EC Audit Report Comments and Corrections

Shaplandk

Description

NZFSA COMMENTS ON THE DRAFT REPORT OF MISSION DG(SANCO)/9261/2003 – MR draft Page Chapter Paragraph EC POINT Comment/Correction 4 Executive 4 It was noted that there is no requirement that Suggest “IANZ” be replaced with Accreditation Summary IANZ send their reports routinely to NZFSA. Body. 4 5 NZFSA’s overview of some aspects of the Suggest “limited’ is replaced with “ is still to be OOAP is still limited. developed”. Our current level of oversight is effective given the relatively short length of time the programme has been operating (i.e. 17 months at time of audit). 4 5 No precise statistical data have been compiled Statistical data has been compiled and is held in about operators participating in the registers by the TPAs. However due to the variable programme. nature of the export industry it is questionable whether such data could ever be precise. 4 5 No summary or analysis have been done of Non-compliance event reports and respective non-compliances of operators and sanctions sanctions applied by the TPAs are now kept in applied by the inspection bodies. This lack of registers by the NZFSA, but have not yet been overview limits the capability of NZFSA to summarised. The process for assessing event reports supervise the inspection system. is still being developed and these reports will be summarised once the process has been finalised. Our current level of oversight is effective given the relatively short length of time the ...

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• Publié par: Chaes
• Nombre de lectures: 10
• Langue: English

Extrait

10 February 2004

Page 1 of 11

NZFSA COMMENTS ON THE DRAFT REPORT OF MISSION DG(SANCO)/9261/2003 – MR draft

Page

Chapter

Paragraph

EC POINT

Comment/Correction

4

Executive

Summary

4

It was noted that there is no requirement that

IANZ send their reports routinely to NZFSA.

Suggest “IANZ” be replaced with Accreditation

Body.

4

5

NZFSA’s overview of some aspects of the

OOAP is still limited.

Suggest “limited’ is replaced with “ is still to be

developed”. Our current level of oversight is

effective given the relatively short length of time the

programme has been operating (i.e. 17 months at

time of audit).

4

5

No precise statistical data have been compiled

about operators participating in the

programme.

Statistical data has been compiled and is held in

registers by the TPAs. However due to the variable

nature of the export industry it is questionable

whether such data could ever be precise.

4

5

No summary or analysis have been done of

non-compliances of operators and sanctions

applied by the inspection bodies. This lack of

overview limits the capability of NZFSA to

supervise the inspection system.

Non-compliance event reports and respective

sanctions applied by the TPAs are now kept in

registers by the NZFSA, but have not yet been

summarised. The process for assessing event reports

is still being developed and these reports will be

summarised once the process has been finalised. Our

current level of oversight is effective given the

relatively short length of time the programme has

been operating (i.e. 17 months at time of audit).

6

5

2

NZFSA

have

not

compiled

a

list

of

processing units and precise data about the

number of producers participating in the

OOAP and their area in cultivation.

Compilation and maintenance of the operator

registers is the responsibility of the TPAs. These

have been compiled, but due to the variable nature of

the export industry it is questionable whether such

data could ever be precise.

7

5.3

1

These rules are almost identical to the

production rules in Council Regulation (EEC)

In New Zealand the term “target spraying” means

restricted use. The use of the product is restricted to

10 February 2004

Page 2 of 11

No 2092/91, with a few exceptions, e.g. the

“targeted application of plant oils” is allowed

as “foliage suppressant”. The mission team

has noted the band spraying of a pine oil

product

as

pre-emergence

herbicide

on

cultivated land. The NZFSA considered this

as targeted use as foliage suppressant.

those areas and/or weeds that require application.

7

5.3

2

However, in the EU there must be separate

storage premises for the different units,

whereas in the OOAP rules only separate

storage locations are required. Thus, storage

in a separate location of the same premise is

allowed.

The term “location” in the NZFSA Tech Rules is

interchangeable

with

“premises”.

Reference

NZFSA Technical Rules for Organic Production,

section 8.1, 8.2, 8.8.

8

5.3

2

It was noted that the requirements for

inspections of sub-contracted operators in the

NZFSA standard are not equivalent to the EU

requirements. In the OOAP standard the

organic operator must provide training to

contractors in their roles and responsibilities

with respect to the organic management, but

there is no provision that the subcontractor

can also be inspected. In Council Regulation

(EEC) No 2092/91, Annex III D, the

subcontractors must have agreed to have their

holding being subject to the inspection

regime.

