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IMPLEMENTING THE FOOD SAFETY ACT OF 2013

and ITS IRRs

THE DAIRY FOOD REGULATIONS

Joshua S. Lomuntad

Sec. 1

Overview and Authority� NDA was mandated to be the Food Safety Regulatory

Agency (FSRA) for pasteurized liquid milk products pursuant to Republic Act No. 10611.

� IRR Sec 16

� For milk production and post harvest handling

� In compliance, NDA prepared its Dairy Food Regulations.

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Dairy Farms

Milk Collection Centers

Milk Processing Plants

Other dairy enterprises

including service and input

providers along the dairy value

chain

Sec. 2

Transition Period� Two (2) years from its effectivity date

Sec. 3

Effectivity Date� Fifteen (15) days after publication in one

newspaper of general circulation

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Sec. 5

The Dairy Food Regulations

and Standards

A. On Dairy Production Chain

B. On Raw Milk Collection Chain

C. On Milk Pasteurization Chain

� Code of Practice

� Risk Management Plan

� Audit Checklist

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A. The Dairy Production Chain

Dairy Production Chain1. Suitability of location, design and construction of

the Dairy Farm

2. Appropriateness of use of Agricultural Chemicals, Compounds or similar substances

3. Availability of necessary services in the farm

4. Availability of suitable quantity and quality of water

5. Assurance of potable water use in contact with milk

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Dairy Production Chain6. Availability of monitoring activities and records

7. Appropriateness and adequacy of farm maintenance

8. Assurance of proper storage of raw milk; away from possible contaminants

9. Assurance of using only approved cleaning reagents or compounds

10. Ensure the compliance of raw milk for acceptance in processing plants and proper disposal if rejected

Dairy Production Chain11. Assurance of only healthy dairy animals are raised

and milked in the dairy farms pursuant to the approved Risk Management Plan with reference to Section 5. A. 1. above, and in accordance also with the Animal Welfare Act of 1998

12. Provisions in filtering and cooling raw milk

13. Ensure that colostrum and other milk for sale for further processing are identified as such

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Dairy Production Chain14. Proper storage and use of other dairy inputs

15. Conformity of the dairy farm operator as the Food Business Operator (FBO) and appointment of a Dairy Food Safety Compliance Officer (DFSCO)

B. Raw Milk Collection Chain

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Raw Milk Collection ChainDairy Safety Standard (Raw Milk)

TEST STANDARD1. Standard Plate Count 0-300,000 cfu/mL (bulk milk)

0-150,000 cfu/mL(individual farm)

2. Antibiotic Residue Test Negative

3. Temperature 2-4°C

4. Somatic Cell Count < 400,000 cells/mL

5. Titratable Acidity 0.14-0.18% lactic acid

6. Hydrogen Ion Concentration (pH) 6.6-6.7

7. Aflatoxin M1 Max 0.5 µg/kg

8. Organoleptic / Sensory a. Smell – pleasantb. Appearance - no visible dirt/or

extraneous matter

9. Contaminants like heavy metals, veterinary drug residues and pesticide residues

Must comply with the MaximumResidue Limits) MRLsestablished by Codex AlimentusCommission

Raw Milk Collection Chain

Dairy Safety Standard (Dairy Animals)

1. Brucella/Leptospira Negative

2. Tuberculin Test Negative

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Raw Milk Collection ChainDairy Quality Standard (Raw Milk)

TEST STANDARD

1. Milkfat Content Cow’s Milk : > 3.0%

Carabao’s Milk: > 6.0%

Goat’s Milk: > 4.0%

2. Specific Gravity Reading at ambient temperature

Cow’s Milk: >1.025

Carabao’s Milk: >1.028

Goat’s Milk: >1.028

3. Organoleptic / Sensory a. Smell – pleasant

b. Appearance - no visible dirt/or

extraneous matter

4. Sediment No visible dirt or extraneous matter

in the filter

Raw Milk Collection Chain1. Reject milk that do not pass minimum standards

2. Encourage milk processors to adopt Premium Pricing Scheme for Raw Milk

3. Milk must not contain biological, chemical, or physical hazards

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Raw Milk Collection Chain4. All persons involved in raw milk collection and

providers of dairy inputs must ensure that these are collected, handled, processed and stored in a manner that minimizes the contamination or deterioration of the milk and the inputs as specified in the Dairy Code of Practice

