USDA Brief  - March 28, 2007
No. 06-2738
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
ARTHUR HARVEY,
Plaintiff/Appellant,
v.
MIKE JOHANNS, SECRETARY OF
THE UNITED STATES DEPARTMENT OF AGRICULTURE
Defendant/Appellee.
ON APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MAINE
BRIEF OF APPELLEE MIKE JOHANNS, SECRETARY OF
THE UNITED STATES DEPARTMENT OF AGRICULTURE
Paula D. Silsby
United States Attorney
Halsey B. Frank
Assistant U.S. Attorney
District of Maine
100 Middle Street Plaza
East Tower, Sixth Floor
Portland, Maine 04104
Tel. (207) 780-3257
ii


TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES. . . . . . . . . . . . . . . . . . . . . iii
JURISDICTIONAL STATEMENT. . . . . . . . . . . . . . . . . . . vi
STATEMENT OF ISSUES PRESENTED . . . . . . . . . . . . . . . . vii
STATEMENT OF FACTS AND THE CASE . . . . . . . . . . . . . . . 1
1. Background of the OFPA. . . . . . . . . . . . . . . 1
2. The OFPA. . . . . . . . . . . . . . . . . . . . . . 2
3. The Initial Rulemaking. . . . . . . . . . . . . . . 3
4. Food Contact Substance policy . . . . . . . . . . . 4
5. Complaint . . . . . . . . . . . . . . . . . . . . . 5
6. Motions for Summary Judgment and
Associated Matters. . . . . . . . . . . . . . . . . 6
7. Recommended Decision, Objections Thereto
and Consent Judgement . . . . . . . . . . . . . . . 8
8. First Appeal. . . . . . . . . . . . . . . . . . . . 10
9. Remand and Consent Judgment . . . . . . . . . . . . 16
10. Congressional Amendment . . . . . . . . . . . . . . 16
11. Agency Rulemaking . . . . . . . . . . . . . . . . . 17
12. Motion to Enforce . . . . . . . . . . . . . . . . . 18
SUMMARY OF THE ARGUMENT . . . . . . . . . . . . . . . . . . . 22
ARGUMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . 23
I. As Amended, the OFPA Permits the Secretary to List
Synthetics for Use in Processing. . . . . . . . . . . . . 23
II. The Secretary’s Food Contact Substance Policy was
Not a Subject of this Litigation. . . . . . . . . . . . . 28
A. The Food Contact Substance Policy is not
Ripe for Review . . . . . . . . . . . . . . . . . . 29
B. The Food Contact Substance Policy was not
a Subject of this Litigation. . . . . . . . . . . . 30
CONCLUSION. . . . . . . . . . . . . . . . . . . . . . . . . . 31
iii
TABLE OF AUTHORITIES
FEDERAL CASES
Abbott Labs v. Gardner, 387 U.S. 136 (1967) . . . . . . . . . . 29
Ass’d Fisheries of Maine, Inc. v. Daley, 127 F.3d 104 (1st Cir.
1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Brown v. Sec. H.H.S., 46 F.3d 102 (1st Cir. 1995) . . . . . 25, 28
Chevron USA, Inc. v. Nat’l Resources Defense Council, Inc., 467
U.S. 837 (1984) . . . . . . . . . . . . . . . . . . . . . . 24, 27
Diaz-Fonseca v. Puerto Rico, 451 F.3d 13 (1st Cir. 2006) . . . 30
Dunn v. U.S.D.A., 921 F.2d 365 (1st Cir. 1990) . . . . . . . . 27
Elien v. Ashcroft, 364 F.3d 392 (1st Cir. 2004) . . . . . . 24, 27
Harvey v. Venneman, 396 F.3d 28 (1st Cir. 2005) . . . . . . . 25-27
Inmates of Suffolk County Jail v. Rouse, 129 F.3d 649 (1st Cir.
1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Ohio Forestry Association, Inc. v. Sierra Club, 523 U.S. 726 (1998) 29
Pennsylvania v. Wheeling & Belmont Bridge Co., 59 U.S. 421 (1855) 26
Rodriguez v. Doral Mortgage Corp., 57 F.3d 1168 (1st Cir. 1995) 30
Rucker v. Lee Holding Co., 471 F.3d 6 (1st Cir. 2006). . . . 27, 28
South Shore Hosp., Inc. v. Thompson, 308 F.3d 91 (1st Cir. 2002) 24
St. Paul Fire & Marine Ins. Co. v. Lawson Bros. Iron Works, 428
F.2d 929 (10th Cir. 1970) . . . . . . . . . . . . . . . . . . . 30
Visiting Nurse Ass’n Gregoria Auffant, Inc. v. Thompson, 447 F.3d
68 (1st Cir. 2006) . . . . . . . . . . . . . . . . . . . . . . 28
FEDERAL STATUTES
5 U.S.C. § 702 . . . . . . . . . . . . . . . . . . . . . . . . iv
5 U.S.C. § 706(2) . . . . . . . . . . . . . . . . . . . . . . . 27
5 U.S.C. § 706(2)( . . . . . . . . . . . . . . . . . . . . . . 25
5 U.S.C. §§ 551 . . . . . . . . . . . . . . . . . . . . . . . . . 5
iv
7 U.S.C. § 6501 . . . . . . . . . . . . . . . . . . . . . . . . . 2
7 U.S.C. § 6503(a) . . . . . . . . . . . . . . . . . . . . . . . 2
7 U.S.C. § 6504 . . . . . . . . . . . . . . . . . . . . . . . . . 3
7 U.S.C. § 6505(a)(1) . . . . . . . . . . . . . . . . . . . . . . 3
7 U.S.C. § 6510 . . . . . . . . . . . . . . . . . . . . . 8, 16, 23
7 U.S.C. § 6510(a)(3) . . . . . . . . . . . . . . . . . . . . . 11
7 U.S.C. § 6517 . . . . . . . . . . . . . . . . . . 3, 8, 9, 12, 13
7 U.S.C. § 6517(b) . . . . . . . . . . . . . . . . . . . . . . . 3
7 U.S.C. § 6517(c)(1) . . . . . . . . . . . . . . . . . . 7, 8, 17
7 U.S.C. § 6517(c)(1)(A) . . . . . . . . . . . . . . . . . . . . 3
7 U.S.C. § 6519(f) . . . . . . . . . . . . . . . . . . . . . . . 4
7 U.S.C. § 6521 . . . . . . . . . . . . . . . . . . . . . 3, 4, 28
7 U.S.C. §§ 6504 . . . . . . . . . . . . . . . . . . . . . 2, 6, 7
7 U.S.C. §§ 6510 . . . . . . . . . . . . . . . . . . . . . . . . 9
7 U.S.C. §§ 6510(a)(1) . . . . . . . . . . . . . . . . . . . . . 6
7 U.S.C. §§ 6510(a)(5) . . . . . . . . . . . . . . . . . . . . . 4
7 U.S.C. § 6504 . . . . . . . . . . . . . . . . . . . . . . . . 27
7 U.S.C. § 6517 . . . . . . . . . . . . . . . . . . . . . . . . 26
21 U.S.C. § 348(h)(1)-(2) . . . . . . . . . . . . . . . . . . . . 4
21 U.S.C. § 348(h)(6) . . . . . . . . . . . . . . . . . . . . . . 4
21 U.S.C. §§ 301 . . . . . . . . . . . . . . . . . . . . . . . . 4
28 U.S.C § 1331 . . . . . . . . . . . . . . . . . . . . . . . . iv
28 U.S.C. § 1291 . . . . . . . . . . . . . . . . . . . . . . . iv
28 U.S.C. § 1294 . . . . . . . . . . . . . . . . . . . . . . . iv
FEDERAL RULES
F.R.A.P. 4(a) . . . . . . . . . . . . . . . . . . . . . . . . . iv
v
FEDERAL REGULATIONS
62 Fed. Reg. 65850 (Dec. 16, 1997) . . . . . . . . . . . . . 1, 2
65 Fed. Reg. 13512 (Mar. 13, 2000) . . . . . . . . . . . . . 3, 4
65 Fed. Reg. 80549 (Dec. 21, 2000) . . . . . . . . . . . . . . . 4
