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(1)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Analisis Dampak Regulasi

(Regulatory Impact Assessment)

ITP602

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id

Keamanan Pangan?

• kondisi dan upaya yang diperlukan untuk mencegah

pangan dari kemungkinan cemaran biologis, kimia, dan

benda lain yang dapat mengganggu, merugikan, dan

membahayakan kesehatan manusia serta tidak

bertentangan dengan agama, keyakinan, dan budaya

masyarakat sehingga aman untuk dikonsumsi. (UU No

18/2012)

Food safety?

• Safe = Reasonable certainty of no Harm (FD&C Act)

(2)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

How safe is

safe enough?

… Notes :

Fokus pd Regulasi Keamanan Pangan

How safe is

safe enough?

(3)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

How safe is

safe enough?

… Notes :

Fokus pd Regulasi Keamanan Pangan

Old Concept

(4)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Notes :

1. Transparan (~informasi)

2. Terbuka (~ keterlibatan)

3. Konsensus dan Tidak Memihak

4. Efektif dan Relevan

5. Koheren ( ~ harmonisasi)

6. Dimensi pengembangan

(5)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

~ WTO Code of good practice  pengembangan SNI

a. Openess

Terbuka bagi agar semua stakeholder yang berkepentingan dapat berpartisipasi dalam pengembangan SNI.

b. Transparency

Transparan agar semua stakeholder yang berkepentingan dapat mengikuti perkembangan SNI mulai dari tahap pemrograman dan perumusan sampai ke tahap penetapannya . Dan dapat dengan mudah memperoleh semua informsi yang berkaitan dengan pengembangan SNI;

c. Consensus and impartiality

Tidak memihak dan konsensus agar semua stakeholder dapat menyalurkan kepentingannya dan diperlakukan secara adil;

d. Effectiveness and relevance

Efektif dan relevan agar dapat memfasilitasi perdagangan karena memperhatikan kebutuhan pasar dan tidak bertentangan dengan peraturan perundangundangan yang berlaku;

e. Coherence

Koheren dengan pengembangan standar internasional agar perkembangan pasar negara kita tidak terisolasi dari perkembangan pasar global dan memperlancar perdagangan internasional; dan f. Development dimension

Berdimensi pembangunan agar memperhatikan kepentingan publik dan kepentingan nasional dalam meningkatkan daya saing perekonomian nasional.

Prinsip Pengembangan Standar/Regulasi

No Kategori Pelaksanaan berdasarkan hasil survey

Rekomendasi

1 Transparan • 18,33% responden: tidak mengetahui prosedur • 34,43% responden: sulit

mendapatkan info • 40,91% responden yang

mengetahui dari web

Publikasi via website agar mempermudah

2 Keterbukaan • 40% responden belum dilibatkan dlm pantek

• 18,64% tidak pernah dimintai masukkan

• 54,39% belum aktif mengusulkan

Optimalisasi peran semua stakeholder melalui asosiasi

(6)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

3 Konsensus

dan Tidak Memihak

• 43,33% responden tidak dilibatkan pengambilan keputusan

• 55,56% responden: hanya sebagian aspirasinya diterima • Perbedaan penilaian antara

pemerintah dan industri (terkait proporsi pengambilan keputusan)

Buat mekanisme yang menjamin bahwa semua masukan berbagai instansi dipertimbangkan 4 Efektif dan Relevan • 28,85% responden: hanya sebagian standar yg diterapkan • 53,33% responden: kendala

penerapan krn keterbatasan lab uji • 98,28% responden: kesehatan

adalah faktor utama

Perlu dilakukan kajian dampak dan kesiapan

infrastruktur  RIA

Prinsip Pengembangan Standar/Regulasi

No Kategori Pelaksanaan berdasarkan hasil survei

Rekomendasi

Sumarto., Hariyadi, P. dan Purnomo, E.H. 2014. Kajian Proses Perumusan Standar dan Peraturan Keamanan Pangan di Indonesia. PANGAN, Vol 23 No. 2 Juni 2014. Hal 108-119