5. Provision of appropriate food grade containers

6. Suitability of location, design and construction of the Dairy Collection Center/ Chilling Facility

C. Milk Pasteurization Chain

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Milk Pasteurization ChainDairy Safety Standard (Pasteurized Milk)

TEST STANDARD

1. Organoleptic / Sensory a. Smell – pleasant

b. Appearance -no visible dirt/or

extraneous matter

c. Taste – pleasant; good

2. Temperature 2-4°C

3. Standard Plate Count ≤ 50,000 cfu/mL

4. Coliform Count ≤ 100 cfu/mL

5. E.coli Count Negative

6. Salmonella/25mL 0

7. Listeria monocytogenes/25 mL 0

8. Psychrotropic Bacteria ≤ 10 cfu/mL

9. Contaminants like heavy metals, veterinary

drug residues and pesticide residues

Must comply with the MRLs

established by Codex Alimentarius

Commission

10. Aflatoxin M1 Max 0.5 µg/kg

Milk Pasteurization ChainDairy Quality Standard (Pasteurized Milk)

TEST STANDARD

1. Milkfat Content Cow’s Milk : > 3.0%

Carabao’s Milk: >6.0%

Goat’s Milk: > 4.0%

2. Milk solids non-fat Cow’s Milk : >8.25%

Carabao’s Milk: >8.5%

Goat’s Milk: >8.5%

3. Organoleptic / Sensory a. Smell – pleasant

b. Appearance - no visible dirt/or

extraneous matter

c. Taste – pleasant; good

4. Temperature 2-4°C

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Milk Pasteurization Chain1. Suitability of location, design and construction of

the Dairy Processing Plant

2. All milk pasteurization plant/center/facility must hire duly accredited managers and milk quality control officers by the NDA

3. Compliance of Dairy Processors/ Employees to Health and Hygiene

Milk Pasteurization Chain4. All milk accepted should come from certified dairy

farms

5. Established and practiced procedures in:

� appropriate and adequate maintenance, cleaning and sanitation;

� proper waste management;

� pest control management;

� control of pathogenic micro-organisms;

� compliance with any other specified requirements; and

� proper cold storage/warehouse management system

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Milk Pasteurization Chain6. Milk for processing should only come from certified

sources

7. Processing Temperatures with records

a. Low Temperature Long Time (LTLT)

� 63-65 degrees Celsius

� 30 minutes

b. High Temperature Short Time (HTST)

� 72-75 degrees Celsius

� 15-20 seconds

Milk Pasteurization Chain8. Packaging materials should be food grade, opaque or

translucent and do not leach harmful chemicals

9. Packaging must be labeled in accordance with the existing PNS for Fresh Milk (including traceability requirements)

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Personnel Hygiene1. All FBOs (from farm to plant) must ensure that all

persons, including visitors, will not cause contamination to milk.

2. All FBOs should exclude ill/sick/infectious employees from the work area.

Sec. 10

Mandatory Enrolment� Dairy businesses - one time fee of P500.00

� Service and input providers – one-time fee of P2,000.00

� If enrolled within 6 mos. from effectivity of Regulations ---- FREE

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Sec. 11

Certificate of Compliance (COC)

and License to Operate (LTO)

Sec. 12Fees and Charges

Certificate of Compliance

Classification No. of Dams, Heifers,

Does

COC Fee

(PHP)

Small Below 25 heads 50/head

Medium 25-100 heads 2,400

Large Over 100 heads 3,600

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License to Operate� Milk Collection Centers

Classification Capacity of the

Center/Facility

LTO Fee

(PHP)

