Tuesday 25 August 2020

FSSAI Regulations: Latest FSSAI Order on GM-Free Certificate for Imported Foods / Crops is Confusing & Vague

FSSAI Regulations: 
FSSAI Order on GM Free Certificate on imported Crops / Foods is Confusing & Vague

Techno-legal Analysis by:
Vijay SARDANA
Advocate, Delhi High Court
Techno-Legal Expert for Bio-economy

FSSAI issued an order (given below) on the need for GM-free certificate on imported products.

The language of the order has created serious confusion and may lead to litigations as well. Let us analyse the order.

  • In the title of the order, it says, it is for "imported food consignments. In the copy, it says only non-GM crops are imported, in the annexure it mentioned the term "Crops" Should we conclude that FSSAI is using these terms interchangeably? (Legally  all these terms have different meanings, I am not sure what is the intention and message from FSSAI)
  • If these terms are used as interchangeable terms, then the use of terms like "date of manufacturing or production" in certificate this clearly indicates that there is a lack of understanding within FSSAI about these terms or about the business practices around the world and within India.
  • Why FSSAI does not demand the date of production from farmers, FCI and companies selling wheat, rice, pulses, etc and all the products mentioned in Annexure -1. 
  • If there are not used interchangeably, then there is a serious legal implication and confusion because then every person is free to make his or her own interpretation and this will open a Pandora’s box for litigations and disputes including corruption.
  • The information expected by the FSSAI in the form of a certificate needs a serious relook. If the notification is for the crops only, in that case why term manufacturing is used.
  • Large consignments are from many fields or factories and consolidated. Can anyone provide the production with the date of production when there is a shipload of the consignment? What should be the entry by the government of India, the same certificate for basmati rice is to be issued by the Government of India?
  • In bulk loading shipments of soybean oil, what should be the date of manufacturing/production/packing? Which date is prefered or expected by FSSAI? Can FSSAI issue a sample document and guidelines for the countries supplying soybean oil to India?
  • Annexure 1: The annexure includes only crops or the products from these crops as well, this should be clarified by FSSAI. 
  • Annexure 2: Let FSSAI come out with proper implementation guidelines for exporters, importers and port officials to avoid unnecessary litigations and disputes.
  • Dispute resolution is missing: Why FSSAI is not providing any contact number and email of FSSAI officials in case there is a problem at Indian ports who should be contacts and approached under this order. This is important to make system accountable, transparent, to minimize chances of corruption and delays. 

Please note such vague orders also spoil diplomatic relations. 


Please see the order below:

FSSAI Order

Annexure -1 

Annexure -2























































































Hope FSSAI will issue clarifications and guidelines regarding this order.

Please do share your views and write in the comments below. Pl. feel free to share. 


Why Expert Committees' Recommendations should be logical?

 Why Expert Committees' Recommendations should be logical?


In today's hyper-connected world, every documented is floating in every part of the world. It is the duty of the author, members of the committee and the head of the institutions under which the work was carried out to ensure that every document is not properly drafted and presented to the readers but also provide logical reasoning behind their recommendations.

These expert committee documents are also used as evidence in the courts. Unfortunately, courts take these expert committees on face value. If these committees have concluded the recommendations without proper assessment, the court's judgements can do more harm to society.

While doing some legal and policy work, I was referring to the documents published by expert committees constituted by the Government of India to study the pesticides and their relevance. This is a very important agenda because the periodic evaluation of all chemicals, systems and products to ensure bad products are phased out and new and safer options are included. There can be various criteria to understand what is useful and what is not useful for society.

As a techno-legal & techno-commercial expert, I have a tendency to read the documents from various angles to understand the perspective of various stakeholders. This helps in coming to a logical conclusion.

While evaluating the recommendations of various expert committees on the pesticides, I came across the following observations:

1. Lack of clearly laid-out procedure and criteria: The committees have randomly picked up a few documents without any justification and then unable to come to any meaningful conclusion. This has created more 

2. Conflict of Interests: The committee is seeking the evidence to come to the conclusion from the stakeholders which has a conflict of interest with the scope of the agenda itself. 

3. 

3. 