The organic operators system addresses the issue of

sub-contractors, and that they do not act in a way

that jeopardises integrity of organic certification.

Reference MAF Standard OP3, 7.0.

8

5.3

3

The standards do not include procedures for

the de-registration of operators as a result of

critical infringements, except for a general

Procedures for the de-registration of operators is the

responsibility of the TPAs and as such procedures

are in their system of organic procedures.

10 February 2004

Page 3 of 11

requirement: “De-registration of operators, or

registration with conditions (e.g. time limit) is

undertaken when appropriate (e.g. operator or

NZFSA request)”.

8

5.3

4

In the EU, the competent authority must,

when approving an inspection body, take into

account the penalties, which the body intends

to

apply

where

irregularities

and/or

infringements are found

5

.

Furthermore, the inspection body must, in

case

of

manifest

infringements

or

an

infringement with prolonged effects, prohibit

the operator from marketing products as

organic for a period to be agreed with the

competent authority

6

. The NZFSA standards

do not include comparable provisions.

The standards include a definition for a

critical

non-compliance,

and

several

examples. A critical non-compliance is “e.g.

an action, event or omission which may result

in failure of organic product to comply with

the importing country requirements”. Also,

there is an obligation for inspection bodies to

notify NZFSA of critical non-compliances

within 24 hours. However, there is no precise

competency

and

procedure

for

the

de-

registration

of

non-compliant

operators

specified.

Before the NZFSA accredits a TPA to the OOAP, a

copy of the TPA’s quality system documentation is

reviewed by the Accreditation Body, to ensure that

penalties which the TPA intends to apply (where

irregularities and/or infringements are found) are

appropriate under the OOAP (refer MAF Std OP1,

Appendix 1, page 16 – Outline of the Accreditation

and Recognition Process)

.

There is a comparable requirement in MAF Standard

OP3, section 8.3.2. Please note that the heading for

this point in the MAF Standard OP3 is incorrect –

the correct heading is “Non-compliant Operators”.

De-registration of non-compliant operators is the

responsibility of the TPA and as such, these

procedures are documented in the TPA systems.

9

5.4

3

In the Unit for Plant Products and Organics, 3

De-registration of non-compliant operators is the

10 February 2004

Page 4 of 11

staff are involved in the OOAP. Their work

dedicated to the OOAP equals to around 2

Full Time Equivalent (FTE). There exists a

set of Operational Procedures for organic

exporter registration, for evaluating input

applications, for surveillance of requirements

of third countries, for training, for control of

organic non-compliance and for assessing

non-compliance reports sent by inspection

bodies. These documents do not include

procedures for the de-registration of any non-

compliant operators.

responsibility of the TPA and as such, these

procedures are documented in the TPA systems.

9

5.4

4

NZFSA

has

not

summarised

the

non-

compliances

of

operators

and

sanctions

applied by the inspection bodies. NZFSA

stated that they plan an analysis of non-

compliances.

The current level of oversight is effective given the

relatively short length of time the programme has

been operating (i.e. 17 months at time of audit).

Non-compliance event reports and respective

sanctions applied by the TPAs are kept by NZFSA.

10

5.5

5

Registered and certified operators have to

reapply annually for the renewal of

certification. The inspection body has a list of

registered operators, containing basic data on

the operator, including the date of the last

audit and the date when the next audit will be

due. The mission team noted that several of

the audit dates in this list were not correct.

Suggest that an extra sentence is included after “The

mission team noted that several of the audit dates in

this list were not correct”, stating that the mission

team also noted that whilst the dates on the register

were incorrect, audit reports were provided to

demonstrate that all operators had been audited at

the required frequency.

11

5.6

Suggest that “IANZ” is replaced with “Accreditation

Body” because two Accreditation Bodies can

operate in New Zealand (JASANZ is the 2

nd

).

11

5.6

1

Suggest this paragraph is reworded as follows:

10 February 2004

Page 5 of 11

An official accreditation body assesses and accredits

the inspection bodies and their personnel to ISO

Standard 17020 and NZFSA supplementary criteria

contained in MAF Standards OP1 and OP2. The

intial assessment of inspection bodies and individual

inspectors is performed by the Accreditation Body,

with members of the NZFSA Compliance and

Investigation Group (CIG) participating in the

assessments as technical experts. On the basis of the

assessment and accreditation by the Accreditation

Body, the inspection bodies and inspectors are

approved by NZFSA……

11

5.7

3

There were no individual identification

clips or tags on lambs, and no register for

the livestock, in one farm. The inspector

had not queried this. Under the EU and

OOAP rules, animals are to be identified

at all stages.

