Processor Organic Compliance Plan (OCP) Matriz

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    PROCESSOR ORGANIC COMPLIANCE PLAN (OCP)

    Under the USDA National Organic Program NOP!, any "roduction or handling o"eration #ee$ing certi%ication

    #ell, la&el or other'i#e re"re#ent good# 'ith any organic claim mu#t de(elo" an organic com"liance "lan that

    a""ro(ed &y an accredited certi%ying agent, in thi# ca#e )A*+

    Any change# u"date# to the organic com"liance "l

    need to &e documented and a""ro(ed &y )A* "rior to im"lementation+

    Physical Location Name RALOP S. DE R.L. DE C.V. Division o Pha!machem La"o!ato!ies Inc.

    Physical A##!ess Camino al E$i#o San Vicente No. %&% Col. Am'liacion Conta#o!a

    City amave State*P!ovince +amali'as

    ,i'*Postal -/0& Cont!y Me1ico

    Contact Pe!son at this Location asen Lavoie

    Phone No. (%2) 30& 3&&& Alte!nate Phone

    4a1 No. (%2) 30& 3355 E6Mail Lavoie7Pha!machemla"s.com

    Name o Pe!son Com'letin8 +his 4o!m asen Lavoie Date Octo"e! 93: 9&%5

    Name o Ce!tiie# Entity (C.E.) Im'!ove ;SA an# Im'!ove!a ;SA LLC: Divisions o Pha!machem

    La"o!ato!ies Inc.

    o a##i#t you in com"leting the O-P, you 'ill %ind guideline# %or each .ue#tion along 'ith re%erence# tothe rele(ant #uection# o% the National Organic Program NOP!, 7 -/ Part 20, %ollo'ing each

    .ue#tion+ Plea#e re%er to the#e #uection# o% the regulation %or the #ource o% each .ue#tion a""earing in

    thi# Organic -om"liance Plan+

    ou 'ill al#o &e a#$ed to com"lete and attach additional )A* document# to (eri%y "roduct, "rocedure

    and material com"liance# a# a""lica&le+

    *% you %ind a .ue#tion i# not a""lica&le to your o"eration, "lea#e clearly indicate thi# in the #"ace

    "ro(ided a%ter the .ue#tion 'ith e3"lanation+ *% needed %or clarity, "lea#e "ro(ide %urther e3"lanation a#

    to 'hy the .ue#tion doe# not "ertain to your o"eration in Section 4+

    he )A* *n#"ector 'ill &e (eri%ying on5#ite that you ha(e documented all "rocedure# indicated in thi#

    Organic -om"liance Plan+ Please "e a#vise# that yo! ins'ection mst occ!

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    A) O!8anic Com'liance Plan Ove!viea8in8 Mate!ials

    1+ Plea#e indicate all ty"e# o% "ac$aging material# or #torage container# u#ed %or organic "roduct+

    -hec$ all that a""ly+

    -on#ider all container# or "ac$aging u#ed %or incoming "roduct#, 'or$ in "rogre## #torage, and

    tem"orary or %inal "ac$aging+7 CFR 205.201(a)(6)

    ;ul$ -ard&oard A#e"tic /oil Synthetic %i&er Pla#tic

    Pa"er >la## Eood etal Natural %i&er Ea3ed "a"er

    Other: "a"er&oard

    2+ Are "ac$aging material# or container# %ree o% "rohi&ited material#, #uch a# #ynthetic %ungicide#,

    "re#er(ati(e#, and %umigant#I

    he u#e o% "ac$aging material#, #torage container#, &ag#, &o3e# or holding &in# that contain any #ynthetic%ungicide#, "re#er(ati(e#, or %umigant# i# "rohi&ited+7 CFR 205.272(b)(1)

    e# No, "lea#e e3"lain:

    8+ Ehat mea#ure# are in "lace to "re(ent contamination o% "ac$aging material# or #torage container#

    %rom "rohi&ited #utance#I-hec$ all that a""ly+

    Sanitation material#, "e#t management material#, or other "rohi&ited #utance# u#ed in the %acility mu#t

    not come in contact 'ith organic "ac$aging material# or #torage &in#+

    7 CFR 205.272(a)

    Segregated #torage Documented remo(al during treatmentSealed %rom contact Documented em"loyee training

    Other:

    + *% "ac$aging material# or container# &o3e#, &in#, tote#, etc+! are re5u#ed, 'hat mea#ure# are in "lace

    to "rotect the integrity o% the organic "roductI

    he re5u#e o% any &ag or container that ha# &een in contact 'ith #utance# or con(entional "roduct# thatmay com"romi#e the organic integrity o% the "roduct i# "rohi&ited unle## it ha# &een thoroughly cleaned+

    7 CFR 205.272(b)(2)

    in#e e#idue te#ting Documented em"loyee training

    na Pac$aging material# andor container# are not re5u#ed+

    Other:

    ASOP 879 *SSU 9 SAUS5PU; 201

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    D) ?ate!

