree that we should establish a
definition for the term ``crop'' as suggested by these commenters.
    (Comment 112) Some comments request that we provide clear
definitions for the terms ``greenhouse,'' ``germination chamber,'' and
``other protected environment production areas.'' Some commenters
request that FDA define the term ``greenhouse'' using the following
statement in a Federal Register document issued by the International
Trade Administration, Department of Commerce: ``Controlled environment
tomatoes are limited to those tomatoes grown in a fully-enclosed
permanent aluminum or fixed steel structure clad in glass, impermeable
plastic, or polycarbonate using automated irrigation and climate
control, including heating and ventilation capabilities, in an
artificial medium using hydroponic methods'' (78 FR 14967 at 14970).
    (Response) None of these terms is used to describe any requirements
in part 112, including in subpart L of 112, and, therefore, their
inclusion in the list of definitions in Sec.  112.3 is not necessary.
We respond to comments about the applicability of subpart L to such
buildings in section XVII of this document.
    (Comment 113) Some comments ask that we establish a definition of
the term ``standard.''
    (Response) As required by section 419 of the FD&C Act, we have
established science-based minimum standards for the safe production and
harvesting of produce in part 112, and we have included definitions
that are relevant to those standards. We do not see the need to further
establish a definition for the term ``standard.'' In addition, FDA has
established many standards related to food safety and we believe this
term is generally understood by the regulated community.
    (Comment 114) Some comments request that we define the term
``visitor,'' and suggest that such definition should exclude visitors
who visit the farm, but do not come into contact with produce or any
other RAC being produced on the farm.
    (Response) We stated in proposed Sec.  112.33(a) that a visitor is
any person (other than personnel) who enters your covered farm with
your permission. We do not expect all visitors to present a reasonable
likelihood of introducing hazards into covered produce. However, we
decline to limit the requirements in this rule related to visitors to
only those visitors who come into contact with produce or other RACs.
See discussion under Comment 172. We do agree, however, that the
definition of ``visitor'' that appeared in proposed Sec.  112.33(a)
should instead appear in Sec.  112.3 with the other definitions, and we
are making this change to Sec.  112.3 and eliminating proposed Sec.
112.33(a).
    (Comment 115) Some comments request definitions for other terms
related to biological soil amendments, including for the terms
``aging,'' ``feedstock,'' ``green waste,'' and ``maturity.''
    (Response) None of these terms is used to describe the requirements
in part 112, including in subpart F of part 112, and, therefore, their
inclusion in the list of definitions in Sec.  112.3 is not necessary.

C. Small Businesses, Very Small Businesses, and Farms That Are Not
Covered or Are Eligible for a Qualified Exemption

    In the 2013 proposed rule, under proposed Sec.  112.3(b), we
proposed to establish the definitions for very small business and small
business, and under proposed Sec.  112.4, we proposed to apply part 112
only to farms above a certain specified average monetary value of sales
(78 FR 3504 at 3549). We also proposed Sec. Sec.  112.5 and 112.6 to
establish the eligibility criteria and modified requirements related to
farms with a qualified exemption. In addition, in the supplemental
notice, taking into account public comment, we proposed to amend the
originally proposed definitions of very small business and small
business in Sec.  112.3(b) as well as the provision in Sec.  112.4
regarding farms not covered under this rule (79 FR 58434 at 58436-
58438). In both the 2013 proposed rule and in the supplemental notice,
we asked for public comment on our proposed provisions.
    We are finalizing Sec. Sec.  112.4, 112.5, and 112.6 with changes,
and adding new Sec.  112.7, as discussed in this section (see Table 4).
In this section, we also discuss comments we received in response to
the 2013 proposed rule, but that we did not address in the supplemental
notice. We also discuss comments that we received on the amended
proposed provisions in the supplemental notice.
1. Suggestions Related to Farms Not Covered or Eligible for a Qualified
Exemption
    (Comment 116) Some comments suggest that farms not covered by this
rule based on their size, or farms that are eligible for a qualified
exemption from this rule should be regulated under scale-appropriate
State-run food safety programs. Some comments also request that FDA
provide support for States to implement such programs.
    (Response) FDA is not requiring States to set up food safety
programs for farms eligible for the qualified exemption, nor are we
prohibiting States from establishing such programs. We do intend to
continue to work collaboratively with our State and other partners in
facilitating compliance with this rule. Such efforts will be
appropriately focused on covered farms, not on farms eligible for the
qualified exemption. However, we do anticipate that some of the
materials and programs generated in that effort are likely to be
helpful to farms eligible for the qualified exemption as well as to
covered farms. Our existing guidance documents, such as the GAPs Guide,
provide relevant

recommendations. In addition, we expect that the training materials
being developed by the PSA and SSA will be useful resources, including
for training farms eligible for the qualified exemption in safe produce
growing, harvesting, packing, and holding practices.
    (Comment 117) One comment recommends that farms not covered by this
rule based on their size or eligible for a qualified exemption should
not be allowed to supply produce to entities such as schools or
hospitals.
    (Response) We do not agree that farms not subject to coverage under
part 112, or eligible for a qualified exemption should be precluded
from marketing their produce to schools or hospitals. Produce marketed
in the United States must be safe for consumption, regardless of
whether the farm that grew the produce is required to comply with part
112. There is no reason to believe that produce is unsafe or otherwise
unfit for consumption by individuals at schools or hospitals simply
because it was produced by a farm not subject to part 112 or eligible
for a qualified exemption.
    (Comment 118) One comment requests that any requirements for
supplier verification in other FSMA rules should not prevent other food
businesses from purchasing produce from farms that are eligible for the
qualified exemption from the produce safety regulation or otherwise not
subject to the produce safety regulation.
    (Response) Nothing in the produce safety regulation, PCHF
regulation, or FSVP regulation precludes food businesses from
purchasing produce grown, harvested, packed, or held by farms that
qualify for a qualified exemption from the produce safety regulation or
are otherwise not subject to the produce safety regulation. In the
rulemakings establishing the PCHF regulation (80 FR 55908) and FSVP
regulation (published elsewhere in this issue of the Federal Register),
FDA explained how the supplier verification requirements in those rules
relate to farms that are not subject to the produce safety regulation.
2. Calculating Farm Sizes
    (Comment 119) Some comments request clarification on how sales will
be calculated for the purpose of determining a farm's size and,
therefore, whether the farm is a covered farm, eligible for a qualified
exemption, and/or eligible for an extended compliance period. Comments
ask whether the value of produce donated to non-profit organizations
such as food banks and senior centers would be counted towards sales.
In addition, comments ask whether sales or donations to public
institutions, such as prisons, would be counted towards sales.
    (Response) For purposes of the sales thresholds in this rule, FDA
does not consider a donation in which there is no payment of money or
anything else of value in exchange for produce to be a ``sale.'' Such
donations, including to public institutions or non-profit
organizations, are not counted toward a farm's sales revenue. However,
sales of produce to any public institutions or non-profit organizations
in which money or anything else of value is exchanged for produce must
be counted as sales for purposes of this rule.
    (Comment 120) Some comments seek clarification on the applicability
of small or very small business definitions in proposed Sec.  112.3
versus the eligibility criteria for a qualified exemption in Sec.
112.5 in the circumstance where a farm meets the conditions for both.
Some comments point out that because the monetary thresholds are based
on produce sales for the former and all food sales for the latter, it
would be possible for certain diversified farms to qualify for extended
compliance periods (as small or very small businesses) as well as for a
qualified exemption and modified requirements. Additionally, one
commenter is concerned that this difference in monetary threshold basis
means that a farm will have to be aware of the implications of its sale
of ``all produce'' and ``all food.''
    (Response) We acknowledge that because of the difference in the
bases for monetary cut-offs established in Sec.  112.3 and in Sec.
112.5, there could be circumstances where a farm that is a small
business or very small business (as defined in Sec.  112.3) is also
eligible for a qualified exemption (in accordance with Sec.  112.5).
Farms eligible for a qualified exemption (in accordance with Sec.
112.5) that also qualify as a small or very small business (as defined
in Sec.  112.3(b)), must comply with the modified requirements of
Sec. Sec.  112.6 and 112.7 within the compliance periods established
for either a small business or a very small business, whichever is
applicable. A farm can be both a farm eligible for a qualified
exemption and a small or very small business. We are revising the
definitions of small business and very small business to acknowledge
that such businesses may be subject to only some of the requirements of
part 112, if they are also a farm eligible for a qualified exemption,
and to all of the requirements of part 112 if they are only a small or
very small business. We have replaced the phrase ``if it is subject to
this part'' with ``if it is subject to any of the requirements of this
part'' in the definitions of both small business and very small
business in Sec.  112.3(b).
    (Comment 121) Some comments ask whether annual sales will be
calculated per owner or per operator, where the farm owner and operator
are different. Other comments ask whether farms may alter their
business structures for the purpose of evading this rule.
    (Response) We have revised the definition of ``farm'' to make clear
that the relevant entity is the farm business, which is either (1) A
Primary Production Farm, an operation under one management in one
general (but not necessarily contiguous) physical location devoted to
the growing of crops, the harvesting of crops, the raising of animals
(including seafood), or any combination of these activities; or (2) a
Secondary Activities Farm, an operation devoted to harvesting, packing,
and/or holding of RACs, provided that the primary production farm(s)
that grows, harvests, and/or raises the majority of the RACs harvested,
packed, and/or held by the secondary activities farm owns, or jointly
owns, a majority interest in the secondary activities farm. Thus, a
farm's sales are those attributable to the farm business. Limits on
permissible business structures for farms are beyond the scope of this
regulation. Thus, it is possible that some farms may attempt to evade
this regulation as suggested by the comment. However, we do not expect
this to occur on a broad scale given that many farms currently already
participate in voluntary industry guidelines or marketing agreements,
many of which include provisions similar to those required under this
regulation.
    (Comment 122) One comment finds the requirements for calculating
sales for the purposes of the coverage threshold and the qualified
exemption to be confusing and notes that small farms may resist a
financial evaluation to determine the applicability of this rule at the
beginning of an inspection.
    (Response) The $25,000 coverage threshold is based on sales of
produce, which we expect a farm to be able to demonstrate using
existing sales records. The criteria for the qualified exemption are
more complex, but are a product of requirements in section 419(f) of
the FD&C Act. In section IX.C.5-7 of this document we discuss how a
farm can demonstrate its eligibility for the qualified exemption and
the associated requirement for farms to maintain necessary
documentation. We expect that farms that are not covered by this rule,
or that