Saturday 22 August 2020

Stop Toxic Adulteration : Open letter to FSSAI and AGMARK

Stop Toxic Adulteration in Food

Open Letter to Food Safety and Standards Authority of India (FSSAI) & AGMARK

To,

The Chairperson / CEO
Food Safety & Standards Authority of India
Ministry of Health
Govt. of India
New Delhi
&
The 
The Joint Secretary / Director, 
Incharge for AGMARK
Ministry fo Agriculture
Government of India

Dear Chairperson / CEO / JS/ Director,

Subject: Letter of 19th Aug 2020 (attached) is legally ineffective and will have no impact on adulterated oil suppliers. : This appears to be an eyewash


Eat Right (adulterated food) is the joke of FSSAI,
if food adulteration is not controlled.

The mentioned letter on the subject is a baby step but this is a half-hearted incomplete attempt to address the serious concerned with public health.

FSSAI has issued the advisory in the form of a letter and it has no legislation under the court of law. In past, such advisories were questions in the court and courts refused to accept such directions unless issues as proper notification.

Unfortunately, the letter reminds the department about the power of food safety officers. The record of the department and the market flooded with adulterated and substandard products clearly indicates that this advisory will have no effect on the ground.

If they had any concern, commitment, and understanding of their moral and legal duty, citizens’ health can be saved from adulterated products. Unfortunately, as a citizen, with the experience I can say, this will have no positive impact on the ground. Corruption is due to these powers under the act. Your letter will only create more corruption opportunities. I will be happy to see the change on the ground this time under your leadership.

1.   As citizen, I also expect transparency in the function of FSSAI. FSSAI must honestly disclose how may oil samples were tested every week, how many were found adulterated, and how many suppliers were booked and factories sealed. Unless there is an action on the ground, do not expect this letter of FSSAI has any impact on the ground.

2.   It is sad to see that citizens of India are suffering due to adulteration and FSSAI is taking too long a time to issue a proper logical notification to protect public health. This letter also ignored many vital parameters which were suggested for controlling adulteration.

As a citizen of India, let me help FSSAI in formulating the proper standard and rules. If the technical advisory committee has any issue with any of the following suggestions, the same should be discussed in an open forum. The industry should know the reason for rejecting the following suggestions.

My humble request is the following points should be considered and included in the regulations to control the adulteration in India edible soil in India.

1)  Raw oils should NOT be allowed for blending under any pretext.

2)  Only refined oils meeting FSSAI standards are allowed for blending.

3) Colour of the edible oils, other than raw oils, must be mandatory parameters under FSSAI and Agmark in line with BIS.

4)  All blended edible oils must mention Fatty acid profiles on the product label to know the truthfulness of the blended oil and claims made on the label.

5) All oils, not added with rice bran oil must mention, must mention “Free from Oryzanol” on the label.

6)   All oil samples must be tested for Oryzanol content

7)  All raw oils and refined edible oil standards must specify mono-glycerides and di-glycerides parameters in FSSAI and AGMARK.

8) Mono-glycerides and di-glycerides parameters oils must be tested for these items in every sample.

9)  Raw Mustard oils (Kacchi Ghani) must have a minimum 35% erucic acid and diglyceride content is not more than 2%.

10)All Invoices must mention the license and registration number of the purchasing dealer to minimize mixing in tankers and in godowns: Modify Point no. 14 in FSSAI licensing condition - The Manufacturer/ Importer/ Distributor shall buy and sell food products only from, or to, licensed /registered vendors and maintain record thereof. The invoice/delivery challan in respect of the sale/movement of vegetable oils must mention the license/registration number of the purchasing dealer. " 

11) Modify Point no. 5 in FSSAI licensing condition. Every sale and movement of stocks of solvents-extracted oil,'semi-refined' or 'raw grade I’, 'fatty acids / acid oils produced during the refining of vegetable oils', edible groundnut flour or edible coconut flour, or both by the producer shall be a sale or movement of stocks directly to a registered user and not to any other person, and no such sale or movement shall be effected through any third party."

12) Ministry of Finance and Corporate Affairs, FSSAI and Agriculture Ministry must enforce Section-148 under Companies Act 2013 on all food companies.  This will ensure only good material and purchased by the company. This will be verified by the statutory auditors and should be made part of the annual report to shareholders and to ROC. This will ensure not only safe products but also proper GST collection for the government.