    1+ 4o' i# 'ater u#ed in a %ood contact ca"acityI

    -hec$ all that a""ly+

    Eater that come# in contact 'ith an organic "roduct or organic %ood contact #ur%ace# mu#t not

    contaminate the "roduct 'ith "rohi&ited #utance#+7 CFR 205.272

    -leaning "roduct -leaning e.ui"ment /lumedum" tan$

    -oo$ing "roduct Steaming "roduct *ngredientna Eater i# not u#ed during organic handling+

    Other:

    2+ Plea#e an#'er the %ollo'ing .ue#tion# a&out the u#e o% "ota&le 'ater:

    Ehen munici"alitie# "ro(ide 'ater, the 'ater .uality i# a##umed to &e com"liant unle## other'i#e noted

    &y the in#"ector+ O"eration# u#ing 'ell# or other "ri(ate 'ater #ource# #hould &e a&le to demon#trate that

    'ater doe# not "re#ent a contamination ri#$ to organic "roduct#+

    7 CFR 205.272

    a+ *# 'ater deri(ed %rom a munici"al #ourceI

    na Eater i# not u#ed+ e# No

    &+ *% GNoH, "lea#e indicate ho' 'ater i# monitored to en#ure that it doe# not "re#ent a contamination

    ri#$ to organic "roduct#ingredient#:

    Eater doe# not come into contact 'ith %ood

    Pota&le 'ater i# u#ed9 "lea#e li#t #ource

    Eater i# chemically treated to ma$e it "ota&le &e%ore u#e+

    Other:

    ASOP 879 *SSU 9 SAUS5PU; 201

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    8+ Plea#e an#'er the %ollo'ing .ue#tion# a&out the u#e o% &oiler chemical#:

    ou mu#t &e a&le to demon#trate that &oiler additi(e# do not "o#e a contamination threat to organic

    integrity at the "oint o% contact+ he National

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    E) Cleanin8 an# Sanitation

    1+ Ehat mea#ure# are in "lace to "re(ent contamination o% organic ingredient#, "roduct#, and %ood

    contact #ur%ace# %rom #anitation material# and cleaner#I-hec$ all that a""ly+

    Ehen u#ing #anitation material# in the %acility, care mu#t &e ta$en to "re(ent contact 'ith organic

    ingredient# and "roduct#+ Pre(enti(e mea#ure# 'ill &e (eri%ied at e(ery #te" in the "roce## %rom recei(ing,

    through "roce##ing to #torage, and %inal di#tri&ution+

    7 CFR 205.201(a)(5), 205.272(a)

    e#idue te#ting in#e "rior to organic run#

    Non5"ermea&le "ac$aging Documented em"loyee training

    na 5 No #anitationcleaning material# are u#ed+

    Other:

    2+ Ehat in%ormation i# included on the #anitation log or #imilar document!I-hec$ all that a""ly+

    A #anitation log i# one method %or demon#trating that #anitation "rocedure# are con#i#tently a""lied+

    Plea#e identi%y the com"onent# o% the #anitation log or de#cri&e the "rocedure# u#ed %or en#uring

    #anitation i# ade.uate and con#i#tent+

    7 CFR 205.272(a)

    e#idue e#t (eri%ication aterial# u#ed Procedure# u#ed

    .ui"ment cleaned"urged Schedule Signature line

    A Sanitation

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    8+ Plea#e an#'er the %ollo'ing .ue#tion# a&out the u#e o% #anitation material#:

    Synthetic cleaner# or #anitiBer# may not contact organic "roduct unle## they are on the NOP National

    #anitiBer re#idue# are remo(ed %rom %ood contact #ur%ace# "rior to organic handling:

    na 5 No #anitationcleaning material# are u#ed+

    na 5 All #anitiBer# are on the National

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    4) 4acility Pest Mana8ement

