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Policy

Indian Pediatrics 2003; 40:747-756

The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply
and Distribution) Amendment Act, 2003. What has Changed?
 


Subhash C. Jain

Secretary to the Government of India.
 

Government of India enacted the ĎInfant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992í (IMS Act), to regulate production, supply and distribution of these products. However, despite the Act, baby food manufacturers found loopholes to market their products.

In 1996, Department of Women and Child Development constituted a multisectorial National Task Force comprising of represen-tatives from various Ministries and Depart-ments of Central Government and Voluntary Agencies authorized under section 21 of the Act to deliberate and suggest amendments to the existing IMS Act. An Amendment Bill of 2002 was presented to the Parliament on March 8, 2002. The Law was enacted on 2 June 2003.

The Breastfeeding Promotion Network of India(BPNI) and Association for Consumers Action on Safety and Health(ACASH), India, the organizations gazetted under the IMS Act, section 21-1-C, spent time and worked hard to see this through. Important changes in the existing law are highlighted in bold letters as below:

Newer Definitions

1. "Advertisement" includes any notice, circular, label, wrapper or any other documents and also includes any visible representation or announcement made by means of any light, sound, smoke or gas or by means of electronic transmission or by audio or visual transmission.

2. "Health care system" means an institution or organization engaged, either directly or indirectly, in health care for mothers, infants or pregnant women, and includes health workers in private practice, a pharmacy, drug store and any association of health workers.

3. "Infant food" means any food (by whatever name called) being marketed or otherwise represented as a complement to motherís milk to meet the growing nutritional needs of the infant after the age of six months and up to the age of two years;

4. "Infant milk substitute" means any food being marketed or otherwise represented as a partial or total replacement for motherís milk for infant up to the age of two years.

5. "Promotion" means to employ directly or indirectly any method of encouraging any person to purchase or use infant milk substitute, feeding bottle or infant food.

Prohibitions extended to Infant Foods

1. No person shall advertise, or take part in the publication of any advertisement, for the distribution, sale or supply of infant milk substitutes, feeding bottles or infant foods.

2. No person shall give an impression or create a belief in any manner that feeding of infant milk substitutes and infant foods are equivalent to, or better than, motherís milk;

3. No person shall take part in the promotion of infant milk substitutes, feeding bottles or infant foods;

4. No person shall supply or distribute samples of infant milk substitutes or feeding bottles or infant foods or gifts of utensils or other articles; or

5. No person shall offer inducement of any other kind, for the purpose of promoting the use or sale of infant milk substitutes or feeding bottles or infant foods.

6. No person shall donate infant milk substitutes or feeding bottles or infant foods to any other person except to an orphanage;

7. No person shall donate any informational or educational equipment or material relating to infant milk substitutes or feeding bottles or infant foods.

8. No container or label referred to in sub-section (1) relating to infant milk substitute or infant food shall have pictures or other graphic material or phrases designed to increase the salability of infant milk substitutes or infant food.

Other Prohibitions

1. Every educational or other material including advertisements or material relating to promotion of infant milk substitutes, feeding bottles and infant foods whether audio or visual, dealing with pre-natal or post-natal care or with the feeding of an infant and intended to reach pregnant women or mothers of infants shall include clear information relating to the date of printing and publication of such material and the name of the printer and publisher.

2. No material referred to in sub-section (1) shall be utilized to promote the use or sale of infant milk substitutes or feeding bottles or infant foods.

3. No producer, supplier or distributor referred to in sub-section (1), shall offer or give any contribution or pecuniary benefit to a health worker or any asso-ciation of health workers, including funding of seminar, meeting, con-ferences, educational course, contest, fellowship, research work or sponsor-ship.

4. Any person who contravenes the provisions of section 3,4,5,7,8,9,10 or sub-section (2) of section 11 and the rules made under section 26 of the Act shall be punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.

