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Records Access

Upon enactment on January 4, 2011, the new legislation gave FDA authority to access all records related to the manufacturing, processing, packing, transportation, distribution, receipt, holding, or importation of an article of food for which there is a reasonable probability that exposure will cause serious adverse health consequences or death. All records relating to any food that is likely to be affected in a similar manner must be provided to FDA upon request.

Hazard Analysis and Risk-Based Preventive Controls

Within one and a half years, all registered facilities, which includes any factory, warehouse, or establishment that manufactures, processes, packs or holds food, will be required to conduct a hazard analysis, implement preventive controls and develop a written food safety plan to document the monitoring, correction, and verification of preventive controls. The food safety plan and all related documents must be made available to FDA upon request. As part of its food safety plan, a facility may be required to document sanitation procedures, a recall plan, a food allergen control program, supplier verification activities, and an environmental sampling program.

Performance Standards

At least every two years, FDA will review and evaluate relevant data to determine which foodborne contaminates pose the greatest risk and, as appropriate, issue guidance documents and action levels. Registered facilities will need to verify that their preventive controls are adequate and effective to mitigate the hazards identified.

Standards for Produce Safety

The legislation requires FDA to establish standards for the safe production and harvesting of produce where FDA has determined that standards would minimize the risk of serious adverse health consequences. FDA is required to publish a proposed rule on the minimum standards and publish updated Good Agricultural Practices within one year. The standards should include science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, water, and intentional and unintentional hazards.

Protection Against Intentional Adulteration

To ensure protection against both known and unknown risks, FDA will conduct an assessment and determine where mitigation strategies are necessary for protection against intentional adulteration. Within one and a half years, FDA will issue regulations that outline appropriate



mitigation strategies at vulnerable points in the supply chain for food at high-risk of intentional adulteration.

Sanitary Transportation of Food

The new law requires FDA to issue regulations within one and a half years to require that shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in transportation of food use sanitary practices. Specific requirements will be outlined in the regulation. In addition, FDA is required to conduct a study of the transportation of food in the United States, including transportation by air, and an examination of the unique needs of rural areas with regard to delivery of safe food.

Increased Inspection Frequency

Upon enactment on January 4, 2011, the new legislation requires FDA to increase inspection frequencies for all registered facilities. FDA must direct inspection resources to high-risk facilities based on the known safety risks of the food, the compliance history of the facility, the

-based preventive controls, and whether the food or facility has met certification requirements for imported food.

Domestic high-risk facilities must be inspected at least once in the first five years following enactment and at least once every three years thereafter. Domestic non-high risk facilities must be inspected at least once in the seven years following enactment and at least once every five years thereafter. In the first year following enactment, FDA must inspect at least 600 foreign facilities and must double the number of inspections every year compared with the previous year for the next five years.

With current resources, it will be nearly impossible for FDA to meet inspection frequencies. The Agency likely will look to other Federal, State, or Local inspectors to assist FDA in meeting the inspection frequency requirements for domestic firms. The Agency may explore the use of foreign governments or third-party auditors to assist with oversight of foreign firms.

Enhanced Tracking and Tracing and Recordkeeping Requirements

The legislation requires FDA to conduct product tracing pilots in the processed food and produce sectors within 270 days of enactment. Within 18 months, FDA must provide Congress with a report on recommendations for establishing more effective product tracing, including consideration of costs and benefits, feasibility of technologies for different sectors, existing practices, and international efforts. Using the information, FDA is directed to create, as appropriate, a product tracing system.



In addition, within one year, FDA is to develop and to publish a list of high-risk foods. Criteria for determining which foods are designated as high-risk includes: the known safety risk of a particular food, likelihood of microbiological or chemical contamination, location in the manufacturing process, and likelihood that consuming the food will result in a foodborne illness.

Within two years, FDA must begin developing regulations for additional record-keeping requirements for high-risk food. The regulation must relate only to information that is reasonability available, consider cost and public health benefit, be scale-appropriate and similar across commodities, and should not prescribe specific technologies. It also may not require a full pedigree, a record of the recipient of food beyond the immediate subsequent recipient, or product tracking to the case level.

Reportable Food Registry

Within 18 months, firms will be required to submit consumer-oriented information for fruits and vegetables that are raw agricultural commodities when submitting to the Reportable Food Registry. FDA will use the consumer-oriented information to post a one-page summary to their website. Chain grocery stores (15+ physical establishments) will be required to print and post consumer notifications at designated locations in the store.

