File No. 229

House of Representatives, March 27, 2013

The Committee on Children reported through REP. URBAN of the 43rd Dist., Chairperson of the Committee on the part of the House, that the substitute bill ought to pass.

AN ACT CONCERNING GENETICALLY ENGINEERED BABY FOOD.

Be it enacted by the Senate and House of Representatives in General Assembly convened:

Section 1. Section 21a-92 of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2013):

For the purposes of this chapter, [and] section 21a-65 and sections 2 and 3 of this act, the following terms shall have the meanings hereinafter specified:

(1) "Advertisement" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of food, drugs, devices or cosmetics;

(2) (A) "Color additive" means a material which (i) is a dye, pigment or other substance made by a process of synthesis or similar artifice, or extracted, isolated or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral or other source, and (ii) when added or applied to a food, drug or cosmetic, or to the human body or any of its parts, is capable, alone or through reaction with other substance, of imparting color thereto, except that the term "color additive" does not include any material exempted by regulation under the federal act, or which the commissioner, by regulation, determines is used, or intended to be used, solely for a purpose or purposes other than coloring; (B) the term "color" includes black, white and intermediate grays, as well as all other colors; (C) nothing in subparagraph (A) of this subdivision shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical used, or intended to be used, solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil which thereby affects its color, whether before or after harvest;

(3) "Commissioner" means the Commissioner of Consumer Protection;

(4) "Contaminated with filth" applies to any food, drug, device or cosmetic not securely protected from dust or dirt, and as far as may be necessary, by all reasonable means, from all foreign or injurious contaminations;

(5) "Cosmetic" means (A) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any of its parts for cleansing, beautifying, promoting attractiveness or altering the appearance; and (B) articles intended for use as a component of any such articles; except that such term shall not include soap;

(6) "Device", except when used in subdivision [(15)] (17) of this section and in subsection (i) of section 21a-93, subsection (f) of section 21a-102, subsection (c) of section 21a-106 and subsection (c) of section 21a-112, means instruments, apparatus and contrivances, including their components, parts and accessories, intended (A) for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; or (B) to affect the structure or any function of the body of man or other animals;

(7) "Director" means the director of the agricultural experiment station;

(8) "Drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them; (B) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (C) articles, other than food, intended to affect the structure or any function of the body of man or any other animal; and (D) articles intended for use as a component of any articles specified in this subdivision; but shall not include devices or their components, parts or accessories;

(9) "Federal act" means the federal Food, Drug and Cosmetic Act, as amended, Title 21 USC 301 et seq.: 52 Stat. 1040 et seq.;

(10) "Food" means (A) articles used for food or drink for man or other animals, and (B) chewing gum, and (C) articles used for components of any such article;

(11) "Food additive" means any substance the intended use of which results or reasonably may be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food; and including any source of radiation intended for any such use, if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food, to be safe under the conditions of its intended use; except that such term does not include (A) a pesticide chemical in or on a raw agricultural commodity; or (B) a pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity; or (C) a color additive; or (D) any substance used in accordance with a sanction or approval granted prior to June 12, 1963, or the federal Food, Drug and Cosmetic Act, the Poultry Products Inspection Act (21 USC 451 et seq.) or the Meat Inspection Act of March 4, 1907, as amended;

(12) "Genetically engineered" or "genetic engineering" means the production of food from or with an organism or organisms with materially altered genetics through the application of: (A) In vitro nucleic acid techniques, including recombinant ribonucleic acid (RNA) techniques, recombinant deoxyribonucleic acid (DNA) techniques and the direct injection of nucleic acid into cells or organelles; or (B) fusion of cells, including protoplast fusion, or hybridization techniques that overcome natural physiological, reproductive or recombination barriers, where the donor DNA, RNA, cells or protoplasts do not fall within the same taxonomic family, in a way that does not occur by natural multiplication or natural recombination. A food shall otherwise be considered to be genetically engineered if the organisms from which the food is derived have been injected or otherwise treated with a genetically engineered material, except that the use of manure as a fertilizer for raw agricultural commodities may not be construed to mean that such commodities are produced with a genetically engineered material, or the food contains an ingredient, component or other article that is genetically engineered;

[(12)] (13) "Immediate container" shall not include package liners;

(14) "In vitro nucleic acid techniques" means techniques, including, but not limited to, recombinant deoxyribonucleis acid techniques, that use vector systems and techniques involving the direct introduction into organisms of hereditary materials prepared outside the organisms such as microinjection, macroinjection, chemoporation, electroporation, microencapsulation and liposome fusion;

