1Amending Title 3 (Agriculture) of the Pennsylvania Consolidated
2Statutes, providing for labeling of genetically engineered
3food.

4The General Assembly of the Commonwealth of Pennsylvania
5hereby enacts as follows:

6Section 1. Title 3 of the Pennsylvania Consolidated Statutes
7is amended by adding a chapter to read:

8CHAPTER 58

9LABELING OF GENETICALLY ENGINEERED FOOD

10Sec.

115801. Scope of chapter.

125802. Definitions.

135803. Labeling.

145804. Mislabeling.

155805. Regulations.

165806. Penalties.

17§ 5801. Scope of chapter.

1This chapter relates to the labeling of genetically
2engineered food.

3§ 5802. Definitions.

4The following words and phrases when used in this chapter
5shall have the meanings given to them in this section unless the
6context clearly indicates otherwise:

7"Advertisement." All representations, other than labeling,
8disseminated in any manner or by any means for the purpose of
9inducing or which are likely to induce, directly or indirectly,
10the purchase of food, drugs, devices or cosmetics.

11"Color additive."

12(1) A material with or without intermediate or final
13change of identity, from a vegetable, animal, mineral or
14other source, both which:

15(i) Is a dye, pigment or other substance made by:

16(A) a process of synthesis or similar artifice;
17or

18(B) extracted, isolated or otherwise derived;
19and

20(ii) When added or applied to a food, drug, cosmetic
21or to the human body or a part of the human body is
22capable, alone or through reaction with other substance,
23of imparting color thereto.

24(2) The term does not include material exempted by
25regulation under the Federal Food, Drug, and Cosmetic Act or
26material which the department determines is used, or intended
27to be used, solely for a purpose or purposes other than
28coloring.

29(3) The term includes black, white and intermediate
30grays, as well as all other colors.

1(4) Nothing in this definition shall be construed to
2apply to any pesticide chemical, soil or plant nutrient or
3other agricultural chemical used or intended to be used
4solely because of its effect in aiding, retarding or
5otherwise directly or indirectly affecting the growth or
6other natural physiological processes of produce of the soil
7which thereby affects its color, whether before or after
8harvest.

9"Cosmetic."

10(1) Articles intended to be rubbed, poured, sprinkled or
11sprayed on, introduced into or otherwise applied to the human
12body or a part of the human body for cleansing, beautifying,
13promoting attractiveness or altering the appearance.

14(2) The term shall also include all articles intended
15for use as a component of any articles.

16(3) The term does not include soap.

17"Device." Except when used in the definition of drug in this
18section, the term includes instruments, apparatuses and
19contrivances, including their components, parts and accessories,
20intended for use in the diagnosis, cure, mitigation, treatment
21or prevention of disease in humans or other animals or to affect
22the structure or a function of the body of humans or other
23animals.

24"Distributor." A person that sells, supplies, furnishes or
25transports food in this Commonwealth that the person does not
26produce.

27"Drug."

28(1) The term includes the following:

29(i) An official compendium.

30(ii) Articles intended for use in the diagnosis,

1cure, mitigation, treatment or prevention of disease in
2humans or other animals.

3(iii) Articles, other than food, intended to affect
4the structure or a function of the body of a human or any
5other animal.

6(iv) Articles intended for use as a component of any
7articles specified in this paragraph.

8(2) The term does not include devices or their
9components, parts or accessories.

10"Enzyme." A protein that catalyzes chemical reactions of
11other substances without being destroyed or altered upon
12completion of such reactions.

13"Federal Food, Drug, and Cosmetic Act." The Federal Food,
14Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 301 et seq.).

15"Food." Articles used for food or drink for humans or other
16animals, chewing gum and articles used for components of food,
17drink or chewing gum.

18"Genetically engineered" or "genetic engineering."

19(1) A process whereby food intended for human
20consumption is produced from an organism or organisms in
21which the genetics are materially altered through the
22application of at least one of the following:

23(i) In vitro nucleic acid techniques, including
24recombinant DNA (deoxyribonucleic acid) techniques.

25(ii) The direct injection of nucleic acid into cells
26or organelles.

27(iii) Encapsulation.

28(iv) Gene deletion and doubling.

29(v) Methods of fusing cells that do not fall within
30the same taxonomic family, that overcome natural

1physiological reproductive or recombinant barriers and
2that are not techniques used in traditional breeding and
3selection such as conjugation, transduction and
4hybridization.