7 C.F.R. 205.606(b) . . . . . . . . . . . . . . . . . . . . . 9, 12
7 C.F.R. Part 205 . . . . . . . . . . . . . . . . . . . . . . 4, 5
7 C.F.R. § 205.403 . . . . . . . . . . . . . . . . . . . . . . . 1
7 C.F.R. § 205.600(b) . . . . . . . . . . . . . . . . . . . . 9, 10
7 C.F.R. § 205.606(b) . . . . . . . . . . . . . . . . . 11, 14, 15
7 C.F.R. §§ 205.600(b) . . . . . . . . . . . 6, 7, 10, 16, 23, 28
vi
JURISDICTIONAL STATEMENT
Original jurisdiction. Pursuant to 28 U.S.C § 1331, “[t]he
district courts shall have original jurisdiction of all civil
actions arising under the Constitution, laws, or treaties of the
United States.” Pursuant to 5 U.S.C. § 702, “[a] person suffering
legal wrong because of agency action, or adversely affected or
aggrieved by agency action within the meaning of a relevant
statute, is entitled to judicial review thereof. . . .”
Appellate jurisdiction. Pursuant to 28 U.S.C. § 1291, the
courts of appeal “shall have jurisdiction of appeals from all final
decisions of the district courts of the United States . . . .” An
appeal from a final judgment of the district court of Maine is
taken to the United States Court of Appeals for the First Circuit.
See 28 U.S.C. § 1294. The amended judgment of the district court
in this matter was entered on November 21, 2006. D. 117.
According to F.R.A.P. 4(a), a notice of appeal must be filed in the
district court within 60 days after entry of the judgment. In this
matter, the notice of appeal was timely filed on December 8, 2006.
D. 118.
vii
STATEMENT OF THE ISSUES PRESENTED
I. Whether the district court erred in denying Mr. Harvey’s
motion to enforce the original consent judgment and in
granting the Secretary’s motion for relief from that
judgment where, in response to this Court’s decision that
the OFPA prohibited the use of synthetics in organic
handling, Congress intervened to amend the OFPA to permit
the listing of synthetics for use in organic handling.
II. Whether the district court erred in denying Mr. Harvey’s
motion to enforce the original consent judgment and in
granting the Secretary’s motion for relief from that
judgment where Mr. Harvey did not litigate on the merits
a claim about the Secretary’s food contact substance
policy, and where neither the district court nor the
Court of Appeals addressed that policy in their
decisions.
1The designation “D.” and a number refers to the pleading
entered on the District Court’s Docket at that number.
1
STATEMENT OF THE FACTS AND THE CASE
This is an appeal from the amended judgment entered in a civil
case in the United States District Court for the District of Maine
(Hon. D. Brock Hornby, United States District Judge) involving
Defendant/Appellee Mike Johanns, Secretary of the United States
Department of Agriculture (Secretary, Department, Agriculture,
Agency, or USDA) and Plaintiff/Appellant Arthur Harvey. D. 117.1
Mr. Harvey is an organic blueberry farmer, a processor and
consumer of organic foods, and an inspector who works for an
accredited certifying agent within the USDA’s National Organic
Program (NOP). D. 1 at p. 2; D. 29 at ¶¶ 5, 6. As an inspector,
Mr. Harvey inspects organic food production and handling operations
to determine whether they comply with program requirements. See 7
C.F.R. § 205.403.
1. Background of the OFPA
Prior to the enactment of the OFPA in 1990, there were as many
as 33 private and 11 state agencies that certified agricultural
products as organic, each with their own standards and
identification marks. 62 Fed. Reg. 65850 (Dec. 16, 1997). There
was no industry-wide agreement with respect to what substance
should be permitted or prohibited from use in organic products.
Id. The number and variety of these regulatory schemes caused
members of the organic community problems producing, marketing,
2
purchasing, and consuming organically produced and handled
products. Id.
In the late 1980s, the organic community tried to address
these problems on its own. Id. It attempted to establish a
national, voluntary organic certification program. Id. When that
effort failed, the organic industry trade association petitioned
Congress to legislate a mandatory, national organic program. Id.
The result was the Organic Foods Production Act of 1990. P.L. 101-
624; Food, Agriculture, Conservation and Trade Act of 1990. See S.
Rep. No. 101-357, 101st Cong., 2d Sess at 290-1 (July 6, 1990),
reprinted in 1990 U.S.C.C.A.N. at p. 4945 (OFPA or Act).
2. The OFPA
The purposes of the Act are to “establish national standards
governing the marketing” of organically produced agricultural
products, to assure consumers that organically produced products
“meet a consistent standard,” and to “facilitate interstate
commerce” in organically produced agricultural products. 7 U.S.C.
§ 6501. The Act does so by establishing a national certification
program for producers and handlers of organic products, 7 U.S.C. §
6503(a), and by regulating the use of labeling terms such as
“organic,” “100% organic,” and “made with organic,” see 7 U.S.C. §§
6504, 6505(a)(1).
In order to be sold or labeled as organic, and subject to
exceptions made in the Act, an agricultural product must be
produced and handled without the use of synthetics (such as
herbicides and pesticides), must be produced and handled in
3
accordance with the Act generally, 7 U.S.C. § 6505(a)(1), and in
accordance with an organic plan agreed to by the certifying agent
and the producer or handler of the product, 7 U.S.C. § 6504.
The major exception to the Act’s general rule that organic
agricultural products be natural and not be produced or handled
with synthetics is the National List of approved and prohibited
substances authorized by 7 U.S.C. § 6517 (National List). The List
itemizes each synthetic substance permitted, and each natural
substance prohibited, in the production and handling of
agricultural products produced, handled, labeled and sold as
organic. 7 U.S.C. § 6517(b).
