November 13, 2013 Division of Dockets Management (HFA-305) Foo an Dr!

g A ministration 5"30 Fis#ers $ane, %m& 10"1 %ockvi''e, MD 205(2 Docket Nos& FDA-2011-N-0)21 an FDA-2011-N-0)20 * %+N 0)10-A,35 an %+N 0)10-A,3" -!bmitte e'ectronica''. via #tt/0**111&reg!'ations&gov Re: Comments on the proposed rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; and comments on the proposed rule for Current Good Manufacturing Practice and Ha ard !nal"sis and Risk#$ased Preventive Controls for Human %ood 2o 3#om +t Ma. 4oncern0 Farm Ai /rovi es t#e fo''o1ing comments on t#e Foo an Dr!g A ministration5s (FDA) /ro/ose r!'e for -tan ar s for t#e ,ro1ing, Harvesting, 6acking, an Ho' ing of 6ro !ce for H!man 4ons!m/tion (t#e 6ro !ce %!'e) an t#e /ro/ose r!'e for 4!rrent ,oo Man!fact!ring 6ractice an Ha7ar Ana'.sis an %isk-8ase 6reventive 4ontro's for H!man Foo (t#e 6reventive 4ontro's %!'e)& Farm Ai 1as fo!n e in 1)(5 to kee/ fami'. farmers on t#e 'an an s!//ort a t#riving s.stem of fami'. farm agric!'t!re in America& 3e #ear from farmers ever. a. on o!r 1-(00FA%M-A+D #ot'ine an 1e connect farmers to t#e reso!rces t#e. nee to t#rive via o!r Farmer %eso!rce Net1ork (#tt/0**i eas&farmai &org)& For over 2( .ears, 1e #ave /artnere 1it# grassroots organi7ations an farm service /rovi ers nation1i e to a vocate for fair farm /o'icies t#at s!//ort farmers an ranc#ers of a'' t./es an si7es& Farm Ai #as raise more t#an 9:3 mi''ion to /romote a strong an resi'ient fami'. farm s.stem of agric!'t!re, one t#at ste1ar s o!r nat!ra' reso!rces an benefits 'oca' economies, r!ra' comm!nities an /!b'ic #ea't#& A #ea't#. an safe farm an foo s.stem is t#e core of o!r vision& Farm Ai be'ieves foo safet. meas!res m!st com/'ement innovation an entre/rene!rs#i/ in agric!'t!re& 3e are /rimari'. concerne t#at FDA5s foo safet. reg!'ations a//'. to farmers of a'' kin s, an are /artic!'ar'. concerne abo!t t#e r!'es5 im/act on sma'' an mi -si7e fami'. farmers, s!stainab'e an organic farmers, va'!e-a e b!sinesses, an a range of innovative foo an farm b!sinesses, a'' of 1#ic# are reb!i' ing more 'oca'i7e an s!stainab'e foo s.stems& 3e /rovi e comments on t#e /ro/ose 6ro !ce %!'e an t#e /ro/ose 6reventive 4ontro's %!'e be'o1& ;e. concerns are to maintain an integrate an f'e<ib'e reg!'ator. frame1ork as man ate b. 4ongress= t#at t#e co-management of conservation, environmenta' an /!b'ic #ea't# consi erations is s!//orte = t#at t#e r!'es are consistent 1it# Nationa' >rganic 6rogram reg!'ations= an to a//'. smart e<em/tions an c'assifications t#at ref'ect t#e rea'it. of farm 'ife, foo safet. risk, an best target /recio!s FDA reso!rces& 2#ese im/rovements m!st be ma e in or er for t#ese reg!'ations to 1ork for t#e f!'' iversit. of farms across t#e co!ntr., an to ens!re t#e contin!e s!ccess of resi'ient farming s.stems an 'oca' markets to effective'. /romote /!b'ic #ea't#& ,iven t#e 'arge n!mber of serio!s /rob'ems in t#e /ro/ose r!'es, it is o!r strong vie1 t#at FDA s#o!' re'ease a secon , s!bstantia''. revise set of /ro/ose r!'es for /!b'ic comment before fina'i7ing t#ese reg!'ations& An interim fina' r!'e for /!b'ic comment 1o!' not be

satisfactor. beca!se it 1o!' trigger im/'ementation of a ver. f'a1e set of r!'es& 2#ank .o! for consi ering Farm Ai 5s comments& -incere'., 4aro'.n M!gar ?<ec!tive Director, Farm Ai

Comments on the Proposed Produce Rule Comments on the Overall Regulatory Framework
A. An Integrated Approach to the Produce Rule is the Correct Approach In the proposed Produce Rule, FDA has implemented part of the requirement from the Food Safety Modernization Act (FSMA to !minimize, as appropriate, the number of separate standards that apply to separate foods" (P#$# %%%&'(', ) %*((a (c (% (D # Specifically, FDA has ta+en an !inte,rated approach" and has not set forth separate standards for separate foods (-ith the sole e.ception of sprouts in the proposed Produce Rule# /e support this# It is Farm Aid0s 1ie- that an inte,rated approach is critical to ensurin, produce re,ulations -or+ for di1ersified farmers, a cohort of producers -ho are introducin, -elcomed inno1ation to our a,ricultural landscape# 2he re,ulations -ould 3e e.tremely 3urdensome for farmers -ith hi,hly di1ersified operations if FDA set separate standards for different commodities# Recommendation: FDA should retain its !inte,rated approach" in the final Produce Rule and should not ta+e a commodity&specific approach# B. The ross !ales "#emption should apply solely to Covered Produce as provided $y F!%A

Farm Aid 3elie1es food safety measures must account for inno1ation and entrepreneurship in a,riculture at a time -hen family farmers of all types and sizes are stru,,lin, in an economy -ith e1er&ti,htenin, profit mar,ins# It is not uncommon for Farm Aid to recei1e a crisis call on our %&4**&FARM&AID hotline from a dairy farmer -ith ,ross sales that -ould classify him as a lar,e family farm or e1en a 1ery lar,e family farm, 3ut is hardly turnin, a profit# 5is a3ility to di1ersify his 3usiness 3y respondin, to local mar+et demand for fresh fruit or 1e,eta3les -ould 3e stifled 3y hi,h compliance costs if forced to comply -ith the full Produce Rule as -ritten# 61en those already producin, a di1ersified selection of fruits and 1e,eta3les to meet local mar+et demand -ill suffer economic harm that threatens their 3usiness and li1elihood as a result of the hi,h costs of compliance# /hen -ritin, FSMA, 7on,ress re8ected a !one&size&fits&all" approach and pro1ided FDA -ith fle.i3ility to ensure that the Produce Rule -or+ed for a di1ersity of farmin, operations# Specifically, FSMA requires FDA to !provide sufficient flexibility to be applicable to various types of entities engaged in production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities" (P#$# %%%&'(', ) %*((a (a (' (A # In its proposed rule, FDA e.empts farms -ith an a1era,e annual monetary 1alue of food sold durin, a pre1ious three&year period of 92(,*** or less# FDA tentati1ely concludes that ! farms with $25,000 or less in sales do not contribute significantly to the produce market and that they account for only !"5# of covered produce acres" (:4 F#R# '(;< # 2his e.emption is consistent -ith 7on,ress0 mandate to create ris+&3ased requirements reflectin, a di1ersity of farmin, systems# Farms eli,i3le for this e.emption represent a tiny fraction of the food supply and should not 3e re,ulated under the Produce Rule# 5o-e1er, FDA should focus the e.emption on the value of covered produce# 2his distinction pro1ides some fle.i3ility for 3e,innin, farmers, non&produce farmers tryin, to di1ersify, and family farmers -ho run di1ersified operations# /hile the FSMA statute may require !all food" to 3e counted a,ainst the t-o&part eli,i3ility test for farms and facilities eli,i3le for modified requirements, that same restriction clearly does not apply in this case# Recommendation: FDA should retain the 92(,*** e.emption in the final Produce Rule 3ut should 3ase it on the value of produce co1ered 3y the Produce Rule produced on the farm and not the 1alue of food, as