Mandatory Recall Authority

Upon enactment on January 4, 2011, the new legislation gave FDA authority to require a mandatory recall of product for which there is a reasonable probability that the product is adulterated or misbranded and will cause serious adverse health consequences or death. The responsible party must be given an opportunity to voluntarily cease distribution and recall the affected product before a recall is ordered.

Accreditation of Laboratories

Within two years, FDA must develop a program for laboratory accreditation. FDA will establish a program to recognize accreditation bodies that will be able to accredit laboratories based on model standards established by FDA. The model standards will include sampling and analytical procedures, internal quality systems and training for individuals conducting sampling and analysis. The goal of the program is to increase the number of qualified laboratories. Both domestic and foreign laboratories are eligible for participation and both must meet the model standards. Two and a half years from the date the law was signed, laboratories will be required to be accredited to conduct any regulatory testing.



Foreign Supplier Verification

Within two years, importers will be required to perform risk-based foreign supplier verification to ensure that all imported food is produced in compliance with the preventive control requirements, the produce safety standards, and other U.S. laws and regulations. FDA is required to issue guidance within one year to assist importers in developing verification programs and issue a regulation within one year that outlines the requirements for verification programs.

Voluntary Qualified Importer Program

Within one and a half years, FDA is required to establish a program that would provide expedited review of food from importers who participate in the voluntary program. Requirements for participation will be outlined in a FDA guidance document.

Authority to Require Import Certifications for Food

Upon enactment on January 4, 2011, the new legislation gave FDA authority to require import certification for food to certify that food is produced in compliance with U.S. laws and regulations. FDA is to determine requirements based on the known risks associated with the food or the country, region, or territory of origin.

Accreditation of Third-Party Auditors

The legislation requires FDA to establish a program to recognize accreditation bodies and third-party auditors. Third-parties can be a foreign government or a private entity. Third-party audit certifications will be used to ensure that the product offered for import is in compliance with U.S. laws and regulations and to determine if a facility is eligible to offer food for import under the voluntary qualified importer program.

(3) Food Safety Modernization Act: Impact on Producers and Processors

Perhaps the most significant new requirement for food processors and producers under the new legislation is the requirement to conduct a hazard analysis and implement preventive controls to mitigate identified risks. Firms will be required to develop a written food safety plan that outlines the hazards identified along with preventive controls and documents for monitoring activities, corrective actions, and verification activities. Within 18 months, FDA is required to issue regulations that establish science-based minimum standards for conducting the hazard analysis and developing the food safety plan. The science-based standards will be supported by data and build upon industry best practices and proven mitigation strategies. The



content of these regulations will determine the extent to which the preventive controls requirement mirrors the current HACCP requirements. Firms that are already required to have a HACCP plan (seafood, juice, and low-acid canned food) are exempt from the new requirements.

Depending on the regulations outlining appropriate mitigation strategies to protect against intentional adulteration and identifying vulnerable points in the supply chain, producers and processors may be required to implement mitigation strategies to protect against intentional adulteration and unknown risks.

In addition, food processors and producers will be subject to increased inspections, expanded FDA record access, additional traceability and recordkeeping requirements and additional accountability for ensuring that imported ingredients are safe and have been manufactured and processed in accordance with U.S. laws and regulations.

The increased scrutiny and accountability placed on producers and processors will likely lead to an increase in the need for preventive control validation and verifications, environmental testing, testing of raw ingredients, and testing of finished product to verify that preventive controls are successfully mitigating hazards.

(4) Food Safety Modernization Act: Impact on Importers

The new legislation includes several provisions that impact imported food. The foreign supplier verification program will require that importers verify that imported food is produced in compliance with applicable U.S. laws and is not adulterated or misbranded. Verification activities include periodically testing and sampling shipments.

The legislation gives FDA immediate authority to require import certifications to certify that food has been processed in compliance with U.S. laws and regulations. Requirements for certification will be based on the known risks associated with the food or country, region, or territory of origin. Within one and a half years, FDA must establish a voluntary qualified importer program to allow for expedited review of food offered by importers who have agreed to participate in the program. The voluntary qualified importer program will likely require importers to demonstrate to FDA that the appropriate standards and controls are in place, which will likely result in more testing programs.

The legislation requires FDA to establish model program standards for accrediting third-party auditors to audit foreign facilities. Third-party auditors will be able to issue certifications to ensure food is in compliance with U.S. laws and to determine if a facility is eligible to offer food for import under the voluntary qualified importer program.