are eligible for an exemption, will be willing to provide supporting
documentation to FDA at relevant times, including during an inspection.
We intend to target our education efforts on small farms to help them
come into compliance. We also plan to work closely with State,
territorial, tribal and local partners to develop the education and
enforcement tools and training programs needed to facilitate consistent
inspection and regulatory activities associated with this rule.
    (Comment 123) Some comments recommend including a multiplier ratio
in the sales thresholds to take into account the growing seasons of
different areas. Another comment recommends replacing monetary income
thresholds for farm size with either produce-unit thresholds or with
the cost of non-farm inputs purchased.
    (Response) We believe it is unnecessary to include a multiplier
ratio because we consider total annual production, rather than
seasonally-adjusted production. We use monetary value of sales of
produce as a proxy for the quantity of produce sold in the United
States marketplace. This provides a clearer picture of volume
contribution to the United States marketplace than produce units or
cost of non-farm inputs purchased, which do not appear to indicate
consumption or even yield.
    (Comment 124) Some comments recommend adjusting the sales
thresholds for all purposes for inflation and recommend using 2011 as
the baseline year for such adjustment, consistent with the monetary
threshold for farms eligible for a qualified exemption (Sec.  112.5).
One comment recommends including adjustments to the sales thresholds in
the rule based on the Consumer Price Index to account for future
inflation.
    (Response) We do not agree that the monetary thresholds for
determining whether a covered farm is a ``small business'' or ``very
small business'' need to be adjusted for inflation. These thresholds
are used only to determine the first date upon which a small or very
small business must comply with the rule, with applicable compliance
periods ranging from two years to a maximum of six years from the
effective date of this rule. In contrast, the $25,000 monetary
threshold in Sec.  112.4(a) affects whether or not a farm is covered
under this rule, with indefinite effect. Therefore, we agree that this
monetary threshold should be adjusted for inflation, and we are
revising Sec.  112.4(a) accordingly. With respect to the monetary
threshold related to eligibility for a qualified exemption, we are
finalizing Sec.  112.5, as proposed. Section 112.5(a)(2) provides that
the $500,000 figure will be adjusted for inflation, and Sec.  112.5(b)
provides that 2011 is the baseline year for calculating such
adjustment. We intend to use the federal calculation for inflation
adjustments provided by the Bureau of Economic Analysis (Ref. 98), and
to make the adjusted dollar value available on our Internet site.
    (Comment 125) One comment asks how farm size will be calculated if
a farm has properties in two States.
    (Response) We have revised the definition of ``farm'' to make clear
that the relevant entity is the farm business. Thus, provided that a
farm is limited to one general (but not necessarily contiguous)
physical location, whether a farm's operation crosses State borders
does not affect the calculations of a farm's size, which are based on
annual sales.
    (Comment 126) Comments request revisions and/or clarification on
the applicability of the farm size monetary thresholds to foreign
farms. Some comments express concern that applying the thresholds
equally to domestic and foreign farms will have significant unintended
consequences. Some comments state that the proposed $25,000 threshold
has significant consequences in relation to imported foods. According
to these comments, foreign farms that export foods to the United States
from around the world are often very small, and produce from these
farms is aggregated for export to the United States. Another comment
states that any gross sales threshold gives an unfair advantage to
foreign farms who sell produce at a low price index, disadvantaging
domestic farmers, who the commenter asserts will sell less produce than
foreign farmers before exceeding any given threshold. This comment asks
FDA to define farm size thresholds based on tonnage, with separate
categories for different classes of produce, rather than on monetary
value of sales.
    (Response) We do not agree that the coverage threshold presents a
particular problem with respect to imported produce. Produce is
aggregated for sale both domestically and abroad. We conclude that the
farms below the threshold do not contribute significantly to the volume
of produce in the marketplace that could become contaminated and,
therefore, have little measurable public health impact. We acknowledge
that dollar amounts are directly related to product value, but
nonetheless disagree that we should base the monetary thresholds in the
rule on the volume or amount of product sold. We see no practical way
to identify a threshold based on volume or amount of product that could
be applied across all applicable commodities and operations, and the
commenter provided no specific suggestions for how this recommendation
could be carried out.
    (Comment 127) Some comments ask us to count only United States
sales to calculate the size of foreign farms that export food to the
United States. Some comments also assert that most foreign farms export
only a small portion of their total produce to the United States, and
that this limited volume of produce poses a relatively low risk to
United States consumers. In addition, one comment also states that
because the farm's coverage or qualified exemption status would be
influenced by fluctuations in foreign exchange rates, monetary
thresholds based on global sales would jeopardize the predictability of
business and have negative effects on trade.
    (Response) We decline this request. The purpose of the definitions
of ``very small business'' and ``small business'' in this rule is to
allow such farms extended periods before their initial compliance with
the rule. We are providing this flexibility because they may have fewer
resources to direct to compliance with the rule under the shorter
timeframes provided to larger farms. As such, we are applying this rule
equally to foreign and domestic farms of the same size. Just like a
similarly situated domestic farm, a foreign farm that sells more than
the threshold dollar amount of food is likely to have the capability of
complying with the rule within the applicable time period, even if not
all of that dollar amount reflects United States sales. We also decline
this request with respect to the monetary threshold in Sec.  112.4(a),
maintaining consistency to the maximum extent possible. The criteria
for eligibility for a qualified exemption (and, therefore, associated
modified requirements) established in Sec.  112.5 are as mandated by
section 419(f)(1) of the FD&C Act. Because these criteria are mandated
by the statute, FDA must include them and we are finalizing them, as
proposed.
    Although it is true that foreign exchange rates fluctuate, we
believe the effect of such fluctuations on a farm's average revenue
over a three year period would be minimal. Foreign exchange prices
fluctuate, but so too, do crop prices. If a covered farm is able to
make more money either by switching crops or selling to new markets
overseas these changes in practice could affect the farm's coverage.
And while such opportunities may present themselves

in the short term, both crop prices and exchange rates tend to
stabilize over the long term.
    (Comment 128) Several comments request that farm sizes be based on
the sale of ``covered produce,'' rather than on the sale of ``all
produce.'' Although supportive of the change from ``all food'' to ``all
produce,'' these comments urge FDA to calculate all monetary thresholds
for businesses based on sales of covered produce to provide what the
commenters believe would be a clear standard and support farm
diversification efforts. Some comments argue that section 419 of the
FD&C Act placed limitations on the scope of the rule that should be
reflected in the rule's calculation of sales by basing them only on
food covered by the rule. One commenter asserts that it would not be
difficult to determine produce that is ``covered'' versus ``not
covered'' or to keep track of ``produce sold'' versus ``produce grown
for personal consumption.'' Some commenters opine that defining
coverage in terms of ``covered produce'' versus ``all produce'' would
likely continue to cover only a small fraction of the total volume of
covered produce in the United States food supply, resulting in minimal
changes to total coverage of the rule. In contrast, some comments
support FDA's revised provisions, and state that basing farm monetary
thresholds on ``covered produce'' might be too difficult to be
practical in that, compared to ``all produce,'' identifying ``covered
produce'' is distinctly more challenging and will change on a more
frequent basis.
    (Response) In the supplemental notice, we considered and rejected
basing farm size on sales of covered produce, and commenters did not
provide specific suggestions responsive to our stated concerns about
the feasibility of this approach. This scenario continues to present a
number of challenges, including the difficulty of determining the scope
and public health impact of not covering farms based on the sales of
covered produce, particularly considering the likely variability in
produce commodities grown year to year; variability resulting from
provisions under which certain commodities would not be considered
``covered produce'' (for example, produce that is rarely consumed raw);
changes in the amount of produce that is used for personal consumption
or for consumption on the farm or another farm under the same
management; and whether and how to account for produce that would be
eligible for exemption under certain conditions, which may be
inherently variable based on market conditions (for example, produce
that is destined for commercial processing). We continue to find it
difficult to quantitatively determine the extent to which businesses
with an average annual monetary value of ``covered produce'' sold of
more than $25,000 would contribute to the overall produce market, or
the public health impact of not covering such businesses under part
112. However, it can be reasonably expected that applying the same
monetary thresholds to covered produce sales (rather than to total
produce sales) would exclude more produce acres and, therefore, a
larger volume of product potentially associated with foodborne illness.
Moreover, the possibly frequent changes to a farm's covered or non-
covered status may also be challenging for compliance and enforcement
purposes. We also disagree that our legal authority requires us to use
``covered produce'' only as the basis for sales thresholds in this
rule. As explained elsewhere, the monetary threshold for a qualified
exemption is established by statute as calculated based on all food,
and we use this basis in Sec.  112.5. Section 419 gives FDA the
discretion to define the terms ``small business'' and ``very small
business,'' and to determine which farms and which produce should be
covered. For all of these reasons, we are not adopting this approach.
3. Definitions of Small and Very Small Businesses (Sec.  112.3(b)) and
Extended Compliance Periods
    (Comment 129) A number of comments asked us to raise the sales
thresholds in the definitions of ``very small business'' and ``small
business'' set forth in proposed Sec.  112.3(b). These comments cite
the relative proportion of farms that would meet each definition and
the economic burden of compliance with the rule as justification. Sales
thresholds suggested for ``very small business'' and ``small business''
ranged across the comments, including suggestions up to $1,000,000 or
even $2,000,000 in average annual monetary value of sales over the
previous 3-year period.
    (Response) As required by section 419(a)(3)(A) and (c)(1)(B) of the
FD&C Act, we have formulated this rule to provide sufficient
flexibility to be practicable for all sizes and types of entities
engaged in the production and harvesting of fruits and vegetables that
are RACs, including small businesses and entities that sell directly to
consumers, and to be appropriate to the scale and diversity of the
production and harvesting of such commodities. Small businesses and
very small businesses are provided extended compliance periods as a
means of providing such businesses with additional flexibility (see
section XXIV of this document). In the supplemental notice, we revised
the proposed definitions of small business and very small business by
replacing the sales thresholds based on sales of all food with sales
thresholds based on sales only of produce, which we expect would
increase the number of farms that would fit within those definitions
and therefore qualify for extended compliance periods (79 FR 58434 at
58437). Small businesses and very small businesses, as defined for the
purpose of this regulation, together account for an estimated total of
17.2 percent of covered produce acres and about 13.6 percent of all
produce acres in the United States, and are significant contributors to
the volume of produce marketed in the United States. We considered the
suggestions to set the monetary thresholds for very small or small
businesses at $1 million or $2 million. Using these thresholds, applied
to annual sales of produce, such businesses account for an estimated
total of 40.6 percent of covered produce acres and about 32 percent of
all produce acres in the United States for the $1 million cutoff, and
an estimated total of 54.6 percent of covered produce acres and about
43 percent of all produce acres in the United States for the $2 million
cutoff. Neither of these cutoffs is appropriate to consider a business
as ``very small business'' or ``small business'' because it would delay
compliance dates significantly for about a third of all produce
marketed in the United States using the $1 million cutoff, and for
nearly a half of all produce marketed in the United States using the $2
million cutoff. We also considered and rejected the possibility of
basing the thresholds on sales of covered produce, as explained in
Comment 128. Therefore, we believe that the sales thresholds in the
definitions of very small business and small business, as revised in
the supplemental notice, are appropriate, and we are finalizing them as
proposed in the supplemental notice. We intend to target our education
and technical assistance efforts to help these farms to comply with the
standards established in part 112.
    (Comment 130) One comment disagrees with providing extended
compliance periods for small and very small businesses, stating that
these provisions would allow such farms to operate at increased risk
for a significant time.