'

defined in ) 2*%(f of the Federal Food, Dru,, and 7osmetic Act and referenced in ) %%2#'(c of the proposed Produce Rule, sold 3y the farm# C. Re&uiring Food !a'ety Plans and on 'arm Registration is Inconsistent with F!%A In the pream3le, FDA requests comment on -hether the a,ency ! should re$uire, in a final rule, some or all covered farms to perform operational assessments and%or develop a food safety plan, and any criteria that should be employed to determine which farms should be sub&ected to such a re$uirement " (:4 F#R# '=%< # Additionally, FDA requests comment on -hether the a,ency ! should re$uire, in the final rule, that covered farms, as described in proposed ' !!2"()a*, register with +,-" (:4 F#R# '=%< # FSMA does not authorize FDA to require farms to perform operational assessments or de1elop food safety plans# 7odifyin, this requirement 1ia re,ulation -ould 3e inconsistent -ith the statute and -ould increase costs of compliance for co1ered farms, -ould further decrease the fle.i3ility of the re,ulations, and -ould ris+ applyin, a !one&size&fits&all" approach that 7on,ress clearly re8ected# 2here are se1eral non& ,o1ernmental or,anizations, farm ,roups, and pri1ate 3usinesses that are -or+in, -ith farmers on appropriate food safety plannin,, (se1eral of -hich Farm Aid has supported and funded and that -or+ should 3e allo-ed to continue outside of the scope of federal re,ulations# FSMA does not authorize FDA to require farms to re,ister -ith FDA# In the pream3le, FDA fails to esta3lish ho- requirin, farms to re,ister -ould contri3ute to impro1ed food safety outcomes in produce production# /ithout a ro3ust 8ustification, and -ith no le,al 3asis for requirin, re,istration, FDA cannot require farms to re,ister# Recommendation: FDA should not require farms to perform operational assessments or de1elop food safety plans in its final Produce Rule# FDA should not require farms to re,ister -ith FDA in the final Produce Rule# (. The scope and magnitude o' pro$lems in the Proposed Rule re&uire promulgation o' a !econd Proposed Rule FDA0s proposed Produce Rule fails to meet a num3er of the si,nificant requirements of FSMA# FSMA requires FDA to>
6sta3lish !minimum science.based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks" (P#$# %%%&'(', ) %*((a (3 (% # !/rovide sufficient flexibility to be applicable to various types of entities engaged in production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities" (P#$# %%%&'(', ) %*((a (a (' (A #

2he proposed produce standards are not sufficiently supported 3y adequate scientific e1idence, and are not supported 3y a quantitati1e ris+ assessment, to 3e considered either science&3ased or ris+&3ased# Additionally, a num3er of the standards are 1ery prescripti1e and do not pro1ide sufficient fle.i3ility? in fact, some of the proposed requirements -ould se1erely limit certain types of production, particularly sustaina3le a,ricultural systems, includin, certified or,anic production# /e pro1ide details on these points in the comments on the proposed standards 3elo-# Recommendation: @i1en the failure to meet 1ery central requirements of FSMA, FDA should release a second proposed rule for pu3lic comment that incorporates the mandates of FSMA and the recommendations in this comment 3efore finalizin, the Produce Rule#

Comments on the Proposed !tandards

A. !u$part ")!tandards directed to Agricultural *ater 'ail to meet the re&uirements o' F!%A 'or a science+ and risk+$ased approach and must $e thoroughly revised Recommendations on Subpart E: In the final Produce Rule, FDA must ta+e a reasona3le, science& and ris+& 3ased approach to a,ricultural -ater that allo-s farmers to respond to specific ris+s in their -ater systems# Specifically> FDA should not include inappropriate numerical thresholds for presence of patho,ens or patho,en indicators (i#e#, ,eneric 0" coli in -ater, and should conduct sufficient research to de1elop an appropriate, science&3ased numerical standard, -hich mi,ht 1ary 3y re,ion# Ance sufficient research has 3een conducted to inform an appropriate, science&3ased numerical standard, it is imperati1e that the numerical standard 3e included in ,uidance, not in the re,ulation itself# 2his allo-s for the standard to 3e updated if ne- research 3ecomes a1aila3le a3out appropriate a,ricultural -ater standards# FDA should not require -ee+ly -ater testin,? FDA should instead require farmers to collect monthly 3aseline information a3out their -ater systems in the first ,ro-in, season and 3ase future actions and testin, frequencies on those results# FDA should not increase pollution and decrease the safety of the food supply 3y encoura,in, treatment of irri,ation -ater -ith chemicals#

B. !u$part F)The proposed standards 'or $iological soil amendments o' animal origin and human waste violate F!%A, harm conservation, and would put entire categories o' 'arms out o' $usiness and there'ore must $e thoroughly revised 2he proposed Su3part FBStandards Directed to Ciolo,ical Soil Amendments of Animal Ari,in and 5uman /aste fails to meet the requirements of FSMA# Specifically, FSMA requires FDA to>
Dot !conflict with or duplicate the re$uirements of the national organic program established under the 1rganic +ood /roduction -ct of !2203" (P#$# %%%&'(', ) %*((a (a (' (6 ? !/rovide sufficient flexibility to be applicable to various types of entities engaged in production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities" (P#$# %%%&'(', ) %*((a (a (' (A ? 6sta3lish !minimum science.based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks" (P#$# %%%&'(', ) %*((a (3 (% ? and !4ake into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by +ederal natural resource conservation, wildlife conservation, and environment agencies" (P#$# %%%&'(', ) %*((a (a (' (D #