These new programs will have a significant impact on importers and their customers. Importers must take responsibility for ensuring and verifying the safety of food that they import into the country. Given the increased scrutiny, processors and manufacturers are also going to be undertaking greater due diligence on ingredients and placing increased pressure on importers to ensure the safety of product they import.

(5) Food Safety Modernization Act: Impact on Laboratories

The Food Safety Modernization Act will have a significant impact on laboratories. Within two years of enactment, FDA must develop a program for laboratory accreditation that includes model standards for laboratory accreditation and recognizes accreditation bodies to accredit laboratories. The standards will include methods to ensure appropriate sampling, analytical procedures, and commercially available techniques are followed; reports and analyses are certified as true and accurate; internal quality systems are established and maintained; procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and individuals who conduct the sampling and analyses are qualified.

FDA will recognize accreditation bodies to accredit laboratories to the model standards established by FDA. Requirements for accreditation bodies will be outlined as part of the program development. A registry of both accreditation bodies and accredited laboratories will be made public.

The goal of the program is to increase the number a qualified laboratories. Both domestic and foreign laboratories are eligible for participation and both must meet the model standards. Two and a half years after enactment, contract test labs and public health labs will be required to be accredited to the model standards to participate in testing of imported products, products on import alert, or in response to testing requirements under the new law.

Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories may provide insight into what will be required in the model standards. The draft guidance requires that laboratories be operating in accordance with the International Organization for Standardization (ISO) standard 17025 General Requirements for the Competence of Testing and Calibration Laboratories.

The accreditation program will include continual review. Once accredited, laboratories will be required to submit any changes to FDA. FDA will periodically (at least once every five years) reevaluate accreditation bodies for compliance with the model standards and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition.



In addition, at least every two years, FDA will review and evaluate relevant data to determine which foodborne contaminants pose the greatest risk and, as appropriate, issue guidance documents, regulations and action levels. New laboratory methods may need to be validated to assure compliance with new action levels.

The new law does not include any provisions that specifically require expansion of the Food Emergency Response Network (FERN). The legislation does require a report be submitted to Congress on FERN within 180 days of enactment. As more federal, state, and local laboratories become accredited labs under the new programs, there will be additional surge capacity and additional laboratories capable of using established methods.

The legislation requires the continuation of the Integrated Consortium of Laboratory Networks (ICLN) coordinated by the Secretary of Homeland Security, in collaboration with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Commerce, and the Administrator of the Environmental Protection Agency. The members of the ICLN (as determined by the Secretary of Homeland Security) will agree on common laboratory methods, identify opportunities to optimize preparedness and provide surge capacity during emergencies. A biennial report on the progress of the ICLN will be made public.

(6) Food Safety Modernization Act: Additional Considerations

Multiple drivers are currently impacting the food safety landscape and many changes are in motion, independent of the new legislation. The implementation of the new legislation will take time and is largely dependent on funding and how FDA drafts the regulations. The Congressional Budget Office estimates the cost of the bill at $1.4 billion over the next five years. The current fiscal situation is not indicative of FDA getting a large increase in funding. The Agency is currently operating under a continuing resolution at the FY 2010 funding level. The outcome of the FY 2011 budget decisions by Congress will be critical to how much FDA can accomplish towards increasing inspections, establishing regulations, and implementing new programs.

(7) Food Safety Modernization Act: Opportunities

The new legislation creates opportunities for companies to respond to new market needs. With the implementation of the preventive controls requirement and increased need for brand protection, food producers and processors will need greater capacity for implementing preventive controls and verifying effectiveness. Activities may include conducting raw ingredient, finished product and environmental testing, as well as verification, validation and monitoring of controls systems. Facilities will also need tools and equipment to mitigate all identified hazards in the supply chain.



The new requirements to ensure the safety of imported food will likely result in increased demand for rapid tests to verify safety and expedite acceptance of product into the U.S. Importers will be required to be in compliance with U.S. laws and regulations, which will likely include greater use of third-party audits and testing programs in order to verify that suppliers are using proper preventive controls and for participation in the voluntary qualified importer program.

Conclusion

With the implementation of the new legislation, there will be changes in the food safety landscape across the supply chain. It is important that every company stays informed on the implementation of the new law and ahead of changes to ensure a position as a food safety leader. By monitoring FDA updates, Federal Register notifications, and industry groups, companies will be able to identify opportunities to provide input and to engage in the rule-making process. , but there is a unique opportunity for industry leaders to share best-practices with FDA, participate in shaping the new regulations and guidance, and position themselves to have the solutions to meet the needs created by the new requirements.