Subsection 6517(c)(1) creates an exemption for prohibited
substances. It permits the use of substances that the Act
otherwise prohibits in organic farming and handling if those
substances are “not . . . harmful to human health or the
environment,” are “necessary to the production or handling of the
agricultural product because of the unavailability of wholly
natural substitute products,” and are “consistent with organic
farming and handling.” 7 U.S.C. § 6517(c)(1)(A).
3. The Initial Rulemaking
7 U.S.C. § 6521 authorizes and requires the Secretary of the
Department of Agriculture to promulgate regulations “to carry out”
the OFPA. After extensive rulemaking, on March 13, 2000, the
Secretary published the first proposed rule to implement the Act.
65 Fed. Reg. 13512 (Mar. 13, 2000). It generated significant
public response. Id. In total, the Secretary received 275,603
2In the OFPA, Congress addressed food contact substances to
a limited extent in 7 U.S.C. §§ 6510(a)(5) and (6), which
prohibit handling operations from using packaging materials and
containers that “contain synthetic fungicides, preservatives or
fumigants” or that “had previously been in contact with any
substance in such a manner as to compromise the organic quality
of such product.” Otherwise, in 7 U.S.C. § 6519(f), Congress
4
comments with respect to the first proposed rule. Id. In response
to those comments, the Secretary rewrote the rule. On December 21,
2000, the Secretary published a second proposed rule which received
an additional 40,774 comments. 65 Fed. Reg. 80549 (Dec. 21, 2000).
On December 21, 2000, the Secretary published the Final Rule,
which is codified at 7 C.F.R. Part 205. The Rule was subject to a
90-day review by Congress, and to an 18-month phase-in period to
allow the industry time to adjust before the Rule became fully
effective, which it did on October 21, 2002. 7 U.S.C. § 6521. See
D. 31 at pp. 2-9.
4. Food Contact Substance policy
Food contact substances (FCS) are substances that come into
contact with food during processing. Congress defined the term
“food contact substance” in the Federal Food, Drug and Cosmetic
Act, 21 U.S.C. §§ 301 et seq. (FFDCA), as “any substance intended
for use as a component of materials used in manufacturing, packing,
packaging, transporting or holding food if such use is not intended
to have any technical effect in such food.” 21 U.S.C. § 348(h)(6).
The FDA lists those food contact substances that have been
demonstrated safe for their intended use, identifies the persons
authorized to market those FCS, and authorizes purchasers to use or
resell the FCS for their intended use. 21 U.S.C. § 348(h)(1)-(2).2
made clear that “nothing in the [OFPA] shall alter the authority
of the . . . Secretary of Health and Human Services under the
Federal Food, Drug and Cosmetic Act . . .”
5
In response to inquiries from the organic community, on
December 12, 2002, the Secretary of Agriculture issued a policy
statement authorizing the use of Food and Drug Administration (FDA)
classified food contact substances. See www.ams.usda.gov/nop/NOP/
PolicyStatements/SyntheticSubstances. In doing so, the Secretary
established a threshold below which substances did not have to go
through National List procedures in order to be used in organic
processing and handling. The Secretary set that threshold at the
level of substances that merely come into contact with organic food
but do not have any technical effect on it.
5. Complaint
On October 23, 2003, only slightly more than a year after the
final rule became fully effective, proceeding pro se, Mr. Harvey
filed his Complaint under the Administrative Procedure Act, 5
U.S.C. §§ 551 et seq. and 701 et seq. (APA). D. 1. Although he
participated in the rulemaking process by making comments, see
e.g., D. 35 at Appendix 5, Mr. Harvey did not make any
administrative claim prior to filing his Complaint, and there is no
administrative record of any proceedings below besides the record
of the rulemaking.
In the 9 counts of his Complaint, Harvey challenged the
validity of the Rule that the Department of Agriculture’s
Agricultural Marketing Service (AMS) wrote to implement the OFPA.
See D. 1 passim. The rule appears at 7 C.F.R. Part 205 (Rule,
6
Regulation, or OFPA Rule or Regulation). Harvey argued that
various provisions of the Rule were arbitrary, capricious, and
contrary to law and procedure. D. 1 passim.
In Count 3 of his Complaint, Mr. Harvey challenged 7 C.F.R. §§
205.600(b) and 205.605(b) which allowed the addition of certain
synthetic ingredients during the handling of processed products
labeled “organic” or “made with organic.” D. 1 at 7-9. Mr. Harvey
claimed that these regulations contravened 7 U.S.C. §§ 6510(a)(1)
and 6517(c)(1)(B)(iii) which he claimed prohibited the addition of
synthetic ingredients and substances during processing. Id. Mr.
Harvey did not make any allegations or claims about food contact
substances in his Complaint.
6. Motions for Summary Judgment and
Associated Matters
On July 1, 2003, Mr. Harvey filed a motion for summary
judgment, including a motion to supplement the administrative
record with two affidavits and a printout from the USDA website.
D. 27, 28, 29. Harvey argued that he had standing to raise his
claims, and that he had exhausted his administrative remedies. D.
27 passim.
With respect to Count 3, Mr. Harvey argued that 7 C.F.R. §§
205.600(b) and 205.606(b) violated 7 U.S.C. §§ 6504, 6510(a) and
6517(c)(1)(B)(iii) by allowing synthetic ingredients in processed
organic products. D. 27 at 8-9. Mr. Harvey did not make any
argument about food contact substances in his motion for summary
judgment.
3These excerpts appear in the district court’s docket
between entries numbers 31 and 32. They do not have their own
docket number and will be referred to using the designation “AR.”
7
On July 22, 2003, the Secretary filed excerpts of the
administrative record relevant to Mr. Harvey’s claims and its
defenses,3 a motion to strike the extra-record material that Harvey
had filed, D. 30, and a consolidated opposition to Harvey’s motion
for summary judgment and cross-motion for summary judgment, D. 31.
In its opposition and cross-motion, the Secretary argued that
Harvey lacked standing and failed to exhaust his administrative
remedies. D. 31.
In response to Mr. Harvey’s argument with respect to Count 3,
the Secretary acknowledged that the OFPA generally prohibits the
addition of synthetic ingredients during processing and handling.
Id. at 24. However, the Secretary argued that the Act
contemplates, and provides for, exceptions to this general rule.
Id. The National List of otherwise prohibited substances is one
such exception. Id. Consistent with this scheme, 7 C.F.R. §§
205.600(b) and 205.606(b) provided criteria for listing such
otherwise prohibited synthetics and a list of specific substances
that had met those criteria. D. 31 at 23-25.
On August 12, 2003, Harvey filed a response to the Secretary’s
motion to strike, D. 34, and a consolidated opposition to its
cross-motion and reply in support of his own motion for summary
judgment, D. 35. With respect to Count 3, Mr. Harvey argued that
the exceptions in 7 U.S.C. § 6517(c)(1) apply only to organic food
production, not handling. D. 35 at 16-17.