[(13)] (15) "Intrastate commerce" means any and all commerce within the state of Connecticut and subject to its jurisdiction, and shall include the operation of any business or service establishment;

[(14)] (16) "Label" means a display of written, printed or graphic matter upon the immediate container of any article, provided a requirement made by or under authority of this chapter that any information or other word or statement appear on the label shall not be considered to be complied with unless such information or other word or statement also appears on the outside container or wrapper, if any, of the retail package of such article, or is easily legible through the outside container or wrapper;

[(15)] (17) "Labeling" means all labels and other written, printed or graphic matter (A) upon any article or any of its containers or wrappers, or (B) accompanying such article; provided, if an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then, in determining whether the labeling or advertisement is misleading, there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device or sound, or any combination thereof, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual, and provided the representation of a drug, in its labeling or advertisement, as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment or dusting powder or for such other use as involves prolonged contact with the body;

[(16)] (18) "Natural food" means food (A) which has not been treated with preservatives, antibiotics, synthetic additives, artificial flavoring or artificial coloring; [and] (B) which has not been processed in a manner that makes such food significantly less nutritive, [. Processing] provided processing of food by extracting, purifying, heating, fermenting, concentrating, dehydrating, cooling or freezing shall not, of itself, prevent the designation of such food as "natural food"; and (C) which has not been grown, raised, manufactured, cultured or created in any way through the process of genetic engineering;

[(17)] (19) "New drug" means (A) any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling; or (B) any drug the composition of which is such that such drug, as a result of investigation to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions, except that the provisions of this subsection pertaining to "effectiveness" shall not apply to any drug which (i) was commercially sold or used in the United States on October 9, 1962, (ii) was not a new drug as defined by this subsection prior to the enactment of these provisions, and (iii) was not covered by an effective application under section 21a-110 or under Section 355 of the federal act, when such drug is intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on whichever of the above dates is applicable;

[(18)] (20) "Official compendium" means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them;

[(19)] (21) "Organically grown" means (A) produced through organic farming methods, which involve a system of ecological soil management and mechanical or biological methods to control insects, weeds, pathogens and other pests and which rely on crop rotation, crop residues, composted animal manures, legumes, green manures, composted organic waste or mineral-bearing rocks; and (B) not grown, raised, manufactured, cultured or created in any way through the process of genetic engineering;

(22) "Organism" means any biological entity capable of replication, reproduction or transferring of genetic material;

[(20)] (23) "Person" includes any individual, partnership, corporation, limited liability company or association;

[(21)] (24) "Pesticide chemical" means any substance which, alone, in chemical combination or in formulation with one or more other substances is an "economic poison" within the meaning of the federal Insecticide, Fungicide and Rodenticide Act, 7 USC 135-135k, and which is used in the production, storage or transportation of raw agricultural commodities;

[(22)] (25) "Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled natural form prior to marketing;

[(23)] (26) The term "safe" has reference to the health of man or animal;

[(24)] (27) "Sale" means any and every sale and includes (A) manufacture, processing, packing, canning, bottling or any other production, preparation or putting up; (B) exposure, offer or any other proffer; (C) holding, storing or any other possessing; (D) dispensing, giving, delivering, serving or any other supplying; and (E) applying, administering or any other using.

Sec. 2. (NEW) (Effective October 1, 2013) (a) For the purposes of this section, (1) "infant formula" means a milk-based or soy-based powder, concentrated liquid or ready-to-feed substitute for human breast milk that is intended for infant consumption and is commercially available, and (2) "baby food" means a prepared solid food consisting of a soft paste or an easily chewed food that is intended for consumption by children two years of age or younger and is commercially available.

(b) Except as provided in subsection (c) of this section, on and after July 1, 2015, no person shall manufacture, sell, offer for sale or distribute in this state any infant formula or baby food containing any genetically engineered materials unless such infant formula or baby food includes labeling stating "produced with genetic engineering" pursuant to section 3 of this act.

(c) A person may sell or distribute his or her existing inventory of infant formula or baby food containing genetically engineered materials as of October 1, 2013, until July 1, 2016, provided such person can demonstrate that such infant formula or baby food was purchased or acquired prior to October 1, 2013, in a quantity comparable to the infant formula or baby food purchased or acquired during the same period of the prior year.