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year

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ves

the

Secr

etar

y au

thor

ity to

susp

end

regi

stra

tion

if th

ere

is a

reas

onab

le p

roba

bilit

y of

serio

us a

dver

se h

ealth

co

nseq

uenc

es o

r dea

th, a

nd g

ives

the

Secr

etar

y au

thor

ity

to re

orga

nize

food

cat

egor

ies.

Fa

cilit

ies s

ubje

ct to

new

regi

stra

tion

requ

irem

ents

X

Or u

pon

FDA

issua

nce

of

regu

latio

n, if

bef

ore

180

days

FDA

may

requ

ire e

lect

roni

c su

bmiss

ion

5

year

s Se

c. 1

03. H

azar

d an

alys

is an

d ris

k-ba

sed

prev

entiv

e co

ntro

ls: R

equi

res r

egist

ered

faci

litie

s to

eval

uate

haz

ards

, im

plem

ent p

reve

ntiv

e co

ntro

ls, m

onito

r the

per

form

ance

an

d ve

rify

the

effe

ctiv

enes

s of p

reve

ntiv

e co

ntro

ls, a

nd

mai

ntai

n re

cord

s, in

clud

ing

a w

ritte

n pl

an, o

n ha

zard

s and

pr

even

tive

cont

rols.

Mod

ified

requ

irem

ents

will

app

ly to

qu

alifi

ed fa

cilit

ies.

In

gen

eral

, req

uire

men

ts u

nder

Sec

tion

103

take

ef

fect

X

Smal

l + 6

mon

ths f

rom

ef

fect

ive

date

of r

egul

atio

n Ve

ry sm

all +

18

mon

ths f

rom

ef

fect

ive

date

of r

egul

atio

n

FDA

to e

stab

lish

scie

nce-

base

d st

anda

rds f

or

cond

uctin

g a

haza

rd a

naly

sis, i

mpl

emen

ting

prev

entiv

e co

ntro

ls, a

nd d

ocum

entin

g im

plem

enta

tion

of p

reve

ntiv

e co

ntro

ls an

d to

X

12Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

APPE

ND

IX: F

ood

Safe

ty M

oder

niza

tion

Act S

umm

ary

and

Tim

elin

e

13

Le

avitt

Par

tner

s, 29

9 So

uth

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

Sect

ion

Upo

n En

actm

ent

180

Days

27

0 Da

ys

1 Ye

ar

1.5

Year

s 2

Year

s 2.

5 Ye

ars

Oth

er

FD

A st

udy

of fo

od p

roce

ssin

g se

ctor

X

FD

A pu

blish

gui

danc

e on

pre

vent

ive

cont

rols

N

o de

adlin

e sp

ecifi

ed

FD

A pu

blish

NPR

M o

n ac

tiviti

es th

at c

onst

itute

on

-farm

pac

king

, hol

ding

, man

ufac

turin

g an

d pr

oces

sing

X

FD

A pu

blish

Fin

al R

ule

on a

ctiv

ities

that

con

stitu

te

on-fa

rm p

acki

ng, h

oldi

ng, m

anuf

actu

ring

and

proc

essin

g

9 m

onth

s aft

er c

omm

ent

perio

d

Sec.

104

. Per

form

ance

stan

dard

s: R

equi

res F

DA to

revi

ew

food

born

e co

ntam

inan

ts a

nd is

sue

guid

ance

or r

egul

atio

ns

as n

eces

sary

to re

duce

risk

s.

As a

ppro

pria

te

Sec.

105

. Sta

ndar

ds fo

r pro

duce

safe

ty: E

stab

lishe

s sc

ienc

e-ba

sed

min

imum

stan

dard

s for

the

safe

pro

duct

ion

and

harv

estin

g of

pro

duce

. Mod

ified

requ

irem

ents

and

ex

empt

ions

will

app

ly to

qua

lifie

d fa

cilit

ies.

FD

A iss

ue p

ropo

sed

rule

X

FDA

issue

fina

l rul

e

1 ye

ar a

fter c

omm

ent p

erio

d Sm

all +

1 y

ear f

rom

effe

ctiv

e da

te o

f reg

ulat

ion

Very

smal

l + 2

yea

rs fr

om

effe

ctiv

e da

te o

f reg

ulat

ion

FD

A pu

blish

upd

ated

GAP

s

X

Se

c. 1

06. P

rote

ctio

n ag

ains

t int

entio

nal a

dulte

ratio

n:

Requ

ires d

evel

opm

ent o

f gui

danc

e an

d re

gula

tions

to

prot

ect a

gain

st in

tent

iona

l adu

ltera

tion.