Small Up to 1000 liters 1,000

Medium Up to 3000 liters 3,000

Large Over 3000 liters 5,000

License to Operate� Dairy Processing Plants

Classification Rated Capacity of the

Center/Facility/hour

LTO Fee

(PHP)

Small Up to 1000 liters 2,500

Medium Up to 3000 liters 5,000

Large Over 3000 liters 7,500

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Sec. 15

NDA Implementation Structure:

Dairy Food Regulatory

Committee (REGCOM)

Chief Dairy Regulatory Officer – NDA Administrator

MEMBERS:

1. Deputy Administrator

2. Operations Department Manager

3. Corporate Planning and Management Services Department

Manager

4. Finance and Administration Department Manager

5. Concerned Regional Department Manager/Task Force Chief

6. Milk Quality Assurance Division head and ex-officio Chief Dairy

Safety Officer

7. NDA Legal Officer

REGCOM

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� To supplement, modify, amend or otherwise adjust the NDA's Dairy Food Regulations and the Dairy Code of Practice when necessary

� To produce the NDA's General and Dairy Industry-wide Risk Analysis and Assessment Report (RAAR) and the corresponding RMP for the dairy industry

REGCOM

� To develop protocols and procedures to evaluate a foreign country’s food safety regulatory system

� To issue directives, clarifications and instructions regarding the proper interpretation and/or implementation of the provisions of the regulation

� To exercise oversight functions over the whole implementation structure of the regulation

REGCOM

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� To provide periodic reports on the implementation and results of NDA’s Dairy Food Regulation to:

� The NDA Dairy Industry Board;

� The Food Safety Regulations Coordination Board (FSCRB);

� The Department of Agriculture; and

� Other related and interested agencies

REGCOM

Sec. 16

The Dairy Food Safety Auditors

(DFSAs) and the NDA’s Regional

Dairy Food Safety Task Forces

(Regional Task Force)

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DFSA

� Food Technologists

� Project Evaluators

� Others that are qualified within its Regional Departments

DFSA

� Shall undergo and complete the NDA’s rigid training program for DFSAs

� Shall perform official controls at the highest level of competence and integrity, ever mindful of conflict of interest situations

� Shall report to and be supervised by the appropriate NDA Regional Safety Task Force

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Regional Task Force

MEMBERS

� The Regional Department Manager as the Regional Dairy Food Safety Officer (RDFSO) and Head of the Regional Task Force

� The Assistant Department Manager

� The Regional Accountant

� All the designated DFSAs within the Regional Department

Regional Task Force - RDFSO

� Shall primarily function as the overall implementing group of the Dairy Food Regulation and its Dairy Code of Practice

� Shall supervise the DFSAs, approve the control activities prior to implementation, and concur in the findings and actions taken by the DFSAs

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Sec. 19

Administrative Remedies and

Proceedings� Denial of Applications

• Fulfill all requirements and comply with DFSA Orders

• Appeal to the Chief Dairy Food Safety Officer (Quality Assurance Div Head)

� Compliance Orders

• DFSA issues CO, with approval of the Regional Dairy Food Safety Officer

• Appeal to the Chief Dairy Safety Officer (Quality Assurance Div Head)

Sec. 20

Prohibited Acts� Produce, handle or manufacture for sale, offer for sale, distribute

in commerce, or import into the Philippines --

� any food or food product which is not in conformity with an applicable food quality or safety standard promulgated in accordance with the Food Safety Law of 2013;

� any food or food product which has been declared as banned food product;

Refuse access to pertinent records or entry of inspection officers of the NDA;

Fail to comply with an order relating to notifications to recall unsafe products;

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� Adulterate, misbrand, mislabel, falsely advertise any food product which misleads the consumers and carry out any other acts contrary to good manufacturing practices;

� Operate a food business without the appropriate authorization;

� Connive with food business operators or food inspectors, which will result in food safety risks to the consumers; and

� Violate the implementing rules and regulations of the Food Safety Act of 2013.