7on,ress -as 1ery clear in FSMA that the proposed Produce Rule should not undermine or,anic production practices, yet FDA has i,nored this mandate# Accordin, to the E#S# Department of A,riculture (ESDA , in 2*%2 there -ere %:,:(* certified or,anic operations (farms and processin, facilities in the E#S# Ar,anic farmers are prohi3ited from usin, the synthetic&3ased chemicals that most farmers use for fertilizer? they rely instead on 3iolo,ical fertilizers such as manure and compost# 2he inter1als 3et-een application and har1est that FDA is proposin,, (specifically, the <&month inter1al on untreated amendments and the ;(&day inter1al

for compost , are in direct conflict -ith Dational Ar,anic Pro,ram (DAP re,ulations# If FDA0s final rule does not chan,e these inter1als to ali,n -ith DAP requirements, it -ill force or,anic farmers out of compliance -ith the DAP and acti1ely discoura,e farmers from 3ecomin, certified or,anic# Additionally, FDA0s 3iolo,ical soil amendments standard fails to meet FSMA requirements to 3e science& 3ased# 2here has 3een 1ery little research on many of the topics related to application -aitin, periods for ramanure and compost and there is not su3stantial e1idence to craft !science&3ased" standards# FDA reco,nizes that !pathogen survival and die.off time in soils amended with raw manure are extremely varied and that it is unclear in the existing literature at what point the population is low enough to minimize the potential for contamination of covered produce" (:4 F#R# '(42 # FDA chose to 8ustify the <&month inter1al -ith too fe- rele1ant studies, and needs to conduct a comprehensi1e re1ie- of the literature# For compost, it is unclear ho- the a,ency decided on a ;(&day inter1al and ho- cited literature supports its conclusion# 2he standard0s requirement of insulation of compost is also pro3lematic# It is not practical to apply insulation to compost as FDA proposes, and doin, so could decrease the quality and increase the cost of the compost# Finally, the use of 3iolo,ical soil amendments of animal ori,in is a foundational practice in sustaina3le production that ali,ns -ith e.istin, conser1ation practices, and the proposed standards create a 3arrier to adoption of top&tier nutrient mana,ement and compostin, conser1ation standards# FDA0s Dotice of Intent to Prepare an 6n1ironmental Impact Statement ac+no-led,es that the proposed 3iolo,ical soil amendment standard requirements !are expected to result in changes in current use of treated and untreated biological soil amendments of animal origin or potentially greater use of synthetic fertilizers " (:4 F#R# (*'(< # 2hese are si,nificant concerns pointin, to the inappropriate nature of the standard# Recommendations on Subpart F: In the final Produce Rule, FDA must ali,n its 3iolo,ical soil amendments of animal ori,in standards -ith the Dational Ar,anic Pro,ram requirements and on&farm practices -idely used in di1ersified, sustaina3le and conser1ation&3ased production systems# Specifically> 2he inter1al 3et-een application of untreated manure and har1est should not e.ceed inter1als required 3y DAP# For compost, there should 3e no inter1al 3et-een application and har1est if the compost is treated consistently -ith DAP or similarly ri,orous compostin, standards# 2o ali,n -ith current 3est mana,ement practices, insulation of compost should not 3e required as part of an accepta3le treatment process for compost#

C. The Produce Rule 'ails to comply with F!%A $y not ade&uately supporting conservation practices and co+management o' conservation, environmental, and pu$lic health considerations Farm Aid 3elie1es that family farmers must 3e re-arded for and supported in their efforts to implement conser1ation measures, en1ironmental ste-ardship practices and other ecolo,ically 3ased standards that promote more resilient farmin, systems# FSMA directs FDA to 3e proacti1e -ith respect to natural resource conser1ation, -ildlife conser1ation, and en1ironmental protection, and the proposed rule fails in that re,ard# Specifically, FSMA requires FDA to>
!4ake into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by +ederal natural resource conservation, wildlife conservation, and environment agencies" (P#$# %%%&'(', ) %*((a (a (' (D ? Dot !conflict with or duplicate the re$uirements of the national organic program established under the 1rganic +ood /roduction -ct of !220F" (P#$# %%%&'(', ) %*((a (a (' (6 ? and

!/rovide sufficient flexibility to be applicable to various types of entities engaged in production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities" (P#$# %%%&'(', ) %*((a (a (' (A #

2he follo-in, areas are of concern to Farm Aid re,ardin, these directi1es in FSMA> Animal and *ildli'e !tandards In the proposed animal standards, FDA fails to protect against farmers 3ein, required to ta+e e.treme measures to prohi3it -ild and domesticated animals in fields of co1ered produce# Enfortunately, certain on& farm food safety certification re,imes de1eloped in response to e1ents such as the 2**= spinach 0" coli out3rea+ ha1e created incenti1es for, or e1en forced, farmers to remo1e conser1ation practices and acti1ely e.clude -ildlife from their farms#% FDA should ensure a,ainst such requirements in the future and 3e proacti1e in supportin, practices that 3enefit 3oth food safety and conser1ation# FDA0s proposed standard for -ild animals also fails to meet FSMA requirements 3y directly conflictin, -ith the Dational Ar,anic Pro,ram (DAP # DAP re,ulations define or,anic production (: 7#F#R# ) 2*(#2 as a production system that inte,rates cultural, 3iolo,ical, and mechanical practices that foster cyclin, of resources, promote ecolo,ical 3alance, and conser1e 3iodi1ersity# 2he proposed standard conflicts -ith the !natural resources standard" of DAP re,ulations (: 7#F#R# ) 2*(#2** and ) 2*(#2 and -ith the !crop rotation standard" of DAP re,ulations (: 7#F#R# ) 2*(#2*( and ) 2*(#2 # If FDA does not protect the ri,ht of or,anic ,ro-ers to use practices that co&mana,e for conser1ation and food safety, then FDA -ill constrain ,ro-ers from 3ecomin, certified and ris+ the certification status of e.istin, or,anic ,ro-ers# Many farmers participate in federal conser1ation pro,rams such as the 7onser1ation Ste-ardship Pro,ram and the 6n1ironmental Guality Incenti1es Pro,ram# 2hese pro,rams help farmers implement conser1ation practices and incorporate those practices into their farmin, systems# 2he final rule must ensure sufficient fle.i3ility in the standards for farmers to implement conser1ation practices# Co+management and sustaina$le conservation practices In the pream3le, FDA includes important te.t on the interplay 3et-een food safety and conser1ation> 6ncoura,es !the application of practices that can enhance food safety, including sustainable conservation practices" (:4 F#R# '(4= ? and States that the !proposed rule would not re$uire the destruction of habitat or the clearing of farm borders" (:4 F#R# '(4= #

