FEBRUARY 2007 AGRICULTURAL LAW UPDATE 1

NSI DE

VOLUME 24, NUMBER 2, WHOLE NUMBER 279 FEBRUARY 2007

Solicitation of articles: All AALAmembers are invited to submit ar-ticles to the Update. Please includecopies of decisions and legislationwith the article. To avoid duplica-tion of effort, please notify the Edi-tor of your proposed article.

Cont. on page 2

•Nebraksa corporate-farming banunconstitutional

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Tolerance of food contamination in Europe

Regulatory tolerances for food contamination in the USA and the European Union arestrikingly different. US regulations regard insect and animal filth as “repulsive,” treatthem as indicia of improper sanitation and elevated health risks, and restrict their sale.European Union regulations explicitly exempt such materials in food, considering theminstead to be either ‘quality’ issues or potential impediments to free trade. At the sametime, US regulations exempt trade in foods made from engineered crops as safe, whileEU regulations restrict them even more severely than foods with detectable amountsof disease-causing microbes.This has come about because EU policy places a higher priority upon free trade in foodamong member states than it does upon consumer health, or even upon the precaution-ary principle.In recent years, Europe has raised a series of barriers to the cultivation of geneticallyengineered crops and the foods made from them. The barriers have been raised bymember states of the European Union,

food manufacturers,

food wholesaling andretailing companies,

and by the European Commission in regulatory attempts

toreconcile the interests of these entities and those of international trading partners,activist groups and voters.European government officials tend to view these barriers as the result of generalconsumer skepticism about food safety which arose during a series of European foodcrises. “[F]ailure to address public concerns over food safety is very dangerous,” saidEU Commissioner Byrne in 1999. “One has only to look at the most contentious issuesto cross the Commission’s desk in recent years. BSE [mad cow disease], GMOs[genetically modified organisms], growth-promoting hormones in beef, antibiotic resi-dues, dioxin etc. have all taken up a huge amount of time and political energy.”

Europe-based activist groups

have been more strident, denouncing engineeredseeds, crops and the foods made from them as “contaminated” and pressing the claimthat they pose risks to public health.

These groups are well-funded and have been highlyeffective in promoting consumer opposition to genetic engineering in agriculture.

The barriers to the introduction of engineered crops and the foods made from them,the claims that these crops and the foods made from them are ‘contaminated,’ and theinternational trade disputes which resulted, all serve to highlight the mutually inconsis-

Federal Register summary: Jan. 13 - Feb. 23, 2007

ANIMAL IDENTIFICATION SYSTEM. The APHIS has announced that it is making availablefor review and comment three documents related to the National Animal IdentificationSystem: A Draft User Guide, a Program Standards and Technical Reference document, anda technical specification document for the animal tracking databases. All three documentsare available at http://animalid.aphis.usda.gov/nais/. The documents may also be viewed inthe APHIS reading room located in room 1141 of the USDA South Building, 14th Street andIndependence Avenue SW., Washington, DC. 72 Fed. Reg. 4680 (Feb.1, 2007).FOOD SAFETY. The Food Safety and Inspection Service (FSIS) has issued a noticeclarifying that flavor products, e.g., flavor bases, and blended and reaction/process flavors,with greater than three percent raw meat or poultry, or two percent or more cooked meat orpoultry, in their formulation are amenable to FSIS jurisdiction. The FSIS stated that recentfindings show that some manufacturers of flavor products formulated with significant levelsof meat, meat byproducts, poultry, and poultry byproducts (e.g., 30-70 percent) are not awarethat such products are under FSIS jurisdiction.The FSIS stated that these manufacturers need to take necessary steps to come underinspection. 72 Fed. Reg. 3779 (Jan. 26, 2007).DISASTER ASSISTANCE. The CCC has adopted as final regulations implementing theEmergency Agricultural Disaster Assistance Act of 2006, Pub. L. 109-234 which provides fundsfor assistance in areas affected by hurricanes Katrina, Ophelia, Rita and Wilma. The fundswill be distributed through eight programs: (1) the Livestock Compensation Program willprovide payments to livestock owners and cash lessees (not both for same livestock) forcertain feed losses; (2) the Livestock Indemnity Program II will provide benefits to livestock

