BASA-CropLife India Meet held on 14.11.2019

Background

An initial meeting was held in Pune on 9 Nov. 2019 of BASAI team to discuss the concerns on the Draft Guidelines on Biostimulants published and placed for public opinion by the DAC&FW. The comments are likely to be submitted by Nov. 25.

Post the meeting in Pune, the same was shared with CropLife India team and discussed further upon on 14.11.2019. The draft compiled by CL India is placed below for comments for your kind perusal and further comments, if any.

BASAI-CropLife India Meeting update

A Joint Association Meeting of CropLife India and Biological Agri Solutions Association of India (BASAI) was held on 14 November 2019 at Sumitomo Chemicals India Pvt. Ltd. Office, Delhi.

Participants:

S.No

Name

Company name

1.

Asitava Sen

CropLife India

2.

Vipin Saini

BASAI

3.

RD Kapoor

BASAI

4.

Anil Kakkar

CLI

5.

Arpita Roy

CLI

6.

TK Mishra

CLI

7.

Jitendra Pathak

CLI

8.

Siddharth Singh

CLI

9.

Subhash Singh

CLI

10.

Manish Jain

CLI

11.

Vijay Jha

CLI

12.

Mritunjay Kumar

CLI

13.

Dathatray Shitole

CLI

14.

Chirag Patel

CLI

15.

Rajesh Dhawan

CLI

16.

A Sanyal

CLI

17.

Nitika

CLI

18.

Ambesh Dubey

CLI

19.

Tanu Sethi

CLI

General Discussion:

  • At the outset, Mr Asitava Sen, CEO CropLife India welcomed Mr V Saini, CEO, BASAI and members from CLI & BASAI at the meeting. It was shared that this is the first Meeting with BASAI. The regulations for Biostimulants are pending since 2017. The draft guidelines are now proposed under FCO Act.
  • Mr Vipin Saini also shared that Biostimulant was discussed with the Sub-Committee formed by DAC under the Chairpersonship of Dr Chakrabarty, former ADG (PP). Also, the background and genesis of these regulations was discussed with the group.

Discussion on the Agenda:

Members discussed the draft provisions/Guidelines on the Biostimulants in details. As mentioned in the uploaded document, the guideline will come as Amendment in the Fertilizer (Control) order, 1985 for Biostimulants.

The Joint comments proposed and agreed by the Members in the meeting are attached in the table.

Action area:

All members are requested to share their comments/suggestions by Tuesday, 19th November 2019 on the attached draft for further submission.

The Meeting was ended with a vote of thanks to the participants and Sumitomo Chemicals India Ltd. for hosting the meeting.

***

Amendment in the Fertiliser ( Control) Order,1985 for inclusion of Bio- Stimulant Draft Provisions Joint Comments (CLI & BASAI)

Draft Provisions

Joint Comments (CLI & BASAI)

(1) In clause 2(h) the term fertiliser is defined. The term Biostimulant is required to be included . The revised definition is as under:

Existing Definition of “Fertiliser” means any essential substance, either in straight or mixed form and derived from either inorganic, organic or mixed sources, that is used or intended to be used to provide essential plant nutrients or beneficial elements or both for the soil or for the crop or makes essential plant nutrients available to the plants either directly or by biological process or by both in the soil or plant as notified from time to time by Central Government and specified in the schedules appended to this order or as may be notified by the State Governments*. Explanation: For the purpose of Fertiliser:

Agreed

(i)m “the essential plant nutrients” include Primary Nutrients (Nitrogen, Phosphorous and Potassium), Secondary Nutrients (Calcium, Magnesium and Sulphur) and Micro Nutrients (Zinc, Manganese, Copper, Iron, Boron and Molybdenum);

Agreed

(ii) “Beneficial element” means any element as notified by Central Government from time to time.’: Amendment

Agreed

2. Insertion of new provision (ab) Bio stimulant Definition:

(1) Bio stimulants means compounds, substances and products including microorganisms whose functions when applied to plants/seeds/ rhizosphere is to regulate and enhance a crops physiological processes independent of the products nutrient contents to improve input use efficiency, growth, yield, quality and/or stress tolerance. The bio stimulants may include products of plants /animals or microbial origin*.