8
For the first time in the litigation, Mr. Harvey alleged that
the USDA was permitting the use of synthetic food contact
substances in processing. He made this argument in support of his
having standing with respect to Count 1 of his Complaint. D. 35 at
7-9.
7. Recommended Decision, Objections Thereto
and Consent Judgement
On October 10, 2003, United States Magistrate Judge Margaret
Kravchuk issued a Recommended Decision recommending that Harvey’s
motion for summary judgment be denied with respect to Counts 1
through 8 of his Complaint and be granted with respect to Count 9.
D. 43. Judge Kravchuk recommended that the Secretary’s cross
motion be granted with respect to Counts 1 through 8 and denied
with respect to Count 9. Id.
The Magistrate decided that Mr. Harvey had standing with
respect to all but Count 7 of his Complaint. D. 43 at 3-4. With
respect to the other counts, the Magistrate decided that Mr. Harvey
had demonstrated concrete and particularized injury as a result of
his “status as an approved certifier, an organic grower, an organic
consumer, and an individual actively involved in the rule making
process.” Id. at 4.
With respect to Count 3, the Magistrate decided that sections
205.600(b) and 205.606(b) were not inconsistent with the spirit of
the OFPA. Id. at 11-13. Making exceptions to 7 U.S.C. § 6510's
general prohibition against synthetics was not contrary to the OFPA
given the contemporaneous enactment of 7 U.S.C. § 6517 and the
4The Secretary responded to Mr. Harvey’s Motion to Narrow
by, among other things, pointing out that Mr. Harvey failed to
exhaust his administrative remedies. As a result, the facts
surrounding Mr. Harvey’s claims had not been developed, and the
issues had not been sharpened and focused, all of which hampered
judicial review. D. 55 at 6.
9
Senate Report’s discussion of the Secretary’s discretion in the
area. Id. at 12.
The parties filed objections to the Recommended Decision, D.
50, 51, and responses to each others’ objections, D. 52, 53. Mr.
Harvey reiterated his position that 7 U.S.C. §§ 6510 and 6517 only
allowed the addition of synthetics during production, not handling.
D. 51 at 6-8. The Secretary responded by pointing out that if Mr.
Harvey’s interpretation of the OFPA were correct and synthetics
could never be added during processing, then organic processed
foods could not meet the basic health and safety requirements
established for food by other regulatory agencies. D. 52 at 3-4.
On December 8, 2003, Mr. Harvey filed a Motion to Narrow the
Scope of Count 3 and Count 5. D. 54. With respect to Count 3, Mr.
Harvey withdrew his challenge with respect to 10 synthetic
substances that had been listed in 7 C.F.R. 205.606(b) pursuant to
the procedures outlined in 7 U.S.C. § 6517 and 7 C.F.R. §
205.600(b). D. at 1-2. It was not always clear why he was doing
so. Apparently, he withdrew his challenge to some of the
substances because he agreed with the Secretary that they were
required to satisfy basic food health and safety requirements. D.
at 1.4
10
On January 8, 2004, over Harvey’s objection, and in accordance
with the Secretary’s objection, United States District Judge Hornby
affirmed the Recommended Decision with respect to Counts 1 through
8, rejected the Recommended Decision with respect to Count 9, and
granted judgment in the Secretary’s favor with respect to all 9
counts. D. 57. Judgment issued the same day. D. 58.
8. First Appeal
On about February 25, 2004, Mr. Harvey obtained counsel. See
D. 59, 60. By notice filed March 8, 2004, Mr. Harvey appealed the
District Court’s Judgment. D. 66.
On June 4, 2004, Mr. Harvey filed his Brief, wherein he
acknowledged that the OFPA provided only general guidance and
argued that it left the details to be worked out in site-specific
organic plans. Appellant’s Brief at 6. He acknowledged that the
Act made limited exceptions to a general prohibition on the use of
synthetics and that the National List was one such exception. Id.
at 7-10.
With respect to Count 3, Mr. Harvey argued that 7 C.F.R. §§
205.600(b) and 205.606(b) contravened the Act. Id. at 31-36. They
allowed synthetics in processed foods when the Act prohibited
synthetics generally and specifically in processing. Id. He
argued that the language and history of the Act made clear that the
National List only allows exceptions for synthetics used in
production, not processing. Id. at 31-2. He argued that the only
other exception for synthetics in processing is for synthetics
required by other food health and safety laws. Id. at 35.
11
Mr. Harvey also argued that the USDA’s food contact substance
policy permitted the use of synthetics without their being on the
National List. Id. at 34. With no foundation in fact or the
record, he argued that some of these food contact substances were
in fact “ingredients” being added to food, in violation of the Act.
Id. at 34. He argued that other food contact substances violated 7
U.S.C. § 6510(a)(3)’s explicit ban on the use of sulfites except in
winemaking and 6510(a)(5)’s ban on the use of synthetic fungicides,
preservatives, or fumigants” in packaging or storage containers.
Id. at 34-5.
Mr. Harvey explained that in his Motion to Narrow, he had
withdrawn his challenge to certain of the 36 items listed in 7
C.F.R. § 205.606(b) because they were “required by other regulatory
regimes,” because they were not “added ingredients,” or because
they were listed for use in “made with organic” products to which
the Act’s ban on synthetics did not apply. Id. at 36.
In its brief, the Secretary argued that Mr. Harvey lacked the
type of concrete injury that would sharpen and focus the issues for
resolution and ensure that the court did not waste its energy on an
abstract dispute. Appellee’s Brief at 9. It noted that Mr. Harvey
had not developed issues by exhausting any administrative remedies.
Id. at 15-17. The Secretary noted that the OFPA explicitly gave it
rulemaking authority. Id. at 8. The Secretary also noted that it
had some expertise in regulating food production and processing and
that its rules were entitled to deference and a presumption of
validity on that account. Id. at 7-8.
12
With respect to Count 3, the Secretary argued that 7 C.F.R.
205.606(b), which listed 36 synthetic substances for use as
ingredients in processing was a permissible construction of the
OFPA in general and of 7 U.S.C. § 6517 in particular. Id. at 21.
The Secretary pointed out language in 7 U.S.C. § 6517 that seemed
to explicitly give it authority to list synthetics for use in
handling. Id. at 21-22. If there was any uncertainty or
inconsistency, the Secretary argued that ambiguity or conflict gave
it the opportunity to employ its expertise and discretion to
reconcile the matter with a reasonable interpretation. Id. at 22.
The Secretary argued that the Court should reject Mr. Harvey’s
arguments about food contact substances because the policy was not
a part of the rulemaking that he had challenged. Id. at 23, n.11.