Recommendations: 2o ensure that the standards support the FSMA mandate to ta+e into consideration conser1ation practice standards and ensure fle.i3ility for different farmin, systems su38ect to the rule, FDA should incorporate statements and concepts from the pream3le into the re,ulatory te.t itself, in the definitions, trainin, requirements, and domesticated and -ild animal standards# Specifically, FDA should> %# Include in ) %%2#' the follo-in, definition of !co&mana,ement"> !7o&mana,ement means farm system mana,ement approaches that respond to site specific conditions 3y inte,ratin, cultural, 3iolo,ical and mechanical practices that promote ecolo,ical 3alance and pu3lic health 3y conser1in, 3iodi1ersity, soil, -ater, air, ener,y and other natural resources, -hile also reducin, patho,en hazards associated -ith food production#" 2# Include under ) %%2#22(a a ne- su3section (; re,ardin, minimum requirements for trainin, personnel -ho conduct a co1ered acti1ity> !(; 2he importance of the co&mana,ement of food safety
%

+arming with +ood 5afety and 6onservation in 7ind, /ild Farm Alliance and 7ommunity Alliance -ith Family Farmers, 2*%'#

and conser1ation, includin, reco,nizin, that sustaina3le conser1ation practices can enhance food safety and not ta+in, measures to destroy -ild animal ha3itat, ta+e endan,ered species or e.clude all -ild animals from the farm#" '# Include under ) %%2#4' ne- su3sections (c and (d re,ardin, animal intrusion> !(c If si,nificant -ild animal intrusion, as made e1ident 3y o3ser1ation of si,nificant quantities of animals, animal e.creta, or crop destruction occurs> (% Hou must not destroy -ild animal ha3itat? (2 Hou must not clear farm 3orders around outdoor ,ro-in, areas, ponds, or draina,es? (' Hou must not ta+e an endan,ered species? and (; Hou must focus measures on e.cludin, only those specific animals and not all animals# (d /hene1er appropriate, use co&mana,ement and sustaina3le conser1ation practices that can enhance food safety#" (iversi'ied crop+livestock 'arming systems and clari'y gra-ing It is Farm Aid0s 1ie- that di1ersified crop&li1estoc+ systems, mana,ed ,razin, systems and other pasture practices are critical to promotin, a more resilient a,riculture# 2hey address a num3er of nutrient mana,ement, en1ironmental quality and natural resource ste-ardship concerns in a,riculture and can promote a more healthful food supply# After decades of -atchin, family farmers of all types stru,,le to turn a profit in increasin,ly industrial and specialized farmin, systems, -e see much 1alue in the ,ro-in, adoption of more di1ersified farmin, systems# FDA should not undermine this 3ur,eonin, di1ersity in the farm sector, 3ut instead support it# In the pream3le, FDA states that the ! proposed rule would not prohibit the use of on.farm domesticated working animals" (:4 F#R# '(4= # 2his is critical 3ecause many farms that ,ro- produce co1ered 3y the Produce Rule rely on domesticated animals to produce their crops, and many farmers ,raze animals in fields that are later used for produce production# Proposed ) %%2#42(a -ould require an !ade$uate grazing period between grazing and harvesting for covered produce3" FDA pro1ides additional ,uidance on that -aitin, period in the pream3le, statin, the a,ency !would not expect it to be necessary for such time periods to exceed 2 months, which is the application interval we propose for use of raw manure as a soil amendment3 " (:4 F#R# '(4: # In addition to the aforementioned issues -ith a <&month -aitin, period 3et-een application of ra- manure and har1est, FDA should not imply that an !adequate" -aitin, period is < months 3ecause there is no scientific 3asis for it# 2he parallel 3et-een feces dropped durin, ,razin, and ra- manure applied as fertilizer is not stron, enou,h to 8ustify this and ris+s confusin, farmers on -hat FDA means 3y !adequate" in proposed ) %%2#42(a # Recommendations: FDA should remo1e the sentence from the pream3le that states the a,ency ! would not expect it to be necessary for such time periods to exceed 2 months, which is the application interval we propose for use of raw manure as a soil amendmentF" (:4 FR '(4: # Produce Rule should not esta$lish a list o' .Animals o' Concern/ In the pream3le, FDA tentati1ely concludes that ! current scientific evidence on the extent to which specific animals present the greatest risk for pathogens is inade$uate to develop such a list " (:4 FR '(4= # /e a,ree -ith FDA0s conclusion and do not thin+ that such a list is required 3y FSMA# Recommendation: FDA should not de1elop a list of !animals of concern#"

Comments on the Proposed Preventive Controls Rule

I. The scope and magnitude o' pro$lems in the Proposed Rule re&uires promulgation o' a !econd Proposed Rule FSMA requires FDA to promul,ate re,ulations that ! provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co.located on a farm" (P#$# %%%&'(', ) %*'(a (a (n (' (A # 2his requirement underpins 7on,ress0 mandate to esta3lish a scale& and supply&chain appropriate re,ulatory frame-or+ for facilities# A num3er of specific pro1isions support that frame-or+> FSMA requires FDA to conduct a science&3ased ris+ analysis of on&farm pac+in,, holdin,, manufacturin,, and processin, acti1ities, and to consider the results of that analysis to e.empt or de1elop modified requirements for small or 1ery small 3usinesses that conduct only lo-&ris+ acti1ities (P#$# %%%&'(', ) %*'(c ? FSMA requires FDA to define !small 3usiness" and !1ery small 3usiness" for the purposes of ne5azard Analysis and Ris+&3ased Pre1enti1e 7ontrols (5ARP7 re,ulations, ta+in, into consideration results of the food processin, sector study (P#$# %%%&'(', ) %*'(a (n (% (C ? and FSMA requires FDA to amend the definition of !retail food esta3lishment" to clarify that the sale of food directly to consumers includes the sale of food throu,h community supported a,riculture pro,rams (7SAs , roadside stands, and farmers0 mar+ets (P#$# %%%&'(', ) %*2(c #

FDA has failed to implement some of the statutory requirements for the Pre1enti1e 7ontrols Rule, has partially implemented some of these requirements, and is see+in, feed3ac+ on a 1ariety of options# /e pro1ide details on these points in the comments 3elo-, 3ut, o1erall, the proposed Pre1enti1e 7ontrols Rule is incomplete and does not adequately esta3lish a fle.i3le re,ulatory frame-or+, particularly for 1alue&added 3usinesses and on&farm processors# Recommendation: @i1en the failure to meet se1eral requirements in FSMA, FDA should release a second proposed rule for pu3lic comment that incorporates the mandates of FSMA and the recommendations in this comment 3efore finalizin, the Pre1enti1e 7ontrols Rule# II. F(A 'ailed to clari'y the de'inition o' .retail 'ood esta$lishment/ 'or direct marketing as re&uired $y law Accordin, to ESDA, local food sales throu,h direct mar+ets and intermediated channels ,rossed 9;#4 3illion in 2**4,2 a si,nificant contri3ution to the food economy that si,nifies 3alloonin, interest amon, consumers and producers ali+e to esta3lish more local and re,ional food systems# Still a small fraction of the total a,ricultural economy, Farm Aid 3elie1es it is essential that these mar+ets not 3e stymied 3y re,ulations that are meant for industrial food facilities# FDA failed to implement the mandate from FSMA that requires FDA to amend the definition of !retail food esta3lishment" to clarify that the sale of food directly to consumers includes the sale of food throu,h community supported a,riculture pro,rams (7SAs , roadside stands, farmers0 mar+ets, and other direct&to& consumer 1enues (P#$# %%%&'(', ) %*2(c # /ithout this clarification, 7SAs, roadside stands, farmers0 mar+ets, and other direct&to&consumer platforms (e#,# farm stores, direct internet sales, tail,ate mar+ets, and pic+&your&o-n operations -ould 3e re,ulated li+e food facilities that must re,ister -ith FDA and are su38ect to the Pre1enti1e 7ontrols Rule# 2his is inconsistent -ith the statute and 7on,ressional intent#
2