Bio stimulants means compounds, substances and products includingmicroorganisms whose functions when applied to plants/seeds/ rhizosphere / s o i l i s t o r e g u l a t e
o r / a n d enhance a crops physiological processes independent of the products nutrient contents to improve input use efficiency, growth, yield, quality and/or stress tolerance and soil health . The bio stimulants may include products of plants /animals, microbial origin or mines (rock source)

*The primary function of the products should be other than that for pesticidal use and Nutrient source.

Heavy metal and other contaminants if any, may be within the prescribed limits given under clause 20 C.

The primary function of the products should be other than that for pesticidal use and Nutrient source. However, essential components including nutrients in the source which enhances plant growth should be included in the scope.

(3) New provision 20 C may be included “20 ( C) specification in respect of Biostimulants

(i) Not withstanding anything contained in this Order, the central Government shall specify the name, active ingredient(s), name of the crop and name of manufacturer / importer and method of analysis for determination of various components, claim benefit(s) of the Bio- Stimulant in Schedule VI of the FCO.;

Not withstanding anything contained in this Order, the central Government shall specify the name, active ingredient(s)/ product specification , name of the crop and name of manufacturer / importer and method of analysis for determination of various parameters declared in specification components, claim benefit(s) of the Bio- Stimulant in Schedule VI of the FCO.;

Justification: Biostimulant is mixture of various ingredient so difficult to name.

(ii) Bio- stimulants notified under sub-clause (i) shall be under any of the following category namely,-

  1. Botanical Extract, including seaweed extracts
  2. Bio-chemicals
  3. Protein hydrolysate and amino acids
  4. Vitamins
  5. Cell-free microbial products
  6. Antioxidants
  7. Anti-transpirants
  8. Humic & fulvic acid and their derivatives ”

Bio- stimulants, either solo or mixture should be notified under sub-clause (i) shall be under any of the following category, namely

  1. Botanical Extract, including seaweed extracts
  2. Bio-chemicals, phytohormones , long chain fatty acids
  3. Protein hydrolysate
  4. Vitamins
  5. Cell-free microbial products (alive or cell free/dead)
  6. Antioxidants
  7. Anti-transpirants
  8. ”Humic & fulvic acid, amino acids organic acid and theirderivatives
  9. Signaling compound to be added in the category
  10. Animal origin/fermented products
  11. Fortified Biostimulants with essential elements

12. A general category “other category” to allow Co’s to

develop ingredients not found in a short positive list.

(iii) No person shall manufacture /import any Biostimulant unless it is notified under the above said clause and conform to the standard set out in the said notification and it contains no traces of Insecticide.

• No person shall manufacture /import any Biostimulant unless it is notified under the above said clause and conform to the standard set out in the said notification and it contains no traces of Insecticide

•However, for the existing products 2 years should be granted for data generation and submission. During the intervening period until these products will be registered under FCO, these should be considered as deemed registered.

• To encourage new products –provisional registration for 3 years within six months from receipt of submission, may be granted with relaxed data (2 location 1 season bioefficacy, basic chemistry data & under Tox (acute oral & dermal studies)

• Insecticide should be replace with pesticide to given in broader sense.

(iv) Every Person desiring to manufacture/import any Biostimulant shall apply to the Controller fertiliser in Form R for its notification and such manufacturer shall submit along with application the following data/details relating to product:-

(a) Chemistry

2. 3.

1. Source (natural extracts of plant/microbe/animal / synthetic)

Source (natural extracts of plant/microbe/animal / synthetic/mines)

2. Chemical composition (chemical analysis from GLP/NABL accredited lab but )

As proposed in 3(i) Chemical composition Product specification (product analysis from GLP/NABL accredited lab as per product specifications)

GLP/NABL should enhance their scope for the testing facilities for biostimulants.