It was part of an ongoing debate about how the Act and Rules
operate and was not reviewable, final action. Id. Mr. Harvey had
not pleaded a challenge to the policy in his Complaint, or made the
argument in his Motion for Summary Judgment. Id. He only first
made the argument in his opposition to the Secretary’s Cross-Motion
for Summary Judgment, and then only in response to an argument that
he lacked standing with respect to Count 1. Id. See Reply Brief
at p. 17 n. 37. It was an argument about the way the Act and Rule
operate that could not be shoehorned into a challenge to the Act on
its face, as written. Id.
In his Reply Brief at 1, Mr. Harvey argued that the
Secretary’s standing argument was half-hearted and argued that he
had been injured by products that did not meet the standard for
13
organic. Id. at 4, 5. With respect to Count 3, he argued that the
specific provisions of 7 U.S.C. § 6517 took precedence over the
general, such that the National List did not permit synthetics in
handling. Id. at 15. Without any basis in the record, he argued
that it made sense to prohibit synthetics in handling but not
production because producers use different synthetics than handlers
and the synthetics used in production generally do not end up as
ingredients in food. Id. at 16.
With respect to the food contact substance policy, Mr. Harvey
argued that the Secretary was surreptitiously permitting the use of
synthetics through the FDA’s list of approved food contact
substances and that the Secretary should not be able to shield its
policy from judicial review. Id. at 17-18. He urged the Court to
rule that the OFPA did “not permit synthetic substances to be used
in processing organically-labelled foods,” including all synthetic
substances, however authorized, whether by regulation, policy
statement or otherwise. Id. at 18.
On January 26, 2005, the Court issued a Slip Opinion. It held
that Mr. Harvey had suffered sufficient injury in fact to satisfy
the constitutional requirements of standing because he was a
consumer of organic foods and had alleged that the challenged
regulations weakened the integrity of the organic program and
degraded the quality of organic food. Slip Op. at 8.
The Court reversed the district court’s grant of summary
judgment with respect to Count 3. Id. at 19-22. It held that
“[t]he challenged regulations [were] contrary to the plain meaning
14
of the OFPA and therefore exceed[ed] the Secretary’s statutory
authority.” Id. at 22. It rejected the Secretary’s argument that
the Act was inconsistent or ambiguous. Id. at 21. It held that
the Act was clear, that section 6517 “plainly forbid[] the use of
synthetic substances in handling operations.” Id. at 20.
The Court wrote:
The Act is neither ambiguous nor inconsistent;
§ 6510 bars addition of ‘any synthetic
ingredient during the processing or any
postharvest handling of the product,’ and §
6517 furthers that prohibition.
Id. at 22. It wrote that “[t]he challenged regulations, which
permit the use of certain synthetic substances ‘as processing
aids,’ thus contravene the plain language of this section of the
Act as well.” Id. at 21. It wrote that “[s]ection 6517(c) clearly
establishes a three-prong test for exemption of otherwise
prohibited substances . . .” and wrote that the second prong of
that test, section 6517(c)(1)(B)(iii), “specifically requires that
substances used in handling be nonsynthetic.” Id. at 21-22.
The Court also noted that Mr. Harvey had withdrawn his
challenge to some of the 36 synthetic substances authorized by 7
C.F.R. § 205.606(b), and held that its “reversal of the District
Court’s judgment is without prejudice to any such concessions . .
.” Id. at 22 n. 4.
On March 11, 2004, Mr. Harvey filed a Motion to Stay the
Mandate and Clarify the Court’s Decision. He explained he was
concerned that the Court’s decision might be misread in ways that
neither Mr. Harvey nor the Court intended, in ways that were
5Mr. Harvey asked the Secretary to join in his Motion to
Clarify. The Secretary declined because it did not agree with
Mr. Harvey’s interpretation of the OFPA, or his characterization
of his litigation positions. Nor could the Secretary discern a
way to reconcile Mr. Harvey’s position in the Motion for
Clarification with the points he had argued for up to that point.
15
inconsistent with the OFPA or that were unworkable and would
obstruct the functioning of the organic program. See Motion to
Clarify at 2-3, 10. For example, the decision might be read to
preclude the use of synthetics in “made with organic” products.
See id. at 2, 3, 9. It might preclude the use of synthetics in
packaging and storage of “organic” or “100% organic” products. See
id. at 10, 11. It might make it difficult or impossible to market
organic foods. Id. at 10.
Mr. Harvey argued that he had only challenged the use of
synthetics in the processing of “organic” and “100% organic”
products. Id. at 3, 9 He argued that in the Act, sections 6510
and 6517 only applied to “organic” and “100% organic” products.
Id. at 5, 6, 10-11.5
In response to Mr. Harvey’s Motion for Clarification, the
Court issued an Errata on March 30, 2005. In it, the Court added a
footnote reading that
[t]he ban on the addition of synthetic
substances in handling applies only to those
products labeled ‘organic’ or ‘100% organic.’
The statute does not prohibit the addition of
synthetic substances to foods labeled ‘made
with organic [ingredients],’ provided the other
requirements of the Act are met.
Errata at 1-2.
16
The Court deleted the sentence reading that “[s]ection 6517
plainly forbids the use of synthetic substances in handling
operations,” and the sentence that “The Act . . . bars addition of
‘any synthetic ingredient during processing . . . ‘“ Id. at 2. It
added the observation that “Section 6517(c)(1)(B)(iii) simply does
not say what the Secretary needs it to say.” Id.
9. Remand and Consent Judgment
After remand, Mr. Harvey moved for entry of judgment and
submitted a proposed order. D. 77. The Secretary responded,
submitted its own proposed order and Mr. Harvey filed a Reply. D.
82, 84. The parties then consented to a judgment that, among other
things, provided that
7 C.F.R. §§ 205.600(b) and 205.606(b) are contrary
to the OFPA and exceed the Secretary’s rulemaking
authority to the extent that they permit the
addition of synthetic ingredients and processing
aids in handling and processing of products which
contain a minimum of 95% organic content and which
are eligible to bear the USDA seal.
D. 88 at 3. It also provided the Secretary with time to comply by
making rules and that gave the organic community time to adjust to
the new rules. D. 88 at 3-4.
10. Congressional Amendment
On November 10, 2005, Congress amended the OFPA. FY2006
Agriculture Appropriations Act, HR-2744, H. Rept. 109-255, P.L.
109-97, Title VII (Nov. 10, 2005), 119 Stat. 2120 (P.L. 109-97).
Congress added to 7 U.S.C. § 6510 language authorizing the use of
synthetics appearing on the National List in processing and post
harvest handling. P.L. 109-97 at §§ 797(a). As a result, 7 U.S.C.
17
§ 6510 (2005) now provides that certified organic “handling
operations . . . not . . . add any synthetic ingredient not
appearing on the National List during the processing or postharvest
handling of the product.” (Emphasis on language added by
amendment.)
Correspondingly, Congress modified Section 6517 to make it
clear that synthetic substances could be listed for use in
processing and handling. It added to the title of 7 U.S.C. §
6517(c)(1) language providing that otherwise prohibited substances
could be exempted for use in organic production and handling. P.L.