Prohibited Acts

� 1st Conviction: Php 50k -100k fine

1 mo. suspension of authorization

� 2nd Conviction: 100K-200K

3 mos. Suspension

� 3rd Conviction: 200K-300K

6 mos. suspension

Sec. 21

Penalties

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� With slight physical injury:

Php 200k -300k fine

6 mos. suspension of authorization

Hospitalization and rehab costs

� With less serious or serious physical injury:

200K-300K

1 year suspension

Hospital & rehab costs

� With death: 6 mos. & 1 day to 6 yrs & 1 day imprisonment

300K-500K

Permanent revocation

Penalties

� The Dairy Food Regulations and Dairy Code of Practice would be amended whenever necessary

Sec. 23

Final Provision

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Process Maps

NOTIFY CLIENT OF

INCOMPLETE

REQUIREMENTS

SUBMIT DEFICIENCIES

ARRANGE AN INSPECTION

DATE WITH CLIENT

NOTE FINDINGS AND

RECOMMEND

ACCORDINGLY

ACT ON FINDINGS AND

REQUEST RE-INSPECTION

NOT COMPLIANT

REQUIREMENTS1

SUBMIT APPLICATION FOR

FARM OPERATIONS

AUTHORIZATION

APPROVE RMP AND

REQUIREMENTS/

RECOMMEND FOR

INSPECTION

REVIEW SUBMITTED

APPLICATION

CONSOLIDATE AND

MAINTAIN RECORDS OF

REGISTRATION

IF COMPLETE

CERTIFICATE

OF

COMPLIANCE

OFFICIAL

RECEIPT

ISSUE CERTIFICATE OF

COMPLIANCE

PAY CORRESPONDING

FEES2

C

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INCOMPLETE

FAR

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ASSESS

DOCUMENTARY

ATTACHMENTS/

REQUIREMENTS

VISIT FARM FOR

INSPECTION

APPLICATION FOR CERTIFICATE OF COMPLIANCE OF DAIRY FARMS

1See Section 9 of the DAIRY FOOD REGULATION2See Section 10 of the DAIRY FOOD REGULATION

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NOTIFY CLIENT OF

INCOMPLETE

REQUIREMENTS

SUBMIT DEFICIENCIES

NOTE FINDINGS/ RESULTS

AND RECOMMEND

ACCORDINGLY

NOT COMPLIANT

REQUIREMENTS1

SUBMIT APPLICATION FOR

FARM OPERATIONS

AUTHORIZATION

APPROVE RMP AND

REQUIREMENTS/

RECOMMEND FOR

INSPECTION

REVIEW SUBMITTED

APPLICATION

CONSOLIDATE AND

MAINTAIN RECORDS OF

REGISTRATION

IF COMPLETE

CERTIFICATE

OF

COMPLIANCE

OFFICIAL

RECEIPT

ISSUE CERTIFICATE OF

COMPLIANCE

PAY CORRESPONDING

FEES2

C

O

M

P

L

I

A

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IF

INCOMPLETE

MIL

K C

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C

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PR

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SIN

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VISIT

COLLECTION

CENTER/

PROCESSING

PLANT FOR

INSPECTION/ TEST

SAMPLES

APPLICATION FOR PERMIT TO OPERATE OF MILK COLLECTION CENTER AND DAIRY PROCESSING PLANTS

ARRANGE AN INSPECTION

DATE WITH CLIENT

MICROBIAL/ PHYSICO

TESTING

ACT ON FINDINGS AND

REQUEST RE-INSPECTION

RESUBMIT SAMPLES

ASSESS

DOCUMENTARY

ATTACHMENTS/

REQUIREMENTS

1See Section 9 of the DAIRY FOOD REGULATION2See Section 10 of the DAIRY FOOD REGULATION

ND

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Schedule of Consultations

AREA DATE

Luzon08 September 201510 September 2015

Mindanao 22 September 2015

Visayas 09 December 2015

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Issues Raised/ Comments from

Stakeholders

North Luzon South Luzon Visayas CDO DAVAO

Sec 5

The Dairy Food

Regulations And

Standards

A. 4. Include

quantity

A. 7. Will the NDA

accredit pest

controllers for farms,

processing, and

collection centers?