FD

A iss

ue g

uida

nce

X

FD

A iss

ue re

gula

tion

X

Sec.

107

. Aut

horit

y to

col

lect

fees

: Giv

es th

e Se

cret

ary

auth

ority

to c

olle

ct fe

es fo

r rei

nspe

ctio

n, re

calls

, and

vo

lunt

ary

qual

ified

impo

rter

pro

gram

.

FD

A pu

blish

fees

60

days

bef

ore

each

FY

X

Sec.

108

. Nat

iona

l agr

icul

ture

and

food

def

ense

stra

tegy

: Re

quire

s FDA

, Uni

ted

Stat

es D

epar

tmen

t of A

gric

ultu

re

X

13Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

APPE

ND

IX: F

ood

Safe

ty M

oder

niza

tion

Act S

umm

ary

and

Tim

elin

e

14

Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

Sect

ion

Upo

n En

actm

ent

180

Days

27

0 Da

ys

1 Ye

ar

1.5

Year

s 2

Year

s 2.

5 Ye

ars

Oth

er

(USD

A), a

nd th

e De

part

men

t of H

omel

and

Secu

rity

(DHS

) to

dev

elop

a n

atio

nal a

gric

ultu

re a

nd fo

od d

efen

se

stra

tegy

. Se

c. 1

09. F

ood

and

Agric

ultu

re C

oord

inat

ing

Coun

cils

: Re

quire

s cre

atio

n of

food

and

agr

icul

ture

coo

rdin

atio

n co

unci

ls, c

ompr

ised

of re

pres

enta

tives

from

DHS

, HHS

, and

U

SDA,

to im

prov

e co

ordi

natio

n an

d co

mm

unic

atio

n.

X

Firs

t rep

ort a

t 180

day

s;

Repo

rts d

ue o

nce

a ye

ar

ther

eaft

er

Sec.

110

. Bui

ldin

g do

mes

tic c

apac

ity: R

equi

res F

DA to

id

entif

y pr

ogra

ms a

nd p

ract

ices

to p

rovi

de fo

od sa

fety

and

se

curit

y.

X

Sec.

111

. San

itary

tran

spor

tatio

n of

food

: Req

uire

s FDA

to

deve

lop

new

regu

latio

ns fo

r the

safe

tran

spor

tatio

n of

fo

od.

X

Sec.

112

. Foo

d al

lerg

y an

d an

aphy

laxi

s m

anag

emen

t: Re

quire

s FDA

to d

evel

op v

olun

tary

gui

delin

es fo

r foo

d al

lerg

y ris

k m

anag

emen

t pla

ns in

scho

ols a

nd e

arly

ed

ucat

ion

faci

litie

s.

X

Sec.

113

. New

die

tary

ingr

edie

nts:

Req

uire

s FDA

to is

sue

guid

ance

to d

efin

e a

new

die

tary

ingr

edie

nt a

nd o

utlin

e th

e ev

iden

ce re

quire

d to

doc

umen

t the

safe

ty o

f a n

ew

diet

ary

ingr

edie

nt.

X

Sec.

114

. Req

uire

men

t for

gui

danc

e re

latin

g to

pos

t ha

rves

t pro

cess

ing

of ra

w o

yste

rs: T

he S

ecre

tary

mus

t pr

ovid

e 90

day

s not

ifica

tion

prio

r to

issui

ng a

ny g

uida

nce,

re

gula

tion,

or a

men

dmen

ts to

the

Nat

iona

l She

llfish

that

rela

tes t

o th

e po

st h

arve

st p

roce

ssin

g of

oys

ters

.

X

Sec.

115

. Por

t sho

ppin

g: R

equi

res F

DA to

pro

vide

no

tific

atio

n to

the

Secr

etar

y of

Hom

elan

d Se

curit

y w

hen

refu

sing

to a

dmit

food

. X

Sec.

116

. Alc

ohol

-rel

ated

faci

litie

s: A

lcoh

ol-r

elat

ed

faci

litie

s are

exe

mpt

from

this

Act.

X

Sec.