If any help is required in explaining these self-explanatory points, undersigned will be happy to explain all the technical and legal justifications in from of any expert in the country or outside India. Please provide the opportunity for the same before rejecting the above points in the public interest.

Appeal: My requests to all FSSAI leadership and officials, you all are paid salaries to sustain your decent lifestyles and families by taxpayers and your inaction is making the same taxpayers and their families sick due to adulterated foods. Is this morally and ethically right?

Your actions will speak louder than your words. Citizens are watching carefully are you ensuring that foods are delivered as per the laws or not.

I wish you all the best so that you have the courage to take a right stand against the wrong door and make the system FSSAI transparent before more citizens of India become victims of adulterated foods. FSSAI actions must be visible and should inspire confidence among citizens. Are we expecting more than the minimum required?

Waiting for proper elaborate notification on this vital concern of the citizens.


With best regards,

 

Vijay Sardana

 

CC:

1.    PM Office

2.    All Concerned Ministers

3.    All Concerned Secretaries

4.    All Concerned Departments


Copy of the letter issues: This letter has no legal standing. This is not a law. Please issue the proper notification.



Sunday 5 July 2020

Can China drag India to WTO for banning Apps and Cancelling existing Orders?

A Techno-Legal Analysis
Can China drag India to WTO for banning Apps and Cancelling existing Orders?
By:
Vijay SARDANA
Advocate, Delhi High Court
Techno-legal Expert on Agribusiness 
& Consumer Products Industries
Priyanka Sardana, Advocate, Supreme Court of India
Aastha Sardana, Researcher on Legal Matters