How can small

farmers afford the

equipment?

A.4. Who would

shoulder water

potability testing.

Will NDA accept just

certificate of water

potability from water

sources.

A.7. Would NDA

allow organic

pesticides? How

about in house pest

control program?

Provided of chemical

used or if these are

registered of FPA.

9. last word should

be parlor

9. Can NDA bulk

buy chemical and

cleaning detergents

for the dairy

enterprises?

A.1. Transitory

period too short for

smallholds to

comply with the

RMP

B.7. Will NDA follow

FDA's requirement

as to building

design?

B.1 Goat Standards.

Where are NDA's

developmental

assistance for goat or

sheep dairy farmers?

C. E.coli count sp C. 7. ESL-Can we

classify it also as

pasteurized milk?

C.3. NDA should just

recommend who to

hire as QC but plant

owner should be the

final decision

C.3. Are food tech.

graduates the only

one qualified as Q.C

. Officer?

E. 10 Tap DTI for

traceability

requirements

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North Luzon South Luzon Visayas CDO DAVAO

Sec 6

Miscellaneous

Regulations

B. Who is the person

selling ? Is it the

farm? What happens

to the farm whose

clients only buy raw

milk to be made into

cheese?

Raw milk selling

must be allowed

provided it comes

from compliant farm

irregardless of

volume

Sec 7

Compliance With

The Dairy Food

Regulations

D.1. include PTO

Sec 10

Mandatory

Registration

Government

controlled

processing plants

where will it be

categorized?

Trucks to transport

animals like 1-2

holds, do they still to

be accredited. How

about the barge for

inter island transfer?

Need to assist

farmers and coops to

prepare financial

reports.

If you own 1-2 heads

the requirements for

registration is

tedious

Would it be possible

for smallhold to be

covered by umbrella

system specially with

those with only 1-2

holds?

Is the registration

from DOLE not

enough.

For small farmers

can they apply with

the DTI's BMBE?

Make 6 categories

for the mandatory

registration? LGU,

SCU, Individual,

Association and

Cooperative?

Simplify

North Luzon South Luzon Visayas CDO DAVAO

Sec 12

Fees and Charges

C. is there a

separate fee when

a processing plant

also has a

collection

facility?

C. Fee if you both

have a collection

and processing

center? Will you

register also your

hauling trucks

used in your

farm?

Goat farmers will

be burdened with

the fee's if the

same like cows

because of

production

difference.

A. Breakdown the

bracket for fees

Is there a fee for

unscheduled

inspection?

B. Instead of

rated capacity can

we replace it with

volume collected?

PCC farmers

would find the

fees too high

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North Luzon South Luzon Visayas CDO DAVAO

Sec 13

Control Measures

and Activities to

Ensure Dairy

Enterprises’

Compliance With

Dairy Regulations

and Standards

Is the fee

collected by the

LGU different

from the one

collected by NDA

when the LGU

will be delegated

by the NDA

A.3. Define

immediately?

a. Classification

for small divide

the 24 heads, so

its per head fee.

A.5. Define grave

infraction?

Separate the

mandatory

requirement for

cattle, cara and

goat/Sheep?

D. lessen layers of

approving body

for the COC/PTO

to save time for

application

the rated capacity

must be changed

to volume

collected or

processed?

In the region how

will the LGU

participate in

implementing the

dairy regulation.

must see to it that

PCC is informed

need to train for

LGU's.

North Luzon South Luzon Visayas CDO DAVAO

Sec 13

Control Measures

and Activities to

Ensure Dairy

Enterprises’

Compliance With

Dairy Regulations

and Standards

Will there be

insurance for farms,

collection centers

and processing

plants?

For toll packers

whose PTO's would

be required.

What system would

NDA establish to

ensure a 'good' dairy

farmer's milk won't

be contaminated by

a 'bad' farmer's milk

at the collection

center where milk

are co mingled?

NDA should have a

system to supply the

farmers with quality

and standard dairy

inputs?

Adjust the fee

payment for small

farmers because

many farmers own

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Thank You ☺