201

. Tar

getin

g of

insp

ectio

n re

sour

ces

for d

omes

tic

faci

litie

s, fo

reig

n fa

cilit

ies,

and

por

ts o

f ent

ry; a

nnua

l re

port

: Req

uire

s tha

t FDA

insp

ectio

nal r

esou

rces

be

X

14Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

APPE

ND

IX: F

ood

Safe

ty M

oder

niza

tion

Act S

umm

ary

and

Tim

elin

e

15

Le

avitt

Par

tner

s, 29

9 So

uth

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

Sect

ion

Upo

n En

actm

ent

180

Days

27

0 Da

ys

1 Ye

ar

1.5

Year

s 2

Year

s 2.

5 Ye

ars

Oth

er

targ

eted

bas

ed o

n ris

k an

d ou

tline

s ins

pect

ion

freq

uenc

y re

quire

men

ts fo

r dom

estic

and

fore

ign

firm

s. Se

c. 2

02. L

abor

ator

y ac

cred

itatio

n fo

r ana

lyse

s of f

oods

: Re

quire

s FDA

to e

stab

lish

a pr

ogra

m fo

r acc

redi

ting

food

la

bora

torie

s.

FD

A es

tabl

ish p

rogr

am fo

r acc

redi

ted

labs

X

Food

test

ing

mus

t be

cond

ucte

d by

acc

redi

ted

labs

whe

n co

nduc

ted

by o

r on

beha

lf of

an

owne

r, in

resp

onse

to te

stin

g re

quire

men

ts in

the

Act,

or

as re

quire

d to

add

ress

susp

ecte

d or

iden

tifie

d fo

od sa

fety

pro

blem

s

X

Sec.

203

. Int

egra

ted

cons

ortiu

m o

f lab

orat

ory

netw

orks

: Re

quire

s FDA

, USD

A, a

nd th

e En

viro

nmen

tal P

rote

ctio

n Ag

ency

(EPA

) to

form

a c

onso

rtiu

m to

iden

tify

com

mon

la

bora

tory

met

hods

and

pro

vide

surg

e ca

paci

ty.

X

Sec.

204

. Enh

ance

d tr

acki

ng a

nd tr

acin

g of

food

and

re

cord

keep

ing:

Req

uire

s FDA

to p

ilot t

raci

ng sy

stem

s, co

nsid

er e

stab

lishi

ng a

pro

duct

trac

ing

prog

ram

, and

ex

pand

reco

rdke

epin

g re

quire

men

ts fo

r hig

h-ris

k fo

ods.

FD

A co

nduc

t tra

ckin

g an

d tr

acin

g pi

lots

X

FDA

repo

rt to

Con

gres

s on

pilo

ts, a

dditi

onal

dat

a

X

FDA

publ

ish li

st o

f hig

h-ris

k fo

od fo

r re

cord

keep

ing

prov

ision

X

FD

A es

tabl

ish p

rodu

ct tr

acin

g sy

stem

No

spec

ified

dea

dlin

e

NPR

M o

n re

cord

keep

ing

X

Sm

all +

1 y

ear f

rom

fina

l rul

e Ve

ry sm

all +

2 ye

ars f

rom

fina

l ru

le

Sec.

205

. Sur

veill

ance

: FDA

and

the

Cent

ers f

or D

iseas

e Co

ntro

ls an

d Pr

even

tion

(CDC

) sha

ll en

hanc

e su

rvei

llanc

e sy

stem

s to

impr

ove

colle

ctio

n, a

naly

sis a

nd re

port

ing.

Co

ordi

natin

g an

d in

fo sh

arin

g X

Revi

ew o

f str

ateg

ies

X

Sec.

206

. Man

dato

ry re

call

auth

ority

: Pro

vide

s FDA

m

anda

tory

reca

ll au

thor

ity.

X

Sec.

207

. Adm

inist

rativ

e de

tent

ion

of fo

od: E

xpan

ds F

DA

15Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

APPE

ND

IX: F

ood

Safe

ty M

oder

niza

tion

Act S

umm

ary

and

Tim

elin

e

16

Le

avitt

Par

tner

s, 29

9 So

uth

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

Sect

ion

Upo

n En

actm

ent

180

Days

27

0 Da

ys

1 Ye

ar

1.5

Year

s 2

Year

s 2.

5 Ye

ars

Oth

er

adm

inist

rativ

e de

tent

ion

of fo

od w

hen

ther

e is

a re

ason

able

bel

ief t

hat t

he fo

od is

adu

ltera

ted

or

misb

rand

ed.