After the border conflict with China, India took various decisions to block the trading interests of China in India. Let us keep the following facts in mind:
  • China encroached about 400-meters of the territory which is on the disputed border.
  • In conflict, India lost 20 soldiers and there are reports that China lost around 40 soldiers.
  • China refused to accept the previous agreements on border disputes and delaying in maintaining status-quo. 
  • India took various retaliatory actions and blocked various commercial interests of the aggressor in the interest of national security.
  • Now, China is treating to take India to WTO for dispute resolution mechanism under the pretext of MFN status is violated.
What is the WTO position on such matters? 
The World Trade Organization (WTO) regime is rules-based. Member States can only invoke exceptions that are expressly provided for. National measures based on these exceptions must comply with the stated conditions and such measures are justiciable. 
However, one of the GATT exceptions, the national security clause in Article XXI GATT, has always been in a category of its own, an exception among the exceptions.
What is Article XXI: on Security Exceptions?
Nothing in this Agreement shall be construed
(a)  to require any contracting party to furnish any information the disclosure of which it considers contrary to its essential security interests, or
(b)  to prevent any contracting party from taking any action which it considers necessary for the protection of its essential security interests
i. relating to fissionable materials or the materials from which they are derived;
ii. relating to the traffic in arms, ammunition and implements of war and to such traffic, in other goods and materials as is carried on directly or indirectly for the purpose of supplying a military establishment; 
iii. taken in time of war or other emergency in international relations, or
(c)  to prevent any contracting party from taking any action in pursuance of its obligations under the United Nations Charter for the maintenance of international peace and security.
Now let us see what is the past experience at WTO on such matters.
Please note, the Dispute Settlement Body of the World Trade Organization (WTO) has never passed judgment on the validity of measures taken under this Article. It means there is no precedence before us.
What will happen if China approaches WTO on the trade restrictions in India on Chinese Products?
According to our assessment. the WTO regime is operating in a normal business environment with disputes related to trade. The Article XXI clearly makes Security Exceptions and no one can interfere in that. 
The UN Charter clearly says that Article 51 provides for the right of countries to engage in self-defence, including collective self-defence, against an armed attack (including cyber-attacks). 
This Article 51 of the UN Charter is particularly vague: it does not define what constitutes an attack. Is the seizure of ships or aircraft an attack? Is the accidental or intentional violation of another country’s airspace an attack? Is industrial espionage an attack? Is a spy satellite taking photographs of military installations an attack? It does not define what constitutes an armed attack. For example, is a cyber-attack an armed attack?
India China Border Conflict: 
The fact is War or other emergencies in international relations, like Indian-China border conflict leading to the death of security persons, “involves a fundamental change of circumstances which radically alters the factual matrix in which the WTO-consistency of the measures at issue is to be evaluated.”
Unlike the evaluation of measures are covered by the exceptions in Article XX, evaluation of measures under Article XXI(b)(iii) does not necessitate a prior determination that the measures would be WTO-inconsistent had they been taken in “normal times”. Therefor in the issues of national security, WTO cannot intervene.
Let us understand the disputes in the past and their outcomes at WTO:
In the GATT Analytical Index, the original thinking behind Article XXI has been explained as taking care “of real security interests and, at the same time, so far as we could, to limit the exception to prevent the adoption of protection for maintaining industries under every conceivable circumstance.”
Let us understand the intention behind the wording of Article XXI:
Paragraphs (a) and (b) of Article XXI, as mentioned above says, “it considers … essential security interests”
During discussions in the Geneva session of the Preparatory Committee, in response to an inquiry as to the meaning of “essential security interests”, it was stated by one of the drafters of the original Draft Charter that “We gave a good deal of thought to the question of the security exception which we thought should be included in the Charter. We recognized that there was a great danger of having too wide an exception and we could not put it into the Charter, simply by saying: ‘by any Member of measures relating to a Member's security interests,’ because that would permit anything under the sun. Therefore we thought it well to draft provisions which would take care of real security interests and, at the same time, so far as we could, to limit the exception to prevent the adoption of protection for maintaining industries under every conceivable circumstance.… there must be some latitude here for security measures. It is really a question of balance. 