5(2) The term includes food which is treated with a
6material described in this definition, except manure that is
7used as a fertilizer for a raw agricultural commodity or
8contains an ingredient, component or substance described in
9this definition.

10"Label." A display of written, printed or graphic matter
11upon the immediate container of an article. The term immediate
12container as used in this definition does not include package
13liners.

14"Labeling." All labels and other written, printed or graphic
15matter on an article or its containers, wrappers or other
16material accompanying the article.

17"Manufacturer." A person who produces seed, seed stock or
18food and sells the item to a retailer or distributor.

19"Natural food."

20(1) Food which has not been:

21(i) Treated with preservatives, antibiotics,
22synthetic additives, artificial flavoring or artificial
23coloring.

24(ii) Processed in a manner that makes such food
25significantly less nutritive.

26(iii) Genetically engineered.

27(2) The term does not automatically exclude the
28processing of food by extracting, purifying, heating,
29fermenting, concentrating, dehydrating, cooling or freezing.

30"New drug."

1(1) A drug not generally recognized among experts 
2qualified by scientific training and experience to evaluate 
3the safety and effectiveness of drugs, as safe and effective 
4for use under the conditions prescribed, recommended or 
5suggested in its labeling.

6(2) The term also includes any drug which, as a result
7of investigation to determine its safety and effectiveness
8for use under such conditions, has become so recognized, but
9which has not, other than in investigations, been used to a
10material extent or for a material time under those
11conditions.

12(3) A drug's effectiveness shall not be considered with
13regard to the following:

14(i) either:

15(A) a drug which was commercially sold or used
16in the United States on or before October 9, 1962; or

17(B) was not a new drug prior to the enactment of
18this chapter; and

19(ii) was not covered by an effective application
20under section 355 of the Federal Food, Drug, and Cosmetic
21Act, when the drug is intended solely for use under
22conditions prescribed, recommended or suggested in
23labeling with respect to the drug on whichever of the
24dates under this paragraph is applicable.

25"Official compendium." The official United States
26Pharmacopoeia, official Homeopathic Pharmacopoeia of the United
27States, official National Formulary or a supplement to any of
28them.

29"Organism." A biological entity capable of replication,
30reproduction or transferring genetic material.

1"Pesticide chemical." A substance which alone, in chemical 
2combination or in formulation with one or more other substances 
3is an "economic poison" within the meaning of the Federal 
4Insecticide, Fungicide, and Rodenticide Act (61 Stat.

5163, 7 U.S.C. § 136 et seq.), and which is used in the
6production, storage or transportation of raw agricultural
7commodities.

8"Processed food." A food other than a raw agricultural
9commodity. The term includes a food produced from a raw
10agricultural commodity that has been processed through canning,
11smoking, pressing, cooking, freezing, dehydration, fermentation
12or milling.

13"Processing aid." The term includes any of the following:

14(1) A substance that is added to a food during the
15processing of the food, but that is removed in some manner
16from the food before the food is packaged in a finished form.

17(2) A substance that is added to a food during
18processing, that is converted into constituents normally
19present in the food and that does not significantly increase
20the amount of the constituents naturally found in the food.

21(3) A substance that is added to a food for its
22technical or functional effect in the processing, but that is
23present in the finished food at insignificant levels and that
24does not have any technical or functional effect in the
25finished food.

26"Raw agricultural commodity." A food in its raw or natural
27state, including all fruits that are washed, colored or
28otherwise treated in their unpeeled natural form prior to
29marketing.

30"Retailer." A person or entity that engages in the sale of

1food to a consumer.

2"Secretary." Includes an authorized representative, employee
3or agent of the Department of Agriculture.

4§ 5803. Labeling.

5(a) General rule.--On and after October 1, 2014, any food,
6seed or seed stock offered or intended for retail sale in this
7Commonwealth that is or may have been entirely or partially
8genetically engineered, shall be labeled as follows:

9(1) In the case of food for retail sale contained in a
10package, by the manufacturer, distributor or retailer of the
11food, with the clear and conspicuous words "Produced with
12Genetic Engineering."

13(2) In the case of food that is a raw agricultural
14commodity, on the package offered for retail sale or, in the
15case of any such commodity that is not separately packaged or
16labeled, on the retail store shelf or bin that holds the
17commodity displayed for sale, by the retailer, with the clear
18and conspicuous words "Produced with Genetic Engineering."