,irect and 8ntermediated 7arketing of 9ocal +oods in the :nited 5tates# ESDA 6RS# Do1em3er, 2*%%#

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Recommendation: FDA must clarify that the sale and distri3ution of food throu,h a 7SA pro,ram, roadside stand, farmers0 mar+et, or other direct&to&consumer platforms is included in the definition of sales direct to consumers for purposes of definin, a !retail food esta3lishment," as required 3y FSMA# III. F(A should adopt a .0ery !mall Business/ threshold o' at least 12,333,333 in covered product FSMA required FDA to define !small 3usiness" and !1ery small 3usiness" for the purposes of ne- 5azard Analysis and Ris+&3ased Pre1enti1e 7ontrols (5ARP7 re,ulations, ta+in, into consideration the results of the food processin, sector study (P#$# %%%&'(', ) %*'(a (n (% (C # 2hese definitions are important for determinin, the scope of co1era,e of the Pre1enti1e 7ontrols Rule? a 1ery small 3usiness can qualify for modified requirements (P#$# %%%&'(', ) %*'(a (l and small and 1ery small 3usinesses are e.empt from the pre1enti1e controls requirements if they only conduct certain lo-&ris+ processin, acti1ities (P#$# %%%&'(', ) %*'(c (% (D # FSMA also requires FDA to !provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co.located on a farm " -hen de1elopin, its 5ARP7 re,ulations (P#$# %%%&'(', ) %*'(a (n (' (A # 2he use of the phrase ! such as a small processing facility co.located on a farm" is not limited to processin, facilities co&located on farms# In the proposed Pre1enti1e 7ontrols Rule, FDA proposed three options for the definition of !1ery small 3usiness"> %# A 3usiness that has less than 92(*,*** in total annual sales of food, ad8usted for inflation? 2# A 3usiness that has less than 9(**,*** in total annual sales of food, ad8usted for inflation? or '# A 3usiness that has less than 9%,***,*** in total annual sales of food, ad8usted for inflation# Accordin, to FDA0s Preliminary Re,ulatory Impact Analysis, the hi,hest threshold proposed (Aption I' -ould co1er a tiny percenta,e, less than 2 percent, of food produced in the E#S# 2he impact of adoptin, this threshold, or a hi,her threshold, -ould 3e minimal for the 1ast ma8ority of facilities in the sector# For farms that mi,ht fall under the definition of !facility" and are considered !farm mi.ed&type facilities," ho-e1er, the impact -ill 3e 1ery si,nificant# Fifty&four percent of farms in the E#S# ha1e ,ross sales under 9%,***,***, thou,h they account for a minority share of total farm,ate sales# Ender the proposed definitions, a lar,e num3er of farms -ill 3e considered !facilities" su38ect to the rule# Cut the 5ARP7 requirements are desi,ned for industrial food facilities, not farms, and do not pro1ide sufficient fle.i3ility for on&farm processors# Adoptin, at least the 9%,***,*** threshold -ill protect many farms from inappropriate 5ARP7 requirements -ithout impactin, the 1ast ma8ority of the food processin, sector# Additionally, FDA0s definitions refer to ,ross sales of !all food" and not product re,ulated under the Pre1enti1e 7ontrols Rule# /hile FSMA may require !all food" to 3e counted a,ainst the t-o&part eli,i3ility test for farms and facilities eli,i3le for modified requirements, that same restriction clearly does not apply to the definition of !1ery small 3usiness" (P#$# %%%&'(', ) %*'(a (a (n (% (C # Focusin, the definition of !1ery small 3usiness" on food re,ulated under the rule -ould pro1ide fle.i3ility to farms di1ersifyin, into necrops or on&farm 1alue&added enterprises, ease the compliance costs for farms and ne- 1alue&added 3usinesses, and help focus limited FDA resources on hi,h&ris+ industrial facilities# Recommendation: FDA should adopt a threshold of at least 9%,***,*** and apply it to sales of food regulated under the /reventive 6ontrols ;ule# I0. "sta$lish an e#emption 'or 'acilities with an average annual monetary value o' covered product o' 145,333 or less FSMA re8ected a !one&size&fits&all" approach, and pro1ided FDA -ith fle.i3ility to ensure that the