We have got to have some exceptions. We cannot make it too tight, because we cannot prohibit measures, which are needed purely for security reasons. On the other hand, we cannot make it so broad that, under the guise of security, countries will put on measures which really have a commercial purpose”. The Chairman of Commission suggested in response that the spirit in which Members of the Organization would interpret these provisions was the only guarantee against abuses of this kind. 
It means every situation will be evaluated on its merit. India-China disputes if we go by the evidence and the merit of the case, it will be difficult for Chai to defend its position at international forums. In our view, China will not take the matter to WTO. 
Let us also evaluate past cases:
Portugal – Ghana Dispute
In 1961, on the occasion of the accession of Portugal, Ghana stated that its boycott of Portuguese goods was justified under the provisions of Article XXI:(b)(iii), noting that “… under this Article each contracting party was the sole judge of what was necessary for its essential security interest. There could, therefore, be no objection to Ghana regarding the boycott of goods is justified by security interests. At that time it was debated that it might be observed that a country’s security interests might be threatened by potential as well as an actual danger.
EU-Argentine Dispute:
During the Council discussion in 1982 of trade restrictions applied for non-economic reasons by the EEC, its member States, Canada and Australia against imports from Argentina, the representative of the EEC stated that “the EEC and its member States had taken certain measures on the basis of their inherent rights, of which Article XXI of the General Agreement was a reflection. The exercise of these rights constituted a general exception and required neither notification, justification nor approval. This procedure showed that every contracting party was - in the last resort - the judge of its exercise of these rights”.
The representative of Australia “stated that the Australian measures were in conformity with the provisions of Article XXI:(c), which did not require notification or justification”. 
The representative of the United States stated, “The General Agreement left to each contracting party the judgment as to what is considered to be necessary to protect its security interests. The CONTRACTING PARTIES had no power to question that judgement”.
Ministerial Declaration adopted 29 November 1982 at the Thirty-eighth Session of the CONTRACTING PARTIES provides that".. the contracting parties undertake, individually and jointly: ...to abstain from taking restrictive trade measures, for reasons of a non-economic character, not consistent with the General Agreement”.
The question of whether and to what extent the CONTRACTING PARTIES can review the national security reasons for measures taken under Article XXI were discussed again in the GATT Council in May and July 1985. 
It was concluded that this provision should be interpreted in the light of the basic principles of international law and in harmony with the decisions of the United Nations and of the International Court of Justice and should, therefore, be regarded as merely providing contracting parties subjected to aggression with the right of self-defence.
The action was taken by Arab League:
Article XXI(b)(iii) says…“taken in time of war or other emergencies in international relations” The 1970 Working Party Report on “Accession of the United Arab Republic” notes that in response to concerns raised regarding the Arab League boycott against Israel and the secondary boycott against firms having relations with Israel, the representative of the UAR stated that “the history of the Arab boycott was beyond doubt related to the extraordinary circumstances to which the Middle East area had been exposed. The state of war which had long prevailed in that area necessitated the resorting to this system. … Because of the political character of this issue, the United Arab Republic did not wish to discuss it within GATT.
It would not be reasonable to ask that the United Arab Republic should do business with a firm that transferred all or part of its profits from sales to the United Arab Republic to an enemy country”.
The Way Forward:
After careful assessment of the Article XXI and based on the previous disputes and issues raised by many countries at GATT meeting, we can conclude the following: 
1. India has not violated any commitment under GATT/WTO agreement.
2. UN Charter allows India to take necessary action in the interest of National security of India.
3. All evidences are against China and therefore China will not be able to defend its position in any forum.
4. India is free to take all possible action, which India feels in the national interest and no international law cannot force India to deal with the enemy state.