19(3) In the case of any seed or seed stock, on the
20container holding the seed or seed stock displayed for sale,
21the sales receipt or any label identifying ownership or
22possession of the commodity, by the manufacturer or
23distributor, with the clear and conspicuous words "Produced
24with Genetic Engineering."

25(b) Placement.--The information, other words or statements
26indicating that the food was produced with genetic engineering
27shall appear on the outside container or wrapper, if any, of the
28retail package of the article or shall be easily legible through
29the outside container or wrapper.

30(c) Exception.--This section does not apply to a processed

1food in which one or more processing aids or enzymes were
2produced or derived from genetic engineering.

3§ 5804. Mislabeling.

4(a) General rule.--A food shall be deemed to be mislabeled
5if the food which is subject to this chapter has labeling that
6is false or misleading in any of the following ways:

7(1) A statement on the label or labeling either directly
8or indirectly implying that the product is recommended or
9endorsed by an agency of the Federal or State government
10shall be considered misleading, unless the agency concerned
11has approved the statement prior to its use.

12(2) If a food is offered for sale under the name of
13another food.

14(3) If a food is an imitation of another food, unless
15its label bears, in type of uniform size and prominence, the
16word "imitation" and, immediately thereafter, the name of the
17food imitated.

18(4) If a food's container is so made, formed or filled
19as to be misleading.

20(5) If in package form, unless it bears a label
21containing the name and place of business of the
22manufacturer, packer or distributor and an accurate statement
23of the quantity of the contents in terms of weight, measure
24or numerical count. Reasonable variations shall be permitted,
25and exemptions as to small packages shall be established by
26regulations promulgated by the department.

27(6) If information, other words or statements required
28by or under authority of this chapter to appear on the label
29or labeling is not prominently placed on the labeling with
30the conspicuousness, as compared with other words,

1statements, designs or devices, in the labeling, and in
2terms, as to render it likely to be read and understood by
3the ordinary individual under customary conditions of
4purchase and use.

5(7) If it purports to be or simulates or is represented
6as a food for which a definition and standard of identity has
7been prescribed by regulations by the department, it conforms
8to the definition and standard, and its label fails to bear
9the name of the food specified in the definition and
10standard, and, so far as may be required by regulations, the
11common names of optional ingredients, other than spices,
12flavoring and coloring, present in the food.

13(8) If it purports to be or is represented as any of the
14following:

15(i) A food for which a standard of quality has been
16prescribed by regulation and its quality falls below that
17standard, unless its label bears a statement that it
18falls below the standard.

19(ii) A food for which a standard of fill of
20container have been prescribed by regulation and it falls
21below the standard of fill of container, unless its label
22bears a statement that it falls below the standard.

23(iii) A food for which no definition and standard of
24identity and no standard of quality has been prescribed
25by regulations and it falls below the standard of purity,
26quality or strength which it purports or is represented
27to possess.

28(9) If it purports to be or is represented to be for
29special dietary uses, unless its label bears the information
30concerning its vitamin, mineral and other dietary properties

1as is necessary in order to fully inform purchasers as to its
2value.

3(10) If it bears or contains artificial flavoring,
4artificial coloring, artificial sweetening or chemical
5preservative, unless it bears labeling stating that fact. To
6the extent that compliance with the requirements of this
7paragraph is impracticable, exemptions shall be established
8by regulations promulgated by the department.

9(11) If it is genetically engineered and does not bear
10labeling as required in accordance with this chapter, unless
11it is a food produced without the producer's knowledge that a
12seed or other component of the food was genetically
13engineered on or before July 1, 2019, it is a processed food
14solely because it contains one or more materials that are
15genetically engineered if the genetically engineered
16materials do not, in the aggregate, account for more than
170.9% of the total weight of the processed food.

18(b) Exceptions.--If it is not subject to this chapter,
19unless its label bears the common or usual name of the food and,
20if it is fabricated from two or more ingredients, the common or
21usual name of each ingredient. Spices, flavorings and colorings,
22other than those sold as such, may be designated as spices,
23flavorings and colorings without naming each to the extent that
24compliance with the requirements of this chapter is
25impracticable or results in deception or unfair competition.
26Exemptions shall be established by regulations promulgated by
27the department.