    (Response) We are providing extended compliance periods for small
and very small businesses to incorporate additional flexibility into
the regulation, consistent with the statutory provisions in section
419(a)(3)(A) and (c)(1)(B) of the FD&C Act, which direct us to provide
sufficient flexibility to be practicable for all sizes and types of
businesses, including small businesses. Small and very small businesses
may have fewer resources available to, for example, invest in new
equipment, or fewer staff with formal training in food safety and,
therefore, may need additional time to come into compliance with the
regulation. Providing extended compliance periods to small and very
small businesses is consistent with our approach to compliance dates in
recent rules directed to food safety (see, e.g., 74 FR 33029 at 33034,
July 9, 2009 and 72 FR 34751 at 34752, June 25, 2007). This allowance
for extended compliance periods does not eliminate or otherwise affect
their responsibility under the FD&C Act to ensure the safety of their
produce.
4. The $25,000 Threshold for Coverage Under the Rule (Sec.  112.4(a))
    (Comment 131) Several comments support the proposed threshold of
more than $25,000 in average annual monetary value of produce sales
during the previous 3-year period. Some comments request that the
threshold be raised. These comments recommend varying thresholds
ranging from $75,000 to $5,000,000 of annual sales of either produce,
covered produce, or all food. One comment suggests that the threshold
should be higher than the majority of farms that could reasonably be
considered viable family-sustaining businesses. Other commenters
suggest using a threshold in line with an average single family income.
    Other comments object to the inclusion of any monetary or otherwise
size-based threshold for coverage under this rule. These comments argue
that this approach creates an ``uneven playing field'' advantaging
small farms over large farms, that pathogens do not discriminate based
on the size of a farm, that such a threshold will minimize the impact
of this rule in terms of consumer confidence in the safety of produce,
and that small farms are nevertheless able to comply in a cost-
effective manner with the same best practices for food safety that
larger producers follow. Some comments also argue that inclusion of
such a threshold puts pressure on State and local agencies to regulate
the smallest farms, and that the smallest operations may be the highest
risk for hazards and contamination because large farms typically
utilize third-party audits but smaller farms do not.
    (Response) We believe it is appropriate to establish a threshold
for coverage of this rule to establish only those requirements that are
reasonably necessary to meet the public health objectives of the
regulation. Because farms below the threshold do not contribute
significantly to the volume of produce in the marketplace that could
become contaminated, we conclude that imposing the requirements of part
112 on these businesses is not warranted. We note that farms that are
not subject to this rule are and will continue to be covered under the
adulteration and other applicable provisions of the FD&C Act and
applicable implementing regulations, irrespective of whether they are
included within the scope of this rule. We recommend that farms that
are not covered under part 112 follow good agricultural practices to
ensure that the produce they grow, harvest, pack or hold does not serve
as a vehicle for foodborne illness.
    In the supplemental notice, we revised the proposed $25,000
threshold for coverage by replacing sales of ``food'' with sales only
of ``produce.'' We tentatively concluded that the farms below this
revised proposed threshold would not contribute significantly to the
volume of produce in the marketplace that could become contaminated
and, therefore, would have little measurable public health impact. We
believe that applying the limit to produce sales rather than all food
sales would accommodate the concerns expressed by some comments without
adversely affecting the level of public health protection envisioned
under the 2013 proposed rule (79 FR at 58434 at 58437). We are
finalizing the $25,000 threshold, based on sales of produce, as
proposed in the supplemental notice. Our analysis shows that farms with
less than $25,000 of annual produce sales account for an estimated
total of 2.5 percent of covered produce acres, and about 2 percent of
all produce acres in the United States. Such businesses do not
contribute significantly to the volume of produce in the marketplace
that could become contaminated and, therefore, we believe that imposing
the requirements of part 112 on these businesses is not warranted. We
also considered and rejected the possibility of basing the threshold on
sales of covered produce, as explained in Comment 128.
    We also considered alternative monetary value thresholds suggested
by commenters. We find that setting a monetary threshold greater than
$25,000 based on sales of produce would adversely affect the level of
public health protection provided by this regulation. For example, if
we were to set the coverage threshold at $1 million or $2 million,
applied to sales of produce, an estimated total of about 32 percent of
all produce acres in the United States for the $1 million cutoff and an
estimated total of about 43 percent of all produce acres in the United
States for the $2 million cutoff would not be subject to this rule.
This would remove about a third to nearly half of all produce marketed
in the United States from coverage, providing significantly less public
health protection. We have incorporated flexibility in the rule to help
smaller farms to comply. We also intend to work with our State, tribal,
and local partners and target our education and technical assistance
efforts to smaller farms to help farms meet the standards established
in subparts A to O, within the specified compliance periods.
5. Qualified Exemptions Generally (Sec. Sec.  112.5 and 112.6)
    (Comment 132) Several comments express support for the qualified
exemption provisions for farms, as proposed, and urge FDA to retain the
modified requirements for such farms. Conversely, some comments oppose
the proposed qualified exemption provisions and recommend that this
exemption be eliminated, arguing that it is not science- or risk-based.
    (Response) As explained in the 2013 proposed rule, the provisions
in Sec. Sec.  112.5 and 112.6 reflect the fact that section 419(f) of
the FD&C Act mandates this exemption. Section 112.5 establishes the
criteria for eligibility for a qualified exemption (and, therefore,
associated modified requirements) based on a farm's average monetary
value of all food sold and direct farm marketing, as mandated by
section 419(f)(1) of the FD&C Act. Similarly, Sec.  112.6 establishes
the modified requirements applicable to those farms that are eligible
for a qualified exemption as mandated by section 419(f)(2) of the FD&C
Act. Because these provisions are mandated by the statute, FDA must
include them and we are finalizing them as proposed. We note, however,
that the qualified exemption from part 112 does not eliminate a farm's
responsibility to comply with all applicable requirements of the FD&C
Act. We encourage such farms to continue following procedures,
processes, and practices that ensure the safety of produce grown,
harvested, packed, or held on their farm or in their operation.

6. Criteria for Eligibility for a Qualified Exemption (Sec.  112.5)
    (Comment 133) Some comments suggest altering the criteria for
eligibility for a qualified exemption in various ways. One comment
recommends exempting farms that sell at least 50 percent of their
produce directly to consumers or retail stores within a 250-mile
radius, and argues that buyers in such circumstances can visually
inspect the growing areas, converse with farmers, and closely examine
their purchasing options. Another comment recommends increasing the
average annual sales monetary limit for eligibility for a qualified
exemption from $500,000 to a minimum of $1,000,000. This commenter
states that the $500,000 limit in Sec.  112.5(a) would not adequately
protect smaller farms, particularly because it would be applied to all
food sales. In this regard, the commenter also recommends that the
monetary value limit should be applied to the sale of covered produce
only, and not all food. Another comment recommends applying the
monetary value limit to sales of produce.
    (Response) Sections 112.5, 112.6, and 112.7 establish the criteria
for eligibility for a qualified exemption and associated modified
requirements, consistent with section 419(f) of the FD&C Act (21 U.S.C.
350h(f)). The criteria established in Sec.  112.5(a), including the
requirements related to sales directly to qualified end-users, are
derived from section 419(f) of the FD&C Act. Similarly, the definition
of a qualified end-user in Sec.  112.3(c) implements section 419(f)(4)
of the FD&C Act. Because these provisions are mandated by the statute,
FDA must include them and we are finalizing them as proposed. We have
identified no basis that would allow us to make the changes suggested
by the commenters, such as applying a distance criterion of 250 miles,
applying a monetary limit of $1,000,000, or changing the basis for the
monetary limit to apply to sales of produce or covered produce rather
than all food. We also addressed this last request regarding monetary
limit based on sales of covered produce in the supplemental notice (see
79 FR 58434 at 58438).
    (Comment 134) Several comments request that FDA allow small farms
that market through produce auctions or CSA operations to be eligible
for the qualified exemption.
    (Response) Consistent with section 419(f) of the FD&C Act, the
provisions in Sec.  112.5 do not identify any produce market
arrangements as specifically eligible for the qualified exemption.
Rather, these provisions establish the criteria that must be met for
any covered farm to be eligible for a qualified exemption. As we
discussed in the 2013 proposed rule (78 FR 3504 at 3549-50), it does
seem likely that many farms that use arrangements such as CSAs, you-
pick operations, or farmers markets, will meet the established criteria
for a qualified exemption. Each covered farm, including farms using
such arrangements to market their produce, should analyze its sales
under the terms of Sec.  112.5 to determine its eligibility for the
qualified exemption.
    In the case of a CSA farm or a farm using a produce auction as a
sales platform, the farm's direct sales to individual consumers
enrolled in the CSA operation, or individual consumers at the auction,
can be counted as sales to qualified end-users (because consumers are
qualified end-users, regardless of location). A direct sale to a
restaurant or retail food establishment enrolled in the CSA or at the
auction can be counted as a sale to a qualified end-user if the
restaurant or retail food establishment is located either in the same
State or the same Indian reservation as the farm or is located not more
than 275 miles from the farm. Considering sales of all food, if the
farm's sales to qualified end-users exceeds sales to all other buyers,
and the farm's average annual monetary value of sales over the previous
3-year period is less than $500,000, the farm would be eligible for the
qualified exemption.
    The definition of a ``qualified end-user,'' which is derived from
section 419(f)(4) of the FD&C Act, explicitly states that the term
``consumer'' does not include a business. In a circumstance where the
CSA farm sells its produce to a separate business that runs a CSA,
rather than directly to individual consumers enrolled in the CSA, these
sales would not be sales to consumers. The analysis is the same in a
circumstance where a farm sells its produce to a separate business that
runs a produce auction, rather than directly to specific buyers at the
auction. Such sales would only be sales to a qualified end-user if the
CSA operation, or the produce auction, fits the definition of a retail
food establishment or a restaurant, and meets the location requirements
explained previously. As noted in response to Comment 103, FDA is
addressing the definition of ``retail food establishment'' in a
separate rulemaking. This rulemaking includes topics related to various
types of sales platforms and the definition of ``retail food
establishment.''
7. Applicable Requirements for Qualified Exemption (Sec. Sec.  112.6
and 112.7)
    (Comment 135) One comment requests that we clarify the cross-
references in Sec.  112.6(a) regarding the subparts applicable to farms
eligible for the qualified exemption.
    (Response) We are amending Sec.  112.6(a) to provide the requested
clarification, separating applicable subparts and including their
titles.
    (Comment 136) Some comments ask whether the required content of the
label and point of purchase display requirements in Sec.  112.6(b)
includes only the name and address of the farm, or whether the
notification must also include a statement notifying consumers of the
farm's qualified exemption from the produce safety regulation.
    (Response) Label and point of purchase displays required under
Sec.  112.6(b) must include the name and the complete business address
of the farm where the produce was grown. You are not required to
include a statement notifying consumers of your qualified exemption.
    (Comment 137) We requested comment on the feasibility of the
labeling and point of purchase display provisions in Sec.  112.6(b),
particularly in the case of consolidating produce from several farm
locations. One comment states that our request was confusing and,
assuming that we meant produce from multiple locations of one farm is
packed or held at one location, the farm name and business address that
is required to be displayed under Sec.  112.6(b) should be the name and
business address of the farm that is eligible for the qualified
exemption.
    (Response) We agree that the relevant farm for purposes of the
requirements in Sec.  112.6(b) is the farm where the produce was grown
that is eligible for the qualified exemption. We acknowledge that our
request for comment was unclear. We did not receive comments suggesting
that consolidating (or commingling) produce from different farms would
create a feasibility problem with respect to this requirement. We are
finalizing the requirement as proposed. If needed, we will consider
issuing guidance in the future with respect to the application of this
requirement when produce from different farms has been commingled.
    (Comment 138) Some commenters question the requirement to disclose
the name and business address of a farm eligible for the qualified
exemption, citing concerns about biosecurity and unannounced or
unplanned visitors to the farm. These comments suggest that