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Do send your queries to us at email address: 
Email: technolegalsardana@gmail.com
Disclaimer: This article is for general information. For any specific techno-legal discussion, you may contact the authors.

Sunday 28 June 2020

Pesticide Regulations Part-6 - Pesticide Prohibition Order & Managing Obsolete Pesticides

Pesticide Regulations Part-6

Pesticide Prohibition Order & Managing Obsolete Pesticides: 

Options before Policymakers

By:
Vijay SARDANA
Advocate, Delhi High Court
Techno-legal Expert on Agribusiness 
& Consumer Products Industries
Priyanka Sardana, Advocate, Supreme Court of India
Aastha Sardana, Researcher on Legal Matters

Government has issued draft prohibitory order for 27 pesticides. After representations from various stakeholders and case-to-case evaluation, the government may decide to declare which molecules to be declared as obsolete or may decide to phase out.
Phasing out is an essential part of the development and happens in every sector and in every country. Human life itself is a classic example of phasing out process. We all have to phase out someday and this will create space for a new and younger generation. With the development of new chemistry and better products, almost every developing country and economy in transition has stocks of obsolete pesticides. These pesticides may not have used in their current location or have become unusable for various reasons including regulatory changes.
Challenges due to Obsolete Pesticides:
By its chemical nature, even in normal practice, all pesticides are hazardous to some degree. If they are misused or overused can cause harm to human health and the environment. Obsolete pesticide stockpiles present additional hazards because they may include outdated chemicals that have been banned by regulatory actions because of their adverse toxic impact on health and environment or due to better and safe alternates or the pesticides may have deteriorated due to some reasons causing a particular danger to human beings and the environment.
Various factors may be responsible for the accumulation of obsolete pesticide stockpiles in many states or in many countries. These situation needs to be urgently addressed before these obsolete toxic products become a problem for society. Delays will aggravate current problems by incurring further deterioration of stocks, causing more harm to public health and the environment.
Dealing with Obsolete Pesticides:
Prevention of obsolete pesticide stockpiles is essential. It depends on the sensible collaborative efforts of governments, pesticide manufacturers and distributors, international organizations, non-governmental organizations (NGOs), donors and end-users themselves. No single entity can solve the problem on its own.
Appropriately dealing with Obsolete:
Pesticides is costly, technically complex and specialized assistance may be needed. Obtaining such assistance can be a complex and lengthy process.  As a country, we have experienced the challenges in clean-up operations during the Bhopal gas leak case.
In some situations, while the policymakers of the country may be seeking and awaiting this technical assistance, much can be done to prepare for the eventual cleanup operation by taking correct decisions in advance while passing the pesticide prohibitory orders.
How to manage obsolete pesticides?
Any prohibitory order must also gauge the size of the problem. It should be part of the preparatory work should. It also considers various factors to stabilize the situation so that any further environmental contamination and health hazards from prohibitory pesticides are avoided.
A country that takes appropriate action before approaching external help demonstrates a commitment to solve the problem of obsolete pesticides and preventing their recurrence.
Capability Building to Manage Obsolete Pesticides:
Besides, taking appropriate action early will reduce the costs of cleanup operations and help to build capacity in the country for the management of pesticides and hazardous waste.
Various measures should to be considered before requesting external financial and technical assistance in disposing of obsolete pesticide stocks.
Protection of Human Health:
Removing obsolete pesticide stocks will protect human health. Pesticides in their normal state are harmful to human beings in various degrees. People exposed to pesticides may suffer short-term acute health effects such as nausea, headaches, sore eyes, skin rashes and dizziness.
In some cases, exposure to pesticides may cause cancer, reduced fertility, nerve or organ damage, unconsciousness and even death. Obsolete pesticides often include outdated chemicals, which are highly toxic.
Many of these chemicals are banned in many countries because of their toxicity, yet are still found in large quantities in numerous countries. Obsolete pesticides with time also deteriorate and may sometimes generate decomposition products that are even more toxic that the pesticide itself.
Handling and storage of obsolete pesticides:
Handling and storage of obsolete pesticides have no commercial value hence often lead to careless handing and weak storage controls.
Stockpiles of obsolete pesticides differ from the normal application of pesticides in agriculture or health care, mainly because large quantities of these hazardous chemicals are located in one place. Any leakages or damage caused to the stockpile could result in serious acute local contamination.
Many obsolete pesticides are also kept in unguarded stores or out in the open where children, adults and animals can easily and frequently come into contact with highly toxic chemicals.
Stockpiles of obsolete pesticides often include leaking containers that allow the pesticides to be dispersed in the environment with the result that people living and working nearby may be exposed to these pesticides and suffer consequent health problems.
The leaked pesticides may also get into drinking-water supplies from rivers, lakes or underground aquifers. People drinking this contaminated water will suffer adverse health effects.
Similarly, food-derived from crops or livestock that have been contaminated by pesticides may be toxic for consumers.
Pesticides in the environment can have adverse effects on wildlife through direct exposure to chemicals, or through indirect exposure in feed or water. Animals may become sick or die, and there may be deleterious effects on the natural environment.
The economic impact should be evaluated:
Obsolete pesticide stockpiles are an economic burden as well as a danger to health and the environment. The money spent on buying the original pesticides – which then become obsolete – is effectively wasted, and the opportunity of buying other potentially useful goods with that money is lost.
Furthermore, the storage of obsolete pesticides incurs a cost in terms of space that cannot be used for other more productive purposes. Where the pesticides are guarded or the effort is put into maintaining the stocks, for example by transferring pesticides from leaking drums to new containers, more costs are incurred.
Replacing obsolete pesticides with new products to control pests (both chemical and non-chemical) again uses funds that could have been used for other purposes had these obsolete pesticides have still been available for use.
What authorities should do before issuing prohibitory order?
Suggestion 1: Prohibitory orders must be based on merit & logic of science and transparency to prevent unnecessary litigations.
Suggestion 2: In most developed countries and in most democracies of the world, all documents, which are related to public health and environment protection, are in the public domain. This also allows experts working with civil society and citizens to give their views on these sensitive matters. This is vital to win public trust in public policy.
Suggestion 3: Each pesticide or molecule should be evaluated based on its own merit and should not be clubbed with other molecules while doing a safety assessment. This will ensure merit-based decision-making process.
Suggestion 4: Before issuing final prohibitory order, the time required for phasing out of the existing stocks should be properly calculated. The timeline should be based on the production data available with the regulators and the policymakers. If required, the physical audit of the licensed facilities can be undertaken. This will avoid stocks of prohibited pesticides in the system.
Suggestion 5: Phasing out timeline should be based on Shelf-life of the pesticides, available current stock of the raw materials for making pesticides. This should ensure that no banned product should be manufactured once existing raw material is exhausted. This can be linked to the shelf-life of the products. Based on the times, the permission to manufacture should be revoked and after the shelf-life is over, permission to sell should be revoked. This will address the problem of the obsolete pesticide in society.
The government must plan for safer and better products under Atmnirbahr Bharat. 
Transition to newer and better chemistry is the need of the society under 'Atmnirbhar Bharat'. Like any other citizen of the developed world, Indian farmers and consumers deserve better and safer options. Use of obsolete chemicals is also also hurting Indian agriculture exports.


New Pesticide Management Bill'2020 is an opportunity, let it address this issue to avoid any controversy in future.

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Do send your queries to us at email address: 
Email: technolegalsardana@gmail.com
Disclaimer: This article is for general information. For any specific techno-legal discussion, you may contact the authors.

Differences between Law and Act

  Differences between Law and Act By: Adv. Vijay Sardana Law  Act The law is an outcome of the Act. A law is defined as an assemblage or col...