28(c) Investigation.--If an article that is regulated by this
29chapter is alleged to be misbranded because the labeling is
30misleading or if an article's advertisement is alleged to be

1false because it is misleading, the department shall conduct an
2investigation. In determining whether the labeling or
3advertisement is misleading, the department shall take into
4account at least the following:

5(1) The representations made or suggested by statement,
6word, design, device or sound or any combination thereof.

7(2) The extent to which the labeling or advertisement
8fails to reveal material facts in light of the
9representations or material facts with respect to
10consequences which may result from the use of the article to
11which the labeling or advertisement relates under the
12conditions of use prescribed in the labeling or advertisement
13thereof or under conditions of use as are customary or usual.

14(3) If the article is a drug, its labeling or
15advertisement as an antiseptic shall be considered to be a
16representation that it is a germicide, except in the case of
17a drug purporting to be or represented as an antiseptic for
18inhibitory use as a wet dressing, ointment or dusting powder
19or for other use that involves prolonged contact with the
20body.

21§ 5805. Regulations.

22Notwithstanding other provisions of law, the department may
23promulgate regulations to carry out this chapter.

24§ 5806. Penalties.

25(a) Criminal penalties.--A person who violates a provision
26of this chapter or a rule, regulation, standard or order made
27under this chapter commits a summary offense for the first or
28second offense. A person who violates this chapter or a rule,
29regulation, standard or order made under this chapter commits a
30misdemeanor of the third degree if the violation is a third or

1subsequent offense and if the violation occurs within two years
2of the date of the last previous offense.

3(b) Civil penalties.--In addition to proceeding under any
4other remedy available at law or in equity for a violation of
5this chapter, or a rule or regulation adopted or any order
6issued under this chapter, the secretary may assess a civil
7penalty not to exceed $10,000 upon an individual or business for
8each offense. No civil penalty shall be assessed unless the
9person charged has been given notice and opportunity for a
10hearing in accordance with law. In determining the amount of the
11penalty, the secretary shall consider the gravity of the
12violation. Whenever the secretary finds a violation which did
13not cause harm to human health, the secretary may issue a
14warning in lieu of assessing a penalty. In case of inability to
15collect the civil penalty or failure of any person to pay all or
16any portion of the penalty as the secretary may determine, the
17secretary may refer the matter to the Attorney General, who
18shall recover the amount by action in the appropriate court.

19(c) Guaranty.--

20(1) No prosecution shall be sustained under the
21provisions of this chapter for the manufacture, delivery,
22consignment, bailment, holding or sale of or offering for
23sale, exposing for sale or having in possession with intent
24to sell a mislabeled or misbranded article against a person
25from whom the article of food, sample or portion was obtained
26by the department if the person can establish a guaranty to
27the effect that the article of food is not mislabeled or
28misbranded within the meaning of this chapter, was mislabeled
29or misbranded prior to coming into the possession of the
30person and the person did not know or have reason to know of

1the mislabeling or misbranding or was mislabeled or
2misbranded after it left the possession and control of the
3person. The guaranty must be signed by the supplier,
4manufacturer, wholesale dealer, jobber or distributor from
5whom the articles of food were purchased or procured.

6(2) The guaranty to afford protection shall contain the
7name and address of the supplier, manufacturer, wholesale
8dealer, jobber or distributor making the sale of the article
9of food to the person holding the guaranty. A supplier,
10manufacturer, wholesale dealer, jobber or distributor giving
11a guaranty under the provisions of this chapter may be held
12responsible and may be proceeded against for the mislabeling
13or misbranding of any article of food sold under the guaranty
14and shall be subject to the penalties provided for violation
15of this chapter. A guaranty shall not operate as a defense to
16prosecution for a violation of the provisions of this chapter
17if the person holding the guaranty continues to sell the same
18food after written or printed notice from the secretary that
19the article is mislabeled or misbranded within the meaning of
20this chapter. However, if the person violated the provisions
21of this chapter by having stored, transported, exposed or
22kept the article in a way or manner to render it diseased,
23contaminated or unwholesome, the person may be proceeded
24against for a violation.

25(d) Minor violations.--Nothing in this chapter shall be
26construed as requiring prosecution or institution of a
27proceeding under this chapter for minor violations of this
28chapter if the secretary believes that the public interest will
29be adequately served in the circumstances by a suitable written
30notice or warning.

1Section 2. This act shall take effect in 60 days.