2 AGRICULTURAL LAW UPDATE FEBRUARY 2007

VOL. 24, NO. 2, WHOLE NO. 279 FEBRUARY 2007AALA Editor..........................Linda Grim McCormick2816 C.R. 163, Alvin, TX 77511Phone: (281) 388-0155E-mail: apamperedchef@peoplepc.com(temporary)Contributing Editors: Andrew Apel,Raymond, IA;Anthony Schutz, Lincoln, NE; Robert P. Achenbach,Eugene, OR.For AALA membership information, contact RobertAchenbach, Executive Director, AALA, P.O. Box 2025,Eugene, OR 97405. Phone 541-485-1090. E-mailRobertA@aglaw-assn.org.Agricultural Law Update is published by the AmericanAgricultural Law Association, Publication office: CountyLine Printing, Inc. 6292 NE 14th Street, Des Moines, IA50313. All rights reserved. First class postage paid at DesMoines, IA 50313.This publication is designed to provide accurate andauthoritative information in regard to the subject mattercovered. It is sold with the understanding that thepublisher is not engaged in rendering legal, accounting, orother professional service. If legal advice or other expertassistance is required, the services of a competentprofessional should be sought.Views expressed herein are those of the individualauthors and should not be interpreted as statements ofpolicy by the American Agricultural Law Association.Letters and editorial contributions are welcome andshould be directed to Linda Grim McCormick, Editor, 2816C.R. 163, Alvin, TX 77511, 281-388-0155.Copyright 2007 by American Agricultural LawAssociation. No part of this newsletter may be reproducedor transmitted in any form or by any means, electronic ormechanical, including photocopying, recording, or by anyinformation storage or retrieval system, without permissionin writing from the publisher.

TOLERANCE/ CONTINUED FROM PAGE 1

Cont. on p. 3

tent views of Europe and the US of whatactually constitutes ‘contamination’ in foodand the degree to which it is tolerated.In the US, where the approval of new GEcrops is a regular event,

thresholds andaction standards have been establishedfor impounding and destroying foodsdeemed to be contaminated because theyare mixed with the detritus of insects, suchas cockroaches, pharaoh ants, latrine flies,redtailed flesh flies, and secondary screw-worms, or with animal filth, such as frommice, rats, birds, bats, lizards, and humans.These contaminants are associated withmicrobes such as

Escherichia coli

Salmonella

Shigella

and

Staphylococcus

, which causehuman disease and death.

US officials can take action without proofof the presence of these potentially deadlymicrobes in food, and consider the pres-ence of insect and animal filth to indicate animpermissible departure from essentialsanitary measures. “The FD&C [US Food,Drug and Cosmetic] Act goes beyond regu-lating contaminants that cause injury ordisease. Sections 402(a) (3) and 402(a) (4) ofthe Act require that foods be protectedfrom contamination with filth and be pro-duced in sanitary facilities. Filth includes‘contaminants such as rat, mouse or otheranimal hairs and excreta, whole insects,insect parts and excreta, parasitic worms,pollution from the excrement of humansand animals, as well as other extraneousmaterials which, because of their repul-siveness, would not knowingly be eaten orused.’”

Regulations in the European Unionlargely exempt these materials. The 1993Council Regulation laying down EuropeanCommunity procedures for handling foodcontaminants begins with this provision:‘Contaminant’ means any substance notintentionally added to food which ispresent in such food as a result of theproduction (including operations carriedout in crop husbandry, animal husbandryand veterinary medicine), manufacture,processing, preparation, treatment, pack-ing, packaging, transport or holding ofsuch food, or as a result of environmentalcontamination.

Extraneous matter, such as, for example, insect fragments, animal hair, etc,is not covered by this definition

(emphasisadded).

Later on in Article 5, the Regulation warnsthat “Member States may not prohibit,restrict, or impede the placing on the mar-ket of foods which comply with this Regula-tion...”