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Pre1enti1e 7ontrols Rule -or+ed for a di1ersity of facilities# Specifically, the Pre1enti1e 7ontrols Rule requires FDA to !provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co.located on a farm " (P#$# %%%&'(', ) %*'(a (a (n (' (A # /hile FDA too+ initial steps to implement the fle.i3ility required 3y FSMA for lo-&ris+ acti1itiesJfood com3inations (see comments 3elo- and qualified facilities (see comments 3elo- , FDA did not create fle.i3ility for e.tremely small facilities as it did in the Produce Rule for farms -ith 92(,*** or less in food sales# FDA should esta3lish an outri,ht e.emption for e.tremely small facilities to ensure fle.i3ility for the smallest food processin, operations# Such an e.emption -ould not si,nificantly add ris+ to the food supply# Accordin, to FDA0s Preliminary Re,ulatory Impact Analysis, food 3usinesses -ith less than 92(*,*** in annual ,ross sales represent less than one&half of %K of all food produced in the E#S# ' Settin, an outri,ht e.emption at a 92(,*** threshold -ould represent an e1en smaller fraction of food 3usinesses# Additionally, the e.emption should 3e 3ased off product re,ulated under the rule and not all food as defined in ) %%:#'# /hile FSMA may require !all food" to 3e counted a,ainst the aforementioned t-o&part eli,i3ility test, that same restriction clearly does not apply to the requirement to ensure fle.i3ility for facilities of all sizes (P#$# %%%&'(', ) %*'(a (a (n (' (A # Focusin, the definition on re,ulated product pro1ides fle.i3ility for 3e,innin, farmers, entrepreneurs tryin, to launch 1alue&added food 3usinesses, and family farmers -ho ha1e di1ersified operations throu,h 1alue&added processin,# Recommendation: 2o ensure sufficient fle.i3ility for a di1erse array of food 3usinesses, FDA should esta3lish an outri,ht e.emption from the Pre1enti1e 7ontrols Rule for 3usinesses -ith 92(,*** or less in annual a1era,e monetary 1alue of product co1ered 3y the Pre1enti1e 7ontrols Rule o1er a three&year period, ad8usted for inflation# 0. F(A 6eeds to "#pand the 7ist o' On+Farm 7ow+Risk Activities8Food Com$inations FSMA required FDA to conduct a science&3ased ris+ analysis of on&farm pac+in,, holdin,, manufacturin,, and processin, acti1ities, and to consider the results of that analysis to e.empt or de1elop modified requirements to the Pre1enti1e 7ontrols requirement for small or 1ery small 3usinesses that conduct only lo-&ris+ acti1ities (P#$# %%%&'(', ) %*'(c # FDA has partially implemented this and ta+en important first steps in identifyin, lo-&ris+ on&farm pac+in,, holdin,, processin,, or manufacturin, acti1ities 3y de1elopin, lists of lo-&ris+ acti1itiesJfood com3inations in ) %%:#((, and )%%:#((h that are not su38ect to Su3part ) %%: (5azard Analysis and Ris+&Cased Pre1enti1e 7ontrols # 5o-e1er, there are a num3er of other lo-&ris+ acti1ities FDA should include# Additionally, the fact that FDA has identified these acti1itiesJfood com3inations as lo-&ris+ should 3e ,rounds for e.emptin, them# Re,ulatin, acti1itiesJfood com3inations that are lo-&ris+ is incredi3le re,ulatory o1erreach, a -aste of scarce federal resources, and comes at a real cost to the economy# $ar,er farms or off&farm 3usinesses that en,a,e in these lo-&ris+ acti1ityJfood com3inations -ill 3e forced to comply -ith re,ulations that, accordin, to FDA, are lo- ris+# Finally, FDA does not pro1ide a mechanism for periodically updatin, the list of lo-&ris+ acti1ities# It is difficult to predict ahead of time -hat each and e1ery possi3le com3ination of farm commodities and on& farm processin, acti1ities -ill 3e# A mechanism for periodic updatin, and impro1ement -ill 3e needed# Recommendations: FDA should retain the list of lo-&ris+ acti1itiesJfood com3inations in ) %%:#((, and ) %%:#((h and add at least the follo-in, lo-&ris+, 1alue&added processin, acti1ities in the final rule> Acidifyin,, pic+lin,, and fermentin, lo-&acid fruits and 1e,eta3les made in compliance -ith
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FDA0s Preliminary Re,ulatory Impact Analysis L Pre1enti1e 7ontrols Rule# Pa,e ;#

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e.istin, @ood Manufacturin, Practices in 2% 7#F#R ) %%' and ) %%; Ca+in, acti1ities in1ol1in, ,rain products Roastin, ,rains for animal feed 6.tractin, oils from seeds 6.tractin, 1ir,in oli1e oil Ma+in, molasses from su,arcane and su,ar 3eets Ma+in, syrups from sor,hum, rice, and malted 3arley

2he e.emption from Su3part 7 of ) %%: 3ased on proposed list of lo-&ris+ acti1itiesJfood com3inations should not 3e limited to on&farm acti1ities, 3ut applied -hene1er the lo-&ris+ foodJacti1ity com3ination ta+es place, includin, on lar,er farms or off&farm 3usinesses# FDA should also esta3lish a mechanism for updatin, the lists of lo-&ris+ acti1ityJfood com3inations ( ) %%:#((, and )%%:#((h and see+ input from 1alue&added processors and farmers operatin, mi.ed&type facilities, includin, small and 1ery small farmers and facility operators# FDA should incorporate these chan,es into its ! ,raft <ualitative ;isk -ssessment of ;isk of -ctivity%+ood 6ombinations for -ctivities )1utside the +arm ,efinition* 6onducted in a +acility 6o.9ocated on a +arm " and issue a re1ised assessment for pu3lic comment 3efore finalizin, the rule# 0I. The Food Processing !ector !tudy is *oe'ully Inade&uate and %ust $e 9ndertaken Again to Comply with the 7aw FSMA requires FDA to conduct a food processin, sector study to determine the size and scope of the sector, includin, the num3er and types of food facilities co&located on farms (P#$# %%%&'(', ) %*'(a (l (( , -hich -ould in turn inform definitions of !small" and !1ery small" 3usinesses# 2he food processin, sector study ; FDA released -ith the proposed rule is ,rossly inadequate and fails to pro1ide the information required 3y FSMA to determine the num3er of facilities co&located on farms and -hat the production, distri3ution, and ris+ profiles of those facilities are# 2he study ac+no-led,es its se1ere data limitations and relies on the opinion of a small ,roup of indi1iduals -ho are not e.perts in on&farm or small&scale processin,# 5ence, FDA cannot adequately determine the impact of the proposed rule, ho- many operations -ill 3e su38ect to the rule, and -hat the costs of compliance -ill 3e# /e +no- of no other federal re,ulations that see+ to re,ulate an indeterminate uni1erse of re,ulated entities# 7on,ress reco,nized this and char,ed the a,ency to conduct a thorou,h study to determine the size and scope of the uni1erse of farms and 3usinesses that may 3e su38ected to re,ulation 3efore issuin, rules# FDA0s study not only completely fails at this tas+, 3ut the a,ency has made no indication of ho- it intends to rectify the situation# Recommendation: FDA should conduct a re1ised food processin, sector study that includes lar,e&scale sur1eys of actual farm mi.ed&type facilities and the acti1ities they conduct# FDA should release that study for pu3lic comment and incorporate findin,s into the Pre1enti1e 7ontrols Rule 3efore finalizin, it# In conductin, the re1ised study, FDA should consider enterin, into cooperati1e a,reements -ith a,encies, or,anizations, andJor ,roups a3le to conduct those sur1eys -ith farm mi.ed&type facility operators#

FDA, !Food Processin, Sector Study," 2*%%# Reference '2 of the proposed Pre1enti1e 7ontrols Rule#