5. Any person who contravenes the provisions of section 6 or sub-section (1) of section 11 and the rules made under section 26 of the Act shall be punishable with imprisonment for a term which shall not be less than six months but which may extend to three years and with fine which shall not be less than two thousand rupees:

6. No suit, prosecution or other legal proceeding shall lie against the Central Government or any State Government or any officer of the Central Government or a representative of such voluntary organization which is notified under clause (c) of sub-section (1) of section 21 for anything which is in good faith done or intended to be done under this Act.

The IMS Amendment Act 2003 is shown in Annexure I. Illustrative examples of products falling under the provision of act are shown in Annexure II.

Annexure-I

The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Amendment Act, 2003

No. 38 of 2003 (1 June 2003)

An Act to amend the Infant Milk Substitutes, Feeding Bottles and Infants Foods (Regulation of Production, Supply and Distribution) Act, 1992. It provides for the regulation of production, supply and distribution of infant milk substitutes, feeding bottles and infant foods with a view to the protection and promotion of breastfeeding and ensuring the proper use of infant foods and for matters connected therewith or incidental thereto.

Be it enacted by Parliament in the Forty-fourth Year of the Republic of India as follows:

1. (a) This Act may be called the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Amendment Act, 2003.

(b) It extends to the whole of India.

(c) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.

2. In this Act, unless the context otherwise requires,

(a) "advertisement" includes any notice, circular, label, wrapper or any other document or visible representation or announcement made by means of any light, sound, smoke or gas or by means of electronic transmission or by audio or visual transmission;

(b) "container" means a box, bottle, casket, tin, can, barrel, case, tube, receptacle, sack, wrapper or other thing in which any infant milk substitute, feeding bottle or infant food is placed or packed for sale or distribution;

(c) "feeding bottle" means any bottle or receptacle used for the purpose of feeding infant milk substitutes, and includes a teat and a valve attached or capable of being attached to such bottle or receptacle;

(d) "health care system" means an institution or organisation engaged, either directly or indirectly, in health care for mothers, infants or pregnant women, and includes a health workers in private practice, a pharmacy, drug store and any association of health workers;

(e) "health worker" means a person engaged in health care for mothers, infants or pregnant women;

(f) "infant food" means any food (by whatever name called) being marketed or otherwise represented as a complement to motherís milk to meet the growing nutritional needs of the infant after the age of six months and up to the age of two years;

(g) "infant milk substitute" means any food being marketed or otherwise represented as a partial or total replacement for motherís milk, for infant up to the age of two years

(h) "label" means a display of written, marked, stamped, printed or graphed matter affixed to, or appearing upon, any container;

(i) "prescribed" means prescribed by rules made under this Act.

(j) "promotion" means to employ directly or indirectly any method of encouraging any person to purchase or use infant milk substitute, feeding bottle or infant food.

(2) Any reference in this Act to any other enactment or any provision thereof, shall, in relation to an area in which such enactment or such provision is not in force, be construed as a reference to the corresponding law or the relevant provision of the corresponding law, if any, in force in that area.

3. No person shall

(a) advertise, or take part in the publication of any advertisement, for the distribution, sale or supply of infant milk substitutes feeding bottles or infant foods; or

(b) give an impression or create a belief in any manner that feeding of infant milk substitutes and infant foods are equivalent to, or better than, motherís milk; or

(c) take part in the promotion of infant milk substitutes, feeding bottles or infant foods;

4. No person shall -

(a) supply or distribute samples of infant milk substitutes or feeding bottles or infant foods gifts of utensils or other articles; or

(b) contact any pregnant woman or the mother of an infant; or

(c) offer inducement of any other kind, for the purpose of promoting the use or sale of infant milk substitutes or feeding bottles or infant foods.

5. Subject to the provisions of sub-section (4) of section 8, no person shall donate or distribute -

(a) infant milk substitutes or feeding bottles or infant foods to any other person except to an orphanage;

(b) any informational or educational equipment or material relating to infant milk substitutes or feeding bottles or infant foods;

Provided that nothing in this clause shall apply to the donation or distribution, subject to such conditions and restrictions as may be prescribed, of such equipment or material through the health care system.