109-97 at § 797(b)(1). As a result, the title of Section
6517(c)(1) (2005) now reads “exemption for prohibited substances in
organic production and handling operations.” 7 U.S.C. § 6517(c)(1)
(2005) (Emphasis on language added by amendment.)
Congress also eliminated from Section 6517(c)(1) subsection
6517(c)(1)(B)(iii). See P.L. 109-97 at § 797(b)(1)(C). This was
the section that provided that in order to be listed for use in
organic handling operations, an otherwise prohibited substance had
to be “non-synthetic.” It was the section that the Court had said
did not say what the Secretary needed it to say.
11. Agency Rulemaking
On June 7, 2006, after providing notice and receiving 13,115
comments, see 71 Fed. Reg. at 32804, the Secretary promulgated a
final rule “revis[ing] the National Organic Program (NOP) to comply
with the final judgment in the case of Harvey v. Johanns.” 71 Fed.
Reg. at 32803. The Secretary stated that:
18
Congress amended the OFPA by permitting the
addition of synthetic substances appearing on
the National List for use in products labeled
‘organic.’ The amendment restores the NOP
regulation for organic processed products
containing at least 95 percent organic
ingredients on the National List and their
ability to carry the USDA seal. Therefore, the
USDA is not revising the NOP regulations to
prohibit the use of synthetic ingredients in
processed products labeled as organic nor
restrict these products’ eligibility to carry
the USDA seal.
71 Fed. Reg. at 32804.
12. Motion to Enforce
On June 30, 2006, Mr. Harvey filed a Motion to Enforce the
Judgment. D. 89. Mr. Harvey sought an order enforcing the Consent
Judgment, requiring the USDA to amend its regulations to prohibit
the use of synthetic processing aids and to revoke its policy
statement with respect to food contact substances. Id. at 4. Mr.
Harvey characterized his position up until that point as being
unequivocal, that the “OFPA specifically forbade the use of
synthetics in organic handling.” Id. at 5. He assumed that the
Court, in its clarified decision, and Congress, in its amendments,
drew a distinction between synthetic ingredients, processing aids
and adjuvants. See id. at 7, 9 and passim.
Mr. Harvey argued that the amendments to the OFPA only
addressed synthetic ingredients, not processing aids. Id. at 2. He
argued that the amendments to the OFPA “at most restore[d] the list
of synthetic ingredients contained in the regulation at the time of
judgment.” Id. at 7 (emphasis in original). As a result, he
argued that the Secretary was violating the Consent Judgment by
19
establishing criteria for the National Listing of synthetics for
use in processing and handling and by allowing the use of unlisted
synthetic food contact substances which Mr. Harvey characterized as
processing aids. Id. at 3.
The Secretary opposed Mr. Harvey’s Motion to Enforce and
cross-moved for relief from the judgement. D. 94, 102. It argued
that Congress amended the OFPA to permit the listing of synthetics
for use in processing. Id. at 5-7. It argued that it had complied
with the Court’s decision and the Consent Judgment to the extent
that they had not been superseded by an intervening change in the
OFPA. Id. at 3-12.
The Secretary argued that its food contact substance policy
was not a part of the litigation. Id. at 15-17. It was not final
agency action that was ripe for review. Id. at 16-18. The
relevant facts had not been developed. Id. Mr. Harvey had not
pleaded it in his Complaint or fairly litigated it. Id. at 16.
Neither the district court nor the Court of Appeals addressed it.
Id. at 17.
In a Response and Reply, D. 106, 107, Mr. Harvey argued that
the amendments were clear and only allowed the Secretary to list
synthetic ingredients and only in “organic” products. Id. He
argued that Congress could not legislate in riders to
appropriations bills or by amending the language of titles of
sections of legislation. Id. He argued that the Secretary had
misled the Court into believing that its food contact substance
policy was not operational. Id.
20
The Secretary replied that Congress could legislate in an
appropriations bill and by changing the wording of a title. D. 112
at 1, 3. Congress did so clearly. Id. at 1. It did not amend the
OFPA by implication but rather operated directly on the OFPA to
remove language that the Court held precluded the Secretary from
authorizing the use of synthetics, and to add language that
permitted the Secretary to do so. Id. at 1-2. The meaning of that
language was reinforced by the context in which the amendments
occurred, including this litigation. Id. at 3.
The Secretary denied that it had misled the Court about its
food contact substance policy. Id. at 4-7. The Secretary
emphasized that to the extent that it had addressed Mr. Harvey’s
belated, undeveloped and changing arguments about food contact
substances, the Secretary always described that policy as
operative. Id. at 4. The Secretary reiterated its arguments that
Mr. Harvey’s claim about its food contact substance policy was not
a part of the litigation (which was closed). Id. at 4. The claim
was not ripe for review because the Secretary had not completed its
decision-making process, and because Mr. Harvey had not developed
the relevant facts. Id. at 5.
On November 2, 2006, the district court issued a Memorandum
Decision denying Mr. Harvey’s Motion to Enforce and granting the
Secretary’s Motion for Relief from Judgment. D. 114. The district
court held that “Congress’s objective in making [the] amendments is
clear: synthetic substances can be permitted in handling.” Id. at
5. See id. at 9 (“the old prohibition . . . no longer applies . .
21
.,” “section 6517 now authorizes the use of synthetic substances .
. . “).
The district court was not persuaded by Mr. Harvey’s emphasis
on a distinction between the terms “processing aid” and
“ingredient” which the court found “farfetched.” Id. at 7. The
court wrote that “the First Circuit opinion did not focus on the
distinction between ingredients and processing aids.” Id. at 7.
In fact, the First Circuit had eliminated such a distinction in
response to Mr. Harvey’s Motion To Clarify. Id. at 8. The
distinction appeared nowhere in the statute either before or after
amendment. Id. at 6. See id. at 8.
The district court rejected Mr. Harvey’s argument about the
Secretary’s food contact substance policy in part because it had
rejected his argument about authorizing synthetics in processing
generally. Id. at 10. In addition, the court “did not see how
this USDA policy, whether consistent with the OFPA or not, is
subject to a motion to enforce a final judgment and order that did
not mention it, ordering compliance with a First Circuit decision
that did not consider it.” Id. at 11. The court declined to
render judgment “on the validity of the FCS policy statement
because it was not raised in the Complaint, not ruled upon by the
First Circuit, and not covered by this Court’s Judgment upon
remand. It is, therefore, beyond the scope of a motion to
enforce.” Id.
22
SUMMARY OF THE ARGUMENT
The district court did not err in denying Mr. Harvey’s motion
to enforce the consent judgment and in granting the Secretary’s
motion for relief form that judgment where Congress intervened to
amend the Organic Food Production Act to allow the Secretary to
list synthetics for use in processing organic food. Nor did the
district court err where Mr. Harvey never litigated on the merits a
challenge to the Secretary’s food contact substance policy and
neither the district court nor the Court of Appeals ever addressed
such a claim in any of their decisions.