5 Koheren •32,76% dan 18,96% responden: cukup dan kurang memperhatikan peraturan/standar lain di dalam negeri

•74,65% responden: Codex sebagai rujukan utama Jika data di Indonesia belum tersedia, menggunakan standar Codex sbg rujukan utama 6 Dimensi pengem-bangan

•Seluruh responden: faktor

pengembangan bahan baku lokal, pengembangan UMKM,

peningkatan daya saing produk Indonesia penting diperhatikan

Pengembangan bahan baku lokal, UMKM, peningkatan daya saing produk Indonesia dijadikan pertimbangan dalam perumusan standar

Prinsip Pengembangan Standar/Regulasi

No Kategori Pelaksanaan berdasarkan hasil survei

Rekomendasi

(7)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Garis mutu Standar Deviasi

Standar/Regulasi dan “Pembangunan”

TMS MS

Standar Deviasi

Garis mutu

Standar

(8)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

MS

Standar Deviasi

Garis mutu

Standar

Standar/Regulasi dan “Pembangunan”

TMS MS

Standar Deviasi

Garis mutu

Standar

(9)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Populasi produk pangan yang memerlukan pembinaan mutu Standar Deviasi Garis mutu Standar

Standar/Regulasi dan “Pembangunan”

Standar Deviasi Pembinaan Akan mendorong TMS MS Garis mutu Standar

(10)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Standar Deviasi

Standar Garis mutu

Standar/Regulasi dan “Pembangunan”

SNI (2000)

CFU : 10

6

Tidak memenuhi SNI

?

(11)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

In 1997 the European Commission proposed a

uniform/harmonized standard for total aflatoxins, setting the

acceptable level of the contaminant in food products

(European Commission, 1997).

• 4 ppb in cereals, edible nuts, dried and preserved fruits, and

groundnuts intended for direct human consumption, and

• 10 ppb in groundnuts subject to further processing.

• 0.05 ppb for Aflatoxin M1 in milk.

The harmonized standard for the European Union is tighter

than those which have been applied in most member countries

Case of Aflatoxin

Maximum allowable aflatoxin levels in Europe and Africa

(ppb)

[T. Otsuki et al. / Food Policy 26 (2001) 495–514]

(12)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Case of Aflatoxin

Maximum allowable aflatoxin levels in Europe and Africa

(ppb)

[T. Otsuki et al. / Food Policy 26 (2001) 495–514]

Case of Aflatoxin

Maximum allowable aflatoxin levels in Europe and Africa

(ppb)

[T. Otsuki et al. / Food Policy 26 (2001) 495–514]

(13)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

*applies to cereals & cereal products, nuts not subject to further processing, & dried fruit

Case of Aflatoxin

(14)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Case of Aflatoxin

What do U think

?

(15)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Case of Aflatoxin

(16)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Case of Aflatoxin

• “Milder” calculation: $450 million annual loss to ALL food

exporters if ALL nations harmonized to EU aflatoxin standard

(Wu, 2004)

• Strict aflatoxin standards can have severe economic impacts

• “A World Bank study has calculated that the European Union

regulation on aflatoxins costs Africa $670 million each year

in exports of cereals, dried fruit and nuts. And what does it

achieve? It may possibly save the life of one citizen of the

European Union every two years…

• Surely a more reasonable balance can be found.”

--Kofi Annan, former UN Secretary General

(17)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

• “Milder” calculation: $450 million annual loss to ALL food

exporters if ALL nations harmonized to EU aflatoxin standard

(Wu, 2004)

• Strict aflatoxin standards can have severe economic impacts

• “A World Bank study has calculated that the European Union

regulation on aflatoxins costs Africa $670 million each year

in exports of cereals, dried fruit and nuts. And what does it

achieve? It may possibly save the life of one citizen of the

European Union every two years…

• Surely a more reasonable balance can be found.”