Thus, member states are prohib-ited from considering “insect fragments,animal hair, etc” in food to be ‘contamina-tion.’The Regulation begins with a preamblereciting the importance “of progressivelyestablishing the internal market... in whichthe free movement of goods, persons, ser-vices and capital is ensured,”

and theimportance of maintaining the free flow oftrade among the member states of the EUemerges even more strongly in later mea-sures.In 2002 the European Commissionwarned member states about applying theprecautionary principle to matters of foodsafety, saying, “The precautionary prin-ciple has been invoked to ensure healthprotection in the Community, thereby giv-ing rise to barriers to the free movement offood or feed.” The Regulation crafted toaddress the potential conflict between pre-caution and free trade in food offers this:“For the purposes of this Regulation, [thedefinition of] ‘food’ ...

shall not include ...residues and contaminants

(emphasis added).”It goes on to establish traceability require-ments for what

considered ‘food’ andmakes precautionary restraints on foodtrade subject to the requirement that therestraints prove to be science-based anddo not have a disproportionate effect ontrade.

There is ample precedent for Europeanaction against national food purity lawswhich impede the free flow of trade amongmember states. Perhaps the world’s mostfamous purity law is the German Purity Law(

Reinheitsgebot

), which dates to 1516 andrequires that beer be made with only a veryshort list of ingredients.

That ancient lawis the precursor of Germany’s Beer TaxLaw (

Biersteuergesetz

), which was derogated by the European Court of Justice followinga complaint by the European Commission.The Court found Germany’s restrictions onthe ingredients for anything labeled ‘

Bier

’(beer) were excessive, an impediment totrade, and a violation of Germany’s obliga-tion to harmonize its laws with Europeantrading partners. Germany’s argumentsthat its law was justified both by publichealth interests and by the precautionaryprinciple were rejected, because the im-pact on trade was disproportionately se-vere.

There are other precedents as well. Eu-ropean Union legislation regulating con-taminants closely parallel provisions in the

Codex Alimentarius

, which define a ‘contami-nant’ as “Any substance not intentionallyadded to food, which is present *** as a resultof environmental contamination.

The termdoes not include insect fragments, rodent hairsand other extraneous matter

(emphasisadded).”

And in a recent report, the CodexCommittee explained this definition bypointing out that the provisions are notmeant to cover “[c]ontaminants havingonly food quality significance, but no publichealth significance, in the food(s).”

There may be an explanation of why theEU regards as a mere “quality” issue whatthe US considers “repulsive,” and “filth,”and indicative of risks to public health.According to one commentator, “[I]n thedrafting of the

Codex Alimentarius

, healthand trade have never been on equal foot-ing. The Netherlands, Germany, Sweden,Switzerland, Italy and Austria supporteduniform standards as a way to ease trade barriers rather than to protect public health- even though all these countries wouldadopt a contrary position during the 1996‘mad cow crisis’.”

The extent to which these countriesadopted a “contrary position” is disput-able. In 2004, a new Regulation was passedprohibiting any “food business operator” inthe European Union from accepting rawmaterials (other than live animals) “if theyare known to be, or might reasonably beexpected to be, contaminated with para-sites, pathogenic microorganisms or toxic,decomposed or foreign substances to suchan extent that, even after the food businessoperator had hygienically applied normalsorting and/or preparatory or processingprocedures, the final product would be unfitfor human consumption.”

Since regulation of insect fragments,animal hair, etc. is prohibited, the “unfit forhuman consumption” standard can be nomore than a subjective assessment of con-sumer acceptability. The Regulation en-courages the use of HACCP (hazard analy-sis and critical control point) principles byfood processors to “help food businessoperators attain a higher standard of foodsafety,” but adds that the use of HACCP

FEBRUARY 2007 AGRICULTURAL LAW UPDATE 3principles “should not be regarded as amethod of self-regulation and should notreplace official controls.”

However, offi-cial controls are not allowed to discriminateagainst foods and food ingredients con-taining insect fragments, animal hair, etc—either because they are not considered“contaminants,” or not considered “food.”Following the obligation of member statesto ‘transpose’ European regulations intonational regulations,

at least one member state has made an express exemptionfor “insect fragments, animal hair, etc” inits laws and in its food.

Consumer guidesfor Germany and Europe note that thesematerials are exempt,

and Canada ad-vises exporters that European nations ex-empt these materials.