FD

A iss

ue in

terim

fina

l rul

e

X

Se

c. 2

08. D

econ

tam

inat

ion

and

disp

osal

stan

dard

s and

pl

ans:

EPA

, in

conj

unct

ion

with

HHS

, USD

A, a

nd D

HS w

ill

deve

lop

stan

dard

s and

pro

toco

ls to

ass

ist S

tate

, loc

al a

nd

trib

al g

over

nmen

ts w

ith p

repa

ring

for,

asse

ssin

g,

deco

ntam

inat

ing,

and

reco

verin

g fr

om a

n ag

ricul

tura

l or

food

em

erge

ncy.

X

Sec.

209

. Im

prov

ing

the

trai

ning

of S

tate

, loc

al, t

errit

oria

l, an

d tr

ibal

food

saf

ety

offic

ials:

FDA

will

est

ablis

h st

anda

rds a

nd a

dmin

ister

trai

ning

and

edu

catio

n pr

ogra

ms

for S

tate

, loc

al, t

errit

oria

l, an

d tr

ibal

food

safe

ty o

ffici

als.

FD

A se

t sta

ndar

ds a

nd a

dmin

ister

trai

ning

on

polic

ies e

stab

lishe

d by

Act

X

FD

A co

ntra

cts a

nd m

emor

andu

m in

clud

e pr

ovisi

ons t

o en

sure

ade

quat

e tr

aini

ng

X

FD

A w

ill e

stab

lish

gran

t pro

gram

with

Nat

iona

l In

stitu

te fo

r Foo

d an

d Ag

ricul

ture

X

Sec.

210

. Enh

anci

ng fo

od s

afet

y: A

llow

s for

FDA

to p

rovi

de

mul

ti-ye

ar g

rant

s to

Stat

e, lo

cal,

terr

itoria

l, an

d tr

ibal

go

vern

men

ts a

nd e

stab

lishe

s Cen

ters

of E

xcel

lenc

e to

se

rve

as re

sour

ces f

or p

ublic

hea

lth p

rofe

ssio

nals

to

resp

ond

to fo

odbo

rne

illne

ss o

utbr

eaks

.

G

rant

s to

stat

es

X

FD

A to

des

igna

te 5

Cen

ters

of E

xcel

lenc

e

X

Se

c. 2

11. I

mpr

ovin

g th

e re

port

able

food

regi

stry

: Req

uire

s ad

ditio

nal i

nfor

mat

ion

to b

e su

bmitt

ed to

the

repo

rtab

le

food

regi

stry

.

X

Sec.

301

. For

eign

supp

lier v

erifi

catio

n pr

ogra

m: R

equi

res

impo

rter

s to

perf

orm

risk

-bas

ed fo

reig

n su

pplie

r ve

rific

atio

n to

ver

ify th

at im

port

ed fo

od is

pro

duce

d in

co

mpl

ianc

e w

ith a

pplic

able

U.S

. law

s and

is n

ot

adul

tera

ted

or m

isbra

nded

.

16Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

APPE

ND

IX: F

ood

Safe

ty M

oder

niza

tion

Act S

umm

ary

and

Tim

elin

e

17

Le

avitt

Par

tner

s, 29

9 So

uth

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

Sect

ion

Upo

n En

actm

ent

180

Days

27

0 Da

ys

1 Ye

ar

1.5

Year

s 2

Year

s 2.

5 Ye

ars

Oth

er

FD

A pu

blish

gui

danc

e

X

FDA

publ

ish re

gula

tion

X

Ef

fect

ive

date

X

Se

c. 3

02. V

olun

tary

qua

lifie

d im

port

er p

rogr

am:

Esta

blish

es a

pro

gram

for e

xped

ited

revi

ew o

f foo

d of

fere

d by

impo

rter

s who

hav

e ag

reed

to v

olun

taril

y pa

rtic

ipat

e in

th

e pr

ogra

m.

FD

A pu

blish

gui

danc

e

X

FDA

esta

blish

pro

gram

X

Se

c. 3

03. A

utho

rity

to re

quire

impo

rt c

ertif

icat

ions

for

food

: Aut

horiz

es th

e Se

cret

ary

to re

quire

impo

rted

food

to

have

a c

ertif

icat

e of

com

plia

nce

with

app

licab

le

requ

irem

ents

.

X

Sec.

304

. Prio

r not

ice

of im

port

ed fo

od sh

ipm

ents

: Re

quire

s the

man

ufac

ture

r or s

hipp

er to

not

ify F

DA o

f any

co

untr

y to

whi

ch th

e ar

ticle

has

bee

n re

fuse

d en

try.