--Kofi Annan, former UN Secretary General

… Key word

… Key word

• “Milder” calculation: $450 million annual loss to ALL food

exporters if ALL nations harmonized to EU aflatoxin standard

(Wu, 2004)

• Strict aflatoxin standards can have severe economic impacts

• “A World Bank study has calculated that the European Union

regulation on aflatoxins costs Africa $670 million each year

in exports of cereals, dried fruit and nuts. And what does it

achieve? It may possibly save the life of one citizen of the

European Union every two years…

• Surely a more reasonable balance can be found.”

(18)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

• “Milder” calculation: $450 million annual loss to ALL food

exporters if ALL nations harmonized to EU aflatoxin standard

(Wu, 2004)

• Strict aflatoxin standards can have severe economic impacts

• “A World Bank study has calculated that the European Union

regulation on aflatoxins costs Africa $670 million each year

in exports of cereals, dried fruit and nuts. And what does it

achieve? It may possibly save the life of one citizen of the

European Union every two years…

• Surely a more reasonable balance can be found.”

--Kofi Annan, former UN Secretary General

… RIA : Effective vs Efficient

RIA

… Key word

RIA

… Framework?

• What, in general terms, is the problem to be

addressed?

• What is the specific policy objective to be

achieved?

(19)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Framework?

Impact?

• What groups in society are being affected;

• What is the size of each group;

• What is the nature of the impact on each

group;

• How large are these effects;

• How long will these effects persist?

… Framework?

Cost?

• Buying new equipment needed to comply with regulations;

• Employing additional staff to work on regulatory

compliance;

• Employing consultants or other sources of expertise to help

with regulatory compliance;

• Changes in production processes made necessary by

regulations;

• Other increases in the costs of producing goods;

• Collecting and storing information that the regulations

(20)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Framework?

Cost? Analysis?

• Risk/Benefit analysis

• Benefit/cost analysis

• Break even analysis

• Cost-effectiveness analysis

• Which of the possible ways of achieving the regulatory

objective has the lowest cost?

• If regulation (or policy action) is to proceed, which

option is preferable?

• Etc???

… Framework?

Cost? Analysis?

Clearly outline the benefits and costs expected

from the regulatory proposal for each group;

• Administrative

• Economic

• Social

• Environmental

(21)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Framework?

Cost? Analysis?

Data Collection?

• Literature reviews

• Review of experience in other countries

• Other government agencies

• Business Test Panels

• Consultation with Stakeholders

• Surveys

(22)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

(23)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

(24)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

(25)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Example? Cost? Analysis?

• ALOP ?

• ALARA ?

… Example? Cost? Analysis?

(26)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Example? Cost? Analysis?

• ALOP ?

… Example? Cost? Analysis?

(27)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

Table 4: Weekly fish consumption amounts required to reach PTWI of 1.6 μg/kg bw at various methylmercury

concentrations.

… Example? Cost? Analysis?

• ALOP ?

… Example? Cost? Analysis?

(28)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Example? Cost? Analysis?

• ALARA ?

… Example? Cost? Analysis?

(29)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Example? Cost? Analysis?

• ALARA ?

• ALARA : As Low as Reasonably Achievable

• Case of “Irreducible level”

that concentration of a substance (hazard)

which cannot be eliminated from a food

without involving the discarding of that food

altogether, severely compromising the

ultimate availability of food supplies

… Example? Cost? Analysis?

• ALARA ?

• ALARA : As Low as Reasonably Achievable

• The phrase refers to a principle of keeping

hazards in food as low as can be achieved,

based on technologic and economic

considerations.

(30)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Example? Cost? Analysis?

• ALARA ?

= f(ALOP)

… Example? Cost? Analysis?

• ALARA ?

(31)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Example? Cost? Analysis?

• Risk/Benefit ratio?

… Example? Cost? Analysis?

(32)

Purwiyatno Hariyadi

phariyadi.staff.ipb.ac.id MPTP, Dept ITP , Fateta, IPB

… Example? Cost? Analysis?

• Chasing zero ?

TERIMAKASIH

Gambar

Table 4: Weekly fish  consumption amounts  required to reach PTWI  of 1.6 μg/kg bw at various  methylmercury

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