The experience of the United States inrefusing food imports based on sanitaryand phytosanitary requirements is instruc-tive. During a one-year period, the greatestnumber of contraventions cited by the USFood and Drug Administration for “importdetentions” totaled 3,519 (31.5%) for “filth,”followed by microbiological contaminationat 1,425 (12.8%).

The European Union placesits regulatory emphasis on the second cat-egory instead,

suggesting that much ofwhat the US refuses on the basis of “filth”would be permitted in the EU.At the same time, EC Regulations re-garding foods made from genetically engi-neered crops—which EC scientists havedeclared safe

—are vastly more stringentthan those regarding food mixed with in-sect fragments or animal hair. In 2003, theEuropean Union passed comprehensivelabeling and traceability requirements onfoods made from genetically modifiedcrops.

By 2004, Europe had established anetwork of 71 laboratories accredited toperform tests to detect biologically inactivegene fragments in food ingredients de-rived from engineered crops at levels lessthan one percent.

The European Unionwill tolerate the pathogenic organism

List-eria monocytogenes

in food at levels up to 100cfu/g (colony forming units per gram),

butimposes labeling and traceability require-ments on foods from engineered cropseven when it is scientifically impossible todetermine the source by protein or DNAanalysis.

While member states are prohibited fromrestricting sale of food ingredients and prod-ucts containing insect and animal filth, manyhave hastened to impose national bans onengineered crops or the foods made fromthem. Austria, France, Germany, Luxem- bourg and Greece have a total of eight such bans in place, all of which have been rejected by the European Scientific Commit-tees as unjustified.

The countries enact-ing these bans have relied on the precau-tionary principle as a justification,

eventhough European policy establishes thefreedom of trade as more important thanprecaution.

Europe-based activist groups purport-ing to represent consumers appear to ad-vocate similar policies. One report on Euro-pean food import requirements, preparedfor an activist group intimately connectedwith the backlash against engineered cropsworldwide,

merely mentions Europe’sexemptions for specific types of food con-tamination, without further comment.

Otherwise, the groups have shown no in-terest in food contamination, except to theextent that it is claimed to result from ge-netic engineering or, to a lesser extent, theuse of chemicals.Europe appears to apply this hierarchyof policy interests only to matters arisingamong member states. This came to lightrecently, when the EU reversed this policyhierarchy and argued before the WorldTrade Organization that the precautionaryprinciple justified trade restrictions on US,Canadian, and Argentine exports of prod-ucts derived from engineered crops. Usinga rationale strikingly similar to that thatemployed by the European Commissionand the European Court of Justice regard-ing the application of the precautionaryprinciple in matters of European trade, theWorld Trade Organization said that EU bans were not scientifically based to theextent that they relied on the principle.

While these reversals of priority appearmutually inconsistent, they are highly con-sistent with a European policy that makesthe protection of domestic trade in foodmore important than consumer health, foodquality, or the precautionary principle.

--Andrew R. Apel, Raymond, IA. .Thisarticle was first published by CropGen,www.cropgen.org/european_food.pdf

“GMOs: Commission reaction on Council votes onsafeguards and GM maize MON863,” EuropeanCommission Press Release IP/05/793 (June 24, 2005),http://europa.eu/rapid/ pressReleasesAction.do?reference=IP/05/ 793&format=HTML&aged=0&language=EN&guiLanguage=en

“Food Manufacturer Responses to BioengineeredFoods,” Muth, M., Beach, R., Fanjoy, M., Gledhill, E.,Kendall, D., Hoban, T., RTI International (April 2002) atp. 3-45, http://www4.ncsu.edu/~hobantj/biotechnology/ articlesfood%20manufacturer%20responses%20to%20bioengineered%20foods-full%20summary.pdf

“Genetically Modified Organisms,” European PolicyCenter (August 7, 2004, updated May 11, 2006), http:// www.euractiv.com/en/biotech/genetically-modified-organ-isms/article-117498

“Biotechnology - Introduction,” European Commis-sion/DG Health and Consumer Protection (web postedAugust 10, 2006), http://ec.europa.eu/food/food/biotech-nology/index_en.htm