6. (1) Without prejudice to the provisions of the Prevention of Food Adulteration Act, 1954 and the rules made thereunder, no person shall produce, supply or distribute any infant milk substitute or infant food unless every container thereof or any label affixed thereto indicates in a clear, conspicuous and in an easily readable and understandable manner, the words "important notice" in capital letters in such language as may be prescribed and indicating thereunder the following particulars in the same language, namely:-

(a) a statement "motherís milk is best for your baby" in capital letters;

(b) a statement that infant milk substitute or infant food should be used only on the advice of a health worker as to the need for its use and the proper method of its use;

(c) a warning that infant milk substitute or infant food is not the sole source of nourishment of an infant;

(d) the instructions for its appropriate preparation and a warning against the health hazards of its inappropriate preparation;

(e) the ingredients used;

() the composition or analysis;

(g) the storage conditions required;

(h) the batch number, date of its manufacture and the date before which it is to be consumed, taking into account the climatic and storage conditions of the country;

(i) such other particulars as may be prescribed.

(2) No container or label referred to in sub-section (1) relating to infant milk substitute or infant food shall -

(a) have pictures of an infant or a woman or both; or

(b) have pictures or other graphic material or phrases designed to increase the saleability of infant milk substitutes or infant food ; or

(c) use on it the word "humanised" or "maternalised" or any other similar word; or

(d) bear on it such other particulars as may be prescribed.

7. (1) Every educational or other material including advertisements or material relating to promotion of infant milk substitues, feeding bottles and infant foods whether audio or visual, dealing with pre-natal or post-natal care or with the feeding of an infant and intended to reach pregnant women or mothers of infants shall include clear information relating to -

(a) the benefits and superiority of breastfeeding;

(b) the preparation for, and the continuance of, breastfeeding;

(c) the harmful effects on breast-feeding due to the partial adoption of bottle feeding;

(d) the difficulties in reverting to breastfeeding of infants after a period of feeding by infant milk substitute;

(e) the financial and social implications in making use of infant milk substitutes and feeding bottles;

() the health hazards of improper use of infant milk substitutes and feeding bottles;

(fa) the date of printing and publication of such material and the name of the printer and publisher;

(g) such other matters as may be prescribed.

(2) No material referred to in sub-section (1) shall be utilised to promote the use or sale of infant milk substitutes or feeding bottles or infant foods.

8. (1) No person shall use any health care system for the display of placards or posters relating to, or for the distribution of, materials for the purpose of promoting the use or sale of infant milk substitutes or feeding bottles or infant foods:

Provided that the provisions of this sub-section shall not apply to

(a) the donation or distribution of informational or educational equipment or material made in accordance with the proviso to clause (b) of section 5; and

(b) the dissemination of information to a health worker about the scientific and factual matters relating to the use of infant milk substitutes or feeding bottles or infant foods along with the information specified in sub-section (1) of section 7.

(2) No person who produces, supplies, distributes or sells infant milk substitutes or feeding bottles or infant foods shall make any payment to any person who works in the health care system for the purpose of promoting the use or sale of such substitutes or bottles or foods.

(3) No person, other than a health worker, shall demonstrate feeding with infant milk substitutes or infant foods to a mother of an infant or to any member of her family and such health worker shall also clearly explain to such mother or such other member the hazards of improper use of infant milk substitutes or feeding bottles or infant foods.

(4) No person, other than an institution or organisation, engaged in health care for mothers, infants or pregnant women, shall distribute infant milk substitutes or feeding bottles to a mother who cannot resort to breastfeeding and who cannot afford to purchase infant milk substitutes or feeding bottles.

(5) An orphanage may purchase infant milk substitutes or feeding bottles at a price lower than their sale price for the purpose of utilising them in the said orphanage.

Explanation - For the purposes of this sub-section, such purchases shall not amount to an inducement for promoting the use or sale of infant milk substitutes or feeding bottles.