FDA consider alternative approaches. One comment points out that farms
that sell to local retailers, restaurants, co-ops or that sell at
produce auctions are often assigned a farm identification number as a
means of traceability, and suggests that FDA consider relying on such
identification. Another comment suggests providing flexibility for
farms to choose whether to disclose its phone number, Web site, email
address, or business address.
    (Response) Sections 112.6 and 112.7 establish the modified
requirements applicable to farms that meet the criteria under Sec.
112.5 for a qualified exemption. As explained in the 2013 proposed
rule, these requirements are derived from the provisions in section
419(f)(2) of the FD&C Act. We conclude that the use of the term
``business address'' in section 419(f)(2)(A) demonstrates Congress'
intent to require the farm's full address, including the street address
or P.O. box, to appear on labels or other required notifications when
the farm qualifies for the exemption (under Sec.  112.5). The use of
the term ``business address'' in section 419(f)(2)(A) of the FD&C Act
contrasts with Congress' use of a different term, ``place of
business,'' in section 403(e) of the FD&C Act (21 U.S.C. 343(e)).
Section 403(e) provides that foods in package form are misbranded
unless the product label bears the name and place of business of the
manufacturer, packer, or distributor of the food. If Congress had
considered the less complete address already required under section
403(e)(1) of the FD&C Act and the ``place of business'' labeling
regulation (Sec.  101.5(d)) to be adequate for notification to
consumers for foods required to bear labels, there would have been no
need to impose a new, more specific requirement in section
419(f)(2)(A)(1) for the farm's ``business address'' to appear on the
food label (78 FR 3504 at 3550.). Similarly, if Congress had intended
that other information (such as a farm identification number, phone
number, Web site, or email address) could substitute for the required
information, there would have been no need to impose the specific
requirement for the business address to be disclosed. Section 112.6(b)
does not prevent farms from voluntarily disclosing such additional
information if desired. We consider that Congress has already struck
the specific balance it intended between farms' need to control visitor
access to the farm for biosecurity purposes and the amount of
information required to be disclosed to consumers when a farm is
eligible for a qualified exemption from this rule. Therefore, we are
finalizing Sec.  112.6(b), as proposed.
    (Comment 139) Comments generally support FDA requiring farms
eligible for the qualified exemption to maintain adequate documentation
to demonstrate the basis for their qualified exemption, and to make
such records available to FDA for inspection upon request. One comment
asks that FDA not require farms eligible for the qualified exemption to
submit documentation to FDA or to establish and maintain records in
accordance with subpart O, and suggests issuing recordkeeping guidance
for these farms instead.
    (Response) If farms were not required to maintain adequate
documentation of their eligibility for a qualified exemption, we would
have no way to determine whether a farm claiming the qualified
exemption, in fact, met the criteria for that exemption. This could be
important, for example, if a farm claiming a qualified exemption is
directly linked to a foodborne illness outbreak during an active
investigation or if FDA determines, based on conduct or conditions
associated with the farm that are material to the safety of the food
produced or harvested at such farm, that it is necessary to protect the
public health and prevent or mitigate a foodborne illness outbreak to
withdraw the farm's qualified exemption (see discussion of subpart R in
section XXIII of this document). In such circumstance, because the
withdrawal procedures in subpart R would only apply to farms eligible
for the qualified exemption, we would need to verify the status of a
farm to consider appropriate follow-up actions, in accordance with
subpart R. Therefore, we are adding a new provision Sec.  112.7 to
establish certain recordkeeping requirements in relation to a qualified
exemption.
    However, we agree that it is not necessary for farms to submit
documentation to FDA of their status with respect to the qualified
exemption, unless FDA requests such information for official review
(for example, during an inspection or investigation). We also do not
oppose the use of existing records or documents (for example, documents
that are developed and maintained during the normal course of a farm's
business) to document the farm's eligibility for a qualified exemption,
provided that they meet all applicable requirements.
    Specifically, in new Sec.  112.7, we are requiring that, if you are
eligible for a qualified exemption in accordance with Sec.  112.5, you
must establish and keep records required under this provision in
accordance with the requirements of subpart O of this part. This means
that the general requirements for maintenance of records in subpart O
apply to the records required under Sec.  112.7, except that we are not
requiring sales receipts kept in the normal course of business to be
signed or initialed by the person who performed the sale (Sec.
112.7(a)). Under Sec.  112.7(b), we are requiring that you must
establish and keep adequate records necessary to demonstrate that you
satisfy the criteria for a qualified exemption as described in Sec.
112.5. Such records may include receipts of your sales to different
buyers; the location of any buyers that are restaurants or retail food
establishments; the monetary value of sales of all food, adjusted for
inflation using 2011 as the baseline year; and any other documentation
that FDA can use, as necessary, to verify your eligibility for a
qualified exemption. For example, if you relied on records kept in the
normal course of your business bearing on the criteria for the
qualified exemption to determine your eligibility, you must retain such
records. Under Sec.  112.7(a) we are not requiring sales receipts kept
in the normal course of business to be signed or initialed by the
person who performed the sale. We are requiring that such receipts be
dated, however, because the dates of sales are relevant to the
computation of eligibility.
    Because the criteria for eligibility for a qualified exemption are
based on calculations regarding the preceding 3-year period (see Sec.
112.5(a)(2)), you must review your sales annually to confirm your
continued eligibility for the qualified exemption for the upcoming
year. Under Sec.  112.7(b), we are now specifying that you must
establish and keep a written record reflecting that you have performed
an annual review and verification of your farm's continued eligibility
for the qualified exemption. Under Sec.  112.161(a)(4), these records
must be dated, and signed or initialed by the person who performed the
activity documented. Thus, we expect that the annual review and
verification document will be signed and dated by the owner, operator,
or agent in charge of the farm. We believe it is necessary for the
party responsible for the covered farm to attest to the status of the
farm with respect to the qualified exemption. As we noted with regard
to Sec.  112.161(a)(4) in the 2013 proposed rule, the signature of the
individual who made the observation (in this case, the annual review
and verification of eligibility for the qualified exemption) will
ensure responsibility and accountability. Moreover, any FDA action
related to withdrawal of the qualified exemption, if necessary,

would be directed to the owner, operator, or agent in charge of the
farm, in accordance with subpart R of part 112. In accordance with
subpart O, records required under this provision must be available and
accessible to FDA for review upon request within 24 hours (see Sec.
112.166). We will consider issuing guidance on the types of records or
documents that may be used to demonstrate a farm's status with respect
to the qualified exemption.
    We also are establishing an earlier compliance date for the records
that a farm maintains under Sec.  112.7 to support its eligibility for
a qualified exemption in accordance with Sec.  112.5. Specifically, the
compliance date for a farm to retain records to support its status
under this provision (e.g., sales receipts and other records as
applicable) is the effective date of this rule, i.e., January 26, 2016.
Farms need not comply with the requirement for a written record
reflecting that the farm has performed an annual review and
verification of continued eligibility for the qualified exemption until
the farm's general compliance date, however. Even with this earlier
compliance date for the records supporting eligibility for the
qualified exemption, we realize that although the calculation in the
codified is based on 3 calendar years, there may be circumstances where
a farm will not be required to have 3 calendar years of records as of
their general compliance date. Under such circumstances, it would be
reasonable for the farm to make the calculation based on records it has
(i.e., for one or two preceding calendar years), and we will accept
records for the preceding one or two years as adequate to support its
eligibility for a qualified exemption in these circumstances. When a
farm does not begin operations until after relevant compliance dates
have passed, it would be reasonable for the farm to rely on a projected
estimate of revenue (or market value) when it begins operations. We
would evaluate the credibility of the projection considering factors
such as the farm's number of employees. After the farm has records for
one or two preceding calendar years, it would be reasonable for the
farm to make the calculation based on records it has (i.e., for one or
two preceding calendar years) and we will accept records for the
preceding one or two years as adequate to support its eligibility for a
qualified exemption in these circumstances. See also section XXIV of
this document.

X. Subpart B--Comments on General Requirements

    In proposed subpart B of part 112, we proposed to establish the
general requirements applicable to persons who are subject to this part
(Sec.  112.11) and to establish a framework for alternatives to certain
requirements established in this part that would be permitted, under
specified conditions (Sec.  112.12). We asked for comment on all
provisions in subpart B.
    We are finalizing these provisions with revisions (see Table 8). We
discuss these changes in this section. We are finalizing the other
provisions of subpart B without change.

             Table 8--Description of Revisions to Subpart B
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.12................  --Revision to refer to new Sec.   112.49,
                                which lists all of the requirements in
                                subpart E for which we allow the use of
                                alternatives.
                               --Revision to eliminate proposed Sec.
                                112.12(a)(2), consistent with revisions
                                to proposed Sec.   112.54.
                               --Revision to replace ``listed in'' in
                                proposed Sec.   112.12(b) and (c) with
                                ``specified in'' to reflect new
                                reference to Sec.   112.49.
                               --Revision to delete ``(including the
                                same microbiological standards, where
                                applicable)'' and ``including agro-
                                ecological conditions and application
                                interval'' as unnecessary in light of
                                other revisions.
                               --Revision to clarify in Sec.   112.12(c)
                                that ``You are not required to notify or
                                seek prior approval from FDA regarding
                                your decision to establish or use an
                                alternative under this section.''
------------------------------------------------------------------------

A. General Requirement in Sec.  112.11

    (Comment 140) One comment states that the definition and
application of the term ``reasonably'' is unclear in Sec.  112.11, and
expresses concern about disagreements between farmers and FDA over what
measures are reasonably necessary to prevent the introduction of known
or reasonably foreseeable hazards and provide reasonable assurances
that the produce is not adulterated.
    (Response) In Sec.  112.3, we revised our proposed term
``reasonably foreseeable hazard'' and corresponding definition to now
use ``known or reasonably foreseeable hazard'' to mean a biological
hazard that is known to be, or has the potential to be, associated with
the farm or the food. We provide a definition for this phrase as it is
used in section 419(c)(1)(A) of the FD&C Act and reflected in several
requirements that we are establishing in part 112. The use of this
phrase in the produce safety regulation is also consistent with its use
in the PCHF and PCAF regulations.
    (Comment 141) Some comments express concern about the possibility
of indirect contamination of covered produce by animal excreta.
Comments state that animal fecal matter could reach produce through
indirect means, such as irrigation water, runoff, wind-blown dust, or
vehicles, particularly in areas where dairies and feedlots exist close
to farms producing covered produce. In addition, one comment suggests
that farms should be required to assess their farm for the possibility
of airborne contamination and should take reasonable steps to avoid it,
whereas another comment suggests that farms should assess and mitigate
the potential for contamination by runoff from storage areas.
    (Response) We agree that animal fecal matter may reach produce
through indirect means. However, various other provisions under part
112 (in particular, within subparts E and F) that focus on the safety
of agricultural water, biological soil amendments of animal origin, and
other growing considerations already address the routes of
contamination that we identified in the QAR. In addition, we have
included a requirement in Sec.  112.11, under which covered farms are
required to take appropriate measures to minimize the risk of serious
adverse health consequences or death from the use of, or exposure to,
covered produce, including those measures reasonably necessary to
prevent the introduction of known or reasonably foreseeable hazards
into covered produce, and to provide reasonable assurances that the
produce is not adulterated under section 402 of the FD&C Act on account
of such hazards. As we explained in the 2013 proposed rule, among other
things, Sec.  112.11 accounts for the variety of possible circumstances
that might arise in which unique farm circumstances

would justify preventive measures. Thus, for example, if a farm's
circumstances are such that airborne or runoff fecal contamination is a
known or reasonably foreseeable hazard to the farm's covered produce,
the farm must take those measures reasonably necessary to prevent
introduction of those hazards and to provide reasonable assurances that
the produce is not adulterated on account of those hazards.