3. Physical & Chemical properties of active ingredients and adjuvants, if any.

Agreed

4. Method of analysis conforming to the specifications.

Agreed

5. Shelf-life claim Agreed

(a) Bio-efficacy trial

Agronomic Bio-efficiency trials be conducted at National Agriculture Research System ( SAU and ICAR) at 3 different doses for minimum one season from 3 locations.

Agronomic Bio-efficiency trials be conducted at National Agriculture Research System (SAU/ State Universities and ICAR) at 3 different doses for one season from 3 locations.

( c) Toxicity: Name of the Institute need to be indicated from where the manufacturer of Biostimulant should obtain certificate in respect of this

  1. Acute oral
  2. Acute dermal
  3. Acute inhalation
  4. Primary skin irritation
  5. Eye irritation
  6. Toxicity to bird
  7. Toxicity to fish
  8. Toxicity to honeybee
  9. Toxicity to earthworm

Test report from CIBRC approved laboratories for toxicity test should only be accepted)

( c) Toxicity: Name of the Institute need to be indicated from where the manufacturer of Biostimulant should obtain certificate in respect of this

  1. Acute oral
  2. Acute dermal
  3. Acute inhalation
  4. Primary skin irritation
  5. Eye irritation
  6. Toxicity to bird
  7. Toxicity to fish
  8. Toxicity to honeybee
  9. Toxicity to earthworm

To Omit Eco-tox data_ justification will be shared.

This is not important but I would like to inform you that requirement of tox data should be exempted for fertilizers. So in same lines Tox data should not be insisted. If mandated, Acute oral dermal should be considered.

Test report from CIBRC approved laboratories for toxicity test should only be accepted)

Test reports should be generated in consonance to the CIB&RC Guidelines for data generation i.e from GLP labs

(d) heavy metal limit prescribe d

Biostimulant are the safest product, requirement of heavy metal should not be insisted. However, if mandated than the proposal will be as below in (v)

(e) The sample of the product along with an Affidavit by the manufacturer/importer on non- judicial stamp paper stating that is not laced with pesticide (> 0.01ppm). the product

Agreed

(a)

(v) The Heavy metals of the product present in the product shall not exceed the following maximum limit prescribed for various metals, namely

In mg/kg maximum Cadmium (as Cd) Chromium (VI) (as Cr) Copper (as Cu) Zinc(as Zn)

Lead (as Pb) Arseniv (as As2O3)

– 5.00 -50.0

– 300.00 -1000.00 -100.00 -10.0

Zinc & Cu should be taken out of the list as these are essential nutrients

(vi) No Biostimulant shall contain any pesticides beyond a permissible limit of 0.01ppm.”

Agreed

4. Label and leaflet requirements- new provision may be included in FCO “(4)

Agreed

In Clause 21 the following sub clause shall be inserted,

namely,-

(ab) Every container in which any Biostimulant is packed shall conspicuously superscribed with Word Bio-Stimulant and shall bear only such particulars and unless otherwise required under any law nothing else

, as may from time to time be specified by the Controller in this behalf.”

Under the above said clause Notification:-

The Controller under above said notification notify for following particulars for printing of particulars on the bags of Bio-Stimulant. If it is in small pack then a separate leaf let shall be placed in the bag

1. Name of the manufacturer/importer.

2. Name of the marketer, if any
3. Name of the bio-stimulant (brand name or trade

Agreed

The Controller under above said notification notify for following particulars for printing of particulars on the bags of Bio-Stimulant. If it is in small pack (pack size specification) then a separate leaf let shall be placed in the bag pack.

Point No. 1-2, 5-9 & 11-12 : Agreed

Point 4. Instead of recommendation (dosage,crops, label expansion) “Direction to use” should be mentioned

4.