X

Sec.

305

. Bui

ldin

g ca

paci

ty o

f for

eign

gov

ernm

ents

with

re

spec

t to

food

safe

ty: R

equi

res F

DA to

dev

elop

a p

lan

to

expa

nd te

chni

cal,

scie

ntifi

c an

d re

gula

tory

cap

acity

of

fore

ign

gove

rnm

ents

and

thei

r res

pect

ive

food

indu

strie

s.

X

Sec.

306

. Ins

pect

ion

of fo

reig

n fo

od fa

cilit

ies:

Aut

horiz

es

the

Secr

etar

y en

ter i

nto

arra

ngem

ents

with

fore

ign

gove

rnm

ents

to fa

cilit

ate

insp

ectio

ns o

f for

eign

regi

ster

ed

faci

litie

s, re

fuse

adm

issio

n of

food

from

faci

litie

s ref

usin

g in

spec

tion,

and

per

mits

the

Depa

rtm

ent o

f Com

mer

ce to

se

nd in

spec

tors

to fo

reig

n se

afoo

d fa

cilit

ies.

X

Sec.

307

. Acc

redi

tatio

n of

third

-par

ty a

udito

rs: R

equi

res

FDA

to e

stab

lish

a pr

ogra

m to

reco

gnize

acc

redi

tatio

n bo

dies

and

third

-par

ty a

udito

rs.

FD

A re

cogn

ize a

ccre

dita

tion

bodi

es

X

FD

A de

velo

p m

odel

stan

dard

s

X

FDA

issue

regu

latio

ns re

: con

flict

of i

nter

est

X

Sec.

308

. For

eign

offi

ces o

f the

Foo

d an

d Dr

ug

Adm

inist

ratio

n: R

equi

res a

stat

us re

port

on

the

FDA

fore

ign

offic

es.

By

Oct

ober

1, 2

011

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avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

APPE

ND

IX: F

ood

Safe

ty M

oder

niza

tion

Act S

umm

ary

and

Tim

elin

e

18

Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

Sect

ion

Upo

n En

actm

ent

180

Days

27

0 Da

ys

1 Ye

ar

1.5

Year

s 2

Year

s 2.

5 Ye

ars

Oth

er

Sec.

309

. Sm

uggl

ed fo

od: R

equi

res F

DA, i

n co

ordi

natio

n w

ith D

HS, t

o de

velo

p an

d im

plem

ent a

stra

tegy

to b

ette

r id

entif

y sm

uggl

ed fo

od a

nd p

reve

nt e

ntry

of s

uch

food

into

th

e U

nite

d St

ates

.

X

Sec.

401

. Fun

ding

for f

ood

safe

ty: A

utho

rizes

ap

prop

riatio

n of

fund

s to

carr

y ou

t act

iviti

es in

the

Act.

X

Sec.

402

. Em

ploy

ee p

rote

ctio

ns: N

o en

tity

enga

ged

in

man

ufac

ture

, pro

cess

ing,

pac

king

, tra

nspo

rtin

g,

dist

ribut

ion,

rece

ivin

g, h

oldi

ng, o

r im

port

atio

n of

food

may

di

scha

rge

or d

iscrim

inat

e ag

ains

t a w

hist

lebl

ower

.

X

Sec.

403

. Jur

isdi

ctio

n; a

utho

ritie

s: T

his A

ct d

oes n

ot a

lter

juris

dict

ion

betw

een

the

Depa

rtm

ent o

f Hea

lth a

nd H

uman

Se

rvic

es a

nd th

e U

nite

d St

ates

Dep

artm

ent o

f Agr

icul

ture

.

X

Sec.

404

. Com

plia

nce

with

inte

rnat

iona

l agr

eem

ents

: N

othi

ng in

this

Act m

ay b

e in

cons

isten

t with

the

agre

emen

t est

ablis

hing

the

Wor

ld T

rade

Org

aniza

tion

or

any

othe

r tre

aty

or in

tern

atio

nal a

gree

men

t to

whi

ch th

e U

nite

d St

ates

is a

par

ty

X

Sec.

405

. Det

erm

inat

ion

of b

udge

tary

effe

cts:

Bud

geta

ry

effe

cts o

f thi

s Act

shal

l be

dete

rmin

ed b

y re

fere

nce

to th

e

X

18Le

avitt

Par

tner

s, 2

99 S

outh

Mai

n, S

uite

230

0, S

alt L

ake

City

, Uta

h 84

111,

USA

Documents

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