B. General Comments About Alternatives in Sec.  112.12

    (Comment 142) Several comments spoke to the use of alternatives
generally. Some comments generally support the allowance for use of
alternatives and state that alternatives provide flexibility for
covered farms to consider and accommodate the particularities of the
commodities, practices and conditions specific to their operations and
new scientific information, as it becomes available. On the other hand,
some comments express concern that the provision on use of alternatives
is unclear, limited in scope, burdensome, and/or is not a realistic
option for farmers. One comment states that by requiring farmers to
have adequate scientific data or information to show that the
alternative would provide the same level of public health protection as
the applicable requirement, FDA is placing the burden on farmers and
private entities to conduct research on public health risks generally.
The commenter believes this is a research and investigative task that
FDA should fulfill.
    (Response) We agree that the allowance for use of alternatives in
Sec.  112.12 provides flexibility for covered farms and disagree that
the allowance for the use of alternatives is unclear, too limited in
scope, or burdensome. We are providing for the use of alternatives to
certain minimum science-based requirements that we have established in
part 112 in order to provide flexibility for farms to identify measures
that are suitable for their operations, in light of conditions,
processes, and practices on their farms and that provide the same level
of public health protection as the applicable requirement. FDA has
conducted the necessary scientific evaluation to determine reasonable
measures that are broadly applicable across a wide range of conditions,
and this scientific analysis is reflected in the codified requirements
for which alternatives are permitted. Our decision to allow the use of
alternatives in lieu of the established requirements does not negate
the underlying scientific basis upon which those requirements are
derived. Rather, we determined that, in the case of certain specified
requirements, alternative measures may be demonstrated to be
scientifically valid, considering the practices and conditions on a
farm and circumstances unique to a specific commodity or types of
commodities and in light of evolving science. FDA cannot reasonably
conduct the necessary scientific evaluation for every set of
circumstances that exist on covered farms.
    (Comment 143) Some comments assert that FDA should recognize
certain guidance (commodity-specific or otherwise), as meeting the
requirements for alternatives in Sec.  112.12. See also comments under
section IV.F of this document. For example, one comment states the
Citrus GAPs developed and implemented by the citrus industry should be
recognized by FDA as an acceptable alternative or variance under the
produce safety regulation.
    (Response) In accordance with Sec.  112.12(c), for any alternative
that you use under the provisions of Sec.  112.12(a), you must
establish and maintain documentation of scientific data or information
in support of your alternative. The scientific data or information may
be developed by you, available in the scientific literature, or
available to you through a third party. Such scientific support may be
derived from or include commodity-specific or other guidance or
recommendations (or the science underlying such guidance or
recommendations), including those developed by industry, academia,
trade associations, or other stakeholders. Such guidance or
recommendations, taken together with any other scientific data or
information on which you rely, must satisfy the requirements in Sec.
112.12(b) to support the use of the alternative.
    We decline the request that FDA recognize certain commodity-
specific guidelines developed by industry (such as the Citrus GAPs) as
an acceptable alternative to the produce safety regulation.
Alternatives are permitted for only certain of the specified
requirements of part 112, specifically related to agricultural water,
which are listed in Sec.  112.49 and cross-referenced in Sec.
112.12(a), and not for all of the provisions of the produce safety
regulation, in general. Moreover, you do not need to notify or seek
approval from FDA prior to establishing and using an alternative, and
we are revising Sec.  112.12(c) to add a sentence making this clear. To
the extent this commenter requests FDA to consider existing commodity-
specific industry guidelines under the variance provisions in subpart
P, such requests must be submitted by a State, tribe, or foreign
government to FDA using the citizen petition process in Sec.  10.30. We
ask industry to work with their relevant State, tribe, or foreign
government agencies to submit such requests to FDA, following the
provisions in subpart P of part 112.
    (Comment 144) One comment suggests that we should expand the
entities eligible to establish alternatives beyond States and foreign
governments to include entities such as commodity boards and State
associations.
    (Response) This comment appears to be confusing the provision
allowing farms to establish certain alternative standards and processes
in subpart B, Sec.  112.12, with the provisions allowing States,
tribes, and foreign governments to request variances from one or more
requirements of the rule in subpart P, Sec. Sec.  112.171-112.182.
Unlike the variance provisions, the alternative provisions do not
require submission of a request by a State, tribe, or foreign
government to FDA before a covered farm may use a procedure, process,
or practice that varies from the requirements established in this rule.
See our discussion of the variance provisions and entities eligible to
request a variance in section XXI of this document.

C. Alternatives for Additional or All Requirements

    (Comment 145) Several comments ask us to permit the use of
alternatives for all provisions of the rule, rather than to restrict
the use of alternatives to only those specified by FDA in the
regulation. Comments state that it is unclear why FDA limited the use
of alternative approaches to only the provisions listed in proposed
Sec.  112.12, and argue that the same option of using alternative
methods should be applicable to all requirements of the rule. Some
comments specifically identified provisions related to animals (subpart
I), worker health and hygiene (subpart D), microbial quality
requirements (proposed Sec.  112.44(a) for certain uses of agricultural
water and proposed Sec.  112.55 for soil amendment treatment
processes), and water testing frequency (proposed Sec.  112.45) as
additional provisions for which we should allow alternatives.
    (Response) As discussed in the 2013 proposed rule, given various
considerations, we proposed an integrated approach that draws on our
past experiences and appropriately reflects the need to tailor
requirements to specific on-farm routes of contamination. In some
cases, our standards are very similar to those contained in the Food
CGMP regulation, especially where the routes of contamination are well-
understood and

appropriate measures are well-established and generally applicable
across covered produce commodities (e.g., personnel qualifications,
training, health, and hygiene; harvesting, packing, and holding
activities; equipment, tools, buildings, and sanitation). We are not
convinced by comments suggesting that we should allow alternatives for
these types of provisions because these measures are well-established,
generally applicable, and flexible enough to apply across the spectrum
of farming conditions and practices. Moreover, these types of
provisions do not involve specific numerical criteria.
    In other cases, our standards require the farm to inspect or
monitor an on-farm route of contamination and take appropriate measures
if conditions warrant. We rely on such a monitoring approach where the
diversity of conditions that can be expected relative to an on-farm
route of contamination is very high and it would be impractical and
unduly restrictive to set out a standard that specifies the appropriate
measures for each possible circumstance (e.g., requirements for
assessment related to animal intrusion in Sec.  112.83 and inspection
of agricultural water system in Sec.  112.42). We are not convinced by
comments suggesting that we should allow alternatives for these types
of provisions because these provisions already provide built-in
flexibility as a result of their monitor-and-respond structure.
Moreover, these types of provisions do not involve specific numerical
criteria.
    In still other cases (e.g., sprouts), our standards require the
farm to develop a written plan, committing itself to specific measures
(e.g., sprout environmental testing and spent sprout irrigation water
testing). The use of written plans is important, for example, where the
details may change over time and a historical record of the evolution
of the measures is important for the operator to assess whether further
changes to the measures are needed (e.g., changes or rotation in the
sampling sites for sprout environmental testing). We are not convinced
by comments suggesting that we should allow alternatives for these
types of provisions because they also provide built-in flexibility as a
result of their structure. Moreover, these types of provisions do not
involve specific numerical criteria.
    Finally, in certain other cases, we are establishing specific
numerical standards against which the effectiveness of a farm's
measures would be compared and actions taken to bring the operation
into conformance with the standards, as necessary (e.g., standards for
agricultural water in subpart E; and standards for biological soil
amendments of animal origin in subpart F). We rely on the numerical
standards approach where our evaluation of current scientific
information to determine reasonable measures allows us to establish
numerical criteria that are broadly applicable across a wide range of
conditions, while acknowledging that such criteria may be tailored, as
appropriate, when applied specifically to a commodity (or group of
commodities) or under a set of farm practices. It is in the case of
this numerical standards approach that an allowance for alternatives
may be warranted because, under this approach, there is a concrete
measurable standard against which the effectiveness of measures that a
farm may take for its operations can be evaluated. In the absence of
specific numerical criteria, such as in the case of the other types of
provisions explained previously, the use of alternative measures would
not be needed because the standards are inherently flexible and already
allow the farm to identify and take measures tailored to the practices,
procedures, and processes specific to that farm's operations. In
addition, alternatives can potentially be warranted for provisions with
specific numerical standards in light of their relatively prescriptive
nature, the diversity of operations, and the likelihood of new or
emerging science.
    The relevant numerical requirements in Sec. Sec.  112.44(b),
112.45(b)(1)(i), 112.46(b)(1)(i) and 112.46(b)(2)(i) for which we are
allowing alternatives include measures that we conclude are appropriate
to require under a wide range of conditions. However, recognizing that
other measures, if properly validated, may also be suitable, we are
providing for the use of scientifically-supported alternatives to these
required measures.
    With respect to application intervals for certain uses of soil
amendments, in the 2013 proposed rule, we proposed specific minimum
application intervals for use of raw manure (proposed Sec.
112.56(a)(1)(i)) and compost (proposed Sec.  112.56(a)(4)(i)), and we
proposed to allow alternatives to these minimum application intervals.
However, in the supplemental notice, we proposed certain amendments to
proposed Sec. Sec.  112.56(a)(1)(i) and 112.56(a)(4)(i)) removing the
application interval requirements, which makes the corresponding
alternatives provisions unnecessary. We are finalizing Sec.  112.56
with some changes, under which alternatives continue to be unnecessary
(see section XIV.G of this document).
    For other provisions that include numerical criteria, i.e.,
Sec. Sec.  112.44(a) and 112.55, we considered and have decided that
the use of alternatives for these provisions is either not appropriate
or not necessary. Section 112.44(a) lists certain uses of agricultural
water that present a high risk because the conditions associated with
those uses of water are conducive to multiplication of pathogens, if
present. Even a low number of pathogens introduced into or onto covered
produce through contaminated water during those uses could rapidly
increase to levels that could present risk of serious adverse health
consequences or death. Therefore, we adopt an appropriately protective
generic E. coli standard (zero detectable generic E. coli per 100 mL)
for uses of agricultural water specified in Sec.  112.44(a), without
further provision for use of an alternative standard. Section 112.55
establishes the microbial standards applicable to the treatment
processes established as acceptable in Sec.  112.54. We do not intend
Sec.  112.55 to require that farms test their treated biological soil
amendments for compliance with the microbial standards. Rather, we
intend these provisions to provide the standards against which
treatment processes described in Sec.  112.54 must be validated. Farms
would be able to use treatment processes that are validated to meet the
relevant microbial standard in Sec.  112.55 without the need to test
the end products of their treatments to confirm that the microbial
standard was achieved. Because our revisions to Sec.  112.54(a) already
provide for the use of any scientifically valid, controlled treatment
processes that are demonstrated to satisfy the microbial standard in
Sec.  112.55(a) for L. monocytogenes, Salmonella spp., and E. coli
O157:H7, further provision under Sec.  112.12 for use of alternatives
is not necessary. Similarly, because in revised Sec.  112.54(b) we
already explicitly provide for the use of any scientifically valid,
controlled treatment process that is demonstrated to satisfy the
microbial standards in Sec.  112.55(b) for Salmonella and for fecal
coliforms (see Sec.  112.54(c)(3)), a corresponding alternatives
provision under Sec.  112.12 is not needed. Given these revisions to
Sec.  112.54 (see section XIV of this document), we have eliminated
proposed Sec.  112.12(a)(3) in finalizing Sec.  112.12(a).
    Furthermore, unlike alternatives, variances may be requested for
any of the provisions of part 112 under the conditions provided in
subpart P, which

involve the submission of a citizen petition by a State, tribe, or
foreign government to FDA. This process builds additional flexibility
into the rule within limits that allow for FDA to review and approve
new approaches outside the alternatives allowed by Sec.  112.12. An
allowance for alternatives to be established and used for all
provisions of part 112 would make the variance process superfluous.
    For these reasons, we do not believe it is appropriate to provide
for the use of alternatives for provisions of part 112 beyond those
listed in Sec.  112.12.