(d) The provisions of this section may be enforced, within available appropriations, by the Commissioner of Consumer Protection.

(e) Any person found to knowingly violate this section shall be liable for a civil penalty not to exceed one thousand dollars per day, per product. Calculation of such civil penalty shall not be made or multiplied by the number of individual packages of the same product displayed or offered for retail sale. Civil penalties assessed under this section shall accrue and be assessed per each uniquely named, designated or marketed product.

Sec. 3. (NEW) (Effective October 1, 2013) (a) On and after July 1, 2015, any infant formula or baby food that is partially or entirely produced with genetic engineering and is offered or intended for retail sale in the state shall include labeling that states in a clear and conspicuous manner, "produced with genetic engineering". Such labeling shall be displayed in the same size and font as the ingredients in the nutritional facts panel on the food label.

(b) Infant formula or baby food that is produced partially or entirely with genetically engineered materials that does not display "produced with genetic engineering" in a clear and conspicuous manner on its labeling according to subsection (a) of this section shall be deemed misbranded pursuant to section 21a-102 of the general statutes, except that (1) such infant formula or baby food shall not be considered misbranded if it is produced by a person who (A) was without knowledge that such infant formula or baby food was created with materials that were partially or entirely produced with genetic engineering, and (B) obtains a sworn statement from the party that sold such materials to such person that such materials have not been knowingly genetically engineered and have not been knowingly commingled with any genetically engineered materials; and (2) on and before July 1, 2019, such infant formula or baby food shall not be considered misbranded if it is subject to the labeling requirement of subsection (a) of this section solely because it includes one or more materials produced with genetic engineering that in the aggregate account for nine-tenths of one per cent or less of the total weight of the infant formula or baby food.

(c) The Department of Consumer Protection, in consultation with the Departments of Agriculture, Energy and Environmental Protection and Public Health, shall adopt regulations, in accordance with chapter 54 of the general statutes, necessary for the implementation and enforcement of sections 2 to 4, inclusive, of this act.

Sec. 4. (NEW) (Effective October 1, 2013) A distributor or retailer that sells or advertises a product that fails to conform to the labeling requirements in section 3 of this act shall not be found liable or negligent in any civil proceeding brought to enforce the provisions of section 3 of this act.

Statement of Legislative Commissioners:

In section 1(12), "any food that is produced from" was changed to "the production of food" for clarity and in section 1(14), "mean" was changed to "means" and "the organisms" was changed to "organisms" for clarity and consistency.

The following Fiscal Impact Statement and Bill Analysis are prepared for the benefit of the members of the General Assembly, solely for purposes of information, summarization and explanation and do not represent the intent of the General Assembly or either chamber thereof for any purpose. In general, fiscal impacts are based upon a variety of informational sources, including the analyst's professional knowledge. Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.


OFA Fiscal Note

State Impact:

Municipal Impact: None

Explanation

The bill results in a cost to the Department of Consumer Protection (DCP) of $117,632 beginning in FY 16 by requiring infant formula or baby food that is partially or entirely produced with genetic engineering meet certain requirements for resale beginning July 1, 2015. The DCP will require a Consumer Protection Food Inspector and a part-time paralegal to respond to complaints and issues related to genetically engineered products. Costs include salaries ($80,000), other expenses including computers, software, travel and miscellaneous costs ($10,000) and fringe benefits ($27,632). The additional staff will need to examine the chain of production of suspect products in order to determine if such products meet the requirements of the bill.

The Out Years

The annualized ongoing fiscal impact identified above would continue into the future subject to inflation.

OLR Bill Analysis

HB 6527

AN ACT CONCERNING GENETICALLY ENGINEERED BABY FOOD.

SUMMARY:

This bill, starting July 1, 2015:

1. requires infant formula or baby partially or entirely produced with genetic engineering offered or intended for retail sale in Connecticut to be clearly and conspicuously labeled as “produced with genetic engineering ” and

2. prohibits anyone from manufacturing, selling, offering for sale, or distributing in Connecticut any infant formula or baby food containing genetically engineered material unless it is labeled as “produced with genetic engineering.”

The bill requires the Department of Consumer Protection (DCP) commissioner to adopt regulations to implement and enforce the bill's provisions. Products violating the labeling requirements are considered misbranded and, with exceptions, subject to seizure. Those making or selling products in violation of the bill are subject to a civil penalty, with an exception for existing inventory.