In New Zealand common practise is that lambs are

identified by an ear notch, usually around the tip of

the ear. This occurs the first time the lambs are

brought into the yards, and may occur from around 6

weeks. By age 3 months all lambs should have an

ear notch.

The exact age this occurs is dependent on factors

such as animal condition, and breed.

The notch should be visible from close proximity,

but may not be noticed otherwise.

The NZFSA Technical Rules require operators to

keep records for all animals arriving, where they

came from, when they arrived and their organic

status. Records are also kept for animals leaving:

their age, number, date, weight, identification and

destination. A specific register is not required.

10 February 2004

Page 6 of 11

11

5.7

4

The use of restricted inputs is allowed, when

an inspector approves a written application of

the operators. The mission team noted that

inspectors had approved the use of sodium

bicarbonate on onions, and a fertiliser

containing hydrolysed protein. Currently,

these products are not included in Annex II of

Council Regulation (EEC) No 2092/91 and

the OOAP technical rules. However, sodium

bicarbonate had been listed in Annex II of the

Regulation, and only been deleted, because it

was no longer used in the EU. The use of

fertilisers containing hydrolysed proteins is

currently under discussion in the EU.

Sodium bicarbonate could be permitted under

section 9.4 of the NZFSA Technical Rules for

Organic Production, and EC Regulation 2092.91,

Article 7, 1a, as amended by Regulation 1935/95 of

22 June 1995. It is approved under IFOAM basic

standards, and is a restricted input in the Bio-Gro

standard for disease control. It was identified in the

NZFSA review of the Bio-Gro standard last year,

and approved by us on the basis that it was allowed

as a food additive and processing aid in Table 4, and

that it had been in use in organic farming for many

years. At the time of the review we also considered

its use as biological, because it creates an alkaline

environment which is not conducive to pathogen

growth.

Sodium bicarbonate was used on the property in

question in the 2002/03 season as a trial to see if it

was a viable alternative to copper (which had been

used in previous seasons for the same purpose i.e.

fungicide). Its use for disease control is rare, perhaps

about two producers each year trial it as a fungicide.

However it is generally seen as preferable to copper

with respect to its effect on the environment. It

breaks down quickly to carbon dioxide and the

sodium salt of whatever acid is present. It changes

the pH on surface of plant to alkaline, which creates

an unsuitable environment for the growth of

pathogens.

A product containing trace elements and hydrolysed

protein was used under the OOAP. Trace elements

10 February 2004

Page 7 of 11

are permitted for use as a fertiliser and hydrolysed

protein is approved for use as a pesticide in the

NZFSA Tech Rules.

In this product the hydrolysed protein is produced

from alkaline hydrolysis of animal or plant tissues to

produce some amino acids. The purpose of the

amino acids is a fertiliser and to provide nitrogen.

Products and by-products of animal and plant origin

are permitted for use as a fertiliser in Table one of

the NZFSA Technical Rules for Organic Production.

Therefore the use of this product does in fact comply

with the NZ Technical Rules.

12

5.7

5

One operator met by the mission team had

used chemically treated conventional seeds,

which from January 2004 will no longer be

permitted in the EU, according to

Commission Regulation (EC) No 1452/2003.

No similar provisions exist in New Zealand.

Suggest another sentence is included in this

paragraph to the effect that at the time of the audit

the use of the seed was in compliance with the

Technical Rules and the EC Regulations.

12

5.8

3

The form for the export certificate is in

accordance with Commission Regulation

(EC) No 1788/2001. However, box 7 of the

form, which relates to the operator who

carried out the last operation, is not always

completed in accordance with the provisions

of the Regulation. In some cases producers

are listed in this box instead of the last

operator. Where necessary, a continuation

sheet is used, and NZFSA stamps one seal on

both pages. In one case, 80 producers were

specified on a continuation sheet of two

pages.

10 February 2004

Page 8 of 11

12

6.1

1

(1) Except a list of organic exporters to the

EU, no precise statistical data has been

compiled about the numbers and activities of

operators participating in the OOAP, and their

area in cultivation. This information has not

been submitted to the EU as specified in

Commission Regulation (EEC) No 94/92,

Article 2.2(c), fifth indent.

Registers containing statistical data have been

compiled and supplied to NZFSA by the TPAs. Due

to the variable nature of the export industry such

data could never be precise.