5. 6.

mark under which the bio-stimulant is sold) and its active ingredient(s) and its percentage content

4. Use of recommendations (dosage, crops, labels

expansion as applicable)

5. Precautions/storage conditions 6.Net content

7.Batch number and date of manufacturing/repacking 8.Expiry date

9. The label shall be so affixed to the containers that it cannot be ordinarily removed

10. The label to be affixed or attached to the package shall be printed in English/Hindi/regional language

11. MaximumRetailPriceoftheproduct. 12.Label claim of the product

Point 3. Active ingredient content for live microbe biostimulants should be expressed as CFU/gm or CFU/ml rather than as a percent. This convention for AI units for microbial products, include biopesticides, has become the established standard globally.

Point No. 10.The label to be affixed or attached to the package shall be printed in English/Hindi only.

5. New provision :- Under clause 38, a separate CFC for Biostimulant with following members shall be constituted under the chairmanship of Agriculture Commissioner with following other members :

(1) DG Health Services,
(2) ADG(NRM) , ICAR,
(3) HeadPlantPhysiology,IARI,
(4) Head Chemical Division, IARI,
(5) Deputy Secretary / Director (INM)- Member Secretary.

Agreed. The CFC should hold quarterly meeting.

Schedule VI A Specification of Bio Stimulant Schedule VI B Tolerance limit

A. For live microbe biostimulant products concentration specification to be expressed as a minimum CFU/gm or CFU/ml.

1. General Requirements of Sampling

1.1 In drawing preparing and handling the samples, the following precautions and directions shall be observed.

Agreed

1.2 Sampling shall be carried out by a trained and experienced person as

it is essential that the sample should be representative of the lot to be examined.

Agreed

7. 8.

1.3 Samples in their original unopened packets should be drawn and sent to the laboratory to prevent possible contamination of sample during handling and to help in revealing the true condition of the material.

Agreed

1.4 Intact packets shall be drawn from a protected place not exposed to dampness, air, light, dust or soot.

Agreed

2. Scale of Sampling 2.1 Lot

All units (containers in a single consignment of type of material belonging to the same batch of manufacture) shall constitute a lot. If a consignment consists of different batches of the manufacture, the containers of the same batch shall be separated and shall constitute a separate lot.

Agreed

2.2Batch:-All biostimulants prepared in a same process constitute abatch.

Agreed

2.3For ascertaining conformity of the material to the requirements of the specification, samples shall be tested from each lot separately.

Agreed

2.4The number of packets to be selected from a lot shall depend on the size of the lot and these packets shall be selected at random.

Agreed

3. Drawal of Samples

3.1 The Inspector shall take three packets as sample from the batch. Each sample constitutes a test sample

Agreed

1. 2.

3.2 These samples should be sealed in cloth bags and be sealed with the Inspector’s seal after putting inside

Form P. Identifiable details such as sample number, code number or any other details which enable its identification shall be marked on the cloth bags.

These samples should be sealed in cloth/plastic bags/ bottle/box etc

3.3 Out of the three samples collected, one sample so sealed shall be sent to incharge of the laboratory notified by the State Government under the clause 29 or the Central Government labs. Another sample shall be given to the manufacturer or importer or dealer as the case may be. The third sample shall be sent by the Inspector to his next higher authority for keeping in safe custody. Any of the latter two samples shall be sent for referee analysis under sub-clause (2) of clause 29B.

Agreed

3.4 The number of samples to be drawn from the lot

Lot/Batch
Upt0 5,000 packets 5,001-10,000 packets More than 10,000 packets

Number of Samples 03
04
05

Agreed

4. Schedule VI C-Methodology of testing

Schedule VI C-Methodology of testing should be as per submitted by applicant

5. Notification under clause 29 of specifying the minimum lab facility to be possessed by the Biostimulant testing laboratory.

CLI / BASAI will add

ImageImage
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We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

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  • Our professionals know how to handle a wide range of car services
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We offer full range of garage services to vehicle owners in Tucson. Our professionals know how to handle a wide range of car services. We can handle any problem on both foreign and domestic vehicles.

  • We make auto repair and maintenance more convenient for you
  • We are a friendly, helpful and professional group of people
  • Our professionals know how to handle a wide range of car services
  • We get the job done right — the first time
  • Same day service for most repairs and maintenance