The bill also changes the definitions of natural and organically grown food to include genetically modified foods, thus changing (1) when anyone can advertise, distribute, or sell food as natural or organically grown and (2) what foods can be certified as organically grown.

EFFECTIVE DATE: October 1, 2013

MISBRANDED INFANT FORMULA OR BABY FOOD

Starting July 1, 2015, any infant formula or baby food that is partially or entirely produced with genetic engineering offered or intended for retail sale in Connecticut will be considered misbranded if it does not include labeling that clearly and conspicuously states “produced with genetic engineering.” The labeling must be displayed in the same size and font as the ingredients in the nutrition facts panel on the food label.

Exceptions

The formula or baby food will not be considered misbranded if the producer (1) did not know that the formula or baby food was created with material that was partially or entirely produced with genetic engineering and (2) gets a sworn statement from the material seller stating that the material has not been knowingly genetically engineered or commingled with any genetically engineered material.

Before July 1, 2019, formula or baby food will not be considered misbranded if it is subject to the labeling requirement only because it includes one or more material produced with genetic engineering that make up .9% or less of its total weight.

Penalties

By deeming food that violates the bill's labeling requirements to be misbranded, the bill allows DCP to place an embargo and, in some circumstances, seize the food (CGS § 21a-96). A person who misbrands food or sells or receives it in Connecticut may be subject to criminal penalties (CGS § 21a-95)(see BACKGROUND).

MANUFACTURE, SALE, OR DISTRIBUTION OF MISLABELED FORMULA OR BABY FOOD

Beginning July 1, 2015, the bill prohibits anyone from manufacturing, selling, offering for sale, or distributing in Connecticut any infant formula or baby food containing genetically engineered material unless it includes labeling stating “produced with genetic engineering.”

A person who knowingly violates this provision is liable for a civil penalty of up to $1,000 per day, per product. The fine must (1) accrue and be assessed for each uniquely named, designated, or marketed product and (2) not be made or multiplied by the number of individual packages of the same product displayed or offered for retail sale.

A person may sell or distribute his or her existing inventory (as of October 1, 2013) of infant formula or baby food containing genetically engineered material until July 1, 2016 if he or she can demonstrate that it was purchased before October 1, 2013 in an amount comparable to that purchased during the same period of the prior year.

The bill authorizes the DCP commissioner to enforce this labeling requirement within available appropriations.

Regulations

The bill requires DCP, in consultation with the departments of Agriculture, Energy and Environmental Protection, and Public Health, to adopt necessary implementing regulations.

DISTRIBUTORS AND RETAILERS

Under the bill, distributors or retailers that sell or advertise misbranded infant formula or baby food cannot be found liable or negligent in a civil proceeding brought to enforce the product labeling requirement. But they can be subject to a (1) civil penalty for distributing or selling the product in violation of the bill and (2) criminal penalty for selling misbranded food (see BACKGROUND).

NATURAL FOOD AND ORGANICALLY GROWN

By law:

1. “natural food” means food that has not been treated with preservatives, antibiotics, synthetic additives, or artificial flavoring or coloring and processed in a way that makes it significantly less nutritive and

2. “organically grown” means produced through organic farming methods, which (a) involve a system of ecological soil management and mechanical or biological methods to control insects, weeds, pathogens, and other pests and (b) rely on crop rotation, crop residues, composted animal manure, legumes, green manure, composted organic waste or mineral-bearing rocks (CGS § 21a-92).

Under the bill, food cannot be defined as “natural” or “organically grown” if it was grown, raised, manufactured, cultured, or created in any way through genetic engineering. Thus, the bill changes (1) when anyone can advertise, distribute, or sell food as natural or organically grown and (2) what foods can be certified as organically grown. Foods advertised, distributed, or sold as natural or organically grown that do not conform to the revised definitions will be considered misbranded (see BACKGROUND).

DEFINITIONS

Genetically Engineered or Genetic Engineering

Under the bill, “genetically engineered” or “genetic engineering” means the production of food from or with an organism or organisms with materially altered genetics by (1) using in vitro nucleic acid techniques, including recombinant RNA and DNA techniques and direct injection of nucleic acid into cells or organelles or (2) fusing cells that are not in the same taxonomic family, in a way that does not occur by natural multiplication or recombination.

A food is considered to be genetically engineered if its derivative organisms have been injected or otherwise treated with a genetically engineered material. Raw agricultural commodities fertilized with manure are not considered to (1) be genetically engineered or (2) contain a genetically engineered ingredient, component, or article.

