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United States of America v. Daniel L. Allgyer.

February 2, 2012


The opinion of the court was delivered by: Stengel, J.


The United States brought this action on behalf of the Food and Drug Administration ("FDA") under the Public Health Services Act ("PHSA"), 42 U.S.C. §§ 264*fn1 and 271,*fn2 and the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 331(a),*fn3 343(e)(1) and (i)(1),*fn4 against Mr. Daniel Allgyer, an individual doing business as Rainbow Acres Farm for the sale and distribution of unpasteurized (or "raw") milk. On December 6, 2011, the government filed this motion for summary judgment. For the reasons stated below, I will grant the motion.

I. Background*fn5

On April 19, 2011, the United States filed its Complaint alleging that Mr. Allgyer is the owner and operator of a dairy farm located in Kinzers, Pennsylvania known as Rainbow Acres Farm. Government's Statement of Undisputed Facts at ¶ 3 ("Doc. #22-2") citing Declaration of Kirk D. Sooter, District Director, Philadelphia District Office, FDA ("Sooter Decl.") ¶¶ 5, 15; Exhibit F; Answer to Complaint for Permanent Injunction ("Answer"). As the owner, Mr. Allgyer has authority over all of the manufacturing and distributing done by Rainbow Acres Farm and has engaged in, and continues to engage in, the milking, packaging, labeling, selling, and distributing of unpasteurized cow milk in interstate commerce for human consumption in violation of the PHSA and FDCA. Id. citing Sooter Decl. ¶¶ 4, 6, 11-12, 15-17, 20, 23-24; Exhibit E*fn6 ; Answer ¶ 3.

From 2009 through 2011, the FDA conducted a two-year undercover investigation into Mr. Allgyer's operations. Id. The bulk of this investigation consisted of placing orders for Rainbow Acres' raw milk online through a Yahoo! group named "grassfedonthehill." Doc. #22-2 at ¶ 4 citing Sooter Decl. ¶ 11; Exhibit E. Buyers were required to join grassfedonthehill to purchase products from defendant. Id. citing Sooter Decl. ¶¶ 6-7; Exhibit A. The grassfedonthehill website describes grassfedonthehill as a "group . . . created to support and organize the delivery of grass fed (no antibiotics or hormones) Raw Dairy and Meat to the Greater Washington, DC area." Doc. #22-2 at ¶ 4 citing Sooter Decl. ¶¶ 6-7; Exhibit A. The website also listed delivery locations in Maryland and the greater D.C. area, and warned members to "not share information" about the group with government agencies or doctors. Id. The website identified Mr. Allgyer as grassfedonthehill's farmer. Customers must sign agreements to join the Communities Alliance for Responsible Eco-farming ("CARE") group "in order to protect [the] farm . from the ongoing harassment" by the Pennsylvania Department of Agriculture.*fn7 Id.

Mr. Allgyer states that he is the not owner or in control of the organization grassfedonthehill. Defendant's Response to the Motion for Summary Judgment at 1 ("Response"). However, Rainbow Acres Farm sold its raw milk online through that organization for $6 per gallon and $3.25 per half-gallon. Doc. #22-2 at ¶ 5 citing Sooter Decl. ¶¶ 6-7; Exhibit A; see also Answer at ¶ 3. Mr. Allgyer also states that he is not the owner or in control of the CARE organization. Response at 1. But Mr. Allgyer signed the CARE Membership Agreement, Sooter Decl. ¶ 8; Exhibit B; Exhibit C, as well as the CARE Membership Contract, Sooter Decl. ¶ 9; Exhibit D, which provide that Mr. Allgyer will enter into a cow share or lease agreement. Farmer Member and Community Member Private Contract at ¶ 5 ("CARE Contract").

Following the purchasing and pick-up instructions on the Rainbow Acres Farm website, the FDA purchased and paid for 23 gallon and half-gallon containers of raw milk, which were tested at an independent laboratory and confirmed to be unpasteurized.*fn8

Doc. # 22-2 at ¶¶ 4-5 citing Sooter Decl. ¶¶ 11-12; Exhibit E. After securing a warrant, the FDA inspected Rainbow Acres Farm and collected evidence that Mr. Allgyer was engaged in milking cows and packaging the unpasteurized milk in unlabeled containers for delivery out of state.*fn9 Id. citing Sooter Decl. ¶¶ 14-16; Exhibit F.*fn10 Following the inspection, the FDA sent Mr. Allgyer a warning letter dated April 20, 2010, which informed Mr. Allgyer of his various violations enforced by federal law and the possible legal repercussions for failing to adhere to those laws. Doc. #22-2 at ¶ 14; see also Answer at ¶ 2; Response at 5-6.

After receiving the warning letter, Mr. Allgyer posted on the Farm's website stating that the government was trying to "shut [him] down," but that he was going to continue selling raw milk by "leasing" his cows through a private organization.*fn11 Doc. #22-2 at ¶¶ 16-17 citing Sooter Decl. ¶ 20; Exhibit H. On May 6, 2010, grassfedonthehill emailed its members a message stating that, with the change over to the Rawsome Club, Mr. Allgyer was making deliveries on Monday and Thursday by 4:00 p.m. Doc. #22-2 at ¶ 18 citing Sooter Decl. ¶ 22; Exhibit J.

On September 28, 2011, FDA investigators accessed the Rainbow Acres Farm website and found that Mr. Allgyer continues to offer unpasteurized milk for direct human consumption to out-of-state consumers under the name "Rainbow Valley Farms."*fn12 Doc. #22-2 at ¶ 20 citing Sooter Decl. ¶ 24; Exhibit K.

Regulation of Raw Milk

From 1974 to 1982, the FDA collected and evaluated scientific and medical information and data to determine if the outbreak of certain diseases was associated with the consumption of raw milk. The FDA worked closely with the Centers for Disease Control and Prevention ("CDC"), a branch of Health and Human Services ("HHS"), and encouraged the states to test milk and milk products for bacteria or microorganisms and to report outbreaks of milk-borne disease to the CDC. See Public Citizen v. Heckler, 653 F. Supp. 1229, 1232 (D.D.C. 1986); Oyarzo v. Md. Dep't of Health & Mental Hygiene, 187 Md. App. 264, 278 (Md. Ct. Spec. App. 2009); Consumers Union v. Alta-Dena Certified Dairy, 4 Cal. App. 4th 963, 6 Cal. Rptr. 2d 193 (1st App. Dist. 1992).

On August 10, 1987, the FDA's final rule on the debate over the regulation of raw milk became effective, codified at 21 C.F.R. § 1240.6. The Rule provides:

No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized or is made ...

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