D. Additional Clarification

    (Comment 146) A number of comments ask what is meant by the
requirement in Sec.  112.12(b) that an alternative ``provide the same
level of public health protection as the applicable requirement'' and
how that is to be measured. Some comments seek clarification on the
types of scientific data and documentation necessary to support the use
of alternatives.
    (Response) Under Sec.  112.12(a), you may establish an alternative
to one or more of certain requirements established in subpart E, as
specified in Sec.  112.49. Because, for clarification, we have listed
all of the requirements in subpart E for which we permit alternatives
within new Sec.  112.49, in Sec.  112.12(a), we simply provide a cross-
reference to Sec.  112.49 rather than listing out each of the specific
requirements for which alternatives are permitted (as we did under
proposed Sec.  112.12(a)). As a conforming edit, we are changing two
occurrences of ``listed in [Sec.  112.12(a)]'' in Sec.  112.12(b) and
(c) to read ``specified in [Sec.  112.12(a)].'' As specified in Sec.
112.49, in accordance with Sec.  112.12, you may establish and use
alternatives to the following specific requirements related to
agricultural water: Sec. Sec.  112.44(b), 112.45(b)(1)(i),
112.46(b)(1)(i)(A), and 112.46(b)(2)(i)(A).
    Sections 112.44(b), 112.45(b)(1)(i), 112.46(b)(1)(i)(A) and
112.46(b)(2)(i)(A), all establish requirements for the microbial
quality, testing, and taking action based on test results when
agricultural water is used during growing operations for covered
produce (other than sprouts) using a direct water application method.
    The Sec.  112.44(b) microbial water quality criteria are a
statistical threshold value (STV) of 410 or less CFU of generic E. coli
per 100 mL of water (STV is a measure of variability of your water
quality distribution, derived as a model-based calculation
approximating the 90th percentile using the lognormal distribution) and
a geometric mean (GM) of 126 or less CFU of generic E. coli per 100 mL
(GM is a measure of the central tendency of your water quality
distribution). We are establishing these numerical criteria based on
our analysis of current scientific information; it relies on an
underlying dataset that has the necessary scientific rigor and
describes illness rates due to incidental ingestion that can be
generalized across different bodies of water. In addition, our
microbial quality criteria use generic E. coli as an indicator organism
because the intent is to detect measurable levels of fecal
contamination and monitor the microbial quality of agricultural water
(see discussion on 79 FR 58434 at 58443-445; see also (Ref. 44)).
Nevertheless, we acknowledge that circumstances unique to a farm's
operation or commodities may justify the use of an alternative
microbial quality criterion (or criteria). Under Sec.  112.49(a), you
may establish an alternative to the microbial quality criterion (or
criteria) using an appropriate indicator of fecal contamination, in
lieu of the microbial quality criteria we established in Sec.
112.44(b). We recommend that the scientific data or information to
support the use of an alternative indicator organism include peer
reviewed scientific material. An example of a potential alternative
microbial quality criterion is use of a different fecal indicator
organism as a basis for a GM and STV that are demonstrated to detect
measurable levels of fecal contamination in agricultural water used for
the purposes identified in Sec.  112.44(b). We expect any such
alternative indicator to be as sensitive to the presence and level of
fecal pollution as generic E. coli. We also expect that any alternative
microbial quality criteria that you establish and use, in lieu of the
FDA-established criteria, would be supported by an equally robust and
rigorous scientific analysis and would be quantitatively demonstrated
to be equivalent to the FDA-established criteria, thus ``providing the
same level of public health protection'' as the FDA-established
criteria and ensuring that your alternative standard would not increase
the likelihood that your covered produce will be adulterated. In
addition, for any use of an alternative indicator, you should also
consider whether the microbial die-off rate that we established in
Sec.  112.45(b)(1)(i), if you choose to apply it in conjunction with
your alternative microbial quality criteria, continues to be
appropriate.
    Similarly, under Sec.  112.49(b), you may establish an alternative
to the microbial die-off rate between last irrigation and harvest and
accompanying maximum time interval established in Sec.
112.45(b)(1)(i). The microbial die-off rate of 0.5 log per day to
determine an adequate time interval (in days) between last irrigation
with untreated water and harvest is established in Sec.
112.45(b)(1)(i). We derived this die-off rate based on a review of
currently available scientific literature, and recognize that microbial
die-off rates are dependent on various environmental factors, including
sunlight intensity, moisture level, temperature, pH, the presence of
competitive microbes, and suitable plant substrate. Generally,
pathogens and other microbes die off or are inactivated relatively
rapidly under hot, dry, and sunny conditions compared to inactivation
rates observed under cloudy, cool, and wet conditions. Our analysis led
us to conclude that a rate of 0.5 log per day provides a reasonable
estimate of microbial die-off under a broad range of variables to
include microbial characteristics, environmental conditions, crop type,
and watering frequency (see discussion on 79 FR 58434 at 58445-446; see
also (Ref. 45)). In final Sec.  112.45(b)(1)(i), we also stipulate a
maximum time interval of four consecutive days. Nevertheless, we
acknowledge that practices and conditions on a farm and circumstances
unique to a specific commodity could result in higher die-off rates
between last irrigation and harvest, especially under conditions of
high ultraviolet radiation, high temperature exposures or low humidity,
coupled with little or no precipitation and, therefore, we are
providing for the use of appropriate alternative microbial die-off
rate(s) and an accompanying maximum time interval. We expect that any
alternative microbial die-off rate between last irrigation and harvest,
and an accompanying maximum time interval, that you establish and use,
in lieu of the FDA-established requirement, would be supported by an
equally robust and rigorous scientific analysis specific to the region
and crop, and would be quantitatively demonstrated to be equivalent to
the FDA-established standard, thus ``providing the same level of public
health protection'' as the FDA-established standard and ensuring that
your alternative standard would not increase the likelihood that your
covered produce will be adulterated.
    In Sec.  112.49(c) and (d), we are providing for the use of
alternative water testing frequency in lieu of the FDA-established
required number of samples for the initial survey (established in Sec.
112.46(b)(1)(i)(A)) and

the annual survey (established in Sec.  112.46(b)(2)(i)(A)) for the
testing of untreated surface water. In the 2013 proposed rule, we
proposed specific numerical requirements for frequency of testing
agricultural water when used during growing in a direct water
application method, and we did not propose to allow alternatives to
these testing frequencies. In the supplemental notice, we made these
requirements more flexible by proposing a tiered approach to testing
untreated surface water used for this purpose (proposed Sec.
112.45(b)), which we are retaining with some changes (final Sec.
112.46(b)). This approach allows farms to make decisions about safe use
of available water sources prior to the beginning of the next growing
season; adjust testing frequencies dependent on long-term test results;
and ultimately reduce the required frequency of testing. Among the
testing requirements in Sec.  112.46(b), we specify that a certain
specified minimum number of samples must be collected for the initial
and annual surveys. We derived these minimum testing frequencies (i.e.,
the minimum number of samples) from our statistical analysis based on
average variability among surface water sources (i.e., a standard
deviation of 0.4) (Ref. 99). In our review of available information
(Ref. 44) (Ref. 99), we cited that among the water bodies studied by
EPA in developing the recreational water quality criteria, EPA reported
an estimate of average standard deviation of log E. coli abundance
measurements in surface waters is 0.4 (Ref. 100). We acknowledge that
circumstances unique to the variability of the microbial quality of a
farm's water source may justify the use of an alternative water testing
frequency. Therefore, if a covered farm determines through analysis of
historical samples that the standard deviation of log10 E.
coli abundance measurements for their surface water source(s) is less
than 0.4 and the difference is statistically significant, then the farm
could utilize the lower variability rate to determine the appropriate
minimum number of samples necessary to establish and characterize the
microbial quality of the farm's water source(s). We expect that any
alternative frequency of testing that you establish and use, in lieu of
the FDA-established minimum number of samples in Sec.
112.46(b)(1)(i)(A) or 112.46(b)(2)(i)(A), would be supported by an
equally robust and rigorous scientific analysis and would be
quantitatively demonstrated to be equivalent to the FDA-established
testing frequency, thus ``providing the same level of public health
protection'' as the FDA-established standard and ensuring that your
alternative standard would not increase the likelihood that your
covered produce will be adulterated. Note also that this allowance for
use of an alternative testing frequency relates only to the minimum
number of samples required under Sec.  112.46(b)(1)(i)(A) and
112.46(b)(2)(i)(A), and does not extend to the other required elements
of testing, specified in Sec.  112.46(b). Likewise, we are not
providing for an alternative to the testing frequency specified in
Sec.  112.46(b)(1)(i)(B) or (b)(2)(i)(B) for the testing of untreated
ground water when used during growing in a direct water application
method because ground water sources are less influenced by external
sources and, therefore, their water quality is less variable, and we
conclude the testing frequency we established in Sec.
112.46(b)(1)(i)(B) and (b)(2)(i)(B) is the minimum necessary to ensure
the quality of ground water sources for that purpose.
    These provisions for use of alternatives are also responsive to
comments that expressed concern about FDA-established quantitative
metrics for water quality or testing in the regulation because the
commenters believed such generally-applicable numerical criteria may
not adequately take into account the unique circumstances related to
different commodities or practices. The allowance for alternatives also
responds to comments that urged us to incorporate flexibility in any
established requirement to allow for appropriate changes to the
microbial quality standards based on advances in scientific information
on water quality. In light of the specific provisions for which we are
allowing alternatives in this rule, we are deleting two phrases from
proposed Sec.  112.12 as unnecessary: ``including meeting the same
microbiological standards, where applicable,'' and ``including agro-
ecological conditions and application interval.''
    The scientific analysis on which you rely may be developed by you,
available in the scientific literature, or available to you through a
third party. It does not need to be published in a peer-reviewed
journal, although we encourage use of peer-reviewed data and
information, to the extent available.
    FDA is collaborating with partners on research that will add to the
scientific information that may help inform specific alternatives. For
example, in an effort to support scientific research in the area of
agricultural water, one of FDA's Centers of Excellence, the Western
Center for Food Safety at University of California, Davis, partnered
with the Center for Produce Safety to provide seed money through a
competitive grants program to fund produce safety projects focused on
agricultural water issues that are topical and/or region specific.
Research areas that have received funding through this process include
transfer and survival of organisms on produce after exposure from
contaminated surface irrigation water, application of biocide
technology on manure-contaminated irrigation water, the potential role
of overhead sprinkler irrigation systems in the contamination of
produce, and the survival of pathogens during the growing, harvesting,
and storage of dry bulb onions after exposure with contaminated water.
We intend to disseminate useful scientific information, when available,
and issue commodity- and region-specific guidance as appropriate, such
that farmers would be able to consider our recommendations and apply
the new scientific information to their operations, as appropriate.
    (Comment 147) Some comments recommend that FDA specifically state
that individual producers or commodities, where there is commonality,
should be able to rely on scientifically credible research and
publications of commodity boards and trade associations that support
potential alternative measures.
    (Response) In Sec.  112.12(c), we provide that the scientific data
and information used to support an alternative may be developed by you,
available in the scientific literature, or available to you through a
third party. The scientific support you rely on to justify the use of
an alternative can be developed by third parties such as industry or
trade associations and commodity boards. You may establish the
alternatives under Sec.  112.12 for which you have adequate data and
information to support a conclusion that the relevant standards are met
in light of your covered produce commodities, practices, and
conditions, in accordance with Sec.  112.12(b). Thus, you must take
your farm's specific commodities, practices, and conditions into
account when evaluating the relevant scientific information. There may
be circumstances in which scientific data and information specific to
one commodity may be appropriately applied to other commodities,
conditions, or practices, allowing that data to support alternatives
across multiple commodities, conditions, or practices. However, such
generalizations may not always be appropriate. We also intend to