    1+ Ehat mea#ure# are in "lace to "re(ent organic ingredient#, "roduct#, "ac$aging material#, and %ood

    contact #ur%ace# %rom contamination o% &y "e#t control material#I-hec$ all that a""ly+

    Ehen u#ing "e#t control material# in the %acility, care mu#t &e ta$en to "re(ent contact 'ith organic

    ingredient# and "roduct#+ Pre(enti(e mea#ure# 'ill &e (eri%ied at e(ery #te" in the "roce## %rom recei(ing,

    through "roce##ing to #torage, and %inal di#tri&ution+

    7 CFR 205.201(a)(5), 205.272(a)

    na 5 No "e#t control material# are u#ed in the %acility+

    Pe#t control material# are only u#ed in non5"roduction area#+ i+e+ the o%%ice, &athroom#, etc+!

    Documented remo(al during treatment#

    Non5"ermea&le "ac$aging in#e "rior to organic run#

    e#idue te#ting Documented em"loyee training

    Other: 'e ha(e "hy#ical and cultural control#+ *n e3terior tram"# 'e u#e contract or rodent ca$e+

    2+ Plea#e an#'er the %ollo'ing .ue#tion# a&out the u#e o% a Pe#t -ontrol O"erator P-O!:

    Plea#e note that it i# im"ortant to clari%y 'ith the contract P-O that you are handling organic good# and

    that #"ecial "e#t management "rotocol# or record# may &e nece##ary to en#ure:

    5-om"liance 'ith the National Organic Program+

    5he organic integrity o% ingredient#, "roduct# K "ac$aging9 and

    5-om"liance 'ith a""lica&le local, #tate and %ederal regulation#+

    7 CFR 205.201(a)(6)

    a+ Do you u#e a contracted Pe#t -ontrol O"erator P-O! at thi# %acilityI

    e# No

    &+ *% Ge#,H ha(e you noti%ied the P-O that thi# o"eration i# organicI

    e# No na 5 A P-O i# not u#ed+

    c+ Ehat i# the name o% the P-O i% a""lica&le!I

    ASOP 879 *SSU 9 SAUS5PU; 201

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    8+ Plea#e an#'er the %ollo'ing .ue#tion# a&out the "e#t control hierarchy in "lace:/or each .ue#tion, chec$ all that a""ly+

    he National Organic Program NOP! regulation# #tre## the im"ortance o% &e#t "ractice "e#t control

    management in handling %acilitie#+ Ehile the u#e o% "e#t control material#, #ynthetic or non5#ynthetic, are

    not "rohi&ited &y the NOP, "re(entati(e "e#t control mea#ure# li$e #anitation, elimination o% ha&itat,e3clu#ion, mani"ulation o% the en(ironment, "roduct in#"ection, and mechanical mea#ure# mu#t &e %irmly

    in "lace to eliminate or greatly reduce the "e#t "re##ure in#ide the %acility+ Note that that #ynthetic "e#t

    control material# may only &e u#ed a%ter "re(entati(e mea#ure#, cultural"hy#ical control#, and material#

    on the national li#t ha(e &een attem"ted and documented to &e ine%%ecti(e+

    7 CFR 205.271

    a+ *ndicate the "re(entati(e "e#t management "ractice# in "lace at thi# %acility:

    No "e#t "re##ure ;arrier# onitoring >ood Sanitation

    anagement o% en(ironmental %actor# e+g+ tem"erature, humidity, light!

    emo(al o% "e#t ha&itat, %ood #ource# and &reeding area#Other:

    &+ *ndicate the mechanical or "hy#ical "e#t control mea#ure# in "lace:

    ra"#

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    G) Reco!#>ee'in8 an# A#it +!ail

    1+ Are the record# "ertaining to the o"eration maintained on5#ite, organiBed in a manner that can &e

    %ully audited, and a(aila&le %or in#"ection during regular &u#ine## hour#I

    he a""ro"riate "er#onnel mu#t &e a(aila&le during the in#"ection to grant acce## to the re.uired

    document# e+g+ accounting, management, etc!+ )A* recogniBe# that great di(er#ity e3i#t# among organichandler# and that a 'ide (ariety o% record $ee"ing #y#tem# may demon#trate com"liance 'ith the

    regulation+ *n addition to (eri%ying record# on5#ite, #am"le co"ie# o% rele(ant record# may &e collected at

    the in#"ection to allo' )A* to (eri%y com"liance 'ith the regulation+

    7 CFR 205.103

    e# No, "lea#e e3"lain:

    2+ Plea#e indicate the ty"e# o% acti(itie# %or 'hich you maintain con#i#tent documentation+-hec$ all that a""ly+

    ou mu#t &e a&le to account %or .uantitie# o% all %ini#hed organic "roduct# #old and in in(entory, and

    .uantitie# o% organic ingredient# recei(ed and u#ed in manu%acturing+ Some #y#tem %or en#uring audit

    trail clarity, #uch a# lin$ing lot num&er# %rom one document to the ne3t, i# nece##ary+

    7 CFR 205.103

    -erti%ication o% organic ingredient# *ngredient "urcha#e Shi""ing K di#tri&ution

    Production K "roce##ing *ngredient recei(ing Product #ale#

    Phy#ical or running in(entory

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    + Plea#e an#'er the %ollo'ing .ue#tion# a&out the u#e o% contract handler# andor o%%#ite #torage%acilitie#:

    4andler# that u#e the #er(ice# o% contract 'arehou#e#, co5"ac$er#, #torage or other handling %acilitie#

    mu#t ma$e #ure that tho#e %acilitie# are maintaining the organic integrity o% the good# they handle+ Any

    #uch %acility #hould either &e certi%ied inde"endently or a""ro(ed under your certi%ication+7 CFR 205.103

    Storage %acilitie# that recei(e "roduct in enclo#ed "ac$age#, and do not re"ac$age or "roce## the "roduct

    %urther, are not re.uired to &e certi%ied+ 4o'e(er, the certi%ied o"erator mu#t en#ure that the integrity o%

    organic ingredient#"roduct# i# maintained during #torage at non5certi%ied %acilitie#+ ea#ure mu#t &e in

    "lace that 'ould "re(ent the integrity o% the organic "roduct %rom &eing com"romi#ed+

    7 CFR 205.101(b)

    a+ *% contracted or o%%#ite #torage %acilitie# 'arehou#e#! are u#ed, do you maintain a%%ida(it# to(eri%y that the integrity o% organic good# i# "rotected 'hile in #torageI

    e# na -ontract or o%%#ite %acilitie# are not u#ed %or organic #torage+

    No, "lea#e e3"lain:

    &+ *% contracted %acilitie# are u#ed %or organic handling or "roce##ing, do you maintain current

    organic certi%icate# %or each contracted %acilityI

    e# na -ontract %acilitie# are not u#ed %or organic handling+

    No, "lea#e e3"lain:

    + Do you maintain all organic record# %or a minimum o% %i(e year#I

    Organic o"eration# mu#t maintain all record# a""lica&le to the organic o"eration %or at lea#t year#

    &eyond their creation+ *% the o"eration i# le## than %i(e year# old, you mu#t ha(e a "lan in "lace to com"ly

    'ith thi# re.uirement+

    7 CFR 205.103(b)(3)

    e# No, "lea#e e3"lain:

    6+ *# there a "rocedure in "lace %or documenting and addre##ing com"laint# relating to com"liance

    'ith organic #tandard#I

    Plea#e note that thi# i# not a re.uirement o% the NOP, &ut it i# a re.uirement o% *SO >uideline 1706 and

    i# rele(ant to other )A* #tandard# and "olicie#+

    e# No, "lea#e e3"lain:

    ASOP 879 *SSU 9 SAUS5PU; 201

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    7+ Are there "rocedure# in "lace to (eri%y that all #u""lier# o% organic commoditie# are currently

    certi%ied to the National Organic Program or e.ui(alent! &y a USDA Accredited -erti%ierI

    -erti%ication agencie# certi%y to multi"le #tandard#+ -erti%ication document# %or #u""lier# o% NOP

    "roduct# mu#t indicate that they 'ere certi%ied to the National Organic Program or an e.ui(alent #tandard'ith 'hich the NOP ha# a recogniBed trade agreement+ Additionally, you 'ill need to demon#trate ho'

    the "rocedure# in "lace (eri%y that certi%ication i# current+

    7 CFR 205.100

    e# No, "lea#e e3"lain:

    ASOP 879 *SSU 9 SAUS5PU; 201

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    @) A''licant E1'lanations Section U#e the #"ace &elo' to e3"lain your re#"on#e# a# needed %orclarity+

    ASOP 879 *SSU 9 SAUS5PU; 201

    P 1? % 1?