23
ARGUMENT
I. As Amended, the OFPA Permits the Secretary to
List Synthetics for Use in Processing
The Secretary does not share Mr. Harvey’s understanding of the
OFPA, the regulations, this Court’s prior decision, the Consent
Judgment, or the amendments to the OFPA.
Mr. Harvey argues that this Court’s prior decision
invalidating 7 C.F.R. §§ 205.600(b) and 205.606(b) did not rely on
section 6517(c)(1)(B)(iii). Appellant’s Brief at 34 (“this court’s
prior decision, as clarified, did not rely on [6517(c)(1)(B)(iii)]
to hold that synthetics in handling were prohibited”). Rather,
according to Mr. Harvey, the Court relied upon 7 U.S.C. § 6510 to
hold that the OFPA did not permit the use of synthetic substances
in processing and that the regulations exceeded the Secretary’s
authority. Appellant’s Brief at 22.
This seems a remarkable position given the sequence of events
leading up to the Court’s reported decision. Mr. Harvey’s claim in
Count 3 was that the OFPA categorically prohibited synthetics of
any type in processing organic foods. He did not distinguish
between any type of synthetic, whether material, substance,
ingredient, processing aid, adjuvant, or contact substance. All
were prohibited. He did not distinguish between tiers of organic
products. Synthetics could not be used in processing or handling
all tiers.
It was not until after the Magistrate issued her Recommended
Decision that Mr. Harvey began to retreat from this position. When
he began his retreat, he did so in piecemeal fashion. First, he
24
withdrew his challenge to certain specific synthetics that the
Secretary pointed out had been listed for use in processing on the
basis that they were required to satisfy basic food health and
safety requirements.
Later, in his Appellant’s Brief, Mr. Harvey explained that he
had withdrawn his challenge to other synthetics on the basis of his
personal belief that they were not “ingredients,” or because they
had been listed for use in “made with organic” products. This was
the first time in the litigation that he distinguished between
different tiers of organic products to which synthetics could or
could not be added during processing. It was also the first time
that he distinguished between different categories of substances.
If an executive agency had been this erratic, its regulations would
not be entitled to much deference. See South Shore Hosp., Inc. v.
Thompson, 308 F.3d 91, 102 (1st Cir. 2002).
Mr. Harvey is not an executive officer or agency. Congress
has not entrusted him with the responsibility of administering the
OFPA. See Chevron USA, Inc. v. Nat’l Resources Defense Council,
Inc., 467 U.S. 837, 843-44 (1984). He does not have the authority
to conduct inquiries, or weigh and consider the competing interests
of different constituencies in light of direction from Congress and
fashion a reasonable resolution that has the force of law. See
id.; Elien v. Ashcroft, 364 F.3d 392, 396 (1st Cir. 2004)(quoting
Morton v. Ruiz, 415 U.S. 199, 231 (1974)).
Mr. Harvey is an individual with a particular agenda who has
sought administrative review of the Secretary’s regulations. That
25
review does not entitle him to rewrite the regulations. See Brown
v. Sec. H.H.S., 46 F.3d 102, 106 (1st Cir. 1995)(a reviewing court
cannot substitute its judgment for that of the agency). It
entitles him to have regulations that he demonstrates are contrary
to law declared contrary to law and vacated. 5 U.S.C. §
706(2)(“[held] unlawful and set aside”). It entitles him to have
the matter remanded to the Secretary for further agency action
consistent with the law as elucidated by the Court. See Ass’d
Fisheries of Maine, Inc. v. Daley, 127 F.3d 104, 109 (1st Cir.
1997) (policy choices are from agency not court, court cannot
substitute its judgment for that of agency, it can set aside agency
action).
Notwithstanding his concessions, and in the face of the
Secretary’s opposition and the district court’s decision, Mr.
Harvey persuaded the Court that the OFPA categorically banned
synthetics in processing. However, once Mr. Harvey achieved what
he sought, a ruling from the Court that the OFPA “plainly forbid[s]
the use of synthetics substances in handling operations,” he felt
remorse. He realized that such a rule would be unworkable and
would obstruct the functioning of the organic program. He filed a
Motion to Clarify in which he gave back some of the ground that he
had won.
In its reported decision, the Court deleted language
describing the OFPA as categorically prohibiting synthetics in
processing. Errata; Harvey v. Venneman, 396 F.3d 28, 39-40 (1st
Cir. 2005). It made abundantly clear that the obstacle to the
26
Secretary listing synthetics for use in processing was 7 U.S.C. §
6517(c)(1)(B)(iii). Id. at 39. It added the observation that
“[s]ection 6517(c)(1)(B)(iii) simply does not say what the
Secretary needs it to say” in order to be able to list synthetics
for use in processing. Id.
Shortly, thereafter, Congress amended the OFPA to eliminate 7
U.S.C. § 6517(c)(1)(B)(iii) and otherwise made it clear that the
Secretary could authorize the use of synthetics in processing. See
supra at pp. 16-17. At that point it was no longer equitable that
the Consent Judgment have further effect. See Pennsylvania v.
Wheeling & Belmont Bridge Co., 59 U.S. 421, 432 (1855)(“since the
decree, this right has been modified by [Congress] so that . . . it
is quite plain that the decree of the court cannot be enforced”);
Inmates of Suffolk County Jail v. Rouse, 129 F.3d 649, 656 (1st
Cir. 1997)(“a forward looking judgment in equity can succumb to
legislative action if the legislature alters the underlying rule of
law”).
At points in his Brief, Mr. Harvey goes so far as to revert to
a hard-line position that Congress did not amend 7 U.S.C. § 6517 to
permit synthetics in processing and argues that, as amended,
section 6517 still only allows the use of synthetics in production.
Appellant’s Brief at 36. Mostly, he adopts the position that
Congress amended the OFPA to authorize synthetic ingredients but
not processing aids in processing “organic” products. Id. at 15,
18, 23. According to Mr. Harvey, this is apparent from the fact
27
that Congress did not amend 7 U.S.C. § 6504 and amended 7 U.S.C. §
6510 to authorize only ingredients. Id. at 24, 25-26, 29.
Mr. Harvey’s interpretation of the OFPA as amended presumes
that Congress parsed the terms “substance,” “ingredient” and
“processing aid.” Id. at 25-30. As the district court said, this
is farfetched with respect to a statute that defines none of those
terms. The meaning of the OFPA as amended is plain from its
amended language. Congress’ intent to authorize the use of
synthetics in processing is all the more apparent when viewed in
the context of this litigation which prompted it.
