7/27/2019 Instructions for Submitting Comments on the Food Safety Modernization Act

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PreparedbytheNationalSustainableAgricultureCoalition,August2013.

Moreinformationisavailablehere:http://www.sustainableagriculture.net/fsmaMoreinformationisavailablehere:http://www.sustainableagriculture.net/fsma

TheFoodSafetyModernizationAct

HowDoICommentontheProposedRules?

TheFoodandDrugAdministrationwillacceptcommentssubmittedonlineorthroughthemail.

FollowtheseinstructionstosubmityourowncommentstoFDA!

CommentsaredueNovember15,2013!

CommentbyMail:

Ifyouaresubmittingawrittencommentbymail,youcantypeorhand-writeyourcommentsandmailthemtothisaddress:

DivisionofDocketsManagement(HFA-305)

FoodandDrugAdministration5630FishersLane,Room1061

Rockville,MD20852

Allsubmissionsreceivedmustincludethefollowing:

YourName YourOrganization(ifany) Theappropriatedocketnumber:

o ForthePreventiveControlsRule:FDA-2011-N-0920andRIN0910-AG36o

FortheProduceRule:FDA-2011-N-0921,andRIN0910-AG35

Ifyouwanttocommentonbothrules,youcanmailthemtogetherbutmustlabelthem

separately.

Note:FDAstatesthatallcommentsreceivedmaybepostedwithoutchangeto

www.regulations.gov,includinganypersonalinformationprovided.

CommentOnline:

1. Doyourhomework!CheckoutNSACsFSMAresourcesonlineandperusetherulesyourself.Youcanaccesstherulesandouranalysishere,includingtipsonwhatyour

commentmightincludeandgoodquestionstoask:

http://www.sustainableagriculture.net/fsma

(over)

7/27/2019 Instructions for Submitting Comments on the Food Safety Modernization Act

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PreparedbytheNationalSustainableAgricultureCoalition,August2013.

Moreinformationisavailablehere:http://www.sustainableagriculture.net/fsmaMoreinformationisavailablehere:http://www.sustainableagriculture.net/fsma

2. ClickontheappropriaterulepageinRegulations.goveithertheProduceRule1(FDA-2011-N-0921)orthePreventiveControlsRule.2(FDA-2011-N-0920)Youcan

commentonbothrules,butyoumustcommentseparately.Ifyourenotcertain

whichissuesapplytowhichrule,refertoourexplanationoftherulesandissues

pages.Someissuesaffectbothrulesthismeansyoullhavetosubmitaseparate

commentoneachformforeachruleifyouwanttocommentonthatissue.

3. ClickontheCommentNow!buttonontheright-handsideofthepage:

4. Double-checkthatyouarecommentingonthecorrectruleonthenextpage,ifyouarecommentingontheProduceRule,itwillsay:StandardsfortheGrowing,

Harvesting,Packing,andHoldingofProduceforHumanConsumption;ExtensionofCommentPeriods.IfyouarecommentingonthePreventiveControlsRule,itwillsay:

CurrentGoodManufacturingPracticeandHazardAnalysisandRisk-BasedPreventive

ControlsforHumanFood;ExtensionofCommentPeriods.

5. EnteryourcommentsandpersonalandbusinessinformationunderSection1,whichislabeledlikethis:

6. FirstupisthecommentboxwhereyourFSMAcommentswillgo.Youcantypethemrightintothebox,pastetheminfromanotherdocument,oruploadaseparatefile.

Whateveryoudo,westronglyrecommendyoupre-draftandprepareyourthoughts

aheadoftimeusingawordprocessorlikeWordorgoodold-fashionedpenand

paper!Notethatthereisa5000-characterlimitfortheboxthisisaboutoneandahalfpagesofsingle-spacedtypedtextoraround700-750words.Ifyouthinkyouhavemoretosay,youshouldUPLOADaseparatedocumentwithyourlongercomments

insteadandtypeSeeattachedfileinthebox.

7. Enteryourfirstandlastname(oropttoremainanonymous).8. (Optional)ClicktheboxthatsaysIwanttoprovidemycontactinformationand

enteryourZIPcodeandemailaddress.Itsagoodideatoprovideyourcontact

informationsothatFDAcanfollowupwithyouiftheyhavequestions,andyour

contactinformationwillnotbemadepublic.

9. (Optional)Ifyouareenteringacommentonbehalfofsomeoneelse,checktheIamsubmittingonbehalfofathirdpartybox.

1http://bit.ly/fsma-pr2http://bit.ly/fsma-pcr 2http://bit.ly/fsma-pcr

7/27/2019 Instructions for Submitting Comments on the Food Safety Modernization Act

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PreparedbytheNationalSustainableAgricultureCoalition,August2013.

Moreinformationisavailablehere:http://www.sustainableagriculture.net/fsmaMoreinformationisavailablehere:http://www.sustainableagriculture.net/fsma

10.Selectwhichcategoryyoufallinto.Therearemanyoptions,includingIndividualConsumerandFoodIndustry(FoodIndustryiswhatyoushouldchooseifyou

areafarmerorfoodprocessor).

11.ClicktheContinuelinktopreviewyourcommentsandensureeverythingis

accurateonthenextscreen:

12.Note:youcannotedityourcommentonceyousubmititbutifyouseeamistake,youcanclicktheEditbuttonatthebottomtogobackandmakechanges.

13.ClickSubmitCommenttoofficiallysubmityourcommenttoFDA.

o Youdidit!FDAwillreadeverycommentsubmitted.Theymaynotrespondtoeachcommentindividuallybuttheywilladdressthesubstanceofthesepublic

commentspubliclyoncethecommentperiodhasclosed.

14.Ascreenwillappearwithaconfirmationnumberforyourcomment.Copythisdownyoucanuseitlatertoensureyourcommentwasreceived.Yourcommentmaynot

appearonRegulations.govrightaway!

AFewFinalTips:

- Havingtrouble?CheckouttheofficialRegulations.govhelppage3orcontacttheRegulations.govhelpdesktheyhavebothemailandphoneoptions(Phone:1-877-

378-5457)

- Makeamistake?Tomakechanges,submitanothercommentreferringtoyourpreviouscomment,correctinganyerrorsand/orre-statingyourpositionoropinion.

-Wanttosubmitadditionalcomments?Youcansubmitmorethanonecommentsimplyfollowthisprocessagain!

- Remembertokeepaseparatecopyofyourcommentjustincase!Thiswayifyouhaveaproblemsubmittingitorneedtoreferenceitlater,youvegotacopy.

3http://www.regulations.gov/#!help