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Comments on Issues in Both Rules : Proposed Produce Rule ; Proposed Preventive Controls Rule
I. Foundational de'initions applica$le to $oth rules are 'lawed and must $e improved In FSMA, 7on,ress included se1eral pro1isions to clarify the definitions of !farm" and !facility" from the Pu3lic 5ealth Security and Cioterrorism Preparedness and Response Act of 2**2 (C2A? P#$# %*:&%44 # 2hese clarifications included ) %*2(c and ) %*'(c discussed a3o1e# Additionally, FSMA pro1ided FDA authority to issue 3road fle.i3ility in the re,ulations to !provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co.located on a farm" (P#$# %%%&'(', ) %*'(a (a (n (' (A and ) %*((a (a (' (A # /e note that the use of the phrase !such as a small processin, facility co&located on a farm" does not limit the application of this re,ulatory discretion solely to processin, facilities co&located on farms# 2his fle.i3ility is critical 3ecause the implementation of C2A and the definition of Mfacility0 has created a ,reat deal of confusion for farmers -ho conduct on&farm acti1ities that fall under the ar3itrary definitions of !manufacturin,Jprocessin,," !pac+in,," and !holdin,," and a lac+ of clarity around -hen a farm is also considered a Mfacility0 that must re,ister -ith FDA and is su38ect to the Pre1enti1e 7ontrols Rule# In 3oth proposed rules, FDA ta+es steps for-ard to pro1ide additional ,uidance for -hen a farm is also a facility that must re,ister# 5o-e1er, there are still si,nificant deficiencies that must 3e fi.ed 3efore the rules are finalized# /ithout specific impro1ements, the entire re,ulatory frame-or+ around the interaction 3et-een the t-o rules -ill ris+ inappropriately o1er&re,ulatin, many farms and lo-&ris+ food 3usinesses# A. F(A<s organi-ing principles are 'undamentally 'lawed In the pream3les of 3oth rules, FDA descri3es fi1e !or,anizin, principles" to help understand the a,ency0s definition of !farm#" Cut these principles rest on a fla-ed understandin, of ho- farmin, -or+s, 3ecause they assume that farms e.ist simply to ,ro- crops, and that ,ettin, crops to mar+et is somethin, that !farms" don0t do# Farm Aid0s e.perience -or+in, -ith and ad1ocatin, for farmers for o1er 24 years has sho-n us that a farm cannot stay in 3usiness -ithout mar+etin, its crops and preparin, those crops for mar+et# 2he imperati1e to ma.imize the 1alue a farm recei1es for its crops creates the need for 1alue&added mar+etin, and cooperati1e distri3ution# Recommendation: FDA should re1ise its or,anizin, principles to reflect the realities and ran,e of acti1ities that farms do to their crops to prepare those crops and ,et them to mar+ets# B. F(A should not use the term .'acility/ to de'ine esta$lishments and properties that are not 'acilities that must register with F(A In C2A, 7on,ress e.plicitly stated that farms, restaurants, and retail food esta3lishments -ere not food processin, facilities that had to re,ister -ith FDA (P#$# %*:&%44, ) '*( # Het the definitions of !farm" and !restaurant" include the term !facility," causin, si,nificant confusion# Recommendation: FDA should amend the definitions of !farm" and !retail food esta3lishment" so that they do not include the term !facility" and to further clarify that they are not facilities su38ect to re,istration under C2A, nor to the FSMA Pre1enti1e 7ontrols Rule# C. Packing and holding someone else<s 'ruits and vegeta$les should not make a 'arm a .'acility/ Ane of the most pro3lematic areas in the definitions of !farm" and !facility" concerns the 1ery common practice on farms to pac+ or hold small amounts of produce from nei,h3orin, farms to meet mar+et demand#

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2he fresh mar+et produce industry is hi,hly 1olatile, especially sensiti1e to -eather e1ents# Het, farms must 3e a3le to meet customer needs to remain economically 1ia3le# From time to time, that may require 3rin,in, in a minimal amount of product# Het, as proposed, FDA -ould consider a farm that pac+s or holds intact fruits and 1e,eta3les a !facility" that has to re,ister -ith FDA and is su38ect to the Pre1enti1e 7ontrols Rule# Farm Aid finds this unaccepta3le, as it -ill result in thousands of farms ha1in, to re,ister -ith FDA as facilities and comply -ith the Pre1enti1e 7ontrols Rule# Recommendation: FDA should chan,e the definitions of !farm," !facility," and !manufacturin,J processin," to ali,n -ith the common&sense understandin, and practice that the 3asic pac+in,, handlin,, and storin, acti1ities farms ha1e traditionally performed in preparin, intact fruits and 1e,eta3les for mar+etin, L includin, someone else0s ra- a,ricultural commodities L do not ma+e a farm a !facility" that must re,ister -ith FDA and that is su38ect to the Pre1enti1e 7ontrols Rule# (. "sta$lishments that pack and hold intact 'ruits and vegeta$les should not $e 'acilities Pac+in, and holdin, intact fruits and 1e,eta3les occurs off&farm and is a strate,y used 3y many farmers, ,roups of farmers, and food 3usinesses to more efficiently and cost&effecti1ely a,,re,ate product# In the proposed Pre1enti1e 7ontrols Rule, FDA identified pac+in, and holdin, of someone else0s intact fruits and 1e,eta3les on&farm as a lo-&ris+ pac+in, of holdin, acti1ity food com3ination (:4 F#R# '4*% # @i1en the lo-&ris+ nature of this acti1ity, it should not tri,,er the Mfacility0 definition in other instances, such as in an off&farm esta3lishment# Farm Aid -or+s -ith and supports a num3er of food hu3s, farmer cooperati1es and other off&farm a,,re,ators that are critical to local and re,ional food system infrastructure across the country# 2hese or,anizations are nothin, li+e the hi,h&ris+ industrial facilities the rules are intended to re,ulate and should 3e protected from re,ulatory o1erreach# Recommendation: FDA should amend the definitions of !farm" and !facility" so that lo-&ris+ pac+in, and holdin, acti1ities of intact fruits and 1e,eta3les conducted in esta3lishments off&farm are not !facilities" that must re,ister -ith FDA and 3e su38ect to the Pre1enti1e 7ontrols Rule# ". F(A needs to include additional activities in .harvesting/ and .packing/ and .packaging/ In its proposed rules, FDA started a list of acti1ities in the definition of Mhar1estin,0 that do not tri,,er the definition of !facility" for the purposes of facility re,istration -hen done to one0s o-n ra- a,ricultural commodities# /e support this clarification and ur,e FDA to ma+e the list as e.hausti1e as possi3le# /e also ur,e FDA to clarify that !pac+in," and !pac+a,in," of ra- commodities on&farm includes affi.in, la3els to pac+in, and pac+a,in, containers, and that this does not tri,,er the definition of !facility" for the purposes of facility re,istration# Recommendation: FDA should 3uild on its e.istin, list of har1estin, acti1ities and include the follo-in, acti1ities in the definition of !har1estin,"> In&field corin,, Remo1in, folia,e, Remo1in, roots, Craidin,, and Cunchin,# FDA should periodically re1ie- the list so it reflects the 3readth and ran,e of practices done as part of har1estin,# FDA should clarify that !pac+in," and !pac+a,in," of ra- a,ricultural commodity on&farm includes affi.in,