13

6.3

2

(4) The production rules are mostly

identical to those specified in Council

Regulation (EEC) No 2092/91, but a few

minor differences were identified. Thus,

the “targeted application of plant oils” is

allowed as “foliage suppressant”. The

mission

team

has

noted

the

band-

spraying of a pine oil product as a pre-

emergence herbicide on cultivated land.

The NZFSA considered this as a targeted

use as a foliage suppressant.

In New Zealand the term “target spraying” means

restricted use. The use of the product is restricted to

those areas and/or weeds that require application.

13

6.3

5

(7) The standards require that the inspection

bodies are accredited to ISO 17020 and the

three standards for the OOAP, but it is not

necessary that inspection bodies satisfy the

requirements of EN 45.011 (ISO Guide 65) as

laid down in Council Regulation (EEC) No

2092/91.

NZFSA considers ISO Standard 17020 and ISO

Guide 65 contain equivalent requirements for

independent bodies.

13

6.3

4 (point (8))

(8) In the standards there are no

requirements for inspections of sub-

contracted operators equivalent to

Council Regulation (EEC) No 2092/91.

The organic operators system addresses the issue of

sub-contractors, and that they do not act in a way

that jeopardises integrity of organic certification.

Reference MAF Standard OP3, 7.0.

10 February 2004

Page 9 of 11

13

6.3

5 (point (9))

(9) The standards do not specify provisions

for the de-registration of non-compliant

operators equivalent to Article 9.9 of Council

Regulation (EEC) No 2092/91.

NZFSA does not register operators and therefore

does not need a procedure for the de-registration of

operators. Operators under the OOAP are registered

and de-registered by the TPAs, as detailed in their

procedure manuals. Reference MAF Standard OP2,

7.0.

14

6.4

2 (point (11)

(11)NZFSA’s overview of some aspects

of the OOAP is still limited:

There is no precise list of processing

units and no precise number of producers

participating in the OOAP and their area

in cultivation.

c) The register for reports of the

inspection bodies and of assessment

reports of the accreditation body was not

complete.

d) NZFSA has not summarised and

analysed

the

non-compliances

of

operators and sanctions applied by the

inspection bodies.

Suggest “limited’ is replaced with “ is still to be

developed”. The current level of oversight is

effective given the relatively short length of time the

programme has been operating (i.e. 17 months at

time of audit).

Registers containing information on processing

units, producers and areas in cultivation have been

compiled by the TPAs and sent to NZFSA. Due to

the variable nature of the export industry the data

could never be precise.

The current level of oversight is effective given the

relatively short length of time the programme has

been operating (i.e. 17 months at time of audit).

Non-compliance event reports and respective

sanctions applied by the TPAs are kept by NZFSA.

10 February 2004

Page 10 of 11

14

6.6

1 (point (14))

(14) IANZ consider the assessment reports as

confidential, and there is no requirement that

they send their reports routinely to NZFSA.

Suggest “IANZ” be replaced with Accreditation

Body.

14

6.8

2 (point (17))

(17) The form for the export certificate is

not always completed exactly in

accordance with the provisions of

Commission Regulation (EC) No

1788/2001. In some cases the producers

are listed in the form instead of the

operators who carried out the last

operation. In the case of several

producers, they are listed in a

continuation sheet, which is not in

accordance with Annex I of the

Regulation.

For some consignments up to ten operators carried

out the last operation and need to be listed on the

certificate – there is insufficient space to list ten

operators on the prescribed certificate.

15

7

Closing

Meeting

A closing meeting was held on 20 November

2003 with representatives of the NZFSA. At

this meeting, the initial findings and

conclusions of the mission were presented by

the inspection team. The representatives

raised no significant objections to the findings

and conclusions presented.

15

8.1

1

(1) To ensure the effective supervision of the

inspection system, the NZFSA should analyse

and file the relevant reports from inspection

and accreditation bodies.

15

8.1

2

(2) Statistical data about the number and

activities of operators participating in the

OOAP and their area under cultivation should

be compiled, kept on file at NZFSA, and

submitted

to

the

EU

as

specified

in

Commission

Regulation

EEC

No

94/92

10 February 2004

Page 11 of 11

Article 2.2(c), fifth indent.

15

8.1

4

(4) The NZFSA should revise the standards

and production rules for the OOAP to address

the conclusions specified in chapter 6.3.

15

8.1

6

(6) The NZFSA should ensure that the form

for the export certificate is completed in

accordance with the provisions of

Commission Regulation (EC) No 1788/2001.

For some consignments up to ten operators carried

out the last operation and need to be listed on the

certificate – there is insufficient space to list ten

operators on the prescribed certificate.