In Vitro Nucleic Acid Techniques

The bill defines "in vitro nucleic acid techniques" as techniques, including recombinant DNA techniques, that use vector systems and techniques involving the direct introduction into organisms of hereditary material prepared outside the organisms such as microinjection, macroinjection, chemoporation, electroporation, microencapsulation, and liposome fusion.

Organism

The bill defines “organism” as any biological entity able to replicate, reproduce, or transfer genetic material.

Infant Formula

The bill defines “infant formula” as a milk-based or soy-based powder, concentrated liquid or ready-to-feed substitute for human breast milk that is commercially available and intended for infant consumption.

Baby Food

The bill defines “baby food” as a prepared solid food consisting of a soft paste or easily chewed food commercially available and intended for consumption by children age two or younger.

BACKGROUND

Misbranding Criminal Penalties

The law prohibits misbranding food or selling or receiving misbranded food in Connecticut (CGS § 21a-93). Violation of this law is punishable by up to six months in prison, a fine of up to $500, or both. If done with the intent to defraud or mislead, the violation is punishable by up to one year in prison, a fine of up to $1,000, or both (CGS § 21a-95).

A person cannot be criminally penalized for selling or receiving misbranded food within the state if he or she obtains a document signed by the person from whom he or she received the food in good faith, stating that the food is not adulterated or misbranded in violation of this law (CGS § 21a-95).

DCP Embargo and Seizure of Misbranded Food

The law authorizes the DCP commissioner to embargo food that he has probable cause to believe is misbranded. Once the commissioner embargoes an item, he has 21 days to either begin summary proceedings to confiscate it or to remove the embargo.

Once the commissioner files a complaint in Superior Court, the law requires the court to issue a warrant to seize the described article and summon the person named in the complaint. The law requires the court to hold a hearing within five to 15 days from the date of the warrant. The court must order the food confiscated if it appears that it was offered for sale in violation of the law. If the food is not injurious to health and could be brought into compliance with the law if it is repackaged or relabeled, the court may order it delivered to its owner upon payment of court costs and provision of a bond to DCP assuring that the product will be brought into compliance (CGS § 21a-96).

Federal Labeling Requirements

Generally, the federal Food, Drugs and Cosmetics Act prohibits states from requiring that food transported between states be labeled in a manner inconsistent with federal labeling requirements. However, a state may file a petition requesting exemption from the prohibition if the state labeling:

1. would not cause any food to be in violation of any applicable federal law,

2. would not unduly burden interstate commerce, and

3. is designed to address a particular need for information that is not met by federal labeling requirements (21 USC § 343-1).

Related Case

The constitutionality of state laws requiring specific food labeling has been raised in federal courts, including our own U.S. Second Circuit Court of Appeals.

In a case involving a Vermont law requiring dairy manufacturers to label milk and milk products derived from or that may have been derived from cows treated with recombinant bovine somatrotropin (a synthetic hormone used to increase milk production), the Second Circuit ruled the law was likely unconstitutional on First Amendment grounds. The district court had denied the dairy manufacturers' request for an injunction to prevent the law's enforcement by ruling that the manufacturers had not shown a likelihood of success under the First Amendment or Commerce Clause of the U. S. Constitution. But the Second Circuit concluded that Vermont's asserted state interest of a public “right to know” and strong consumer interest was inadequate to compel the commercial speech (i.e., the labeling requirement). Because the Second Circuit ruled on First Amendment grounds, it did not reach the Commerce Clause claims (International Dairy Foods Association v. Amestoy, 92 F. 3d 67 (2d Cir. 1996)).

The Commerce Clause of the U. S. Constitution gives Congress the power “to regulate commerce with foreign nations, and among the several states” (U.S. Const. Art. I, § 8). A law that facially discriminates against interstate commerce violates the Constitution unless there is no other means to advance a legitimate local interest. If a law is facially nondiscriminatory, supports a legitimate state interest, and only incidentally burdens interstate commerce, it is constitutional unless the burden is excessive in relation to local benefits.

COMMITTEE ACTION

Children Committee

Joint Favorable

¹ The fringe benefit costs for most state employees are budgeted centrally in accounts administered by the Comptroller. The estimated active employee fringe benefit cost associated with most personnel changes is 34.54% of payroll in FY 14 and FY 15.

² In addition, normal annual pension costs (currently estimated at 7.5% of payroll) attributable to the identified personnel changes will be recognized in the state's annual required pension contribution in future actuarial valuations.