9. (1) No person who produces, supplies, distributes or sells infant milk substitutes or feeding bottles or infant foods shall offer or give, directly or indirectly, any financial inducements or gifts to a health worker or to any member of his family for the purpose of promoting the use of such substitutes or bottles or foods.

(2) No producer, supplier or distributor referred to in sub-section (1), shall offer or give any contribution or pecuniary benefit to a health worker or any association of health workers, including funding of seminar, meeting, conferences, educational course, contest, fellowship, research work or sponsorship.

10. (1) No person who produces, supplies, distributes or sells infant milk substitutes or feeding bottles or infant foods shall fix the remuneration of any of his employees or give any commission to such employees on the basis of the volume of sale of such substitutes or bottles or foods made by such employees.

(2) The employees of such person shall not perform any function which relates to educating a pregnant woman or mother of an infant on pre-natal or post-natal care of the infant.

11. (1) No person shall sell or otherwise distribute any infant milk substitute or infant food unless it conforms to the standards, specified for such substitute or food under the Prevention of Food Adulteration Act, 1954, and the rules made there under and the container thereof has the relevant Standard Mark specified by the Bureau of India Standards established under section 3 of the Bureau of Indian Standards Act, 1986 to indicate that the infant milk substitute or infant food conforms to such standards:

Provided that where no standards have been specified for any infant milk substitute or infant food under the Prevention of Food Adulteration Act, 1954, no person shall sell or otherwise distribute such substitute or food unless he has obtained the approval of the Central Government in relation to such substitute or food and the label affixed to the container thereof under the rules made under that Act.

(2) No person shall sell or otherwise distribute any feeding bottle unless it conforms to the Standard Mark specified by the Bureau of Indian Standards referred to in sub-section (1) for feeding bottles and such mark is affixed on its container.

12. (1) Any food inspector appointed under section 9 of the Prevention of Food Adulteration Act 1954 (hereinafter referred to as the food inspector) or any officer not below the rank of a Class I officer authorised in this behalf by the State Government (hereinafter referred to as the authorised officer) may, if he has any reason to believe that any provision of section 6 or section 11 has been or is being contravened, enter and search at any reasonable time any factory, building, business premises or any other place where any trade or commerce in infant milk substitutes or feeding bottles or infant foods is carried on or such substitutes or bottles or foods are produced, supplied or distributed.

(2) The provisions of the Code of Criminal Procedure, 1973, relating to searches and seizures shall, so far as may be, apply to every search or seizure made under this Act.

13. (1) If any food inspector or authorised officer has reason to believe that in respect of any infant milk substitute or feeding bottle or infant food or container thereof, the provisions of this Act have been or are being contravened, he may seize such substitute or bottle or food or container.

(2) No such substitute or food or bottle or container shall be retained by any food inspector or authorised officer for a period exceeding ninety days from the date of its seizure unless the approval of the District Judge, within the local limits of whose jurisdiction such seizure has been made, has been obtained for such retention.

14. Any infant milk substitute or feeding bottle or infant food or container thereof, in respect of which any provision of this Act has been or is being contravened, shall be liable to confiscation:

Provided that where it is established to the satisfaction of the court adjudging the confiscation that the person in whose possession, power or control any such substitute or bottle or food or container is found is not responsible for the contravention of the provisions of this Act, the court may, instead of making an order for the confiscation of such substitute or bottle or food or container, make such other order authorised by this Act against the person guilty of the breach of the provisions of this Act as it may think fit.

15. (1) Whenever any confiscation is authorised by this Act the court adjudging it may, subject to such conditions as may be specified in the order adjudging the confiscation, give to the owner thereof an option to pay in lieu of confiscation such cost not exceeding the value of the infant milk substitute or feeding bottle or infant food or container thereof in respect of which the confiscation is authorised as the court thinks fit.

(2) On payment of the cost ordered by the court the seized infant milk substitute or feeding bottle or infant food or container shall be returned to the person from whom it was seized on the condition that such person shall, before making any distribution, sale or supply of such substitute or bottle or food or container, give effect to the provisions of this Act.