disseminate useful scientific information, when available, and issue
commodity- and region-specific guidance as appropriate, such that
farmers would be able to consider our recommendations and apply the new
scientific information to their operations, as appropriate.

E. Prior Approval of Alternatives

    (Comment 148) Some comments request us to provide a voluntary
process for pre-approval of alternatives, either by FDA or by
recognition of private sector experts. These comments seek protection
for farms using pre-approved alternatives, as well as guidance for
farmers and researchers to follow when developing alternatives that
will meet FDA standards. Similarly, one comment suggests amending
proposed Sec.  112.12 to specifically state that use of alternative
procedures does not require prior approval by FDA.''
    (Response) We are not requiring you to notify or seek prior
approval from FDA regarding your decision to establish or use an
alternative or to otherwise submit relevant scientific data or
information to FDA prior to using an alternative. We are adding an
explicit statement to Sec.  112.12 that FDA pre-approval of
alternatives is not required. However, we note that if FDA determines
that the use of an alternative is not in compliance with the provisions
of Sec.  112.12, FDA may take enforcement or other action, as
appropriate. However, we are requiring that you maintain a record of
any such scientific data or information, including any analytical
information, under Sec.  112.12(c), and make such data and information
available to us to evaluate upon request, under Sec.  112.166. We are
not establishing a voluntary pre-approval process; however, FDA intends
to continue encouraging and supporting development of useful scientific
data and information, as well as conducting significant education and
outreach related to this rule. We also intend to disseminate useful
scientific information, when available, and issue commodity- and
region-specific guidance as appropriate, such that farmers would be
able to consider our recommendations and apply the new scientific
information to their operations, as appropriate.

XI. Subpart C--Comments on Personnel Qualifications and Training

    In subpart C of proposed part 112, we proposed minimum standards
directed to personnel qualifications and training that are reasonably
necessary to minimize the risk of serious adverse health consequences
or death from the use of, or exposure to, covered produce, including
those reasonably necessary to prevent the introduction of known or
reasonably foreseeable hazards into covered produce, and to provide
reasonable assurances that the covered produce is not adulterated under
section 402 of the FD&C Act. We asked for comment on our proposed
provisions, including the proposed requirements for training on
principles of food hygiene and food safety and the feasibility of the
proposed training requirements, particularly with respect to harvest
activities.
    We are finalizing these provisions with revisions (see Table 9). We
discuss these changes in this section. For Sec.  112.23, we did not
receive any comments or received only general comments in support of
the proposed provision and, therefore, we do not specifically discuss
this provision.

             Table 9--Description of Revisions to Subpart C
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.21(a).............  --Revision such that required training
                                must be repeated periodically
                                thereafter, at least once annually.
Sec.   112.21(b).............  --Revision to require that personnel must
                                have a combination of education,
                                training, and experience necessary to
                                perform the person's assigned duties.
Sec.   112.22................  --Revision to change ``should'' to
                                ``must'' in Sec.   112.22(b)(1).
Sec.   112.30................  --No change.
------------------------------------------------------------------------

A. General Comments

    (Comment 149) One comment expresses concern that under subpart C,
as proposed, agricultural workers are viewed as ``disease vectors'' and
a ``potential pathway for contamination'' rather than as ``fundamental
partners.''
    (Response) Agricultural workers are invaluable and fundamental
partners in ensuring food safety on the farm. However, as discussed in
the 2013 proposed rule, it is well-documented in the scientific
literature that bacteria, viruses, and parasites are frequently
transmitted from person to person and from person to food. In addition,
our QAR demonstrates that humans (i.e., workers and visitors) are
potential carriers of foodborne pathogens and can be a source of
contamination of produce. Therefore, farm workers need training on the
importance of health and hygiene. In addition, employees need training
on subparts C through O that are applicable to the employee's job
responsibilities and on how to recognize and prevent potential
contamination problems (e.g., a leafy green vegetable contaminated with
manure, contaminating the water supply during sample collection for
testing, etc.) and to be trained to know what to do when those
situations present themselves. The farm worker is a key component in
the food chain for ensuring the safety of covered produce.
    (Comment 150) Several comments object to proposed subpart C based
on the size of the farm or number of full-time employees.
    (Response) We have considered the burden to small businesses and
provided sufficient flexibility within the final rule to be practicable
for different sizes and types of businesses, including for small and
very small businesses. See section IX.C of this document. We do not
agree that additional flexibility should be incorporated by exempting
farms from the training requirements based on the size of the business.
Training farm workers is important regardless of the size of the farm.
    (Comment 151) Two commenters question the need for the provisions
in subpart C and state that a farm should instead be responsible for
developing its own training programs that are shown to meet specified
regulatory outcomes.
    (Response) The requirements in part 112 do not preclude farmers or
industry associations from developing training materials or programs
uniquely suited to their commodities or operations; however, we have
determined that the training must cover the specified topics in order
to ensure that farm workers have sufficient training.
    (Comment 152) Some comments recommend that we develop a process or
system whereby workers who are properly trained would receive a
``training certificate'' or a ``food safety certificate,'' which
commenters believe would be particularly useful for workers

who work on multiple farms during the year. These comments suggest that
such certificates may be received (and updated) after undergoing
training using an FDA-approved standardized curriculum or an equivalent
curriculum. According to these comments, such a certificate could be
valid for a harvest season or a calendar period, such as one year, and
could also be valid for multiple crops of a similar nature, such as all
deciduous tree fruits. Some comments state that a certificate should
not obviate the need for training upon hire, at the beginning of each
growing season and periodically thereafter, but could provide covered
farms with a better sense of the food safety capacity of their
workforce.
    (Response) We see the value of workers receiving a ``training
certificate'' or a ``food safety certificate'' documenting the training
they have received. However, at this time, we are not requiring use of
such a program (either as a new requirement or to satisfy any of the
requirements of this rule), nor are we able to develop such a system or
recommend a specific certification process or certification body to
enable such an approach. Note, under Sec.  112.30(b)(1), you must
establish and keep records of training that document required training
of personnel, including the date of training, topics covered, and the
persons(s) trained. We are willing to work with an organization that is
interested in developing and implementing a training certification
program, including through the PSA and SSA and using corresponding
training materials.
    (Comment 153) Some comments urge the use of Web site(s) (or web-
based training) for educating employees about food safety and hygiene
as a means to reduce the cost burden of training requirements,
especially for smaller farms. One comment notes the advantages of using
online resources, including that it can be continuously updated over
time.
    (Response) Internet-accessible training materials are a convenient
way for workers, supervisors, and other farm staff to obtain rapid
access to training materials and other resources. We are considering
whether and to what extent the Alliance courses can be made available
online or offered as Internet-based training. At a minimum, we will
make the standardized curriculum available online.
    (Comment 154) One comment (from a foreign government) requests that
we provide training materials or guidelines to the foreign government
in a timely manner so relevant parties (including manufacturers,
exporters, and regulators) can understand and properly implement the
rule.
    (Response) We are working to ensure the Alliance courses and
training resources to be generated by the NCC and RC are consistent
with the requirements of this rule. We intend to publish a notice of
availability of these documents in the Federal Register, and our
domestic and foreign stakeholders will be informed of and have access
to these documents. We will partner with our foreign government
counterparts as well as industry stakeholders to identify areas for
outreach and technical cooperation to achieve greater understanding and
implementation of the Produce Safety standards. In this regard,
organizations such as the PSA, SSA, and JIFSAN can aid in providing
appropriate qualification and training materials for foreign
governments as well as training of foreign industry entities.