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la3els to pac+in, and pac+a,in, containers, and that la3elin, does not tri,,er the definition of !facility" for the purpose of facility re,istration# II. F(A must esta$lish a ro$ust regulatory 'ramework around the modi'ied re&uirements 'or &uali'ied e#empt 'arms and &uali'ied 'acilities as mandated $y law FSMA re8ected a !one&size&fits&all" approach and pro1ided FDA -ith fle.i3ility to ensure that the Produce Rule and Pre1enti1e 7ontrols Rule -or+ for a di1ersity of farms and facilities# A +ey part of the scale& and supply&chain appropriate re,ulatory frame-or+ includes pro1isions in FSMA requirin, FDA to esta3lish modified requirements for farmsJfacilities that ,ross under 9(**,*** in sales of all food in a pre1ious three& year period (ad8usted for inflation and sell the ma8ority of their food directly to a consumer, or a restaurant or retail esta3lishment that is located in the same state as the farmJfacility or not more than 2:( miles from that farmJfacility (P#$# %%%&'(', ) %*((a (f and ) %*'(a (a (l # If a farmer or facility meets these qualifications, instead of 3ein, su38ect to the entire produce standards or 5ARP7 requirements, the farmer or facility is only su38ect to modified requirements# In 3oth proposed rules, -hile FDA included the 3asic statutory lan,ua,e from FSMA, it has not created a complete and ro3ust re,ulatory frame-or+ for qualified e.empt farms and qualified facilities# Many critical details remain unclear or unans-ered and must 3e addressed in the final Produce Rule and Pre1enti1e 7ontrols Rule to 3e consistent -ith 7on,ressional intent to esta3lish a fle.i3le and appropriate re,ulatory frame for farms and facilities that supply direct&to&consumer mar+ets# Additionally, -hile FSMA specifies that the 9(**,*** threshold should apply to !all food," 7on,ress also ,a1e FDA fle.i3ility to ensure that the re,ulations -ould 3e appropriate and practical for a di1ersity of farmin, systems (P#$# %%%&'(', ) %*'(a (a (n (' (A and ) %*((a (a (' (A # 2he calculation of the 9(**,*** 3ased on !all food" creates si,nificant 3arriers for farmers that are di1ersifyin, into produce production or 1alue&added production# 2hose farmers, 3ecause they ha1e sales from other a,ricultural products L includin, dairy, ,rain crops, hay, li1estoc+, etc# L -ould 3e su38ect to the full -ei,ht of the food safety re,ulations if they ,ro- a small amount of fruits or 1e,eta3les, or process a small a3out of product throu,h 1alue&added processin, acti1ities# 2his is a si,nificant 3arrier to the di1ersification of farmin, systems and to the transition of farmers into fruit and 1e,eta3le production to meet ,ro-in, demand# FDA should promul,ate fle.i3le re,ulations that -or+ for all sizes and types of farms and facilities to fi. this issue# Recommendations: FDA must retain and si,nificantly impro1e the re,ulatory frame-or+ for qualified e.empt farms and qualified facilities in the final Produce Rule and the final Pre1enti1e 7ontrols Rule# Specifically, in 3oth rules> %# F(A must retain the modi'ied re&uirements 'or &uali'ied e#empt 'arms in the Produce Rule and &uali'ied 'acilities in the Preventive Controls Rule. 2# F(A must esta$lish a clear and 'air process 'or withdrawing a 'arm or 'acility<s .&uali'ied e#empt/ or .&uali'ied/ status. Specifically, FDA should> a# Increase the e1identiary standard for -ithdra-in, an e.emption, includin, e1idence that sho-s direct lin+a,e to a pro3lem on a specific farm or facility, and should require the FDA officer recommendin, the -ithdra-al to sho- credi3le and su3stantial e1idence to merit -ithdra-al# 3# Define critical terms that clarify the situations under -hich a farm or facility0s status as !qualified e.empt" or !qualified," respecti1ely, can 3e -ithdra-n# Specifically, FDA should> i# Define !directly lin+ed" and !associated" to limit 3road interpretation of these terms and so upstream actors, unrelated to the conduct and practices of the farm or facility in question, cannot endan,er that farm or facility0s status# 2here should 3e e.plicit temporal, location&

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3ased, and product& or acti1ity&3ased su,,estions to determine direct lin+a,e or association# ii# Define !material to the safety of food" to mean measura3le traits that can 3e clearly identified in indi1idual cases, and ne1er 3y con8ecture applied to a -hole class of persons, types of operations, or 3road description of food 3ein, produced# c# First issue a -arnin, letter 3efore resortin, to e.emption -ithdra-al proceedin,s# d# If a -ithdra-al order is -arranted, su3mit an order to -ithdra- the e.emption to the FDA District Director or official senior to such Director -ithin %* calendar days of ma+in, that determination# 2he FDA District Director or other senior to such Director must appro1e or deny the order to -ithdra- -ithin %* calendar days of -hen it is su3mitted# 2he order to -ithdramust 3e deli1ered to the o-ner, operator, or a,ent in char,e of the farm or facility -ithin ( calendar days after that determination# e# In the -ithdra-al order, state clearly that the o-ner, operator, or a,ent in char,e of a qualified e.empt farm or qualified facility must either comply -ith the requirements or appeal the order, and include information a3out the opportunity to request an informal hearin,# '# F(A must esta$lish a process $y which &uali'ied e#empt 'arms or &uali'ied 'acilities can regain their e#empt status and outline the criteria 'or such a course o' action. ;# F(A must apply the 1533,333 threshold to product or product covered $y the Produce Rule or Preventive Controls Rule, respectively, not to .all 'ood./ III. Food !a'ety Training should $e a central part o' the Implementation o' the F!%A Rules Reco,nizin, the 3urdens that the ne- re,ulations place on farms and food facilities, and the importance of trainin, as part of a food safety system focused on prevention, 7on,ress created a competiti1e ,rants pro,ram in FSMA (the Dational Food Safety 2rainin,, 6ducation, 6.tension, Autreach, and 2echnical Assistance Pro,ram to fund trainin, efforts throu,h ESDA0s Dational Institute of Food and A,riculture (P#$# %%%&'(', ) 2*<(3 # FSMA prioritized trainin, for small and mid&sized farms, 3e,innin, farmers, socially disad1anta,ed farmers, small processors, and small fresh fruit and 1e,eta3le merchant -holesalers# FSMA emphasized that trainin, should inte,rate food safety standards and ,uidance -ith the 1ariety of a,ricultural production systems, encompassin, con1entional, sustaina3le, or,anic, and conser1ation and en1ironmental practices# Enfortunately, 7on,ress has not appropriated funds to launch this pro,ram# Farm Aid0s o-n national competiti1e ,rant pro,ram has supported se1eral effecti1e models for on&farm food safety trainin, throu,h the Appalachian Sustaina3le De1elopment, A,ricultural N $and&Cased 2rainin, Association, 7ommunity Alliance -ith Family Farmers, FamilyFarmed#or,, the De- 6ntry Sustaina3le Farmin, Pro8ect, and se1eral other or,anizations# /e ha1e seen the impact of these pro,rams on impro1in, not only the quality and safety of food produced 3y small or midsized ,ro-ers, 3ut on farmer li1elihoods in ,eneral# If the final rules are to 3e successfully implemented, trainin, for farmers and food processin, 3usinesses is essential and -ithout it, the re,ulations -ill fall short of impro1in, food safety# Recommendation: As FDA mo1es to finalize the proposed rules, the a,ency must prioritize -or+in, -ith ESDA and pu3lic sector farmer&3ased or,anizations to launch and secure fundin, for the Dational Food Safety 2rainin,, 6ducation, 6.tension, Autreach, and 2echnical Assistance Pro,ram#

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