16. No confiscation made or cost ordered to be paid under this Act shall prevent the infliction of any punishment to which the person affected thereby is liable under the provisions of this Act or under any other law.

17. Any confiscation may be adjudged or costs may be ordered to be paid -

(a) without any limit, by the principal civil court of original jurisdiction within the local limits of whose jurisdiction such confiscation has been made or costs have been ordered to be paid, as the case may be;

(b) subject to such limits as may be specified by the Central Government in this behalf, by such other court, not below a civil court having pecuniary jurisdiction exceeding five thousand rupees, as the Central Government may, by notification in the Official Gazette, authorise in this behalf.

18. (1) No order adjudicating confiscation or directing payment of costs shall be made unless the owner of the infant milk substitute or feeding bottle or infant food or container thereof has been given a notice in writing informing him of the grounds on which it is proposed to confiscate such substitute or bottle or food or container and giving him a reasonable opportunity of making a representation in writing, within such reasonable time as may be specified in the notice, against the confiscation and if he so desires, of being heard in the matter:

Provided that where no such notice is given within a period of ninety days from the date of the seizure of the infant milk substitute or feeding bottle or infant food or container thereof, such substitute or bottle or food or container shall be returned after the expiry of that period to the person from whose possession it was seized.

(2) Save as otherwise provided in sub-section (1), the provisions of the Code of Civil Procedure, 1908, shall, so far as may be, apply to every proceeding referred to in sub-section (1).

19. (1) Any person aggrieved by any decision of the court adjudicating a confiscation or ordering the payment of costs may prefer an appeal to the court to which an appeal lies from the decision of such court.

(2) The appellate court may, after giving the appellant an opportunity of being heard, pass such order as it thinks fit confirming, modifying or revising the decision or order appealed against or may send back the case with such directions as it may think fit for a fresh decision or adjudication, as the case may be, after taking additional evidence if necessary:

Provided that an order enhancing any fine in lieu of confiscation or for confiscating goods of greater value shall not be made under this section unless the appellant has had an opportunity of making a representation and if he so desires of being heard in his defence.

(3) No further appeal shall lie against the order of the court made under sub-sector (2).

20. (1) Any person who contravenes the provisions of section 3,4,5,7,8,9,10 or sub-section (2) of section 11 and the rules made under section 26 of the Act shall be punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.

(2) Any person who contravenes the provisions of section 6 or sub-sector (1) of section 11 and the rules made under section 26 of the Act shall be punishable with imprisonment for a term which shall not be less than six months but which may extend to three years and with fine which shall not be less than two thousand rupees.

Provided that the court may, for any adequate and special reasons to be mentioned in the judgement, impose a sentence of imprisonment for 44 Law - 2, a term which shall not be less than three months but which may extend to two years and with fine which shall not be less than one thousand rupees.

21. (1) Save as otherwise provided in section 173 of the Code of Criminal Procedure, 1973, no court shall take cognizance of any offence punishable under this Act except upon a complaint in writing made by

(a) a person authorised in this behalf under sub-section (1) of section 20 of the Prevention of Food Adulteration Act, 1954; or

(b) an officer not below the rank of a Class I officer authorised in this behalf, by general or special order, by the Government; or

(c) a representative of such voluntary organisation engaged in the field of child welfare and development and child nutrition as the Government may, by notification in the Official Gazette, authorise in this behalf.

(2) Where a complaint has been made by a representative of the voluntary organisation authorised under clause (c) of sub-section (1) and the court has issued a summons or, as the case may be, a warrant under sub-section (1) of section 204 of the Code of Criminal Procedure, 1973, the Assistant Public Prosecutor for that court shall take charge of the case and conduct the prosecution.

22. (1) Where an offence under this Act has been committed by a company, every person who, at the time the offence was committed, was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:

Provided that nothing contained in this sub-section shall render any such person liable to any punishment, if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence.