B. Qualification and Training for Personnel Who Handle (Contact)
Covered Produce or Food-Contact Surfaces (Sec.  112.21)

    (Comment 155) Some comments suggest exceptions to proposed subpart
C based on types of employees. Although many commenters believe all
types of employees should be covered by the provisions, including
temporary, part-time, seasonal, and contracted employees, some other
commenters believe complying with proposed subpart C would be
prohibitively difficult and, therefore, certain types of employees
should be exempted. Comments state that requiring seasonal training for
all employees, including long-term, non-seasonal workers, is
unnecessary and wasteful. One commenter believes that training should
not be required ``periodically'' but instead only for new hires, when
rules are changed, or when problems are observed. Another comment is
additionally concerned that, because the term ``season'' is not
defined, the mandatory training provisions might be interpreted to
require a separate training for each crop, some of which may have short
planting-harvest cycles.
    (Response) We continue to believe that adequate and appropriate
training of all personnel who handle covered produce or food-contact
surfaces, or who are engaged in the supervision thereof, is an
essential component of standards for produce safety. Therefore, we
disagree that certain types of farm workers should be exempt from a
requirement that they receive training. Rather, we agree the content of
the required training can be tailored to the specific duties of the
type of farm worker or supervisor. Under Sec.  112.21, all personnel
(including temporary, part time, seasonal and contracted personnel) who
handle (contact) covered produce or food-contact surfaces and their
supervisors must receive training that is appropriate to the person's
duties (Sec.  112.21(a)), and must have a combination of education,
training, and experience to perform their assigned duties in a manner
that ensures compliance with part 112 (Sec.  112.21(b)).
    With respect to the comments about when training should be
conducted, all personnel who contact covered produce and food-contact
surfaces must receive training when hired, before they participate in
the growing, harvest, packing or holding of covered produce in which
they contact covered produce, and must be periodically reminded about
the need to follow these practices through refresher training. However,
we acknowledge the concerns raised by commenters about our proposed
requirement that training must be conducted at the beginning of each
growing season, if applicable. We agree that requiring all personnel to
receive training at the beginning of each growing season could be
unduly burdensome for certain farms, such as those that grow multiple
crops annually, grow crops with short harvest cycles, or grow certain
types of year-round crops with no set growing season. Therefore, in
lieu of the proposed requirement to train workers at the beginning of
each growing season if applicable, we are revising the requirement to
specify that periodic training must be conducted at least once
annually. This requirement is in addition to the training that is
conducted at the time of hiring. Periodic training can be conducted at
a time that is appropriate, but must be conducted at least once
annually. This allows farms to take into account such issues as the
crop cycle, type and number of crops grown and harvested, and the
timing when employee was hired and initially trained. As discussed in
the 2013 proposed rule, periodic training serves to remind employees of
the proper procedures including any changes in those procedures. Such
updates may not need full training sessions, but only short descriptive
sessions to ensure that all personnel remain aware of all procedures
necessary to maintain the safety of produce.
    (Comment 156) One comment asks us to recognize that ``education or
experience'' can replace the need for specific training.
    (Response) As discussed in the 2013 proposed rule, the standards in
subparts

C through O often involve action by farm personnel (e.g., assessment
for animal intrusion, inspecting agricultural water system) that
require specific knowledge, skills, and abilities, without which the
standard cannot be properly achieved. Therefore, it is important those
farm personnel have the training so they will have the necessary
knowledge, skills, and abilities to perform their duties. In addition,
experience at farming does not necessarily convey knowledge of food
safety, particularly of microbial food safety hazards, and therefore
specialized training is needed to address the specific concerns of on-
farm food safety. Consequently, we disagree with the suggestion that
education or experience can serve as a substitute for appropriate
training.
    (Comment 157) Some comments seek clarification on whether ``pick-
your-own'' farms would be required to provide training to customers who
pick their own produce.
    (Response) We are establishing requirements for training of on-farm
personnel. We are not establishing any requirements for training of
visitors or customers at any farm, including at a ``pick-your-own''
farm. However, we note that this rule requires, in Sec.  112.33, that
covered farms make visitors aware of policies and procedures to protect
covered produce and food-contact surfaces from contamination by people
and take all steps reasonably necessary to ensure that visitors comply
with such policies and procedures, and make toilet and hand-washing
facilities accessible to visitors. As discussed in section XII of this
document, for example, a ``pick-your-own'' farm could comply with these
requirements by indicating the location of restrooms and hand-washing
facilities that are accessible to visitors, and by clearly posting such
information where it is likely to be seen and read by visitors at the
beginning of their visit to the farm, such as near the entrance or a
cash register of the farm.
    (Comment 158) One comment states people harvesting remnant crops
following the main harvest for non-profit organizations (referred to as
``gleaners''), often for donation to food banks, should not be subject
to training requirements. Another comment states that in scenarios
where a farm has completed its main harvest, and a third party
purchases and harvests the remaining unharvested crop, it should be the
responsibility of the remnant harvesting entity to ensure that their
harvesters are appropriately trained.
    (Response) An operation that harvests crops but does not grow them,
such as a ``gleaner'' operation or other remnant harvester operation,
may meet the revised definition of ``farm'' as established in the PCHF
regulation and as we are establishing it in this rule (see definition
of ``farm'' in Sec.  112.3(c)). While we are not exempting operations
that harvest remnant crops from the provisions of part 112, we believe
that it is likely that most such operations (including those who do so
for donation to food banks) will not be covered by this rule because
they will have $25,000 or less in annual sales of produce or will be
eligible for a qualified exemption. Specifically, in response to the
comment about harvesting remnant crops, we expect those farms
conducting the covered activities (harvesting of remnant crop and any
subsequent packing or holding) to comply with the applicable
requirements of the rule. Personnel employed by such entities must be
trained appropriately.
    (Comment 159) One comment states that, when a farm contracts with
another company for a contracted harvest crew, the company providing
the harvest crew should be responsible for the initial, more
comprehensive, food safety training, and the harvest crew should be
made aware of food safety specifics at each farm at which they are
harvesting, including standard operating procedures specific to the
farm.
    (Response) Where a covered farm uses contracted harvest crews to
harvest covered produce on the farm's behalf, the farm continues to be
required to fulfill all relevant duties applicable under this rule.
Thus, the farm is responsible for ensuring that the harvest crew has
received required training. The farm may rely on the company that
provides the harvest crew to provide or conduct the training, or the
farm may provide or conduct the training. For example, if the harvest
crew company provides training to workers who move from farm to farm
under the employment of the harvest crew company, farms that employ
such harvest crews may choose to rely on the harvest crew company to
provide or conduct the training, request relevant certification from
the harvest crew company, and maintain appropriate records to
demonstrate compliance with the applicable training requirements.
    In addition, as discussed previously, an operation that harvests
crops but does not grow them, such as a contract harvest crew company,
may meet the revised definition of ``farm'' as established in the PCHF
regulation and as we are establishing it in this rule (see definition
of ``farm'' in Sec.  112.3(c)). Thus, if they are covered farms,
contracted harvest crew companies also have duties to comply with this
rule.
    (Comment 160) Some comments object to the ``education or
experience'' clause in proposed Sec.  112.21(b). Comments argue the
level of education or experience that would satisfy this requirement is
unclear, and it would unnecessarily limit the pool of workers eligible
to work on farms. One comment further notes a requirement for
``experience'' would, by definition, preclude inexperienced workers
from seeking such employment, although training could provide the
knowledge necessary to perform tasks appropriately. A few comments
recommend revising this provision to use the phrase ``must have the
training, education or experience to perform the person's assigned
duties'' whereas others recommend incorporating flexibility for
personnel to be ``otherwise qualified through job experience'', in the
same manner as allowed in 21 CFR parts 120 and 123 and in the proposed
human preventive controls rule.
    (Response) We are revising this provision to require that personnel
have ``a combination of education, training, and experience necessary
to perform the person's assigned duties in a manner that ensures
compliance with this part.'' This provides flexibility for how
personnel are qualified to perform their duties. Depending on the job
duties, this could include training (such as training provided on-the-
job), in combination with education, or experience (e.g., work
experience related to an employee's current assigned duties).
    (Comment 161) Several comments support making the trainings easily
accessible and understood by all employees, regardless of native
language or education level. One comment asks that we provide, via
guidance, specific examples, such as pictograms, that can help
facilitate understanding across language barriers.
    (Response) We recognize that the goals of training cannot be
achieved if the persons receiving the training do not understand the
training. Training could be understood by personnel being trained if,
for example, it was conducted in the language that employees
customarily speak and at the appropriate level of education. In some
cases, it may be necessary to use easily understood pictorials or
graphics of important concepts. The PSA and SSA are developing training
materials to be easily understood by farm workers of different
languages, literacy, and educational levels by using pictorials or
graphics of important concepts, along with offering the materials in
multiple languages.

C. Training Personnel Who Conduct a Covered Activity (Sec.  112.22)

    We are revising Sec.  112.22(b)(1) to replace ``covered produce
that should not be harvested'' with ``covered produce that must not be
harvested'' to reflect the mandatory nature of the requirements in this
rule and specifically, the requirements of Sec.  112.112.
    (Comment 162) Several comments request that we recognize existing
food safety education and training programs that either meet or exceed
the PSA materials, as an efficient way to gain compliance with subpart
C. One comment asks that FDA allow existing educational programs that
wish to gain equivalency with PSA materials to be able to modify their
materials and program structure to fit the PSA learning objectives,
rather than be required to adopt the exact format and materials
developed by the PSA. The commenter further requests us to provide
guidance on how existing programs can obtain equivalency with the PSA
standardized curriculum, when it becomes available. Still other
comments request that FDA develop approved curricula to meet the
training requirements under subpart C. Yet another comment asks whether
and what accreditation FDA would accept for training of on-farm
trainers.
    (Response) See our response to Comment 3. The PSA and SSA training
materials will include a standardized curriculum. FDA is working with
the PSA and SSA to ensure that FDA will be able to recognize this
curriculum, once developed, as adequate (see requirement under Sec.
112.22(c)). We expect this standardized curriculum to be available in
time for covered farms to be able to use it, as they work toward
achieving compliance with the produce safety regulation. Under Sec.
112.22(c), at least one supervisor or responsible party for your farm
must have successfully completed food safety training at least
equivalent to that received under standardized curriculum recognized as
adequate by FDA. Accordingly, successful completion of training using
the standardized curriculum by your farm personnel (at a minimum, by
one supervisor or responsible party for your farm) is sufficient to
satisfy the requirements of Sec.  112.22(c). Alternatively, at least
one supervisor or responsible party for your farm must successfully
complete training using any other training material or program,
provided such training is at least equivalent to the standardized
curriculum, and all of your other farm personnel must be trained in
accordance with Sec.  112.22(a) and, as applicable, Sec.  112.22(b). We
encourage trainers outside the PSA and SSA to evaluate their courses
against the PSA and SSA materials when they become available and to
modify or adapt curricula, where necessary, to ensure that they are
consistent with, and provide at least an equivalent level of
instruction to, the Alliance courses. We agree that existing programs
can modify their training program structures and curriculum to ensure
consistency with, and provide at least an equivalent level of
instruction to, the standardized curriculum without necessarily
adopting the PSA or SSA training structure or materials. We also intend
to fund the development of certain alternate training programs for
specific target audiences through cooperative agreements. The agency
will work closely with the participants in those agreements and expects
to recognize the training programs that are developed through these
collaborations. We intend that the standardized curricula being
developed by the Alliances and the alternate curricula to be developed
through cooperative agreements are the only ones that will be
officially recognized by the FDA. We emphasize, however, that official
recognition by FDA is not required for training curricula to be ``at
least equivalent to that received under standardized curriculum
recognized as adequate by the Food and Drug Administration'' as stated
in Sec.  112.22(c). Any training curricula that are at least equivalent
to the officially recognized curriculum satisfy this requirement. We
have no plans to establish an accreditation system for the training of
on-farm trainers, although it is an area that is being explored through
the PSA and SSA.
    (Comment 163) Some comments ask for clarification on the content of
the food safety training based on the standardized curriculum
recognized by FDA. One comment asks FDA to better define the elements
of ``food hygiene and food safety'' that should be covered in
comprehensive training, and offers suggestions on such elements.
    (Response) FDA concludes that the broad topic areas addressed in
Sec.  112.22(a) are those minimum topic areas necessary to be covered
during training for all employees who handle or contact covered
produce. Training in the principles of food hygiene and food safety is
a necessary component of such required training because it will provide
an overall framework for job performance. We expect the standardized
curriculum, when it becomes available, will provide information about
the content to be covered under these minimum required topic areas,
including with respect to principles of food hygiene and food safety.

D. Records Related to Personnel Qualifications and Training (Sec.
112.30)

    (Comment 164) One comment states it is not reasonable for