Executive officers and their agencies have the expertise and
authority to implement and administer legislation by making rules
and running programs. See Elien, 364 F.3d at 396 and n.3 (citing
Morton, 415 U.S. at 231). Where a statute is clear, an executive
officer must implement its directive. Rucker v. Lee Holding Co.,
471 F.3d 6, 9-10 (1st Cir. 2006)(citing Chevron, 467 U.S. at 842).
Where a statute is ambiguous or silent, an executive agency may
promulgate implementing regulations that are a permissible
construction of the statute. Harvey, 396 F.3d at 33-34 (quoting
Chevron, 467 U.S. at 842-44) (where statute is silent or ambiguous
court defers to agency’s rational and consistent interpretation);
Dunn v. U.S.D.A., 921 F.2d 365, 366-67 (1st Cir. 1990) (same).
Regulations are subject to invalidation if they are arbitrary,
capricious, or contrary to law or procedure. See 5 U.S.C. §
706(2); Chevron, 467 U.S. at 844.
6If the OFPA as amended is not clear on this point, then the
Secretary, to whom Congress explicitly delegated rulemaking
authority in 7 U.S.C. § 6521, has discretion to fashion a
reasonable interpretation. Rucker, 471 F.3d at 11; Visiting
Nurse Ass’n Gregoria Auffant, Inc. v. Thompson, 447 F.3d 68, 72
(1st Cir. 2006); Brown, 46 F.3d at 106.
28
The Secretary’s decision that 7 C.F.R. §§ 205.600(b) and
205.606(b) had been revitalized by intervening legislation is not
contrary to law. As amended, the OFPA permits the Secretary to
list synthetics for use in processing.6 The district court was
correct to deny Mr. Harvey’s Motion to Enforce and grant the
Secretary’s Motion for Relief. That judgment should be affirmed.
II. The Secretary’s Food Contact Substance Policy was
not a Subject of this Litigation.
Mr. Harvey argues that the Secretary’s food contact substance
policy was a part of the underlying litigation. Appellant’s Brief
at 46. He argues that he raised and briefed the issue, and that in
any event, the question is not whether the issue was litigated but
rather whether the Secretary’s policy violates this Court’s
decision and the district court’s Consent Judgment. Id. at 46-47.
He argues that the policy conflicts with this Court’s decision and
the Consent Judgment. Id. at 40. He argues that if the courts did
not address the issue, that is because the Secretary misled them
into believing that its policy was not being implemented. Id. at
47.
To the extent that it has addressed the matter, the Secretary
has consistently described its food contact substance policy as
operative. Mr. Harvey first referred to the food contact substance
policy in his consolidated response to the Secretary’s cross-motion
29
for summary judgment and reply in support of his own motion for
summary judgment. He did so in response to an argument that he
lacked standing with respect to Count 1 of his Complaint.
The issue is not a part of this litigation. The Secretary’s
food contact substance policy is not a part of the Final Rule that
Mr. Harvey challenged in his Complaint. That Rule was promulgated
in December of 2000. The food contact substance policy was posted
on December 12, 2002. Mr. Harvey did not mention it in his
Complaint much less make a substantive claim about it.
A. The Food Contact Substance Policy is not
Ripe for Review.
The food contact substance policy is a matter that requires
the technical expertise of the expert agency as directed by
Congress issue. It requires factual development that has not been
done and is not a part of the administrative record of this closed
case. Abbott Labs v. Gardner, 387 U.S. 136, 148 (1967) (ripeness
doctrine designed to avoid abstract disagreements over
administrative policies). See Ohio Forestry Association, Inc. v.
Sierra Club, 523 U.S. 726, 736-7 (1998)(focus on particular logging
proposal could provide focus for judicial review of elaborate,
technical plan for logging forest). As this litigation
demonstrates, it does not make sense to address Mr. Harvey’s claim
in the abstract without developing the facts such as what
substances are being used in what amounts for what purposes and
with what effect, if any, on food.
7In its Memorandum Decision on Mr. Harvey’s Motion to
Enforce, the district court held that Mr. Harvey’s claim about
the food contact substance policy must be the subject of a
separate lawsuit. See D. 114 at n. 8.
30
B. The Food Contact Substance Policy was not
a Subject of this Litigation
Contrary to Mr. Harvey’s argument, it does matter whether an
issue was actually litigated and decided on the merits. Courts
lack authority to decide issues that have not been presented to
them. They lack authority to enforce judgments and decisions they
have not made and orders they have not issued. See Rodriguez v.
Doral Mortgage Corp., 57 F.3d 1168, 1174 (1st Cir. 1995)(district
court cannot decide case on the basis of a theory that was neither
pleaded nor proved); Diaz-Fonseca v. Puerto Rico, 451 F.3d 13, 42
(1st Cir. 2006) citing St. Paul Fire & Marine Ins. Co. v. Lawson
Bros. Iron Works, 428 F.2d 929, 931 (10th Cir. 1970)(judgments that
go beyond the issues presented constitute advisory opinions founded
on hypothetical bases).
The Secretary’s food contact substance policy was never
litigated or decided on the merits. Neither the district court nor
this Court addressed the policy in its prior decisions. This Court
did not address the policy in its Slip Opinion, Errata, or its
reported decision. The district court did not address the policy
in its initial decision or in the Consent Judgment. It is not a
proper subject for a motion to enforce and the district court was
correct to deny Mr. Harvey’s motion on that basis.7
31
CONCLUSION
This Court should affirm the amended judgment entered by the
district court.
Dated at Portland, Maine on March 28, 2007.
Paula D. Silsby
United States Attorney
Halsey B. Frank
Assistant United States Attorney
32
United States Court of Appeals
FOR THE FIRST CIRCUIT
CERTIFICATE OF COMPLIANCE WITH
TYPEFACE AND LENGTH LIMITATIONS
No. 06-2738
ARTHUR HARVEY
v.
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in monospaced type such as Courier or Courier New).

I understand that a material misrepresentation can result in the Court striking the brief or
imposing sanctions. If the
Court so directs, I will provide a copy of the word or line print-out.
________________________________
Signature of Fi1ing Party
33
CERTIFICATE OF SERVICE
I hereby certify that on March 28, 2007, I served two copies
of the Brief of Appellee Mike Johanns, Secretary of the United
States Department of Agriculture, on the following parties of
record by first class mail, postage prepaid:
Martica S. Douglas, Esq.
DOUGLAS, DENHAM, BUCCINA & ERNST
103 Exchange Street
Portland, ME 04101
Paula Dinerstein, Sr. Counsel
Public Employees for Environmental Responsibility
2000 P Street NW, Suite 240
Washington, DC 20036
William J. Friedman, Esq.
COVINGTON & BURLING, LLP
1201 Pennsylvania Avenue, NW
Washington, DC 20004-2401
Richard L. O’Meara, Esq.
MURRAY, PLUMB & MURRAY
75 Pearl Street
Portland, ME 04101
James Riddle
31762 Wiscoy Ridge Road
Winona, MN 55987
F. James Handley, Esq.
Handley Environmental Law
1707 Bay Street, S.E.
Washington, DC 20003
Melody A. Richardson
Paralegal Specialist