See, e.g

., speech by EU Commissioner DavidByrne (Health and Consumer Protection Food Safety inEurope): Arthur Cox Conference on food law Dublin,Nov. 5 , 1999, http://www.europa.eu/rapid/ pressReleasesAction.do?reference=SPEECH/99/ 156&format=HTML&aged=1&language=EN&guiLanguage=en

“Major European organisations supporting the ‘Saveour Seeds’ Petition,” Save Our Seeds (n.d.), http:// www.saveourseeds.org/Download_Centre/ Major%20Organisations.pdf

See

, “Petition regarding the contamination of Europe-ans seeds with genetically modified organisms,” Save OurSeeds (n.d.), http://www.saveourseeds.org/ Download_Centre/Petition/Petition_en.pdf

and

“FoEE Bio-technology Programme and European GMO Campaign,”Friends of the Earth/Europe (web posted January 18,2007), http://www.foeeurope.org/GMOs/Index.htm

See, e.g

., “European Response to Genetically Modi-fied Soybeans,” American Soybean Association (ASANews, November 1996), http://www.soygrowers.com/ newsroom/releases/documents/gmoupdat.htm

and

“Con-sumer Attitudes about Agricultural Biotechnology,” Hoban,T., The Forum for Family & Consumer Issues (Vol. 6, No.1, Winter 2001), http://www.ces.ncsu.edu/depts/fcs/pub/ 2001w/hoban.html

“U.S. Database of Completed Regulatory AgencyReviews,” US Departments of Agriculture, Health andHuman Services, US Food and Drug Administration andUS Environmental Protection Agency (n.d.), http:// usbiotechreg.nbii.gov/database_pub.asp

“Regulatory Action Criteria for Filth and OtherExtraneous Materials v. Strategy for Evaluating Hazard-ous and Nonhazardous Filth,” Alan R. Olsen, John S.Gecan, George C. Ziobro, and John R. Bryce, RegulatoryToxicology and Pharmacology 33, 363–392 (2001)doi:10.1006/rtph.2001.1472, available online at http:// www.idealibrary.com

Ibid

Council Regulation (EEC) No 315/93 of 8 February1993 laying down Community procedures for contami-nants in food, Art. 1, Sec. 1, http://eur-lex.europa.eu/ smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31993R0315&model=guichett

Ibid

Regulation (EC) No 178/2002 (28 January 2002),http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_031/ l_03120020201en00010024.pdf

“German Beer Purity Law,” TED Case Study No. 219,American University/Trade Environment Database (No-vember 1, 1997), http://www.american.edu/TED/ germbeer.htm

Commission of the European Communities v Federal Republic of Germany

, European Court ofJustice, Case 178/84 (March 12, 1987), http://eur-lex.europa.eu/smartapi/cgi/ sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=en&numdoc=61984J017

Codex General Standard for Contaminants andToxins in Foods, Codex Stan. 193-1995 (Rev.1-1997,2004), Sec. 1.2.2.

“Report Of The 38th Session Of The Codex Commit-tee On Food Additives And Contaminants,” CodexAlimentarius Commission (April 2006),www.codexalimentarius.net/download/report/678/ fa39_01e.pdf

"Making Food Safety an Issue: InternationalizedFood Politics and French Public Health from the 1870s tothe Present,” Zylberman, P. Med Hist. 2004 January 1;48(1): 1-28, http://www.pubmedcentral.nih.gov/ articlerender.fcgi?artid=546293

Regulation (EC) No 852/2004 of the EuropeanParliament and of the Council of 29 April 2004 on thehygiene of foodstuffs, Official Journal of the EuropeanUnion L 139/1, http://eur-lex.europa.eu/LexUriServ/site/ en/oj/2004/l_139/l_13920040430en00010054.pdf

Ibid

See generally

, Council Resolution of 7 May 1985 ona new approach to technical harmonization and standards(Council Resolution (85/C 136/01) - Official Journal C 136of 4 June 1985), http://europa.eu/scadplus/leg/en/lvb/ l21001a.htm

European Communities (Sampling Methods and theMethods of Analysis for the Official Control of the Levelsof Certain Contaminants in Foodstuffs) Regulations,