(2) Notwithstanding anything contained in sub-section (1), where any offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

Explanation - For the purposes of this section,

(a) "company" means any body corporate and includes a firm or other association of individuals; and

(b) "director", in relation to a firm, means a partner in the firm.

23. Notwithstanding anything contained in the Code of Criminal Procedure, 1973, an offence punishable under this Act shall be

(a) bailable;

(b) cognizable.

24. No suit, prosecution or other legal proceeding shall lie against the Central Government or any State Government or any officer of the Central Government or a representative of such voluntary organisation which is notified under clause (c) of sub-section (1) of section 21 for anything which is in good faith done or intended to be done under this Act.

25. The provisions of this Act, or the rules made thereunder shall be in addition to, and not in derogation of, the Prevention of Food Adulteration Act, 1954, or the rules made thereunder.

26. (1) The Central Government may, by notification in the Official Gazette, make rules to carry out the provisions of this Act.

(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:

(a) the conditions and restrictions subject to which educational equipment and other material may be donated or distributed under the provision to clause (b) of section 5;

(b) the language in which the notice and other particulars shall be indicated under sub-section (1) of section 6;

(c) the particulars which are to be indicated under clause (i) of sub-section (1) of section 6;

(d) the particulars which a container or label shall not bear under clause (d) of sub-section (2) of section 6;

(e) the matters to be included in the information which reaches pregnant women or mothers of infants under clause (g) of sub-section (1) of section 7;

() any other matter which is required to be, or may be, prescribed.

(4) Every rule made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in section, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.

Annexure II

Illustrative Examples of Products falling under the IMS Amendment Act, 2003

Promotional marketing activities of manufacturers of the following products are prohibited under the act
Infant Milk Substitutes such as Lactogen-I, Lactogen-II, Nestogen-I, Nestogen-II, Lactodex-I, Lactodex-II, Amul Spray, Zerolac, Dexolac, ProSoyal, Simyl- MCT, Similac, Neosure.

Infant Foods
such as Nestum, Cerelac, Farex, Weano, Infacare, First Food, Dexrice, Easum.

Feeding Bottles of any brand like Bonny Baby, Hello Baby, Wipro.

These Products come under the purview of the following sections of IMS Amendment Act, 2003

Section 3(a) Advertisements by any means including any notice, circular, label, wrapper, audio or visual transmission such as through television, radio, internet etc.

Section 3(a) Promotion for infants less than two years of age by any person

Section 3(b) Creating impression that a product is equivalent to better than motherís milk

Section 3(c) Encouraging the use and purchase of product by any person

Section 4(a) Distributing free samples by any person

Section 4(c) Offering benefit for the purpose of sale.

Section 5(a) Donation or distributing the product

Section 5(b) Donation and distribution of any informational or educational material related to the product

Section 6(2b) Having pictures of infant or a women or both or a graphic on the label of the product

Section 7 Use of educational material to promote products.

Section 8 Promotion through a health care system like hospital, clinic, private practitioners, association of health workers, pharmacy, chemist shop.

Section 8(1) Use of health care system for display of play cards or posters or distribution of material related to product

Section 8(2) Making payment to a person working in a healthcare system for promoting the use of the product

Section 8(3) Demonstration of method of feeding of the product to a mother of an infant or any member of her family.

Section 9(1) Offering benefits or giving gifts to a health worker or to any member of his family

Section 9(2) Contributing or giving pecuniary benefits to a health worker or any association of health workers

Section 10 Fixing remuneration or commission to companyís employee on the basis of the volume of sale of the product

N. B. The above analysis has been done by the Breastfeeding Promotion Network of India (BPNI); The list is illustrative and not exhaustive.

 

For more information please contact: Breastfeeding Promotion Network of India, BP-33, Pitampura, Delhi (India). Tel: 911127312445, Fax: 91-11-27315606, Email - bpni@bpni.org

Compiled by: Panna Choudhury, Editor-in-Chief and Piyush Gupta, Associate Editor.

 

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